Rfit-Prt-0435 Filmarray RP Faiv Panel Ivd Instruction Booklet en PDF

RFIT-ASY-0124
RFIT-ASY-0125
FilmArray® Respiratory Panel (RP)

Instruction Booklet
For use with the FilmArray Injection Vial-based loading
system
2797
Customer and Technical Support for U.S. Customers
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© Copyright 2007–2019 BioFire Diagnostics, LLC. All rights reserved. RFIT-PRT-0435-04 November 2019
The information contained in this document is subject to change without notice. No part of this document may be
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FilmArray Software, Detector, and Metacall software modules © 2002–2019 BioFire Diagnostics, LLC.
BioFire Diagnostics, BioFire, the BioFire logo, FilmArray and LCGreen are trademarks of BioFire Diagnostics, LLC or
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and the University of Utah Research Foundation
BioFire Diagnostics, LLC FilmArray Respiratory Panel (RP) CE-IVD Instruction Booklet i
SYMBOLS GLOSSARY
The following symbols can be found on FilmArray Respiratory Panel Kit components or throughout this Instruction
Booklet. Use the definitions below as a guideline to interpreting the symbols.
ISO 15223-1:2012
Medical devices - Symbols to be used with medical devices labels, labeling and information to be supplied
5.1.1 5.1.2 Authorized 5.1.4
representative in the Use-By date
Manufacturer
European (YYYY-MM-DD)
Community
5.1.5 5.1.6 5.1.7
Batch Code
Catalog Number Serial Number
(Lot Number)
5.2.8 Do Not Use if 5.3.2 5.3.7

Keep Away from
Package Is Temperature Limit
Sunlight
Damaged
5.4.2 5.4.3 Consult 5.5.1

In vitro Diagnostic
Do Not Reuse Instructions for
Medical Device
Use
5.5.5
Contains Sufficient For <n> Tests
United Nations Globally Harmonized System of Classification and Labeling of chemicals (GHS) (ST/SG/AC.10/30)
Acute toxicity, cat. 4 & Skin irritation,

Serious eye damage, cat. 1
cat. 2
European Union Directive 98/79/EC of the European Parliament and of the Council
on in vitro Diagnostic Medical Device
European Union Conformity
Manufacture Symbols (BioFire Diagnostics, LLC)
Consult Instructions for Use - Online Consult Instructions for Use - Phone
Use of Symbols in Labeling – 81 FR 38911, Docket No. (FDA-2013-N-0125)
Rx Only Prescription Use Only
BioFire Diagnostics, LLC FilmArray Respiratory Panel (RP) CE-IVD Instruction Booklet ii
E-LABELING
The manual for this product can be accessed online at www.online-ifu.com/KEY-CODE. The product KEY-CODE is
provided on the outer box label at the end of the URL. The KEY-CODE for this instruction booklet is also listed
below. Additionally, a paper copy is available upon request by contacting customer service via phone, fax, email, or
regular mail.
FilmArray Respiratory Panel (RP) CE IVD 6 and 30 Pack Kit - IFU https://www.online-ifu.com/ITI0040
FilmArray Respiratory Panel (RP) CE IVD 6 and 30 Pack Kit – Quick Guide https://www.online-ifu.com/ITI0050
FilmArray Respiratory Panel (RP) CE IVD 6 and 30 Pack Kit - SDS https://www.online-ifu.com/ITI0054
BioFire Diagnostics, LLC FilmArray Respiratory Panel (RP) CE-IVD Instruction Booklet iii
TABLE OF CONTENTS
SYMBOLS GLOSSARY .........................................................................................................................................................................II
E-LABELING ..................................................................................................................................................................................... III
TABLE OF CONTENTS ....................................................................................................................................................................... IV
NAME AND INTENDED USE ................................................................................................................................................................2
FILMARRAY RESPIRATORY PANEL ................................................................................................................................................................... 2
SUMMARY AND EXPLANATION OF THE TEST .....................................................................................................................................3
SUMMARY OF DETECTED ORGANISMS ............................................................................................................................................................ 4

PRINCIPLE OF THE PROCEDURE ...................................................................................................................................................................... 5
MATERIALS PROVIDED ......................................................................................................................................................................7
MATERIALS REQUIRED BUT NOT PROVIDED ......................................................................................................................................7
WARNINGS AND PRECAUTIONS ........................................................................................................................................................7
GENERAL PRECAUTIONS ............................................................................................................................................................................... 7

SAFETY PRECAUTIONS.................................................................................................................................................................................. 7
LABORATORY PRECAUTIONS ......................................................................................................................................................................... 8
PRECAUTION RELATED TO PUBLIC HEALTH REPORTING IN THE UNITED STATES ....................................................................................................... 9
REAGENT STORAGE, HANDLING AND STABILITY ................................................................................................................................9
SPECIMEN COLLECTION AND PREPARATION .................................................................................................................................... 10
PROCEDURE .................................................................................................................................................................................... 10
PREPARE POUCH ...................................................................................................................................................................................... 10

HYDRATE POUCH...................................................................................................................................................................................... 11
PREPARE SAMPLE MIX............................................................................................................................................................................... 11
LOAD SAMPLE MIX ................................................................................................................................................................................... 12
RUN POUCH ............................................................................................................................................................................................ 12
QUALITY CONTROL .......................................................................................................................................................................... 14
PROCESS CONTROLS.................................................................................................................................................................................. 14
MONITORING TEST SYSTEM PERFORMANCE................................................................................................................................................... 14
INTERPRETATION OF RESULTS ......................................................................................................................................................... 15
ASSAY INTERPRETATION ............................................................................................................................................................................. 15

FILMARRAY RP TEST REPORT ..................................................................................................................................................................... 17
CONTROL FIELD ........................................................................................................................................................................................ 17
RESULT SUMMARY.................................................................................................................................................................................... 19
LIMITATIONS OF THE PROCEDURE ................................................................................................................................................... 20
EXPECTED VALUES ........................................................................................................................................................................... 22
PERFORMANCE CHARACTERISTICS .................................................................................................................................................. 26
BioFire Diagnostics, LLC FilmArray Respiratory Panel (RP) CE-IVD Instruction Booklet iv
CLINICAL PERFORMANCE ............................................................................................................................................................................ 26
LIMIT OF DETECTION ................................................................................................................................................................................. 37
ANALYTICAL REACTIVITY (INCLUSIVITY) ......................................................................................................................................................... 38
ANALYTICAL SPECIFICITY (CROSS-REACTIVITY AND EXCLUSIVITY) ........................................................................................................................ 50
CROSS-CONTAMINATION AND CARRYOVER .................................................................................................................................................... 54
REPRODUCIBILITY ..................................................................................................................................................................................... 54
REPEATABILITY ......................................................................................................................................................................................... 73
INTERFERENCE ......................................................................................................................................................................................... 74
PERFORMANCE CHARACTERISTICS OF FILMARRAY RP ON FILMARRAY 2.0 AND FILMARRAY TORCH .............................................. 76
CLINICAL COMPARISON.............................................................................................................................................................................. 76
REPRODUCIBILITY ..................................................................................................................................................................................... 77
REFERENCES .................................................................................................................................................................................... 79
WARRANTY INFORMATION ............................................................................................................................................................. 80
BioFire Diagnostics, LLC FilmArray Respiratory Panel (RP) CE-IVD Instruction Booklet v
NAME AND INTENDED USE
FilmArray Respiratory Panel
FilmArray Respiratory Panel (RP) is a multiplexed nucleic acid test intended for use with FilmArray systems for the
simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in
nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections. The following
organism types and subtypes are identified using the FilmArray RP: Adenovirus, Coronavirus 229E, Coronavirus
HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A subtype H1,
Influenza A subtype H3, Influenza A subtype H1-2009, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2,
Parainfluenza Virus 3, Parainfluenza Virus 4, Human Rhinovirus/Enterovirus, Respiratory Syncytial Virus, Bordetella
pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The detection and identification of specific viral
and bacterial nucleic acids from individuals exhibiting signs and symptoms of a respiratory infection aids in the
diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. The results
of this test should not be used as the sole basis for diagnosis, treatment, or other management decisions. Negative
results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test
or, lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not
rule out co-infection with other organisms: the agent(s) detected by the FilmArray RP may not be the definite cause of
disease. Additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) may be
necessary when evaluating a patient with possible respiratory tract infection.
Due to the small number of positive specimens collected for certain organisms during the prospective
clinical study, performance characteristics for Bordetella pertussis, Coronavirus 229E, Coronavirus OC43,
Influenza A H1, Influenza A H3, Influenza A H1-2009, Influenza B, Mycoplasma pneumoniae, Parainfluenza
Virus 1, Parainfluenza Virus 2, and Parainfluenza Virus 4 were established primarily with retrospective clinical
specimens. Performance characteristics for Chlamydophila pneumoniae were established primarily using
contrived clinical specimens.
Due to the genetic similarity between Human Rhinovirus and Enterovirus, the FilmArray RP cannot reliably
differentiate them. A positive FilmArray RP Rhinovirus/Enterovirus result should be followed-up using an alternate
method (e.g., cell culture or sequence analysis).
The FilmArray RP assay for Coronavirus OC43 may cross-react with some isolates of Coronavirus HKU1. A dual
positive result may be due to cross-reactivity or may indicate a co-infection.
Performance characteristics for Influenza A were established when Influenza A H1-2009, A H1, and A H3 were the
predominant Influenza A viruses in circulation. Performance of detecting Influenza A may vary if other Influenza A
strains are circulating or a novel Influenza A virus emerges. If infection with a novel Influenza A virus is suspected
based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens
should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state
or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is
available to receive and culture specimens.
BioFire Diagnostics, LLC FilmArray Respiratory Panel (RP) CE-IVD Instruction Booklet 2
SUMMARY AND EXPLANATION OF THE TEST
Respiratory pathogens cause acute local and systemic disease of varying severity, with the most severe cases
occurring in children, the elderly and immunocompromised individuals. Respiratory symptoms can include coughing,
nasal discharge, congestion, fever, wheezing, headache and myalgia. Due to the similarity of diseases caused by
many viruses and bacteria, diagnosis based on clinical symptoms alone is difficult. Identification of potential causative
agents provides data to aid the physician in determining appropriate patient treatment and public health response for
disease containment. The FilmArray RP pouch is designed for simultaneous detection and identification of the
following upper respiratory viruses and bacteria: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus
NL63, Coronavirus OC43, Influenza A (with subtyping for hemagglutinin genes H1, H1-2009 and H3), Influenza B,
Human Metapneumovirus, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4,
Respiratory Syncytial Virus, Rhinovirus/Enterovirus, Bordetella pertussis, Chlamydophila pneumoniae, and
Mycoplasma pneumoniae. A summary of characteristics for these organisms is provided in Table 1.
Table 1. Respiratory Pathogens Detected in the FilmArray Respiratory Panel
Classification Season of Highest Most Commonly Infected
Organism (abbreviation)
(Genome type) Incidencea Demographic
Late winter to early All ages,
Adenovirus (AdV) Adenovirus (DNA)
summer[1] immunocompromised[1]
Coronavirus (CoV) 229E,
Coronavirus (RNA) Winter, spring[2-3] Children, adults[2-3]
HKU1, NL63, OC43
Enterovirus (EV) Picornavirus(RNA) Summer, early fall [4] All ages[5]
Human Rhinovirus (HRV) Picornavirus (RNA) Fall, spring[6] All ages[6]

Human Metapneumovirus
Paramyxovirus (RNA) Winter, early spring[7] Children[7]
(hMPV)
Influenza A (Flu A)
All ages [8], 5-20 % of US
(subtypes H1, H1-2009, and Orthomyxovirus (RNA) Winter [8]
population[9]
H3)
All ages [8], 5-20 % of US
Influenza B (Flu B) Orthomyxovirus (RNA) Winter [8]
population[9]
Fall, periodicity of 1-2 Infants, young children,

Parainfluenza Virus 1 (PIV1) Paramyxovirus (RNA)
years[10] immunocompromised[10]
Fall, periodicity of 1-2 Infants, young children,

Parainfluenza Virus 2 (PIV2) Paramyxovirus (RNA)
years[10] immunocompromised[10]
Infants, young children,

Parainfluenza Virus 3 (PIV3) Paramyxovirus (RNA) Spring, summer[10]
immunocompromised [10]
Parainfluenza Virus 4 (PIV4) Paramyxovirus (RNA) Unknown All ages[11]

Respiratory Syncytial Virus Winter, varies by
Paramyxovirus (RNA) Children, older adults[12-13]
(RSV) location[12-13]
Bordetella pertussis Bacterium (DNA) No peak season All ages[14]
Older children, young adults,

Chlamydophila pneumoniae Bacterium (DNA) No peak season
immunocompromised[15]
Outbreaks most common

Older children, young adults[16-
Mycoplasma pneumoniae Bacterium (DNA) in summer, outbreak 17]
periodicity 4 – 7 years
a based on North American seasons
Summary of Detected Organisms
Adenoviruses are a diverse group of non-enveloped DNA viruses with seven species (A to G) categorized by
hemagglutination and approximately 55 serotypes. All serotypes have been associated with human disease.
Adenovirus species B, C, and E cause acute respiratory disease. Outbreaks occur in institutional settings such as
military training, long-term care facilities, and pediatric tertiary-care hospitals, due to high rates of transmission in
closed populations [18-20]. Adenoviruses (species A, D, F and G) can cause a variety of illnesses, including cystitis,
gastroenteritis, and conjunctivitis [1]. Adenoviruses are shed for long periods of time and persist on surfaces in an
infective state [20].
Coronaviruses 229E, HKU1, NL63, and OC43. Human Coronaviruses were established as respiratory pathogens in
the 1960’s. Initially, two serologic variants were characterized (229E and OC43) and recently, two additional human
coronaviruses (HKU1 and NL63) have been identified [2, 21-23]. These viruses are most commonly associated with
upper respiratory tract infections; however, they have also been detected in individuals with lower respiratory tract
infections [2-3, 24]. Coronaviruses have been associated with croup and exacerbation of asthma [2, 22]. Coronavirus
infection occurs more often in the winter and there appears to be a periodicity of epidemics for strains 229E and OC43
of every two to three years [3].
Human Metapneumovirus was discovered in 2001 as a respiratory pathogen in children [25]. Further studies
confirmed hMPV infections in persons of all ages [26]. Human Metapneumoviruses are in the family Paramyxoviridae
[7]. Infection in infants and young children is commonly associated with bronchiolitis [7]. The two genotypes, A and B,
can circulate at the same time and do not appear to differ in the severity of illness [7].
Influenza A and B are RNA viruses in the Orthomyxoviridae family. During annual Influenza epidemics, 5-20% of the
population is affected with upper respiratory tract infections with rapid onset of fever [8]. The dominant type of
Influenza virus varies often due to antigenic drift and shift [27]. During the 2009-10 Influenza season, Influenza A H1-
2009 was the dominant circulating Influenza virus, accounting for approximately 99% of reported Influenza infections
[28] (Table 2). Influenza A can be subtyped by the hemagglutinin (H) and neuraminidase (N) genes; subtypes H1N1
and H3N2 are the strains that most commonly infect humans. More severe disease and increased mortality are
associated with H3N2 subtype [27]. Currently, at least four antiviral medications are available for Influenza treatment –
amantadine, rimantadine, zanamivir and oseltamivir – with type-specific efficacy and drug resistance arising with the
spread of new strains of the virus [27, 29]. Complications with viral or bacterial pneumonia increase mortality from
Influenza infections [30].
Table 2. Proportions of Influenza Subtype Infections in the United States
(as reported by the US Centers for Disease Control)
Flu % of Influenza A
Season Influenza A H1 H1-2009 H3 Influenza B
2009-20101,2 99.6% 0.1 99.8 0.1 0.4%
2008-2009 89.4% 13.2 79.9 6.9 10.6%
2007-2008 71% 26.2 0.0 73.8 29%
2006-2007 79.2% 62.3 0.0 37.7 20.8%
2005-2006 79.7% 8.1 0.0 91.9 20.3%

1 Season during which prospective clinical data described in this package insert were accumulated
2 Cumulative results from August 30, 2009 to May 22, 2010
Parainfluenza Viruses. Parainfluenza viruses are RNA viruses in the Paramyxoviridae family. In the 1950’s,
Parainfluenza viruses were determined to be respiratory pathogens different from influenza viruses [10].
Parainfluenza viruses are divided into four types antigenically and genetically, with type 4 further subtyped as A and B
[10]. Parainfluenza Virus 1 causes biennial epidemics in the fall, with 50% of croup cases attributed to this virus [10].
Parainfluenza Virus 2 has a periodicity of epidemics of one to two years that may alternate with Parainfluenza 1
outbreaks [10]. Children less than six months old are particularly susceptible to Parainfluenza Virus 3 infection, with
outbreaks occurring in neonatal intensive care units and epidemics are most common in the spring and summer [10].
Parainfluenza Virus 4 infection affects all age groups and a periodicity of infection has not been established [11].
Respiratory Syncytial Virus is a member of the RNA viruses in the Paramyxoviridae family, related to human
metapneumoviruses and parainfluenza viruses [12]. RSV is the most common cause of severe respiratory disease in
infants, with acute bronchiolitis as the major cause of hospitalization [12]. An association of asthma with RSV infection
is being investigated [12]. Treatment or prophylaxis with a humanized monoclonal antibody against the fusion protein
of RSV has shown a reduction in disease for high risk infants [12].
Rhinoviruses and Enteroviruses are related RNA viruses in the Picornavirus family [6]. There are more than 100
serotypes of Human Rhinovirus based on the serology of the capsid protein [6]. Rhinovirus is noted as causing the
“common cold”, but may also be involved in precipitating asthma attacks and severe complications [6]. Enteroviruses
are divided into four species that include a total of 89 serotypes. Individual serotypes can be associated with different
clinical manifestations, including nonspecific respiratory illnesses in infants or adults [5].
Bordetella pertussis is the causative agent of whooping cough or pertussis, a vaccine-preventable disease that is
reportable to public health organizations [31-32]. B. pertussis is a gram-negative bacterium with a high infectivity rate
that is treatable with several antibiotics [14]. Vaccine-induced immunity has been shown to decrease after 5-10 years.
Pertussis occurs most commonly in children but also occurs in adolescents and adults and outbreaks have been
documented in fully vaccinated populations due to waning immunity [14, 33]. The highest mortality from pertussis
occurs with infants and elderly [14]. Early (catarrhal) pertussis disease is non-specific, and classic signs of pertussis
(paroxysmal coughing, inspiratory ‘whoop’, post-tussive emesis, as well as apnea or cyanosis in infants) do not arise
until approximately 2 weeks after the initial onset of symptoms. Symptoms of B. pertussis infection are known to vary
due to a number of factors including: age, previous immunization or infection, passively acquired antibody, and
antibiotic treatment [14]. No peak season has been defined for B. pertussis infection.
Chlamydophila pneumoniae is an obligate intracellular bacterium that causes acute respiratory infections and is a
common cause of community-acquired pneumonia [34-35]. Outbreaks occur in schools, military barracks, and nursing
homes [36]. No peak season has been identified for C. pneumoniae infections.
Mycoplasma pneumoniae is a causative agent of community-acquired atypical pneumonia, frequently in outbreak

situations [17, 37]. Incubation time for M. pneumoniae infection is approximately 1 to 4 weeks [16]. M. pneumoniae
respiratory disease does not have a defined season of highest incidence but epidemics have a periodicity of 3-7 years
[37].
Principle of the Procedure

The FilmArray RP pouch is a closed system disposable that houses all the chemistry required to isolate, amplify and
detect nucleic acid from multiple respiratory pathogens within a single NPS specimen. The rigid plastic component
(fitment) of the FilmArray RP pouch contains reagents in freeze-dried form. The flexible plastic portion of the pouch is
divided into discrete segments (blisters) which, through interactions with actuators and sensors in the FilmArray
instrument, are where the required chemical processes are carried out. The user of the FilmArray RP loads the
sample into the FilmArray RP pouch, places the pouch into the FilmArray instrument/Module, and starts the run. All
other operations are automated.
The following is an overview of the testing procedure:
1. Remove the FilmArray pouch from its vacuum-sealed package. Since solutions are drawn into the FilmArray
RP pouch by vacuum, it is important to keep pouches in their protective packaging until the time of use.
2. Place the FilmArray RP pouch into the FilmArray Pouch Loading Station. The FilmArray Pouch Loading
Station has been designed to prevent error by providing instructions and visual cues in the form of color-
coded arrows to ensure that the pouch is properly loaded.
3. Load Hydration Solution into the FilmArray RP pouch. Loading the pouch with Hydration Solution rehydrates
the freeze-dried reagents contained in the pouch fitment.
4. Mix NPS specimen with Sample Buffer. The Sample Buffer contains reagents that inactivate RNases in the
sample and promote binding of nucleic acids to magnetic beads for isolation.
5. Load the sample/buffer mixture into the FilmArray RP pouch. A process control contained in the fitment of the
pouch is introduced into the sample. The process control monitors all of the critical processes that occur in the
pouch.
6. Transfer the pouch to the instrument/Module and initiate a run. To aid in proper insertion of the pouch in the
instrument, the FilmArray software provides on-screen animations illustrating the steps needed to start the
run.
7. View results on the test report at the completion of the run.
The following is an overview of the operations and processes that occur during a FilmArray run:
1. Nucleic Acid Purification - Nucleic acid purification occurs in the first three blisters of the pouch. The sample
is lysed by agitation (bead beating) and the liberated nucleic acid is captured, washed and eluted using
magnetic bead technology. These steps require about ten minutes and the bead-beater apparatus can be
heard as a high-pitched whine during the first minute of operation.
2. Reverse Transcription and 1st Stage Multiplex PCR - Since many pathogens identified by the FilmArray RP
pouch are RNA viruses, a reverse transcription (RT) step is performed to convert the viral RNA into cDNA
prior to amplification. The purified nucleic acid solution is combined with a preheated master mix to initiate the
RT step and subsequent thermocycling for multiplex PCR. The effect of 1st stage PCR is to enrich for the
target nucleic acids present in the sample.
3. 2nd Stage PCR - The products of 1st stage PCR are diluted and mixed with fresh PCR reagents containing an
intercalating fluorescent DNA dye (LCGreen® Plus, BioFire Diagnostics, LLC). This solution is distributed over
the 2nd stage PCR array. The individual wells of the array contain primers for different assays (each present in
triplicate) that target specific nucleic acid sequences from each of the pathogens detected, as well as control
template material. These primers are ‘nested’ or internal to the specific products of the 1st stage multiplex
reaction, which enhances both the sensitivity and specificity of the reactions.
4. DNA Melting Analysis – After 2nd stage PCR, the temperature is slowly increased and fluorescence in each
well of the array is monitored and analyzed to generate a melting curve. The temperature at which a specific
PCR product melts (melting temperature or Tm) is consistent and predictable and the FilmArray software
automatically evaluates the data from replicate wells for each assay to report results. For a description of data
interpretation and reporting see the Interpretation of Results section of this booklet.
The FilmArray software controls the operation of the instrument/Module, collects and analyzes data, and automatically
generates a test report at the end of the run. The entire process takes about an hour. Additional detail for each
FilmArray system can be found in the appropriate FilmArray Operator’s Manual.
MATERIALS PROVIDED
Each kit contains sufficient reagents to test 30 or 6 specimens:
 Individually packaged FilmArray RP pouches
 Single-use (1.0 mL) Sample Buffer ampoules
 Single-use pre-filled (1.5 mL) Hydration Injection Vials (blue)
 Single-use Sample Injection Vials (red)
 Individually packaged Transfer Pipettes
MATERIALS REQUIRED BUT NOT PROVIDED

FilmArray system including:
 FilmArray, FilmArray 2.0, or FilmArray Torch and software
 FilmArray Pouch Loading Station
WARNINGS AND PRECAUTIONS

General Precautions
1. For in vitro diagnostic use only.
2. This device is restricted to sale by or on the order of a physician, or to a clinical laboratory; its use is restricted
to, by, or on the order of a physician.
3. A trained healthcare professional should carefully interpret the results from the FilmArray RP in conjunction
with a patient’s signs and symptoms and results from other diagnostic tests.
4. FilmArray RP pouches are only for use with FilmArray systems.
5. Performance characteristics of the FilmArray RP have only been determined with nasopharyngeal swab
(NPS) specimens.
6. Always check the expiration date on the pouch and do not use a pouch after its expiration date.
7. FilmArray pouches are stored under vacuum in individually-wrapped canisters. To preserve the integrity of the
pouch vacuum for proper operation, be sure that a FilmArray instrument/Module will be available and
operational before unwrapping any pouches for loading.
8. Pertussis is a nationally notifiable infectious condition in the U.S. If Bordetella pertussis is detected, notify the
state and/or local health departments.
Safety Precautions
1. Wear appropriate Personal Protective Equipment (PPE), including (but not limited to) disposable powder-free
gloves and lab coats. Protect skin, eyes and mucus membranes. Change gloves often when handling
reagents or specimens.
2. Handle all specimens and waste materials as if they were capable of transmitting infectious agents. Observe
safety guidelines such as those outlined in CDC/NIH Biosafety in Microbiological and Biomedical Laboratories
[38], the CLSI Document M29 Protection of Laboratory Workers from Occupationally Acquired Infections [39],
or other appropriate guidelines.
3. Follow your institution's safety procedures for handling biological samples.
4. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening
criteria recommended by public health authorities, specimens should be collected with appropriate infection
control precautions for novel virulent Influenza viruses and sent to state or local health department for testing.
Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and
culture specimens.
5. Dispose of materials used in this assay, including reagents, specimens, and used buffer vials, according to
federal, state, and local regulations.
6. Sample Buffer is assigned the following classifications: Acute toxicity (Category 4), Serious Eye damage
(Category 1), and Skin irritation (Category 2). Accordingly, the Sample Buffer is harmful if swallowed, causes
serious eye damage, and causes skin irritation. The following precautions should be observed:
Wear protective gloves/eye protection/face protection.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and
easy to do. Continue rinsing. Seek medical attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
Please refer to the FilmArray Respiratory Panel Safety Data Sheet (SDS) for more information.
7. Sample Buffer will form hazardous compounds and fumes when mixed with bleach or other disinfectants.
WARNING: Bleach should never be added to Sample Buffer or sample waste.
8. Bleach, a recommended disinfectant, is corrosive and may cause severe irritation or damage to eyes and
skin. Vapor or mist may irritate the respiratory tract. Bleach is harmful if swallowed or inhaled. The following
first aid measures are recommended.
Eye contact: Hold eye open and rinse with water for 15-20 minutes. Remove contact lenses after the
first 5 minutes and continue rinsing eye. Seek medical attention.
Skin contact: Immediately flush skin with plenty of water for at least 15 minutes. If irritation develops,
seek medical attention.
Ingestion: Do not induce vomiting. Drink a glassful of water. If irritation develops, seek medical
attention.
Please refer to the appropriate Safety Data Sheet (SDS) for more information.
Laboratory Precautions
1. Preventing organism contamination
Due to the sensitive nature of the FilmArray RP, it is important to guard against contamination of the work
area by following these guidelines:
 Laboratory workers can be infected with common respiratory pathogens and can inadvertently
contaminate the sample while it is being processed. To avoid this, specimens should be processed and
pouches should be loaded in a biosafety cabinet. If a biosafety cabinet is not used, a dead air box (e.g.,
AirClean PCR workstation), a splash shield (e.g., Bel-Art Scienceware Splash Shields), or a face shield
should be used when preparing specimens.
 A biosafety cabinet that is used for performing viral or bacterial culture should not be used for specimen
preparation or pouch loading.
 Prior to processing a specimen, thoroughly clean both the work area and the FilmArray Pouch Loading
Station using a suitable cleaner such as freshly prepared 10% bleach or a similar disinfectant. To avoid
residue build-up and potential PCR inhibition, wipe disinfected surfaces with water.
 Some Bordetella pertussis acellular vaccines (i.e. Pentacel®, Daptacel®, and Adacel®) contain PCR-
detectable DNA. Contamination of specimens or testing materials with vaccine can cause false-positive
B. pertussis results. Specimens should not be collected or processed in areas that are exposed to B.
pertussis vaccine material and particular care should be taken during specimen collection and handling to
avoid contamination (http://www.cdc.gov/pertussis/clinical/diagnostic-testing/diagnosis-pcr-
bestpractices.html).
 Specimens and pouches should be handled one-at-a-time.
 Use clean gloves to remove materials from bulk packaging bags, and reseal bulk packaging bags when
not in use.
 Change gloves and clean the work area between preparation of each patient specimen.
 Laboratory workers with active respiratory symptoms (runny nose, cough) should wear a standard
surgical mask (or equivalent) and should avoid touching the mask while preparing specimens.
2. Preventing amplicon contamination

A common concern with PCR-based assays is false positive results caused by contamination of the work area
with PCR amplicon. Because the FilmArray RP pouch is a closed system, the risk of amplicon contamination
is low provided that pouches remain intact after the test is completed. Adhere to the following guidelines to
prevent amplicon contamination:
 Discard used pouches in an appropriate biohazard container immediately after the run has completed.
 Avoid excessive handling of pouches after test runs.
 Avoid exposing pouches to sharp edges or anything that might cause a puncture.
WARNING: If liquid is observed on the exterior of a pouch, the liquid and pouch should be
immediately contained and discarded in a biohazard container. The instrument/Module and
work space must be decontaminated as described in the appropriate FilmArray Operator’s
Manual.
DO NOT PERFORM ADDITIONAL TESTING UNTIL THE AREA HAS BEEN DECONTAMINATED.
Precaution Related to Public Health Reporting in the United States

Local, state, and federal regulations for notification of reportable disease are continually updated and include a
number of organisms for surveillance and outbreak investigations [40-41]. Additionally, the Centers for Disease
Control (CDC) recommends that when pathogens from reportable diseases are detected by a culture independent
diagnostic test (CIDT), the laboratory should facilitate obtaining the isolate or clinical materials for submission to
the appropriate public health laboratory to aid in outbreak detection and epidemiological
investigations. Laboratories are responsible for following their state and/or local regulations and should consult
their local and/or state public health laboratories for isolate and/or clinical sample submission guidelines.
REAGENT STORAGE, HANDLING AND STABILITY
1. Store the test kit, including reagent pouches and buffers, at room temperature (15–25 ºC). DO NOT
REFRIGERATE.
2. Avoid storage of any materials near heating or cooling vents or in direct sunlight.
3. Always check the expiration date and do not use reagents beyond the expiration date printed on the pouch or
kit.
4. All kit components should be stored and used together. Do not use components from one kit with those of
another kit.
5. Do not remove pouches from their packaging until a sample is ready to be tested. Once the pouch packaging
has been opened, the pouch should be loaded as soon as possible (within approximately 30 minutes).
6. Once a pouch has been loaded, the test run should be started as soon as possible (within 60 minutes).
SPECIMEN COLLECTION AND PREPARATION

This section describes the requirements for specimen collection, preparation, and handling that will help
ensure accurate test results.
Nasopharyngeal Swab Collection - NPS specimens should be collected according to standard technique
and immediately placed in viral transport media (VTM).
Minimum Sample Volume – 0.3 mL (300 µL) of sample is required for testing.
Transport and Storage - Specimens in VTM should be processed and tested as soon as possible. If storage
is required, specimens in VTM can be held at room temperature (18 –30 ºC) for up to 4 hours, at refrigerator
temperature (2-8 °C) for up to 3 days, or at freezer temperature (<-15 °C) for up to 30 days.
PROCEDURE
Refer to the FilmArray Respiratory Panel Quick Guide, the FilmArray Training Video or the appropriate FilmArray
Operator’s Manual for more detail and pictorial representations of these instructions.
Gloves and other Personal Protective Equipment (PPE) should be used when handling pouches and specimens.
Only one FilmArray RP pouch should be loaded at a time. Once the pouch is loaded, it should be promptly
transferred to the instrument/Module to start the run. After the run is complete, the pouch should be discarded in a
biohazard container.
Prepare Pouch
1. Thoroughly clean the work area and the FilmArray Pouch Loading Station with freshly prepared 10% bleach
(or suitable disinfectant) followed by a water rinse.
2. Remove the FilmArray RP pouch from its vacuum-sealed package by tearing or cutting the notched outer
packaging and opening the protective aluminum canister.
NOTE: If the vacuum seal of the pouch packaging is not intact, the pouch may still be
used. Attempt to hydrate the pouch using the steps below. If hydration is successful,
continue with the run. If hydration fails, discard the pouch and use a new pouch to test
the sample.
3. Place the FilmArray Pouch into the FilmArray Pouch Loading Station. To do so, hold the pouch so that the
barcoded label is upright and readable, and then slide the flexible film portion of the pouch into the loading
station. In the correct configuration, the inlet ports on both ends of the rigid plastic part of the pouch will point
up, and the red and blue labels on the pouch will align with the red and blue arrows on the FilmArray Pouch
Loading Station.
4. Place a blue-capped Hydration Injection Vial in the blue well of the FilmArray Pouch Loading Station.
5. Place a red-capped Sample Injection Vial in the red well of the FilmArray Pouch Loading Station.
Hydrate Pouch
1. Twist and lift the Hydration Injection Vial, leaving blue cap in the well of the FilmArray Pouch Loading Station.
2. Insert the cannula tip into the port in the pouch located directly below the blue arrow of the FilmArray Pouch
Loading Station. Push down forcefully in a firm and quick motion until you hear a faint “pop” and feel an ease
in resistance. The correct volume of liquid will be pulled into the pouch by vacuum.
3. Verify that the pouch has been hydrated.
4. Flip the barcode label down and check to see that fluid has entered the reagent wells (located at the base of
the rigid plastic part of the pouch). Small air bubbles may be seen. If the pouch fails to hydrate (dry reagents
appear as white pellets), repeat Step 2 to verify that the seal of the port was broken or retrieve a new pouch
and repeat from Step 2 of the Prepare Pouch section.
Prepare Sample Mix

1. Hold the Sample Buffer ampoule so that the tip is facing up.
NOTE: Use care to avoid touching the tip during handling, as this may introduce
contamination.
2. Gently pinch the textured plastic tab on the side of the ampoule until the seal snaps.
3. Invert the ampoule over the red-capped Sample Injection Vial and re-position thumb and forefinger to grip the
bottom of the ampoule. Dispense Sample Buffer using a slow, forceful squeeze, followed by a second
squeeze. Squeezing the ampoule additional times will generate excessive bubbles, which should be avoided.
4. Using the Transfer Pipette provided in the test kit, draw sample (NPS in VTM) to the third line (approximately
0.3 mL). Add sample to the red Sample Injection Vial. Tightly close the lid of the Sample Injection Vial.
NOTE: DO NOT use the Transfer Pipette to mix the sample once it is added to the Sample
Injection Vial.
5. Remove the Sample Injection Vial from the FilmArray Pouch Loading Station and gently invert the vial at least
three times to mix.
6. Return the Sample Injection Vial to the FilmArray Pouch Loading Station.
Load Sample Mix
1. Slowly twist the Sample Injection Vial so it loosens from its red cap and pause for 3-5 seconds. Lift the
Sample Injection Vial, leaving the red cap in the well of the FilmArray Pouch Loading Station.
2. Insert the cannula tip into the port in the pouch located directly below the red arrow of the FilmArray Pouch
Loading Station. Push down forcefully in a firm and quick motion until you hear a faint “pop” and feel an ease
in resistance. The correct volume of liquid will be pulled into the pouch by vacuum.
3. Verify that the sample has been loaded. Flip the barcode label down and check to see that fluid has entered
the reagent well next to the sample loading port. If the pouch fails to pull sample from the Sample Injection
Vial, the pouch should be discarded. Retrieve a new pouch and repeat from Step 2 of the Pouch Preparation
section.
4. Discard the Sample Injection Vial and the Hydration Injection Vial in an appropriate biohazard sharps
container.
5. Record the Sample ID in the provided area on the pouch label (or affix a barcoded Sample ID) and remove
the pouch from the FilmArray Pouch Loading Station.
Run Pouch
The FilmArray software includes step-by-step on-screen instructions that guide the operator through performing a
run. Brief instructions for FilmArray, FilmArray 2.0, and FilmArray Torch systems are given below. Refer to the
appropriate FilmArray operator’s manual for more detailed instructions.
FilmArray and FilmArray 2.0
1. Ensure that the FilmArray system is on and the software is launched.
2. Open the lid of an available instrument (if not already open).
NOTE: An available instrument is indicated by a constant green light on the front of the
instrument.
3. Insert the pouch into the instrument.

Position the pouch so that the array is on the right with the film directed downward into the FilmArray
instrument. The red and blue labels on the pouch should align with the red and blue arrows on the FilmArray
instrument. The pouch will click into place. If inserted correctly, the barcode is visible and the label is readable
on the top of the pouch. The instrument and software must detect that the pouch has been inserted correctly
before continuing to the next step.
NOTE: If the pouch does not slide into the instrument easily, gently push the lid of the
instrument back to be sure that it is completely open.
4. Scan the barcode on the FilmArray pouch using the barcode scanner.
Pouch identification (Lot Number and Serial Number), Pouch Type and Protocol are preprogrammed in the
rectangular barcode located on the FilmArray pouch. The information will be automatically entered when the
barcode is scanned. If it is not possible to scan the barcode, the pouch Lot Number, Serial Number, Pouch
Type and Protocol can be manually entered from the information provided on the pouch label into the
appropriate fields. To reduce data entry errors, it is strongly recommended that the pouch information be
entered by scanning the barcode.
NOTE: The barcode cannot be scanned prior to placing the pouch in the instrument.
5. Enter the Sample ID. The Sample ID can be entered manually or scanned in by using the barcode scanner
when a barcoded Sample ID is used.
6. If necessary, select and/or confirm a protocol from the Protocol drop down list.
7. Enter a user name and password in the Name and Password fields.
8. Close the FilmArray instrument lid.
9. Click the Start Run button on the screen.
Once the run has started, the screen displays a list of the steps being performed by the instrument and the
number of minutes remaining in the run.
NOTE: The bead-beater apparatus can be heard as a high-pitched noise (whine) during
the first minute of operation.
10. When the run is finished, follow the on-screen instructions to open the instrument and remove the pouch.
11. Immediately discard the pouch in a biohazard container.
12. Results are automatically displayed in the report section of the screen.
Select Print to print the report, or Save to save the report as a file.
FilmArray Torch
1. Ensure that the FilmArray Torch system is on.
2. Select an available Module on the touch screen.

3. Scan the barcode on the FilmArray pouch using the barcode scanner.
Pouch identification (Lot Number and Serial Number), Pouch Type and Protocol are preprogrammed in the
rectangular barcode located on the FilmArray pouch. The information will be automatically entered when the
barcode is scanned. If it is not possible to scan the barcode, the pouch Lot Number, Serial Number, Pouch
Type and Protocol can be manually entered from the information provided on the pouch label into the
appropriate fields. To reduce data entry errors, it is strongly recommended that the pouch information be
entered by scanning the barcode.
4. Enter the Sample ID. The Sample ID can be entered manually or scanned in by using the barcode scanner
when a barcoded Sample ID is used.
5. Insert the pouch into the Module.
Ensure that the pouch fitment label is lying flat on top of pouch and not folded over. As the pouch is inserted,
the Module will grab onto the pouch and pull it into the chamber.
6. If necessary, select and/or confirm a protocol from the protocol drop down list.
7. Enter operator user name and password, then select Next.
NOTE: The font color of the username is red until the user name is recognized by the
software.
8. Review the entered run information on the screen. If correct, select Start Run.
Once the run has started, the screen displays a list of the steps being performed by the instrument and the
number of minutes remaining in the run.
NOTE: The bead-beater apparatus can be heard as a high-pitched noise (whine) during
the first minute of operation.
9. At the end of the run, the status of the Module changes to Finished and the pouch is partially ejected.
10. Select the Finished Module on the Dashboard to view the report.
Select Print to print the report, or Save to save the report as a file
11. Removed the pouch from the Module and immediately discard the pouch in a biohazard container.
NOTE: Once the pouch has been removed, the report can only be viewed through the
Browse Runs feature.
QUALITY CONTROL
Process Controls
Two process controls are included in each pouch:
1. RNA Process Control
The RNA Process Control assay targets an RNA transcript from the yeast Schizosaccharomyces pombe. The
yeast is present in the pouch in a freeze-dried form and becomes rehydrated when sample is loaded. The
control material is carried through all stages of the test process, including lysis, nucleic acid purification,
reverse transcription, 1st stage PCR, dilution, 2nd stage PCR and DNA melting. A positive control result
indicates that all steps carried out in the FilmArray RP pouch were successful.
2. PCR2 Control
The PCR2 Control assay detects a DNA target that is dried into wells of the array along with the
corresponding primers. A positive result indicates that 2nd stage PCR was successful.
Both control assays must be positive for the test run to pass. When either control fails, the Controls field of the test
report (upper right hand corner) will display Failed and all results will be listed as Invalid. If the controls fail, the sample
should be retested using a new pouch.
Monitoring Test System Performance
It is possible to trend Tm values for the RNA Process Control and/or PCR2 Control assays and maintain records
according to standard laboratory quality control practices [42-43]. The FilmArray software will automatically fail the run
if the Tm for either the RNA Process Control or the PCR2 Control is outside of the acceptable range (80.6-84.6 for the
RNA Process Control and 74.5-78.5 for the PCR2 Control). Any trend variations should be investigated. Contact
Technical Support for help with out-of-range controls.
NOTE: Trending for the two control assays (RNA Process Control and PCR2 Control) should be
tracked on separate control charts as the expected Tm values for these two controls are different.
Good laboratory practice recommends running external positive and negative controls regularly. Use viral transport
medium as the external negative control, and previously characterized positive samples or negative samples spiked
with well characterized organisms as external positive controls. External controls should be used in accordance with
the appropriate accrediting organizations, as applicable.
INTERPRETATION OF RESULTS
The FilmArray software automatically analyzes and interprets the assay results and displays the final results in a test
report (see the FilmArray Respiratory Panel Quick Guide to view an example of a test report). The analyses
performed by the FilmArray software and details of the test report are described below.
Assay Interpretation
When 2nd stage PCR is complete, the FilmArray instrument/Module performs a high resolution DNA melting analysis
on the PCR products and measures the fluorescence signal generated in each well (for more information see
appropriate FilmArray Operator’s Manual). The FilmArray software then performs several analyses and assigns a final
assay result.
Analysis of melting curves. The FilmArray software evaluates the DNA melting curve for each well of the 2 nd stage
PCR array to determine if a PCR product was present in that well. If the melt profile indicates the presence of a PCR
product, then the analysis software calculates the melting temperature (Tm) of the curve. The Tm value is then
compared against the expected Tm range for the assay. If the software determines that the melt is positive and the
melt peak falls inside the assay-specific Tm range, the curve is called positive. If the software determines that the melt
is negative or is not in the appropriate Tm range, the curve is called negative.
Analysis of replicates. Once melt curves have been identified, the software evaluates the three replicates for each
assay to determine the assay result. For an assay to be called positive, at least two of the three associated melt
curves must be called positive, and the Tm for at least two of the three positive curves must be similar (within 1°C).
Assays that do not meet these criteria are called negative.
Organism Interpretation. For most organisms detected by the FilmArray RP, the organism is considered to be
Detected if a single corresponding assay is positive. For example, Human Metapneumovirus will have a test report
result of Human Metapneumovirus Detected if at least two of the three replicates of the one Human Metapneumovirus
assay have similar positive melt peaks with Tm values that are within the assay-specific Tm range. The test results for
Adenovirus, the Human Rhinovirus/Enterovirus group, and Influenza A depend on the interpretation of results from
several assays. Interpretation and follow-up testing for these three results are provided below.
Rhinovirus/Enterovirus Group
The FilmArray RP pouch contains six different assays (HRV1, HRV2, HRV3, HRV4, Entero 1, Entero 2) for
the detection of Rhinoviruses and Enteroviruses. Though these viruses are both very diverse, they are also
closely related. Therefore, the six assays are not able to reliably differentiate Rhinovirus and Enterovirus. The
FilmArray software interprets each of the six assays independently (as described above) and the results are
combined as a final test result for the virus(es). If any of the six assays are positive, the test report result will
be Human Rhinovirus/Enterovirus Detected. If all six assays are negative, the test report result will be Human
Rhinovirus/Enterovirus Not Detected. A positive FilmArray RP Human Rhinovirus/Enterovirus result should
be followed-up using an alternate method (e.g., viral culture or sequence analysis).
NOTE: Despite the names, the HRV (1-4) and Entero (1-2) assays are not specific for detection of Human
Rhinovirus or Enterovirus, respectively. Individual assay results cannot be used to differentiate these two
viruses.
Adenovirus
The FilmArray RP pouch contains two different assays (Adeno, Adeno2) for the detection of Adenovirus. The
FilmArray software interprets each of these assays independently (as described above) and the results are
combined as a final test result for the virus. If either or both assays are positive, the test report result will be
Adenovirus Detected. If both the Adeno and Adeno2 assays are negative, the test report result will be
Adenovirus Not Detected.
Influenza A
The assays in the FilmArray RP are designed to both detect Influenza A and to differentiate commonly
occurring hemagglutinin subtypes. To accomplish this, the FilmArray RP uses two Influenza A assays, (FluA-
pan-1 and FluA-pan-2) and three subtyping assays directed at the hemagglutinin gene (FluA-H1-pan, FluA-
H1-2009 and FluA-H3). The FluA-H1-pan assay is designed to detect both Influenza A H1 and the Influenza A
H1-2009 variant. Each of the individual assays is interpreted independently (as described above) and the test
result reported for Influenza A is based on the combined results of the five assays as outlined in Table 3.
In general, Influenza A is determined to be Detected if at least one of the two FluA-pan assays is positive and
a subtyping assay is also positive. If neither of the FluA-pan assays is positive, but a subtyping assay is
positive, then the result is considered Equivocal for that specific subtype and the sample should be retested. If
one of the FluA-pan assays is positive and none of the subtyping assays are positive, the result is Equivocal
for Influenza A and the specimen should be retested. All Equivocal results should be retested.
Table 3. Possible Assay Results for Influenza A and the Corresponding Interpretation
FluA-pan
Assay Assays FluA-H1- FluA-H1- Required
Final Result (n=2) pan 2009 FluA-H3 Follow-up
Influenza A Not Detected Negative Negative Negative Negative
Influenza A H1 ≥1 positive Positive Negative Negative

None
Influenza A H3 ≥1 positive Negative Negative Positive
Influenza A H1-2009 ≥1 positive Any result Positive Negative

Influenza A H1 and Multiple
≥1 positive Positive Negative Positive
Influenza A H3 infections are
possible but
Influenza A H1-2009 and rare a, retest
≥1 positive Any result Positive Positive
Influenza A H3 to confirm
result b
Influenza A (no subtype detected) 2 positive Negative Negative Negative See below
Influenza A Equivocal 1 positive Negative Negative Negative
Influenza A H1 Equivocal Negative Positive Negative Negative

Retest
Influenza A H3 Equivocal Negative Negative Negative Positive
Influenza A H1-2009 Equivocal Negative Any result Positive Negative
a The FilmArray RP can simultaneously detect multiple Influenza viruses contained in the FluMist® nasal Influenza vaccine
(see “Interference” section below).
b Repeated multiple positives should be further confirmed by other FDA cleared Influenza subtyping tests.
Influenza A (no subtype detected)
If both of the FluA-pan assays are positive, but none of the hemagglutinin subtyping assays are positive, then
the interpretation is Influenza A (no subtype detected). This result could occur when the titer of the virus in the
specimen is low and not detected by the subtyping assays. This result could also indicate the presence of a
novel Influenza A strain. In both cases, the sample in question should be retested. If the retest provides a
different result, test the sample a third time to ensure the accuracy of the result. If the retest provides the
same result, then the function of the RP pouches should be verified by testing with appropriate external
control materials (known positive samples for Influenza A H1, Influenza A H3 and Influenza A H1-2009), and
a negative control should also be run to test for PCR-product contamination. If the FilmArray RP accurately
identifies the external and negative controls, contact the appropriate public health authorities for confirmatory
testing.
FilmArray RP Test Report

The FilmArray RP test report is automatically displayed upon completion of a run and contains three sections, the Run
Summary, the Results Summary, and the Run Details (see the FilmArray Respiratory Panel Quick Guide to view an
example of a test report). The test report can be saved as a file or printed.
The Run Summary section of the test report provides the Sample ID, time and date of the run, control results and an
overall summary of the test results. Any target with a Detected or Equivocal result will be listed in the corresponding
field of the summary. If all of the tests were negative then None will be displayed in the Detected field. Controls are
listed as Passed, Failed or Invalid. See Control Field section below for detailed information about the interpretation of
controls and appropriate follow-up in the case of control failures.
The Results Summary section of the test report lists the result for each target tested by the panel. Possible results
are Detected, Not Detected, Equivocal or Invalid. See Results Summary section below for detailed information about
interpretation of test results and appropriate follow-up for Invalid and Equivocal results. The assay-by-assay results for
each target are available in an optional 2nd page of the report. To access the 2nd page of the report, select the Details
button at the bottom of the report screen or Print All for a printed report. The 2nd page of the report provides the results
of each assay regardless of the pouch control results.
The Run Details section provides additional information about the run including: pouch information (type, lot number,
and serial number), run status (Completed, Incomplete, Aborted, Instrument Error, Instrument Communication Error,
or Software Error), the protocols that were used to perform the test, the identity of the operator that performed the
test, and the instrument used to perform the test.
Once a run has completed, it is possible to edit the Sample ID. If this information has been changed, an additional
section called Change History will be added to the test report. This Change History section lists the field that was
changed, the original entry, the revised entry, the operator that made the change and the date that the change was
made. Sample ID is the only field of the report that can be changed.
Control Field
The Control field on the test report will display Passed, Failed, or Invalid. The Control field will display Passed only if
the run completed successfully (no instrument or software errors) and both of the pouch control assays (RNA Process
Control and PCR2 Control) were successful. The Control field will display Failed if the run was completed successfully
(no instrument or software errors) but one or both of the pouch control assays failed (0 or 1 positive replicates for
either of the controls, each of which is tested in triplicate). If the control result is Failed, then the result for all of the
tests on the panel are displayed as Invalid and the specimen will need to be retested with a new pouch.
Table 4 provides a summary and explanation of the possible control results and follow-up actions.
The FilmArray monitors each run to ensure that the instrument is working within specification and to detect hardware
or software errors that might compromise the accuracy of the test result. If the instrument detects an out-of-
specification condition, or a significant error, it will automatically abort the run. If this happens, or if a run is aborted by
the user, then the Control field on the report will display Invalid and all test results in the Result Summary of the report
will also be displayed as Invalid. To determine why a run failed to complete, note any specific error codes that are
displayed on the screen and refer to the Run Status in the Run Details section of the report. The Run Status will
display Incomplete, Aborted, Software Error, Instrument Error, or Instrument Communication Error. Refer to the
FilmArray Operator’s Manual or call Technical Support for further instruction. The specimen should be retested after
the error is corrected or by using an alternate FilmArray instrument/Module.
Table 4. Interpretation of Control Field on the FilmArray RP Test Report
Control Result Explanation Action Required Outcome
Passed The run was successfully None Report the results

completed provided on the test
report.
AND
Both pouch controls were
successful.
Failed The run was successfully Repeat the test using a new Accept the results of the
completed pouch. repeat testing. If the error
persists, contact Technical
BUT Support for further
At least one of the pouch instruction.
controls failed.
Invalid The controls are invalid Note any error codes displayed Accept the valid results of
because the run failed. during the run and the Run the repeat testing. If the
Status field in the Run Details error persists, contact
(typically a software or section of the report. Refer to the Technical Support for
hardware error) appropriate FilmArray Operator’s further instruction.
Manual or contact Technical
Support for further instruction.
Once the error is resolved,
repeat the test or repeat the test
using another instrument.
If the error occurred in the first 30
seconds of the run, the same
pouch may be used for the
repeat test (within 60 minutes of
pouch loading) using the same
instrument or another
instrument/Module, as available.
If the error occurred later in the
run or you are unsure when the
error occurred, return to the
original sample to load a new
pouch. Repeat the test with the
new pouch on the same or
another instrument/Module, as
available.
Result Summary
Test results for the organisms included in the FilmArray RP are provided in two locations on the report. The Result
Summary section provides a complete list of the test results. Possible results include Detected, Not Detected,
Equivocal, and Invalid. Positive (Detected) and Equivocal results are also displayed in the Run Summary section.
Table 5 provides an explanation for each interpretation and any follow-up necessary to obtain a final result.
Table 5. Interpretation of Results on the FilmArray RP Test Report

Organism Result Explanation Action
Detected The run was successfully completed Report results.

AND
The pouch controls were successful (Passed)
AND
The assay(s) for the organism were POSITIVE
(i.e., met the requirements for a positive result described in the
Assay Interpretation section above)
Not Detected The run was successfully completed Report results.

AND
The pouch controls were successful (Passed)
AND
The assay(s) for the organism were NEGATIVE
(i.e., did not meet the requirements for a positive result
described in the Assay Interpretation section above)
Equivocal The run was successfully completed Retest the original

specimen using a new
(Influenza A only) AND pouch and report the
The pouch controls were successful (Passed) results of the retest.
AND
The combination of positive and negative assay results for
Influenza A was inconclusive (see Table 3)
Invalid The pouch controls were not successful (Failed) See Table 4 ,
Interpretation of Control
OR Field on the FilmArray
The run was not successful Test Report for instruction.
(Run Status displayed as: Aborted, Incomplete, Instrument
Error, Software Error, or Instrument Communication Error)
LIMITATIONS OF THE PROCEDURE
• For prescription use only
• FilmArray Respiratory Panel performance has only been established on the FilmArray, FilmArray 2.0 and
FilmArray Torch systems.
• This test is a qualitative test and does not provide a quantitative value for the virus(es) and/or bacteria
detected in the specimen.
• The performance of the test has been evaluated for use with human specimen material only.
• This test has not been validated for testing specimens other than nasopharyngeal swab (NPS) specimens.
• The performance of this test has not been established for immunocompromised individuals.
• The performance of this test has not been established for patients without signs and symptoms of respiratory
infection.
• Results from this test must be correlated with the clinical history, epidemiological data, and other data
available to the clinician evaluating the patient.
• Viral and bacterial nucleic acids may persist in vivo independent of organism viability. Detection of organism
target(s) does not imply that the corresponding organisms are infectious or are the causative agents for
clinical symptoms.
• The detection of viral and bacterial nucleic acid is dependent upon proper specimen collection, handling,
transportation, storage and preparation. Failure to observe proper procedures in any one of these steps can
lead to incorrect results. There is a risk of false positive or false negative values resulting from improperly
collected, transported or handled specimens.
• A negative FilmArray RP result does not exclude the possibility of viral or bacterial infection. Negative test
results may occur from the presence of sequence variants in the region targeted by the assay, the presence
of inhibitors, technical error, sample mix-up or an infection caused by an organism not detected by the panel.
Test results may also be affected by concurrent antiviral/antibacterial therapy or levels of organism in the
specimen that are below the limit of detection for the test. Negative results should not be used as the sole
basis for diagnosis, treatment, or other management decisions. Negative results in the setting of a respiratory
illness may be due to infection with pathogens that are not detected by this test or lower respiratory tract
infection that is not detected by a nasopharyngeal swab specimen.
• Positive and negative predictive values are highly dependent on prevalence. False negative test results are
more likely during peak activity when prevalence of disease is high. False positive test results are more likely
during periods when prevalence is moderate to low.
• Organism and amplicon contamination may produce erroneous results for this test. Particular attention should
be given to the Laboratory Precautions noted under the Warnings and Precautions section.
• There is a risk of false positive values resulting from cross-contamination by target organisms, their nucleic
acids or amplified product, or from non-specific signals in the assay.
• Cross-reactivity with respiratory tract organisms other than those listed in the Analytical Specificity section
below may lead to erroneous results.
• The FilmArray RP Adenovirus assay may show variable detection with non-respiratory serotypes within
species A, D, F and G.
• The FilmArray RP Influenza A subtyping assays target the Influenza A hemagglutinin gene only. The
FilmArray RP does not detect or differentiate the Influenza A neuraminidase gene.
• Clinical specificity was established when Influenza A H1-2009 was the predominant Influenza A virus in
circulation. When other Influenza A viruses are emerging, clinical specificity may vary.
• Due to the small number of positive specimens collected for certain organisms during the prospective clinical
study, performance characteristics for Bordetella pertussis, Coronavirus 229E, Coronavirus OC43, Influenza
A H1, Influenza A H3, Influenza A H1-2009, Influenza B, Mycoplasma pneumoniae, Parainfluenza Virus 1,
Parainfluenza Virus 2, and Parainfluenza Virus 4, were established primarily with retrospective clinical
specimens. Performance characteristics for Chlamydophila pneumoniae were established primarily using
contrived clinical specimens. The performance of this test has not been established for monitoring treatment
of seasonal Influenza A H1, A H3, A H1-2009 or RSV infections.
• The performance of this test has not been established for screening of blood or blood product for the
presence of seasonal Influenza A H1, A H3 or A H1-2009.
• The performance of this test has not been established with potentially interfering medications for the
treatment of influenza or cold viruses. The effect of interfering substances has only been evaluated for those
listed in the labeling. Interference by substances other than those described in the “Interference” section
below could lead to erroneous results.
• The performance of the FilmArray RP has not been established in individuals who received influenza vaccine.
Recent administration of a nasal influenza vaccine may cause false positive results for Influenza A and/or
Influenza B.
• Due to the genetic similarity between Human Rhinovirus and Enterovirus, the FilmArray RP cannot reliably
differentiate them. A positive FilmArray RP Rhinovirus/Enterovirus result should be followed-up using an
alternate method (e.g. cell culture or sequence analysis).
• The Coronavirus OC43 assay may cross-react with Coronavirus HKU1. As a result, when both HKU1 and
OC43 are detected in the same patient specimen, the result may be due to assay cross-reactivity. A co-
infection with these two viruses is also possible.
• The FilmArray RP may not be able to distinguish between existing viral strains and new variants as they
emerge. For example, the FilmArray RP can detect Influenza A H3N2v (first recognized in August, 2011), but
will not be able to distinguish this variant from Influenza A H3N2 seasonal.
• Results of the FilmArray RP B. pertussis assay may not be concordant with the results of commonly used
Bordetella PCR assays that target the multi-copy insertion sequence (IS481) due to differences in sensitivity
and specificity. IS481 is a multi-copy target and is present in several Bordetella species (B. pertussis, B.
holmesii and B. bronchiseptica). The FilmArray RP B. pertussis assay targets the single-copy promoter region
of the pertussis toxin gene and is designed to be highly specific for detection of B. pertussis. Although cross-
reactivity with closely-related Bordetella species was not observed in the clinical study or Analytical Specificity
testing of a variety of strains at 1 x 106 CFU/mL, instances of cross-reactivity can occur with high levels
(above 1 x 106 CFU/mL) or with rare sequence variants of other Bordetella species, such as B. bronchiseptica
and B. parapertussis.
EXPECTED VALUES
NOTE: The expected values presented in this section were obtained prior to the addition of a second Adenovirus
assay to FilmArray RP.
In the first phase of the prospective FilmArray RP clinical study, 853 eligible prospective nasopharyngeal (NPS) swab
specimens were collected and tested at three sites across the U.S. from December 2009 thru May 2010. A second
phase of the prospective FilmArray RP clinical study was conducted to obtain additional positive specimens for
Parainfluenza Viruses 1, 2, and 4. During the anticipated peak season for Parainfluenza Viruses 1 and 2 (September
2010 thru January 2011), another 264 eligible specimens were collected and tested at two of the three sites. The
number and percentage of positive cases as determined by the FilmArray RP calculated by testing site or by age
group are presented in the following tables:
Table 6. Expected Value (as Determined by the FilmArray RP) Summary by Site for the First Phase Prospective Clinical Evaluation
(December 2009 – May 2010)
Overall (n=853) Site 1 (n=275) Site 2 (n=333) Site 3 (n=245)
Organism Number Expected Expected Expected Expected
Number Number Number
Value Value Value Value
Adenovirus 38 4.5% 5 1.8% 11 3.3% 22 9.0%
Influenza A 11 1.3% 10 3.6% 1 0.3% 0 0%
Influenza A H1 0 0% 0 0% 0 0% 0 0%
Influenza A H3 0 0% 0 0% 0 0% 0 0%
Influenza A H1-2009 11 1.3% 10 3.6% 1 0.3% 0 0%
Influenza B 0 0% 0 0% 0 0% 0 0%
Parainfluenza Virus 1 1 0.1% 0 0% 0 0% 1 0.4%
Parainfluenza Virus 2 0 0% 0 0% 0 0% 0 0%
Parainfluenza Virus 3 33 3.9% 1 0.4% 1 0.3% 31 12.7%
Parainfluenza Virus 4 8 0.9% 0 0% 4 1.2% 4 1.6%
Respiratory Syncytial Virus 139 16.3% 4 1.5% 86 25.8% 49 20.0%
Coronavirus 229E 14 1.6% 5 1.8% 3 0.9% 6 2.4%
Coronavirus HKU1 25 2.9% 9 3.3% 13 3.9% 3 1.2%
Coronavirus NL63 23 2.7% 4 1.5% 9 2.7% 10 4.1%
Coronavirus OC43 8 0.9% 2 0.7% 6 1.8% 0 0%
Human Metapneumovirus 94 11.0% 12 4.4% 41 12.3% 41 16.7%
Human Rhinovirus/Entero 225 26.4% 36 13.1% 92 27.6% 97 39.6%
Bordetella pertussis 4 0.4% 2 0.7% 1 0.3% 1 0.4%
Chlamydophila pneumoniae 1 0.1% 0 0% 0 0% 1 0.4%
Mycoplasma pneumoniae 2 0.2% 2 0.2% 0 0% 0 0%
Table 7. Expected Value (as Determined by the FilmArray RP) Summary by Site for the Second Phase Prospective Clinical Evaluation
(September 2010 – January 2011)
Overall (n=264) Site 2 (n=180) Site 3 (n=84)
Organism Expected Expected
Number Number Number Expected Value
Value Value
Adenovirus 15 5.7% 11 6.1% 4 4.6%
Influenza A 5 1.9% 0 0% 5 6.0%
Influenza A H1 0 0% 0 0% 0 0%
Overall (n=264) Site 2 (n=180) Site 3 (n=84)
Organism Expected Expected
Number Number Number Expected Value
Value Value
Influenza A H3 5 1.9% 0 0% 5 6.0%
Influenza A H1-2009 0 0% 0 0% 0 0%
Influenza B 1 0.4% 1 0.6% 0 0%
Parainfluenza Virus 1 1 0.4% 0 0% 1 1.1%
Parainfluenza Virus 2 9 3.4% 4 2.2% 5 5.7%
Parainfluenza Virus 3 5 1.9% 0 0% 5 5.7%
Parainfluenza Virus 4 2 0.7% 1 0.6% 1 1.1%
Respiratory Syncytial Virus 31 11.7% 11 6.1% 20 23.8%
Coronavirus 229E 0 0% 0 0% 0 0%
Coronavirus HKU1 0 0% 0 0% 0 0%
Coronavirus NL63 1 0.4% 1 0.6% 0 0%
Coronavirus OC43 11 4.2% 1 0.5% 10 11.9%
Human Metapneumovirus 4 1.5% 0 0% 4 4.6%
Human Rhinovirus/Entero 125 47.3% 91 50.6% 34 39.1%
Bordetella pertussis 3 1.1% 3 1.6% 0 0%
Chlamydophila pneumoniae 0 0% 0 0% 0 0%
Mycoplasma pneumoniae 2 0.8% 1 0.5% 1 1.2%
Table 8. Expected Value (as Determined by FilmArray RP) Summary by Age Group for First Phase Prospective Clinical Evaluation
(December 2009 – May 2010)
Total
Organism ≤ 5 years 6-21 years 22-49 years ≥ 50 years
(Expected Value)
Adenovirus 38 (4.5%) 32 2 3 1
Influenza A 11 (1.3%) 1 1 7 2
Influenza A H1 0 (0%) 0 0 0 0
Influenza A H3 0 (0%) 0 0 0 0
Influenza A H1-2009 11 (1.3%) 1 1 7 2
Influenza B 0 (0%) 0 0 0 0
Parainfluenza Virus 1 1 (0.1%) 0 1 0 0
Parainfluenza Virus 2 0 (0%) 0 0 0 0
Respiratory Syncytial Virus 139 (16.3%) 127 3 4 5
Coronavirus 229E 14 (1.6%) 6 2 5 1
Coronavirus HKU1 25 (2.9%) 12 1 8 4
Coronavirus NL63 23 (2.7%) 17 2 2 2
Coronavirus OC43 8 (0.9%) 4 0 2 2
Human Metapneumovirus 94 (11.0%) 76 4 10 4
Human Rhinovirus/Entero 225 (26.4%) 161 24 29 11
Bordetella pertussis 4 (0.4%) 2 1 0 1
Chlamydophila pneumoniae 1 (0.1%) 1 0 0 0
Mycoplasma pneumoniae 2 (0.2%) 0 0 2 0
Table 9. Expected Value (as Determined by FilmArray RP) Summary by Age Group for Second Phase Prospective Clinical
Evaluation (September 2010-January 2011)
Total
Organism ≤ 5 years 6-21 years 22-49 years ≥ 50 years
(Expected Value)
Adenovirus 15 (5.7%) 15 0 n/a n/a
Influenza A 5 (1.9%) 4 1 n/a n/a
Influenza A H1 0 (0%) 0 0 n/a n/a
Influenza A H3 5 (1.9%) 4 1 n/a n/a
Influenza A H1-2009 0 (0%) 0 0 n/a n/a
Influenza B 1 (0.4%) 1 0 n/a n/a
Parainfluenza Virus 1 1 (0.4%) 1 0 n/a n/a
Respiratory Syncytial Virus 31 (11.7%) 30 1 n/a n/a
Coronavirus 229E 0 (0%) 0 0 n/a n/a
Coronavirus HKU1 0 (0%) 0 0 n/a n/a
Coronavirus NL63 1 (0.4%) 1 0 n/a n/a
Coronavirus OC43 11 (4.2%) 9 2 n/a n/a
Human Metapneumovirus 4 (1.5%) 4 0 n/a n/a
Human Rhinovirus/Entero 125 (47.3%) 118 7 n/a n/a
Bordetella pertussis 3 (1.1%) 3 0 n/a n/a
Chlamydophila pneumoniae 0 (0%) 0 0 n/a n/a
Mycoplasma pneumoniae 2 (0.8%) 2 0 n/a n/a
The number and percentage of co-infection cases as determined by the FilmArray RP calculated by age group are
presented in the following tables:
Table 10. Expected Value (Co-infections as Determined by FilmArray RP) Summary by Age Group for First Phase Prospective
Clinical Evaluation (December 2009 – May 2010)
Total
Co-Infection (Expected ≤ 5 Years 6-21 Years 22-49 Years ≥ 50 Years
Value)
HRV/EV + RSV 21 (2.46%) 20 0 1 0
HRV/EV + AdV 8 (0.94%) 8 0 0 0
HRV/EV + PIV3 8 (0.94%) 7 1 0 0
HRV/EV + hMPV 7 (0.82%) 7 0 0 0
hMPV + RSV 4 (0.47%) 4 0 0 0
HRV/EV + CoV NL63 4 (0.47%) 3 0 1 0
CoV HKU1 + hMPV 3 (0.35%) 3 0 0 0
CoV HKU1 + HRV/EV 3 (0.35%) 1 0 2 0
CoV HKU1 + RSV 3 (0.35%) 3 0 0 0
CoV NL63 + hMPV 3 (0.35%) 3 0 0 0
CoV NL63 + RSV 3 (0.35%) 3 0 0 0
hMPV + PIV3 3 (0.35%) 3 0 0 0
Total
Value)
AdV + HRV/EV + PIV3 2 (0.23%) 2 0 0 0
CoV OC43 + RSV 2 (0.23%) 2 0 0 0
CoV HKU1 + CoV OC43 2 (0.23%) 0 0 1 1
HRV/EV + PIV4 2 (0.23%) 2 0 0 0
AdV + hMPV 1 (0.12%) 1 0 0 0
AdV + PIV3 1 (0.12%) 1 0 0 0
AdV + RSV 1 (0.12%) 1 0 0 0
AdV + CoV NL63 1 (0.12%) 1 0 0 0
AdV + RSV + CoV 229E 1 (0.12%) 1 0 0 0
AdV + HRV/EV + B. pertussis 1 (0.12%) 1 0 0 0
AdV + C. pneumoniae 1 (0.12%) 1 0 0 0
CoV 229E + RSV 1 (0.12%) 1 0 0 0
CoV 229E + CoV NL63 +
1 (0.12%) 1 0 0 0
HRV/EV+RSV
CoV 229E + HRV/EV 1 (0.12%) 1 0 0 0
CoV HKU1 + HRV/EV + RSV 1 (0.12%) 1 0 0 0
CoV NL63 + hMPV + RSV 1 (0.12%) 1 0 0 0
HRV/EV + B. pertussis 1 (0.12%) 1 0 0 0
HRV/EV + PIV1 1 (0.12%) 0 1 0 0
hMPV + PIV4 1 (0.12%) 1 0 0 0
PIV4 + RSV 1 (0.12%) 1 0 0 0
Table 11. Expected Value (Co-infections as Determined by FilmArray RP) Summary by Age Group for Second Phase
Prospective Clinical Evaluation (September 2010 – January 2011)
Total
Value)
HRV/EV + RSV 6 (2.2%) 6 0 n/a n/a
HRV/EV + AdV 6 (2.2%) 6 0 n/a n/a
CoV OC43 + HRV/EV 5 (1.9%) 5 0 n/a n/a
HRV/EV + PIV2 1 (0.4%) 1 0 n/a n/a
HRV/EV + PIV3 1 (0.4%) 1 0 n/a n/a
HRV/EV + PIV4 1 (0.4%) 1 0 n/a n/a
hMPV + RSV 1 (0.4%) 1 0 n/a n/a
Flu B + RSV 1 (0.4%) 1 0 n/a n/a
AdV + CoV OC43 1 (0.4%) 1 0 n/a n/a
CoV OC43 + hMPV 1 (0.4%) 1 0 n/a n/a
CoV OC43 + RSV 1 (0.4%) 1 0 n/a n/a
HRV/EV + B. pertussis 1 (0.4%) 1 0 n/a n/a
PIV2 + M. pneumoniae 1 (0.4%) 1 0 n/a n/a
PERFORMANCE CHARACTERISTICS
Clinical Performance
NOTE: The clinical performance data presented in the first part of this section were obtained prior to the addition of a
second Adenovirus assay to FilmArray RP. Data from a clinical comparison study demonstrating performance of a
modified FilmArray RP (containing a second Adenovirus assay) as compared to the original FilmArray RP are
presented starting on page 34.
The clinical performance of the FilmArray RP was established during two phases of a prospective clinical study. The
first phase of the prospective clinical study was conducted at 3 U.S. clinical sites over a 6 month time period
(December 2009 thru May 2010). The second phase of the prospective clinical study was carried out at 2 of the 3
sites for an additional 5 month time period (September 2010 thru January 2011) in an attempt to achieve increased
detection of several low prevalence organisms (i.e. PIV1, PIV2, and PIV4) during the anticipated peak season for
PIV1 and PIV2. Subjects with signs and symptoms of respiratory infection were invited to participate. Upon obtaining
informed consent, NPS samples were collected for FilmArray and comparator testing. A total of 857 subjects were
initially enrolled in the 2009/2010 respiratory season (Phase 1) and 4 were withdrawn. Table 12A provides a summary
of demographic information for the 853 subjects that participated in the first phase of the prospective study. Another
287 subjects were enrolled in the 2010/2011 respiratory season (Phase 2) and 20 specimens were omitted from
analysis due to improper specimen storage prior to testing. Another 3 specimens were also excluded from analysis
due to the lack of clinical protocol-required associated valid external control mix results. Table 12B provides a
summary of the remaining 264 subjects.
Table 12. Demographic Summary for FilmArray RP Prospective Clinical Study

A. December 2009 thru May 2010 B. September 2010 thru January 2011
Sex Number of Subjects Sex Number of Subjects
Male 449 (53%) Male 151 (57%)
Female 404 (47%) Female 113 (43%)
Age Number of Subjects Age Number of Subjects
≤5 484 (57%) ≤5 240 (91%)
6-21 95 (11%) 6-21 24 (9%)
22-49 190 (22%) 22-49 0 (0%)
≥50 84 (10%) ≥50 0 (0%)
A NPS specimen from each subject was tested with the FilmArray RP. The performance of the FilmArray RP was
evaluated by comparing the FilmArray RP test result for each member of the panel with the appropriate
comparator/reference methods shown in Table 13.
Table 13. Reference/Comparator Methods Used to Assess FilmArray RP Performance

Reference/Comparator
Virus
Method(s)
Adenovirus
Viral culture
Influenza A followed by DFA identificationa
Influenza B
Reference/Comparator
Virus
Method(s)
Parainfluenza Virus 1
Respiratory Syncytial Virus
Influenza A H1 subtyping
Viral Culture
Influenza A H3 subtyping followed by 1 PCR test of viral culture
Influenza A H1-2009 subtyping with bi-directional sequence confirmationb
Human Rhinovirus
Human Enterovirus
Coronavirus 229E
Coronavirus HKU1
Coronavirus NL63
Coronavirus OC43 2 PCR tests of patient specimens
Human Metapneumovirus with bi-directional sequence confirmationc
Bordetella pertussis
Chlamydophila pneumoniae
Mycoplasma pneumoniae
a Performance of the FilmArray RP detecting AdV, Flu A, Flu B, PIV1, PIV2, PIV3, or RSV, respectively, was compared to
viral culture followed by fluorescent antibody identification. “True” positives were considered as any sample that tested
positive by viral culture followed by DFA testing. “True” negatives were considered as any sample that tested negative by
viral culture followed by DFA testing.
b Performance of the FilmArray RP detecting Flu A H1, A H3, A H1-2009, or PIV4, respectively, was compared to viral
culture followed by one analytically validated PCR assay with bi-directional sequence confirmation. The comparator
assays were designed to amplify a different sequence from that amplified by the FilmArray assay(s). None of the
comparator PCR assays overlapped any FilmArray amplicon sequence even if the same gene was targeted. “True” Flu A
H1, A H3, or A H1-2009 positives, respectively, were considered as any sample that tested positive for Flu A by viral
culture, and had bi-directional sequencing data meeting pre-defined quality acceptance criteria that matched the
respective subtype sequences deposited in the National Center for Biotechnology Information (NCBI) GenBank database
(www.ncbi.nlm.nih.gov) with acceptable E-values. “True” Flu A H1, A H3, or A H1-2009 negatives, respectively, were
considered as any sample that tested negative for Flu A by viral culture, or any sample that tested positive for Flu A virus
by viral culture, but tested negative by the respective subtype specific PCR assay. “True” PIV4 positives were considered
as any sample for which bi-directional sequencing data matching PIV4 sequences deposited in the NCBI GenBank
database was obtained from testing of viral culture material. “True” PIV4 negatives were considered as any sample where
testing of viral culture material with the analytically validated PIV4 specific PCR assay was negative.
c Performance of the FilmArray RP detecting HRV, EV, CoV 229E, CoV HKU1, CoV NL63, CoV OC43, hMPV, B.
pertussis, C. pneumoniae, or M. pneumoniae respectively, was compared to a predetermined algorithm that used
composite comparator methods. The methods consist of two analytically validated PCR assays followed by bi-directional
sequencing. The comparator assays were designed to amplify a different sequence from that amplified by the FilmArray
assay(s). None of the comparator PCR assays overlapped any FilmArray amplicon sequence even if the same gene was
targeted. “True positives were considered as any sample that had bi-directional sequencing data meeting pre-defined
quality acceptance criteria that matched organism-specific sequences deposited in the NCBI GenBank database
(www.ncbi.nlm.nih.gov) with acceptable E-values. “True” negatives were considered as any sample that tested negative
by both of the comparator PCR assays.
A total of 853 specimens were evaluated for Adenovirus, Influenza A, Influenza B, Parainfluenza Virus 3, Respiratory
Syncytial Virus, Coronavirus HKU1, Coronavirus NL63, Human Metapneumovirus, and Human Rhinovirus/Enterovirus
in the first phase of the study. A total of 1117 specimens were evaluated for Parainfluenza Virus 1, Parainfluenza
Virus 2, Parainfluenza Virus 4, Coronavirus 229E, Coronavirus OC43, B. pertussis, C. pneumoniae, and M.
pneumoniae in the first and second phases of the study. (During the second phase of the prospective clinical study,
only the reference/comparator methods for Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 4,
Coronavirus 229E, Coronavirus OC43, B. pertussis, C. pneumoniae, and M. pneumoniae were performed on all
specimens and used to calculate the performance.) Clinical sensitivity or positive percent agreement (PPA) was
calculated as 100% x (TP / TP + FN). True positive (TP) indicates that both the FilmArray RP and comparator method
had a positive result for this specific organism, and false negative (FN) indicates that the FilmArray result was
negative while the comparator result was positive. Specificity or negative percent agreement (NPA) was calculated as
100% x (TN / TN + FP). True negative (TN) indicates that both the FilmArray RP and the comparator method had
negative results, and a false positive (FP) indicates that the FilmArray RP result was positive but the comparator
result was negative. The exact binomial two-sided 95% confidence interval was calculated. The results are
summarized in Table 14.
Table 14. Clinical Sensitivity and Specificity or Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) for the
FilmArray RP Prospective Clinical Study
Organism Sensitivity 95% CI Specificity 95% CI
Adenovirus 24/27a 88.9% 70.8 - 97.7% 812/826b 98.3% 97.2 - 99.1%
Influenza A 9/10 90.0% 55.5 – 99.8% 841/843c 99.8% 99.2 -100%
Influenza A H1 0/0 n/a n/a 853/853 100% 99.6 - 100%
Influenza A H3 0/0 n/a n/a 853/853 100% 99.6 - 100%
Influenza A H1-2009 8/9 88.9% 51.8 - 99.7% 841/844c 99.6% 99.0 - 99.9%
Influenza B 0/0 n/a n/a 853/853 100% 99.6 - 100%
Parainfluenza Virus 1 1/1 100% n/a 1115/1116d 99.9% 99.5 – 100%
Parainfluenza Virus 2 7/8e,g 87.4% 47.4 – 99.7% 1107/1109f,g 99.8% 99.4 – 100%
Parainfluenza Virus 3 23/24h 95.8% 78.9 – 99.9% 819/829i 98.8% 97.8 - 99.4%
Parainfluenza Virus 4 9/9 100% 66.4 – 100% 1107/1108j 99.9% 99.5 – 100%
Respiratory Syncytial Virus 52/52 100% 93.2 - 100% 714/801k 89.1% 86.8 - 91.2%
Organism PPA 95% CI NPA 95% CI
Coronavirus 229E 12/12 100% 73.5 - 100% 1103/1105l 99.8% 99.4 - 100%
Coronavirus HKU1 23/24 95.8% 78.9 - 99.9% 827/829m 99.8% 99.1 - 100%
Coronavirus NL63 23/24 95.8% 78.9 - 99.9% 829/829 100% 99.6 - 100%
Coronavirus OC43 14/14 100% 76.8 - 100% 1098/1103n,o 99.6% 99.0 - 99.9%
Human Metapneumovirus 88/93 94.6% 87.9 - 98.2% 754/760 99.2% 98.3 - 99.7%
Human Rhinovirus/Enterovirus 190/205 92.7% 88.2 - 95.8% 613/648 94.6% 92.6 - 96.2%
Bordetella pertussis 6/6 100% 54.1 - 100% 1110/1111 99.9% 99.5 - 100%
Chlamydophila pneumoniae 1/1 100% n/a 1116/1116 100% 99.7 - 100%
Mycoplasma pneumoniae 4/4 100% 39.8 - 100% 1113/1113 100% 99.7 - 100%
a The FilmArray RP detected Adenovirus in 1/3 false negative specimens when retested. The Adenovirus in the retested
specimen was identified as species C by bi-directional sequence analysis. The Adenoviruses in the remaining two false
negative specimens were identified as species C and species B.
b Adenoviruses were identified in 13/14 false positive specimens using bi-directional sequence analysis. Ten were
identified as species C, two as species B, and one as species E.
c Influenza A viruses (H1-2009 subtype) were identified in 3/3 false positive specimens (2/2 false positive compared to
influenza A culture alone) using sequence analysis with an alternate assay.
d PIV1 was identified in this specimen using bi-directional sequence analysis.
e PIV2 virus was not detected in the single false negative specimen using PCR analysis.
f PIV2 virus was detected in both false positive specimens using bi-directional sequencing analysis.
g Two adjacent specimens (one false positive and one false negative) may have been switched during the viral culture
reference method testing as is evidenced by bi-directional sequence analysis of these specimens.

h The FilmArray RP detected PIV3 in the single false negative specimen when retested.
i. PIV3 viruses were identified in 10/10 false positive specimens using bi-directional sequence analysis.
j A PIV4 virus was detected in this false positive NPS specimen by bi-directional sequence analysis although it was not
detected from viral culture.

k RSV viruses were identified in 83/87 false positive specimens using bi-directional sequence analysis.
l CoV 229E was identified by bi-directional sequence analysis in 1/2 false positive specimens using an alternate assay.
m CoV HKU1 viruses were identified in 2/2 false positive specimens using bi-directional sequence analysis with an
alternate assay.
n CoV OC43 was detected in 2/5 false positive specimens using an alternate assay with bi-directional sequence analysis.
o 2/5 false positives were determined to be cross-reactive products derived from amplification of CoV HKU1 virus with the
CoV OC43 assay primers.
The FilmArray RP detected a total of 94 mixed infections in the first phase of the prospective clinical evaluation
performed from December 2009 thru May 2010 (853 tested and analyzed specimens). This represents 18% of the
total positive specimens (94/524). Eighty-seven (87/94; 92.6%) were double infections, 6 (6/94; 6.3%) were triple
infections, and one was a quadruple infection (1/94; 1.1%). The total number of test results comprising these co-
infections was 189. The single most common co-infection was Human Rhinovirus/Enterovirus with Respiratory
Syncytial Virus (20/94; 21.1%). These viruses were the most prevalent in the tested population. Out of the 94 co-
infections, 54 contained one or more organisms that had not been detected with the reference/comparator methods,
i.e. discrepant co-infection.
Table 15. Distinct Co-infection Combinations Detected by the FilmArray RP in the First Phase of the Prospective Clinical Trial
(December 2009 to May 2010)
Distinct Co-infection Combinations
Co-infections
Detected by FilmArray RP
Number of
Total
Discrepant Discrepant Organism(s) a

Organism 1 Organism 2 Organism 3 Organism 4 Co-infectionsa
AdV B. pertussis HRV/EV 1 1 AdV/B. pertussis

AdV HRV/EV PIV3 2 2 AdV (2)
AdV CoV 229E RSV 1 1 AdV; RSV
AdV C. pneumoniae 1 0
AdV CoV NL63 1 1 AdV
AdV hMPV 1 1 AdV; hMPV
AdV HRV/EV 8 2 AdV; HRV/EV

AdV PIV3 1 1 PIV3
AdV RSV 1 1 RSV
CoV 229E RSV 1 0
B. pertussis HRV/EV 1 1 HRV/EV
CoV 229E CoV NL63 HRV/EV RSV 1 1 RSV; CoV 229E
CoV 229E HRV/EV 1 0
Distinct Co-infection Combinations
Co-infections
Detected by FilmArray RP
Number of
Total
Discrepant Discrepant Organism(s) a
Organism 1 Organism 2 Organism 3 Organism 4 Co-infectionsa
CoV HKU1 HRV/EV RSV 1 1 RSV

CoV HKU1 CoV OC43 2 2 CoV OC43 (2)b
CoV HKU1 hMPV 3 0
CoV HKU1 HRV/EV 3 0
CoV HKU1 RSV 3 1 RSV
CoV NL63 hMPV RSV 1 1 RSV
CoV NL63 hMPV 3 0
CoV NL63 HRV/EV 4 1 HRV/EV
CoV NL63 RSV 3 2 RSV (2)
CoV OC43 RSV 2 2 RSV (2); CoV OC43 (2)
hMPV HRV/EV 7 3 hMPV (2); HRV/EV (1)
hMPV PIV3 3 1 PIV3
hMPV PIV4 1 1 hMPV
hMPV RSV 4 4 hMPV (1); RSV (3)
HRV/EV PIV1 1 1 PIV1
HRV/EV PIV3 8 6 HRV/EV (3); PIV3 (3)
HRV/EV PIV4 2 0
HRV/EV RSV 21 16 HRV/EV (8); RSV (13)
PIV4 RSV 1 0
Total Co-infections 94 54 65/200(32.5%)
Total Double Infections 87 47 55/178 (30.9%)
Total Triple Infections 6 6 8/18 (44.4%)
Total Quadruple Infections 1 1 2/4 (50%)
a A discrepant co-infection or discrepant organism was defined as one that was detected by FilmArray RP but not detected by the
reference/comparator methods or by discrepancy investigation using bi-directional sequence analysis. Sixty-five (65) organisms
from 54 of the 94 co-infections were not detected by the reference/comparator methods. Forty-four (44) were investigated using bi-
directional sequence analysis with an alternate assay; in 37 cases the investigative assay successfully identified the organism in
the specimen.
b Both discrepant CoV O43 results were false-positive due to cross-reactivity of the CoV OC43 assay with CoV HKU1 viruses in the
specimens.
Table 16. Additional Distinct Co-infection Combinations Detected by Reference/Comparator Methods, but not by the FilmArray
RP in the First Phase of the Prospective Clinical Trial (December 2009 to May 2010)
infections
Number of
Total
Co-
Distinct Co-infection Combinationsa Discrepant Discrepant Organism(s)
Co-infections
Organism 1 Organism 2
CoV 229E HRV/EV 1 1 HRV/EV (1)

hMPV HRV/EV 3 3 hMPV (2); HRV/EV (1)
HRV/EV RSV 1 1 HRV/EV (1)
Total Co-infections 5 5
Total Double Infections 5 5
aThis table includes only distinct co-infections that were detected by the reference/comparator method but not by FilmArray RP;
the remaining co-infections detected by the reference/comparator methods are already represented in the table above.
Table 17. Mixed Infections Detected by FilmArray RP in the First Phase (December 2009 to May 2010) and the Second Phase
(September 2010 to January 2011) of the Prospective Clinical Trial and Prevalence of Individual Organisms in Mixed Infections
Percentage
Number Prevalence
of Total Number
of in Mixed
Organism Combinations Samples Organism of Mixed
Positive Infections
Tested Infections
Samples (n/121)
(n/1117)
HRV/EV + RSV 27 2.40% HRV/EV 82 68%
AdV + HRV/EV 14 1.30% RSV 59 49%
HRV/EV + PIV3 9 0.80% AdV 24 20%
hMPV + HRV/EV 7 0.60% hMPV 25 21%
CoV OC43 + HRV/EV 5 0.50% PIV3 15 15%
hMPV + RSV 5 0.40% CoV NL63 13 11%
CoV NL63 + HRV/EV 4 0.40% CoV OC43 12 10%
CoV HKU1 + hMPV 3 0.30% CoV HKU1 12 10%
CoV HKU1 + HRV/EV 3 0.30% PIV4 5 4%
CoV HKU1 + RSV 3 0.30% CoV 229E 4 3%
CoV NL63 + hMPV 3 0.30% B. pertussis 3 2%
CoV NL63 + RSV 3 0.40% PIV2 2 2%
CoV OC43 + RSV 3 0.30% C. pneumoniae 1 1%
hMPV + PIV3 3 0.30% Flu B 1 1%
HRV/EV + PIV4 3 0.30% M. pneumoniae 1 1%
AdV + HRV/EV + PIV3 2 0.20% PIV1 1 1%
AdV + RSV 1 0.20%
CoV HKU1 + CoV OC43 2 0.20%
HRV/EV + B. pertussis 2 0.10%
AdV + B. pertussis + HRV/Entero 1 0.10%
AdV + C. pneumoniae 1 0.10%
Percentage
Number Prevalence
of Total Number
of in Mixed
Organism Combinations Samples Organism of Mixed
Positive Infections
Tested Infections
Samples (n/121)
(n/1117)
AdV + CoV 229E + RSV 1 0.10%
Adenovirus + CoV NL63 1 0.10%
Adenovirus + CoV OC43 1 0.10%
Adenovirus + hMPV 1 0.10%
Adenovirus + PIV3 1 0.10%
CoV 229E + CoV NL63 + HRV/EV + RSV 1 0.10%
CoV 229E + HRV/EV 1 0.10%
CoV 229E + RSV 1 0.10%
CoV HKU1 + HRV/EV + RSV 1 0.10%
CoV NL63 + hMPV + RSV 1 0.10%
CoV OC43 + hMPV 1 0.10%
hMPV + PIV4 1 0.10%
HRV/EV + PIV1 1 0.10%
HRV/EV + PIV2 1 0.10%
Flu B + RSV 1 0.10%
PIV4 + RSV 1 0.10%
PIV2 + M. pneumoniae 1 0.10%
A total of 1117 prospective clinical specimens were tested and analyzed during the first phase and the second phase
of the prospective clinical evaluation (2009/2010 respiratory season and 2010/2011 respiratory season). Of the 1117
analyzed prospective clinical specimens, 94.6% (1057/1117) of these specimens yielded valid results on the first
attempt (i.e. first loaded pouch). Invalid results or no results were obtained for the remaining 60 (5.4%) specimens (no
results for 24 specimens due to incomplete runs; 36 specimens were Invalid due to pouch control failures). Of the 24
incomplete runs, 3 were aborted by users (0.3%); 6 were due to software-related errors (0.6%) and 15 were due to
instrument errors (1.3%). Fifty-seven (57) of the 60 initially failed (no results or invalid) specimens yielded valid results
after a single retest using a new pouch/sample. The remaining three (3) specimens failed on the second attempt (2
due to failed pouch controls, 1 due to an instrument error), but yielded valid results following a second retest using
another pouch/sample.
A single pouch leak (1/1244 loaded pouches; 0.08%) was observed during the first phase of the prospective clinical
evaluation. Following discovery of the leak, the operator followed recommended decontamination procedures and
performed contamination surveillance swab testing of the area surrounding the instrument. No contamination was
detected. No pouch leaks were observed in the second phase of the prospective clinical study.
Testing of Preselected Archived Specimens
Several organisms, such as Influenza, were either not encountered in the prospective clinical study or had a low
prevalence. To supplement the results of the prospective clinical study, an evaluation of preselected archived
specimens was performed. The specimens were archived clinical NPS that were selected because they had
previously tested positive for one of the following organisms: Adenovirus, Bordetella pertussis, Coronaviruses 229E
and OC43, Enterovirus, Influenzas A H1, H1-2009, and H3, Influenza B, Mycoplasma pneumoniae, and Parainfluenza
Viruses 1-4. Prior to testing with the FilmArray RP, the presence (or absence for negative specimens) of the expected
organisms was confirmed in each specimen using validated organism-specific PCR assays followed by bi-directional
sequencing. The specimens were organized into “test panels” and randomized such that the users performing the
FilmArray RP testing were blinded as to the expected test result. Each panel contained specimens known to be
positive and specimens known to be negative for the specific organism being evaluated, which allows for the
calculation of a positive percent agreement (PPA) and a negative percent agreement (NPA). A summary of the
available demographic information of the tested samples is provided in Table 18 and the results of the FilmArray
testing are presented in Table 19.
Table 18. Demographic Summary of FilmArray RP Archived Specimen Study
Total Specimens 668
Female (%) 217 (32.5%)
Sex Male (%) 217 (32.5%)
Unknowna 234 (35%)
Avg 13
Median 7
Age
Min 0.5
Max 91
≤5 239 (35.8%)
6-21 112 (16.8%)
22-49 42 (6.3%)
Age Range
≥50 47 (7%)
≥5b 3 (0.4%)
Unknowna 225 (33.7%)
a Demographic information was not provided for specimens from one source. Because the specimens were provided by a
pediatric hospital, it is understood that the age range of specimens was from <1 yrs to 21 yrs.
b One source provided age category “less than 5 years of age or equal to/greater than 5 years of age”
Table 19. Summary of FilmArray RP Archived Specimen Performance Data

Positive Percent Agreement (PPA) Negative Percent Agreement (NPA)
Organism
TP/TP +FN Percent 95% CI TN/TN+FP Percent 95% CI
Adenovirus 27/27a 100% 87.2 - 100% 28/28 100% 87.7 - 100%
B. pertussis 53/56b 94.6% 85.1 - 98.9% 56/58c 96.5% 88.1 - 99.6%
Coronavirus 229E 13/13 100% 75.3 - 100% 45/47d 95.7% 85.5 - 99.5%
Coronavirus OC43 24/24 100% 85.8 - 100% 33/36e 91.7% 77.5 - 98.2%
Enterovirus 22/23f 95.7% 78.0 - 99.9% 90/90 100% 96.0 - 100%
Influenza A H1 32/32g 100% 89.1 - 100% 127/127 100% 97.1 - 100%
Influenza A H1-2009 34/34h 100% 89.7 - 100% 125/125 100% 97.1 - 100%
Influenza A H3 54/54i 100% 93.4 - 100% 105/105 100% 96.5 - 100%
Influenza B 30/30j 100% 88.4 - 100% 129/129 100% 97.2 - 100%
M. pneumoniae 54/64k 84.4% 73.1 - 92.2% 58/65l 89.2% 79.1 - 95.6%
Parainfluenza Virus 1 34/35m 97.1% 85.1 - 99.9% 94/94 100% 96.2 - 100%
Parainfluenza Virus 2 28/28n 100% 87.6 - 100% 101/101 100% 96.4 - 100%
Parainfluenza Virus 3 36/36 100% 90.3 - 100% 93/93 100% 96.1 - 100%
Parainfluenza Virus 4 11/11o 100% 71.5 - 100% 6/6 100% 54.1 - 100%
aOut of 28 AdV specimens received for testing, the organism status of one (1) specimen could not be confirmed by
organism specific PCR followed by bidirectional sequencing and was excluded from further analysis.
b Two (2) B. pertussis-positive specimens were originally identified by the source lab as negative for B. pertussis but were
unexpectedly found to be positive by organism specific PCR followed by bidirectional sequencing. Both of these
specimens were negative when tested with the FilmArray, and both were found to be negative for B. pertussis during
discrepancy investigation of confirmation testing.
c Ten (10) B. pertussis-negative specimens were originally identified by the source lab as positive for B. pertussis but this
could not be confirmed by organism specific PCR followed by bidirectional sequencing. Two (2) of these specimens were
positive when tested with the FilmArray and both of these specimens were found to be positive for B. pertussis during
discrepancy investigation of confirmation testing. Two (2) source laboratory positive samples were found to contain B.
holmesii; both of these samples gave the expected negative result when tested with the FilmArray RP.
d One (1) CoV 229E-negative specimen was originally identified by the source lab as positive for CoV 229E but this could
not be confirmed by organism specific PCR followed by bidirectional sequencing. This specimen was positive when tested
with the FilmArray RP.
e Four (4) CoV OC43-negative specimens were originally identified by the source lab as positive for CoV OC43 but this
could not be confirmed by organism specific PCR followed by bidirectional sequencing. Two (2) of these specimens were
positive when tested with the FilmArray RP.
f Out of 30 Enterovirus specimens received for testing, the organism status of 7 specimens could not be confirmed with
organism-specific PCR and bi-directional sequencing and were excluded from further analysis.
g Out of 37 Flu A H1 specimens received for testing, the organism status of 5 specimens could not be confirmed with
h Out of 37 Flu A H1-2009 specimens received for testing, the organism status of 2 specimens could not be confirmed with
organism-specific PCR and bi-directional sequencing and were excluded from further analysis. One additional sample
was excluded due to an invalid FilmArray result.
i Out of 58 FluA A H3 specimens received for testing, the organism status of 4 specimens could not be confirmed with
j Out of 36 Flu B specimens received for testing, the organism status of 5 specimens could not be confirmed with
organism-specific PCR and bi-directional sequencing and were excluded from further analysis. One additional sample
was excluded due to an invalid FilmArray result.
k The Ct results obtained during confirmation PCR testing for the 10 samples that were not detected by FilmArray
indicated low organism levels in the sample (Ct range 34.3-38.7) possible resulting from sample degradation during
storage of these archived specimens.
l Twenty-two (22) M. pneumoniae-negative specimens were originally identified by the source lab as positive for M.
pneumoniae but this could not be confirmed by organism specific PCR followed by bidirectional sequencing. Seven (7) of
these specimens were positive when tested with the FilmArray RP.
m Out of 38 PIV1 specimens received for testing, the organism status of 3 specimens could not be confirmed with
n Out of 29 PIV2 specimens received for testing, the organism status of 1 specimen could not be confirmed with organism-
specific PCR and bi-directional sequencing and was excluded from further analysis.
o Out of 13 PIV4 specimens received for testing, the organism status of 2 specimens could not be confirmed with
Testing of Contrived C. pneumoniae Specimens
Archived NPS specimens that had previously tested positive for C. pneumoniae were unavailable for testing.
Therefore, contrived C. pneumoniae specimens were used as surrogate clinical specimens to test the sensitivity and
specificity of the FilmArray RP C. pneumoniae assay. Residual specimens that had been collected during the
prospective clinical evaluation were spiked with C. pneumoniae at clinically relevant levels (or unspiked; 50 of each).
The organism status of each contrived specimen was blinded to the users testing the specimens.
Table 20. FilmArray RP Contrived C. pneumoniae Specimen Performance Data

Positive Percent Agreement (PPA) Negative Percent Agreement (NPA)
Organism
TP/TP +FN Percent 95% CI TN/TN+FP Percent 95% CI
C. pneumoniae 50/50 100% 92.9 – 100% 50/50 100% 92.9 – 100%
Clinical Comparison Study (Modified FilmArray RP as Compared to Original FilmArray RP)
The original FilmArray RP was modified by the addition of a second Adenovirus assay to improve Adenovirus
detection by the device. To demonstrate performance of the modified FilmArray RP, a comparison study was
performed by testing 222 de-identified archived nasopharyngeal swab specimens collected between 2008 and 2011
throughout the U.S. (at least 8 geographically distinct locations) and Scotland (at least 1 location) with both the
original FilmArray RP and modified FilmArray RP. A total of 26 Adenovirus specimens were detected by the modified
FilmArray RP, of these only 15 were detected by the original FilmArray RP, demonstrating a 73% greater detection
rate by the modified FilmArray RP in this clinical comparison study. For the other 19 organisms on the panel,
performance appeared to be equivalent between the original and modified FilmArray RP versions.
Table 21. Performance Comparison of the Modified FilmArray RP to the Original FilmArray RP using Archived Specimens
Positive Agreement Negative Agreement
Analyte orig + orig + orig - orig -
mod + mod -
PPA 95% CI mod - mod +
NPA 95% CI
100% 94.7%
Adenovirus 15 0 78.2 – 100% 196 11 a 90.7 – 97.3%
(15/15) (196/207)
100% 100%
CoV 229E 6 0 54.1 – 100% 216 0 98.3 – 100%
(6/6) (216/216)
100% 100%
CoV HKU1 8 0 63.1 – 100% 214 0 98.3 – 100%
(8/8) (214/214)
93.8% 100%
CoV NL63 15 1b 69.8 – 99.8% 206 0 98.2 – 100%
(15/16) (206/206)
100% 99.5%
CoV OC43 13 0 75.3 – 100% 208 1c 97.4– 100%
(13/13) (208/209)
100% 98.6%
hMPV 10 0 69.2 – 100% 209 3d 95.9 – 99.7%
(10/10) (209/212)
93.4% 98.1%
HRV/EV 57 4e 84.0 – 98.2% 158 3e 94.6 – 99.6%
(57/61) (158/161)
100% 99.5%
Flu A 36 0 90.3 – 100% 184 1f 97.0 – 100%
(36/36) (184/185)
100% 100%
Flu A H1 9 0 66.4 – 100% 213 0 98.3 – 100%
(9/9) (213/213)
Flu A H1- 100% 99.5%
15 0 78.2 – 100% 205 1f 97.3 – 100%
2009 (15/15) (205/206)
100% 100%
Flu A H3 13 0 75.3 – 100% 209 0 98.3 – 100%
(13/13) (209/209)
100% 100%
Flu B 10 0 69.2 – 100% 212 0 98.3 – 100%
(10/10) (212/212)
100% 100%
RSV 21 0 83.9 – 100% 201 0 98.2 – 100%
(21/21) (201/201)
100% 100%
PIV1 11 0 71.5 – 100% 211 0 98.3 – 100%
(11/11) (211/211)
100% 100%
PIV2 8 0 63.1 – 100% 214 0 98.3 – 100%
(8/8) (214/214)
100% 100%
PIV3 18 0 81.5 – 100% 204 0 98.2 – 100%
(18/18) (204/204)
100% 99.1%
PIV4 6 0 54.1 – 100% 214 2g 96.7 – 99.9%
(6/6) (214/216)
96.2% 100%
B. pertussis 25 1h 80.4 – 99.9% 196 0 98.1 – 100%
(25/26) (196/196)
C. 100% 100%
1 0 n/a 221 0 98.3 – 100%
pneumoniae (1/1) (221/221)
M. 100%
0 0 n/a n/a 222 0 98.4 – 100%
pneumoniae (222/222)
orig = original FilmArray RP, mod = modified FilmArray RP, PPA = positive percent agreement, NPA = negative percent
agreement, CI = confidence interval
a 10/11 of the additional AdV detections by the modified FilmArray RP were confirmed to contain AdV by bi-directional sequence
analysis; these AdV were identified by sequencing as AdVC2, AdVC5, AdVC6, AdVE4, and one undetermined serotype. One
specimen could not be sequenced due to low analyte levels.
b A single specimen was found to be positive for CoV NL63 when tested with the original RP pouch but not the modified RP
pouch. The specimen had previously been identified as positive for B. pertussis and had not been tested for CoV NL63 by the
source laboratory. This specimen previously tested using the original pouch was negative for CoV NL63 . There was insufficient
specimen for discrepancy investigation. Low viral load is suspected to have caused this spurious result.
c The Coronavirus OC43 discrepancy was due to cross-reactivity between the OC43 assay and HKU1 virus that was detected in
the RP modified pouch and not in the original RP pouch.

d 2/3 human Metapneumovirus discrepant specimens were confirmed by bi-directional sequence analysis. Low viral load is
suspected to have prevented detection by sequencing for the other specimen.

e 0/7 Human Rhinovirus/Enterovirus discrepant specimens were confirmed by bi-directional sequence analysis. Low viral load is
suspected to have prevented detection by sequencing.

f A single specimen containing Influenza A H1-2009 provided repeated equivocal results on the original RP pouch, but was
detected by the modified pouch.

g Parainfluenza Virus 4 was confirmed in both discrepant specimens by bi-directional sequence analysis.
h B. pertussis was confirmed in the discrepant specimen by bi-directional sequence analysis.
To supplement the archived specimen data for low prevalence organisms and to provide additional Adenovirus
performance data specifically for AdVC2 and AdVC6, a set of 44 contrived (spiked NPS) specimens (10 AdVC2, 10
AdVC6, 10 C. pneumoniae, and 14 M. pneumoniae) was tested with both the modified FilmArray RP and the original
FilmArray RP. The organism status of each contrived specimen was blinded to the users analyzing the specimens.
Modified FilmArray RP detected all 20 Adenovirus-spiked specimens, while original FilmArray RP detected none of
the Adenovirus-spiked specimens. Modified FilmArray RP also detected another Adenovirus in the background of a
specimen spiked with C. pneumoniae. Performance appeared to be equivalent between modified FilmArray RP and
original FilmArray RP for C. pneumoniae and M. pneumoniae.
Table 22. Clinical Comparison Data of the Modified FilmArray RP to the Original FilmArray RP for 44 Contrived Specimens
Positive Agreement Negative Agreement
Organism orig + orig + orig - orig -
PPA 95% CI NPA 95% CI
mod + mod - mod - mod +
Adenovirus
52.3%
(AdVC2 and 0 0 n/a n/a 23 21a 36.7 – 67.5%
(23/44)
AdVC6)
C. 88.9% 100%
8 1 51.8 – 99.7% 35 0 90.0 – 100%
pneumoniae (8/9) (35/35)
M. 100% 100%
14 0 76.8 – 100% 30 0 88.4 – 100%
pneumoniae (14/14) (30/30)
orig = original FilmArray RP, mod = modified FilmArray RP, PPA = positive percent agreement, NPA = negative percent
agreement, CI = confidence interval
a In addition to ten specimens spiked with AdVC6 and ten specimens spiked with AdVC2, modified FilmArray RP also detected
an Adenovirus in the background of one specimen that had been spiked with C. pneumoniae. This detection was confirmed by
bi-directional sequence analysis to be AdVC2.
The Adenoviruses detected in archived specimens were categorized into serotype groups using bi-directional
sequence analysis. Combined, the archived and contrived specimen comparison data demonstrates improved
detection of AdVC2, AdVC5, AdVC6, AdVE4 by modified FilmArray RP as compared to original FilmArray RP.
Table 23. Adenovirus Serotype Detections by the Modified FilmArray RP and the Original FilmArray RP in Archived and
Contrived Specimens
Number of Adenovirus-positive
Adenovirus Specimens Detections by Original FilmArray
(Serotyped by PCR) (as Detected by Modified RP
FilmArray RP)
AdVC1 8 8/8 (100%)
AdVC2 15 a 2/15 (13%)
AdVC5 2 1/2 (50%)
AdVC6 16 a 1/16 (6%)
AdVB3 1 1/1 (100%)
AdVE4 3 2/3 (67%)
AdV serotype unknown 2 0/2 (0%)
a Ten AdVC2 specimens and ten AdVC6 specimens were contrived by spiking these viruses into NPS specimens.
One AdVC2 was also detected and sequence confirmed in the background of a specimen spiked with C. pneumoniae.
Limit of Detection
The analytical sensitivity or Limit of Detection (LoD) for FilmArray RP organisms was determined by testing limiting
dilutions of quantified cultures or clinical specimens. LoD is defined as the lowest concentration at which the organism
is consistently detected (detection in ≥95% of samples tested). Simulated NPS sample matrix (cultured human cells in
VTM) was spiked with one or more organisms and at least 20 replicates were tested at the estimated LoD
concentration. The LoD concentration for each FilmArray RP analyte listed in Table 24 has been confirmed with
detection in at least 19/20 replicates (≥95%) on the FilmArray and FilmArray 2.0 systems. The FilmArray Torch
system detected these same analytes at 1x LoD (based on FilmArray 2.0) with a rate of ≥95% (n=20).
Table 24. LoD for Organisms Detected by FilmArray RP
Organism Strain LoD Concentration
AdVC1
AdVC2
Adenovirusa 100 TCID50/mLa
AdVE4
AdVC6
Coronavirus 229E ATCC VR-740 4 TCID50/mL
Coronavirus HKU1b Clinical Specimen a 1.9 x 106 RNA copies/mL
Coronavirus NL63 NR-470 5 TCID50/mL
Coronavirus OC43 ATCC VR-759 600 TCID50/mL
Enterovirus Echovirus 6 30,000 TCID50/mLc
hMPV-16, IA10-2003
Human Metapneumovirus 2 TCID50/mL
(Type A1)
Human Rhinovirus Type 1A 1 TCID50/mL
A/Brisbane/59/07 200 TCID50/mL
Influenza A H1N1
A/New Caledonia/20/99 2,000 TCID50/mL
Influenza A H1-2009 A/SwineNY/03/2009 100 TCID50/mL
A/Wisconsin/67/2005 5 TCID50/mL
Influenza A H3N2
A/Port Chalmers/1/73 50 TCID50/mL
B/FL/04/06
Influenza B 60 TCID50/mL
B/Taiwan/2/62
Parainfluenza Virus 1 Type 1 500 TCID50/mL
Organism Strain LoD Concentration
Parainfluenza Virus 4 Type 4 (subtype A) 5,000 TCID50/mL
Respiratory Syncytial Virus Type A 2 TCID50/mL
Bordetella pertussis A639 4,000 CFU/mL
Chlamydophila pneumoniae TW183 3,000 DNA copies/mL
Mycoplasma pneumoniae M129 (Type 1) 30 TCID50/mL
a LoD for Adenovirus of 100TCID50/mL was confirmed using the modified FilmArray RP (v1.7). The original FilmArray RP
Adenovirus LoD was 300 TCID50/mL.
b Coronavirus HKU1 was evaluated using a clinical specimen containing a high load of Coronavirus HKU1. The
specimen was quantified by real-time PCR against a standard curve of synthetic Coronavirus HKU1 RNA transcript to
obtain quantification of the viral nucleic acid in specimen (RNA copies/mL).
c The Enterovirus LoD (30,000 TCID /mL) represents the sensitivity of the Entero1 and Entero2 assays. A positive
50
Human Rhinovirus/Enterovirus result can be obtained at 100-fold lower concentrations (300 TCID50/mL) based on
detection of the virus with a combination of 6 relevant assays (HRV1-4, Entero1, and Entero2).
NOTE: Most viruses were re-grown and quantified in TCID50 (50% Tissue Culture Infectious Dose) for LoD
determination. The unit TCID50 is a measure of infectivity or cytotoxicity rather than number of organisms or
copies of nucleic acid. Variability in TCID50/mL may not accurately reflect differences in the relative sensitivity of
detection between different organisms or different strains of the same organism.
Analytical Reactivity (Inclusivity)

The analytical reactivity of the FilmArray RP assays was evaluated with an inclusivity panel consisting of
strains/isolates that represent the genetic, temporal, and geographic diversity of the FilmArray RP: 33 Adenovirus, 6
Coronavirus (1 229E, 3 HKU1, 1 OC43, and 1 NL63), 10 human Metapneumovirus, 12 Enterovirus, 14 Rhinovirus, 22
Influenza A (including 10 Influenza A H1, 3 Influenza A H1-2009, and 9 Influenza A H3), 11 Influenza B, 12
Parainfluenza Virus (3 PIV1, 2 PIV2, 3 PIV3, and 4 PIV4), 6 Respiratory Syncytial Virus, 9 Bordetella pertussis, 4
Chlamydophila pneumoniae, and 9 Mycoplasma pneumoniae. Each strain was initially tested in a simulated NPS
sample matrix at or near the LoD (using the original FilmArray RP unless otherwise noted). Higher concentrations
were tested if the organism was not detected at LoD. Each of the 148 strains tested in this study were detected by the
FilmArray RP.
For some organisms, additional analysis of clinical data and in silico analysis of NCBI database sequences was
carried out to supplement the testing of the inclusivity panel.
Adenovirus
Adenovirus inclusivity testing was performed on 33 Adenovirus isolates representing 22 different serotypes within
species A-F. Each isolate was tested at LoD concentration (100 TCID50/mL) using the modified FilmArray RP. If
an Adenovirus isolate was not detected at LoD, testing was repeated at 10x LoD. Isolates not detected at 10x
LoD (1,000 TCID50/mL) are listed as Not Detected, however, some reactivity may be observed with these
serotypes if present in a sample at high levels.
Table 25 provides inclusivity results for respiratory serotypes belonging to species B, C, and E. The FilmArray RP
was designed to detect all respiratory species/serotypes of Adenovirus.
AdVB55 and AdVC57 are the only respiratory serotypes that were not evaluated for inclusivity. Available
sequence information for these serotypes indicates a perfect match to FilmArray RP Adenovirus assay primers
and efficient detection at 1x LoD is predicted.
Table 25. Results of Inclusivity Testing for Adenovirus - Respiratory Serotypes
Concentration Multiple of LoD
Species Serotype Isolate Detected Detected
3 Zeptometrix #0810062CF 100 TCID50/mL 1x
7a Zeptometrix #0810021CF 100 TCID50/mL 1x
7d2 Iowa/2001 100 TCID50/mL 1x
7h Iowa/1999 100 TCID50/mL 1x
11 Wisconsin/2005 100 TCID50/mL 1x
B 14 Missouri/2005 100 TCID50/mL 1x
16 ATCC VR-17 100 TCID50/mL 1x
21 Missouri/2005 100 TCID50/mL 1x
34 Texas/2005 100 TCID50/mL 1x
New York/2004 100 TCID50/mL 1x
ATCC VR-846 100 TCID50/mL 1x
2 Clinical isolate #266153 100 TCID50/mL 1x
Clinical isolate #266161 100 TCID50/mL 1x
C
Colorado/2005 100 TCID50/mL 1x
ATCC VR-6 100 TCID50/mL 1x
6 Clinical isolate #274924 100 TCID50/mL 1x
4a South Carolina/2004 100 TCID50/mL 1x
E
4p3 New Jersey/2005 100 TCID50/mL 1x
Table 26 provides inclusivity results for non-respiratory serotypes belonging to species A, D, and F. The
sensitivity of detection for non-respiratory adenoviruses will vary.
Table 26. Results of Inclusivity Testing for Adenovirus - Non-Respiratory Serotypes

Species Serotype Isolate Detected Detected
12 ATCC VR-863 Not Detecteda
A 18 ATCC VR-19 Not Detecteda
Db 20 Zeptometrix #0810115CF 100 TCID50/mL 1x
40 Zeptometrix #0810084CF Not Detecteda
F
41 Indiana/2004 100 TCID50/mL 1x
a Adenovirus serotypes AdVA12, AdVA18 and AdVF40 were not detected when tested at 10x LoD (TCID50/mL).
b Adenovirus species D is comprised of over 30 different serotypes.
Supplemental Adenovirus Reactivity Information (clinical data from original and modified FilmArray RP):
A subset of prospective and retrospective archived clinical specimens that were FilmArray RP positive for
Adenovirus was subjected to PCR and bi-directional sequence analysis. BLAST analysis of the sequence data
obtained for a region of the Adenovirus hexon gene identified species B (serotypes 3, 3+11p, 7, 16 and 21),
species C (serotypes 1, 2, 5, and 6), and species E (serotype 4) in these clinical specimens. Species A, D, F, and
G (often associated with conjunctivitis and gastroenteritis) were not identified in clinical specimens.
Coronaviruses 229E, HKU1, OC43 and NL63

Table 27. Results of Inclusivity Testing for Coronaviruses
Coronavirus Strain / Isolate Detected Detected
229E ATCC VR-740 4 TCID50/mL 1x
6
2.08 x 10
Clinical Specimen #1120 1.1x
RNA copies/mLb
1.41 x 104 TCID50/mLa
HKU1 Clinical Specimen #6123 1x
~1.9 x 106 RNA copies/mLb
Clinical Specimen #6213
1.9 x 106 RNA copies/mLb 1x
(Type B)c
NL63 BEI Resources NR-470 50 TCID50/mL 1x
OC43 ATCC VR-759 600 TCID50/mL 1x

a Viruscontained in Clinical Specimen #6123 was grown in culture and quantified (TCID50/mL) by infectivity assay.
b Quantification of the viral RNA contained in clinical specimens containing Coronavirus HKU1 was performed using real-time
RT-PCR against a standard curve generated from a synthetic RNA template.
c Classification of Coronavirus HKU1 Clinical Specimen #6213 (Type B) was determined by bi-directional sequence analysis of
the nucleocapsid (N) gene.
Table 28. Results of Inclusivity Testing for Human Metapneumovirus
Subtype Strain ID Detected Detected
9 IA3-2002 2 TCID50/mL 1x
A1
16 IA10-2003 2 TCID50/mL 1x
20 IA14-2003 2 TCID50/mL 1x
A2
27 IA27-2004 2 TCID50/mL 1x
3 Peru2-2002 2 TCID50/mL 1x
5 Peru3-2003 2 TCID50/mL 1x
B1
13 IA7-2003 2 TCID50/mL 1x
18 IA18-2003 2 TCID50/mL 1x
B2 8 Peru6-2003 2 TCID50/mL 1x
Subtype Strain ID Detected Detected
22 IA16-2003 2 TCID50/mL 1x
Human Rhinovirus and Enterovirus

Analytical inclusivity testing evaluated the reactivity of the FilmArray RP HRV and Entero assays with 25
individual serotypes representing various species, including Enterovirus species A-D and Human Rhinovirus
species A and B.
Table 29. Results of inclusivity Testing for Human Rhinovirus / Enterovirus
Concentration Multiple of LoDa
Species Strain / Serotype Detected Detected
Coxsackievirus A10
30,000 TCID50/mL 1x
ATCC VR-168
Enterovirus A Enterovirus 71 1:30,000
n/a
ATCC VR-1432 dilution of stock
Enterovirus 71 9,400 TCID50/mL b <1x
Coxsackievirus A9 9,400 TCID50/mL b <1x
Coxsackievirus B3 30,000 TCID50/mL 1x
Coxsackievirus B4 30,000 TCID50/mL 1x

Enterovirus B
Echovirus 6 30,000 TCID50/mL 1x
b
Echovirus 9 9,400 TCID50/mL <1x
Echovirus 11 300,000 TCID50/mL 10x

Coxsackievirus A21 /Kuykendall
30,000 TCID50/mL 1x
ATCC VR-850
Enterovirus C
Coxsackievirus A24 DN-19
30,000 TCID50/mL 1x
ATCC VR-583
Enterovirus 68 (F02-3607 corn)
Enterovirus D 30,000 TCID50/mL 1x
ATCC VR-1197
A1 1 TCID50/mL 1x
A2 (HGP)
10 TCID50/mL 10x
ATCC VR-482
A7 (68-CV11)
1 TCID50/mL 1x
ATCC VR-1601
A16 (11757)
10 TCID50/mL 10x
ATCC VR-283
Rhinovirus A A34 (137-3)
1 TCID50/mL 1x
ATCC VR-507
A57 (Ch47)
100 TCID50/mL 100x
ATCC VR-1600
A77 (130-63)
1 TCID50/mL 1x
ATCC VR-1187
A85 (50-525-CV54)
10 TCID50/mL 10x
ATCC VR-1195
B3 (FEB)
Rhinovirus B 1 TCID50/mL 1x
ATCC VR-483
Concentration Multiple of LoDa
Species Strain / Serotype Detected Detected
B14 (1059)
1 TCID50/mL 1x
ATCC VR-284
B17 (33342)
100 TCID50/mL 100x
ATCC-282
B27 (5870)
1 TCID50/mL 1x
ATCC VR-1137
B42 (56822)
10 TCID50/mL 10x
ATCC VR-338
B83 (Baylor 7)
1 TCID50/mL 1x
ATCC VR-1193
a The LoD for Enterovirus used for this study was 30,000 TCID50/mL. The LoD for Rhinovirus was 1 TCID50/mL.
b Strains were tested below the Enterovirus LoD concentration due to a lesser concentration of virus in the culture fluid.
Supplemental Human Rhinovirus/Enterovirus Reactivity Information (clinical data and in silico analyses):
In addition to the analytical inclusivity testing, BLAST analysis was performed on sequence data obtained from
prospective and retrospective archived clinical specimens that were FilmArray positive for Human
Rhinovirus/Enterovirus. The following species and subtypes were identified in clinical specimens:
Enterovirus Species A: Enterovirus serotype 71

Coxsackievirus A2 and A6
Enterovirus Species B: Echovirus serotypes 3, 6, 7, 11, 15, 21 and 30

Coxsackievirus B1, B3 and A9
Enterovirus serotypes 81 and 88
Rhinovirus Species A: Human Rhinovirus serotypes 1B, 8, 9,10, 13, 19, 21, 22, 23, 28, 30, 32, 34, 38,
39, 40, 46, 47, 49, 51, 54, 56, 58, 59, 61, 62, 66, 68, 75, 77, 78, 80, 82, 98 and
100
Rhinovirus Species B: Human Rhinovirus serotypes 27, 69, 83 and 91
Rhinovirus Species C: at least 3 individual strains and 12 distinct isolates a
aHuman Rhinovirus species C (also known as Enterovirus species D) has not been classified into serotypes.
Enterovirus species C includes Poliovirus types 1-3. Simulated reactivity of the FilmArray RP Human
Rhinovirus/Enterovirus assays with Enterovirus Species C Poliovirus sequences was generated using a
bioinformatics approach. Alignment of assay primer sequences with the listed GenBank sequences indicates the
FilmArray RP assay can react with Poliovirus types 1, 2 and 3, giving a Human Rhinovirus/Enterovirus result.
Table 30. Simulated Reactivity of the FilmArray RP HRV and Entero Assays with Poliovirus Sequences
Strain GenBank ID Simulated FilmArray RP Result
Human poliovirus 1 strain CHN8264c/GZ/CHN/2004 FJ769385 Human Rhinovirus/Enterovirus
Human poliovirus 2, complete genome AY177685 Human Rhinovirus/Enterovirus
Human poliovirus 3 strain IRA10853, complete genome EU684056 Human Rhinovirus/Enterovirus
Influenza A
Table 31. Results of Inclusivity Testing for Human Isolates of Influenza A
Type Strain Detected Detected
A/Brisbane/59/07 200 TCID50/mL 1x
A/Solomon Islands/3/2006 200 TCID50/mL 1x

A/Hawaii/15/01
1:300a n/a
CDC#2001701117
A/New Caledonia/20/99 200 TCID50/mL 1x
Influenza A A1/Denver/1/57 200 TCID50/mL 1x

H1
A/Mal/302/54 200 TCID50/mL 1x
A1/FM/1/47 200 TCID50/mL 1x
A/Weiss/43 200 TCID50/mL 1x
A/PR/8/34 2000 TCID50/mL 10x
A/NWS/33 200 TCID50/mL 1x
A/SwineNY/01/2009 100 TCID50/mL 1x

Influenza A
H1-2009
A/Brisbane/10/07 5 TCID50/mL 1x
A/Wisconsin/67/2005 5 TCID50/mL 1x
A/NewYork/55/2005
1:300,000 a n/a
CDC#2005705561
A/Victoria/3/75 5 TCID50/mL 1x
Influenza A
H3
A/Port Chalmers/1/73 5 TCID50/mL 1x
A/Aichi/2/68 50 TCID50/mL 10x
A/Hong Kong/8/68 5 TCID50/mL 1x

Alice (vaccine) A/England/42/72
5 TCID50/mL 1x
ATCC VR-776
Type Strain Detected Detected
MRC-2 Recombinant strain
5 TCID50/mL 1x
ATCC VR-777
a Strain was not re-cultured and titered. Dilutions of the original culture/titer from the CDC were used.
The HA titer for A/Hawaii/15/01 is unknown and the HA titer for A/NewYork/55/2005 was 256.
Supplemental Reactivity Information for Influenza Strains of Human, Swine and Avian Origin (analytical testing data and in silico
analyses):
Influenza A viruses are classified by host and subtype, a combination of H (hemagglutinin) and N (neuraminidase)
types. Occasionally, non-human Influenza strains are transferred to human hosts. Several strains of swine and
avian influenzas were tested or analyzed using bioinformatics for reactivity with the Influenza A and subtyping
assays contained in the FilmArray RP. The Influenza A assays (FluA-pan1 and FluA-pan2) were designed to
react with all strains of Influenza A. FilmArray RP Influenza A subtyping assays (FluA-H1-pan, FluA-H1-2009 and
FluA-H3) were designed to react with specific HA subtypes, with a focus on human host strains. The FluA-H1-
2009 assay was designed to be specific for the human pandemic variant of swine origin H1N1 that emerged in
2009.
Testing of viral isolates or nucleic acid from viral culture indicate that the FilmArray RP Influenza A and subtyping
assays react with some strains of swine and avian origin as expected (Table 32)
Table 32. Results of Inclusivity Testing with Swine and Avian Isolates of Influenza A
FilmArray
Host Subtype Isolate / Strain Test Concentration Result
H1N1 Influenza A/Swine/1976/31 ~1 x 106 EID50/mL
Swine Influenza A H1a
H1N1 Influenza A/Swine/Iowa/15/30 ~1 x 107 EID50/mL
Avian Kilbourne F63

H1N2 14.8 ng RNA Influenza A H1
A/NWS/34 (HA) x A/Rockefeller Institute/5/57 (NA)b
a No reactivity was observed with the H1-2009 subtyping assay or other FilmArray RP assays.
b Purified and quantified RNA from avian influenza culture was obtained from BEI Resources.
Laboratory testing of Influenza A strains was supplemented with in silico predictions of reactivity using
bioinformatics and sequence alignments between FilmArray RP assay primers and sequences for Influenza A
strains of human, swine, and avian origin. For each strain, multiple (3) GenBank IDs were evaluated,
corresponding to the gene segments targeted by the FilmArray RP assays (matrix (MA), non-structural (NS) and
hemagglutinin (HA)). Simulated reactivity was determined based on the number and location of mismatches in the
targeted region.
Based on this analysis, the strains listed in Table 33 are predicted to react with the FilmArray RP Influenza A and
H1 or H3 subtyping assays as indicated.
Table 33. Simulated Reactivity of FilmArray Influenza A assays with Human, Swine, and Avian Influenza Strains
Simulated FilmArray
Host Subtype Isolate / Strain GenBank ID Result
CY026540
H1N1 A/California/UR06-0393/2007(H1N1) CY026543
CY026539
Influenza A H1
CY002668
H1N2 A/New York/297/2003(H1N2) CY002665
CY002664
CY063606
Human H1-2009 A/Aalborg/INS133/2009(H1N1) CY063610 Influenza A H1-2009
CY063607
CY044581
H3N2 A/Boston/38/2008(H3N2) CY044584
CY044580
Influenza A H3
JN655537
A/(H3N2)va A/Pennsylvania/09/2011(H3N2) JN655534
JN655538
CY022414
H1N1 A/swine/Wisconsin/1/1971(H1N1) CY022417
CY022413
Swine Influenza A H1
GQ229348
H1N2 A/swine/Hong Kong/NS857/2001(H1N2) GQ229350
GQ229347
CY004635
H3N1 A/blue-winged teal/ALB/452/1983(H3N1) CY004638
CY005940
CY060261
H3N5 A/mallard/Netherlands/2/1999(H3N5) CY060264
CY060265
Avian Influenza A H3
CY033372
A/northernshoveler/California/HKWF1367/200
H3N7 CY033375
7(H3N7)
CY033376
GU052299
A/American black
H3N8 GU052302
duck/Washington/699/1978(H3N8)
GU052300
aSwine-origin variant H3N2 virus identified in human clinical specimens in 2011. All available GenBank sequences (as of Dec.
12, 2011) were evaluated and a single representative sequence is provided in this table. All isolates for which sequences are
available are predicted to generate an Influenza A H3 result when tested with the FilmArray RP.
The strains of human, swine or avian origin listed in Table 34 are predicted to react only with the FilmArray RP
Influenza A (FluA-pan1 and FluA-pan2) assays, giving an Influenza A (no subtype detected) result.
Table 34. Simulated Reactivity of FilmArray Influenza A assays with Human, Swine, and Avian Influenza Strains
Simulated
Host Subtype Strain GenBank ID
FilmArray RP Reactivity
CY022013
H2N2 A/Albany/20/1957(H2N2) CY022014
CY022017
HQ200572
A/Cambodia/R0405050/2007(H5N1) HQ200573
FJ225472
H5N1
AF084281
A/Hong Kong/486/97(H5N1) AF255368
AF115289
EU587368
Human H7N2 A/New York/107/2003(H7N2) EU587373
EU587374 Influenza A
CY015006 (no subtype detected)
H7N3 A/Canada/rv504/2004(H7N3) CY015007
CY015010
AY340089
H7N7 A/Netherlands/219/03(H7N7) AY342422
AY338459
AJ404626
H9N2 A/Hong Kong/1073/99(H9N2) AJ278647
AJ278649
GQ495135
H1N2 A/swine/Sweden/1021/2009(H1N2) GQ495136
GQ495132
Swine
HM440124
H5N1 A/swine/East Java/UT6010/2007(H5N1) HM440111
HM440123
CY014822
A/chicken/New York/13828-3/1995(H2N2) CY014825
CY014821
CY045804
H2N2 A/Japan/305/1957(H2N2) CY014977
CY014980
CY031595
A/Korea/426/1968(H2N2) CY031596
CY031599
GU051135
A/American black duck/North Carolina/675-
H3N2 GU051136
075/2004(H3N2)
Avian GU051137
CY047696
A/American black duck/New
H3N6 CY047697
Brunswick/25182/2007(H3N6)
CY047700
CY063977
A/blue-winged teal/Minnesota/Sg-
H4N6 CY063978
00043/2007(H4N6)
CY063981
EU814503
A/rook/Rostov-on-Don/26/2007(H5N1) EU814504
H5N1 EU814507
GU186509
A/turkey/VA/505477-18/2007(H5N1)
GU186510
Simulated
Host Subtype Strain GenBank ID
FilmArray RP Reactivity
GU186513
HQ156765
A/chicken/Bangladesh/1151-
HQ156766
10/2010(H5N1)
HQ156764
AB295603
H5N2 A/duck/Pennsylvania/10218/1984(H5N2) AB286120
AB286652
GU052802
H5N3 A/duck/Singapore/F119/3/1997(H5N3) GU052803
GU052805
EU743286
H6N1 A/duck/PA/486/1969(H6N1) EU743287
EU743289
HQ244430
A/mallard/Czech Republic/15902-
H6N2 HQ244433
17K/2009(H6N2)
HQ244434
FJ750872
H7N7 A/mallard/Korea/GH171/2007(H7N7) FJ959087
FJ959090
CY014663
H9N2 A/turkey/Wisconsin/1/1966(H9N2) CY014664
CY014667
GQ176136
H10N7 A/chicken/Germany/N/1949(H10N7) GQ176135
GQ176132
CY014691
H11N9 A/duck/Memphis/546/1974(H11N9) GQ257441
CY014687
Influenza B
Table 35. Results of Inclusivity Testing for Influenza B
Multiple of LoD
Strain Concentration Detected Detected
B/FL/04/06 60 TCID50/mL 1x
B/Ohio/01/2005
1:3,000,000a n/a
CDC#2005743348
B/Florida/07/04 60 TCID50/mL 1x
B/Malaysia/2506/04 600 TCID50/mL 10x
B/Hong Kong/5/72 ATCC VR-823 60 TCID50/mL 1x
B/Taiwan/2/62 ATCC VR-295 60 TCID50/mL 1x
B/Maryland/1/59 ATCC VR-296 600 TCID50/mL 10x
B/GL/1739/54 ATCC VR-103 60 TCID50/mL 1x
B/Allen/45 ATCC VR-102 6,000 EID50/mL n/a
B/Lee/40ATCC VR-101 60 TCID50/mL 1x
Multiple of LoD
Strain Concentration Detected Detected
B/Brigit Recombinant ATCC VR-786 60 TCID50/mL 1x
a Strain
was not re-cultured and titered. Dilutions of the original culture/titer from the CDC were used.
The HA titer for B/Ohio/01/2005 was 128.
Parainfluenza Viruses
Table 36. Results of Inclusivity Testing for Parainfluenza Viruses
Multiple of LoD
Type Strain or Source Concentration Detected
Zeptometrix #0810014CF 500 TCID50/mL 1x
PIV1 C-35 ATCC VR-94 500 TCID50/mL 1x
C39 BEI NR-3226 500 TCID50/mL 1x

PIV2
Greer ATCC VR-92 10 TCID50/mL 1x
PIV3 C-243 ATCC VR-93 500 TCID50/mL 50x
NIH 47885 BEI NR-3233 100 TCID50/mL 10x
M25 ATCC VR-1378 5000 TCID50/mL 1x

A
PIV4 Zeptometrix #0810060CF 5000 TCID50/mL 1x
CH-19503 ATCC VR-1377 5000 TCID50/mL 1x

B
Zeptometrix #08010060BCF 5000 TCID50/mL 1x
Respiratory Syncytial Virus

Table 37. Results of Inclusivity Testing for Respiratory Syncytial Virus
Type Strain or Source Detected Detected
Zeptometrix #0810040ACF 2 TCID50/mL 1x
A A/A2 ATCC VR-1540 2 TCID50/mL 1x
A/Long ATCC VR-26 2 TCID50/mL 1x
B/9320 ATCC VR-955 2 TCID50/mL 1x
B B/Wash18537/62 ATCC VR-1580 2 TCID50/mL 1x
B/WV/14617/85 ATCC VR-1400 2 TCID50/mL 1x
Table 38. Results of Inclusivity Testing for Bordetella pertussis
Multiple of LoD
Strain Concentration Detected
Detected
A639 4000 CFU/mL 1x
E431 4000 CFU/mL 1x
F ATCC 8467 4000 CFU/mL 1x
5 [17921] ATCC 9340 4000 CFU/mL 1x
18323 [NCTC 10739] ATCC 9797 4000 CFU/mL 1x
10-536 ATCC 10380 4000 CFU/mL 1x
CNCTC Hp 12/63 [623] ATCC 51445 4000 CFU/mL 1x

Tohama I ATCC BAA-589
4000 CFU/mL 1x
(vaccine strain)
MN2531 ATCC BAA-1335 4000 CFU/mL 1x
Chlamydophila pneumoniae
Table 39. Results of Inclusivity Testing for Chlamydophila pneumoniae
Multiple of LoD
Strain Concentration Detected
Detected
AR-39 ATCC 53592 3000 copies/mL 1x
CDC/CWL-029 VR-1310 3000 copies/mL 1x
CM-1 ATCC VR-1360 3000 copies/mL 1x
TW183 ATCC VR-2282 3000 copies/mL 1x
Table 40. Results of Inclusivity Testing for Mycoplasma pneumoniae
Multiple of LoD
Type Strain Concentration Detected
Detectedb
M129 30 TCID50/mL 1x
M129-B7
Type 1 300 CCU/mLa 10x
ATCC 29342
PI 1428
3,000 CCU/mL 100x
ATCC 29085
FH strain [NCTC 10119]
300 CFU/mLc n/a
ATCC 15531
Type 2
[Mac]
300 CCU/mL 10x
ATCC 15492
[M52]
300 CCU/mL 10x
ATCC 15293
[Bru]
Not Determined 30,000 CCU/mL 1,000x
ATCC 15377
Mutant 22
30 CCU/mL 1x
ATCC 39505
Multiple of LoD
Type Strain Concentration Detected
Detectedb
UMTB-10G
300 CCU/mL 10x
ATCC 49894
a CCU = Color Changing Unit. Both TCID50 and CCU were determined according to the Reed-Muench method. Quantification
in CCU/mL was considered equivalent to quantification in TCID50/mL.
b Following inclusivity testing, all M. pneumoniae isolates previously quantified in CCU/mL were re-evaluated by real-time PCR
against a standard curve of the LoD strain (M129, TCID50/mL). Based on relative molecular quantification, all isolates were
detected at levels <1x – 10x LoD, rather than 1-1,000x LoD determined by CCU/mL. ATCC 49894, ATCC 15293, ATCC
29342, and ATCC 39505 were detected at or below 1x LoD, while ATCC 15492, ATCC 29085, and ATCC 15377 were
detected between 1-10x LoD.
c This was the only M. pneumoniae isolate in the panel able to form colonies on plates and was quantified in CFU/mL.
Analytical Specificity (Cross-Reactivity and Exclusivity)

The potential for cross-reactivity between assays contained in the FilmArray RP was evaluated by testing
simulated NPS samples containing high concentrations of respiratory panel organisms (tens to thousands-fold
higher than LoD). Exclusivity testing was performed with the modified FilmArray RP, except where indicated. No
cross-reactivity was observed with the strains and concentrations listed in Table 41.
NOTE: The Coronavirus OC43 assay may cross-react with certain strains of Coronavirus HKU1 when present in
the sample at high concentrations.
Table 41. Results of Testing for Cross-Reactivity with FilmArray RP Organisms
Virus or
Bacterium Type / Strain Test Concentration Multiple of LoD Tested
Adenovirus AdVC1 1.00x105 TCID50/mL 1,000x
229E
5.67x103 TCID50/mL 1,418x
ATCC VR-740
HKU1a
1.34x108 copies/mL 70x
Clinical specimen 42/08
Coronavirus
NL63
5.67x103 TCID50/mL 1,134x
NR-470
OC43
7.30x104 TCID50/mL 122x
ATCC VR-759
Human Type A1 hMPV-16
8.17x103 TCID50/mL 4,085x
Metapneumovirus IA10-2003 A1
Human Rhinovirus / Echovirus 6 3.40x106 TCID50/mL 113x

Enterovirus Rhinovirus A1 5.67x103 TCID50/mL 5,670x
A/Brisbane/59/07 1.00x105 TCID50/mL 500x
A/New Caledonia/20/99b 1.00x105 TCID50/mL 500x
A/PR/8/34b 1.00x106 TCID50/mL 5,000x
Influenza A A1/FM/1/47b 4.70x103 TCID50/mL 24x

H1N1 A/NWS/33b 4.70x103 TCID50/mL 24x
A1/Denver/1/57b 4.70x103 TCID50/mL 24x
A/Solomon Islands/3/2006 b 1.39x104 TCID50/mL 70x
A/Weiss/43b 4.70x103 TCID50/mL 24x
Virus or
A/Mal/302/54b 1.39x104 TCID50/mL 70x
Influenza A
A/SwineNY/03/2009 8.40x104 TCID50/mL 840x
H1-2009
A/Wisconsin/67/2005 8.17x103 TCID50/mL 1634x
A/Victoria/3/75b 4.70x103 TCID50/mL 940x
A/Port Chalmers/1/73b 5.67x103 TCID50/mL 1,134x
Influenza A A/Aichi/2/68b 1.00x105 TCID50/mL 20,000x

H3N2 A/Hong Kong/8/68b 1.00x105 TCID50/mL 20,000x
A/Aliceb 4.70x103 TCID50/mL 940x
A/MRC 2b 8.17x103 TCID50/mL 1,634x
A/Brisbane/10/07b 8.17x103 TCID50/mL 1,634x
B/FL/04/06 1.67x104 TCID50/mL 278x
B/Lee/40b 8.17x103 TCID50/mL 136x
B/Taiwan/2/62b 5.03x104 TCID50/mL 838x
B/GL/1739/54b 8.17x103 TCID50/mL 136x
B/Maryland/1/59b 8.17x103 TCID50/mL 136x

Influenza B
B/Florida/07/04b 1.00x105 TCID50/mL 1,667x
B/Malaysia/2506/04b 5.67x103 TCID50/mL 95x
B/Allen/45b 1.00x105 TCID50/mL 1,667x
B/HongKong/5/72b 8.17x103 TCID50/mL 136x
B/Brigitb 3.50x104 TCID50/mL 583x
Type 1 1.39x104 TCID50/mL 28x
Type 2 1.6x104 TCID50/mL 1,670x

Parainfluenza Virus
Type 3 1.00x105 TCID50/mL 10,000x
Type 4A 5.67x103 TCID50 /mLc 1.13xc
Respiratory A 1.39x104 TCID50/mL 6,950x

Syncytial Virus B 2.14x104 TCID50/mL 10,700x
E431b
A639
ATCC 8467b
Bordetella pertussis ATCC 9797b 1.00x106 CFU/mL 250x
ATCC 51445b
ATCC BAA-589b
ATCC 9340b
Virus or
ATCC 10380b
ATCC BAA-1335b
Chlamydophila
TW183 2.42x105 copies/mL 81x
pneumoniae
M129 1.88x105 TCID50/mL 6,267x
ATCC 15531b 4.27x105 CFU/mL n/a
ATCC 15293b
ATCC 15377b
Mycoplasma
ATCC 15492b
pneumoniae
1.00x106 CCU/mL 33,333x
ATCC 29085b
ATCC 29342b
ATCC 39505b
ATCC 49894b
a Cross-reactivity was not observed between this isolate of Coronavirus HKU1 and the Coronavirus OC43 assay at the
concentration tested. However, in the clinical data set, 2 specimens showed cross-reactivity between the OC43 assay and the
HKU1 virus contained in the specimen.
b Exclusivity testing was performed with the original FilmArray RP.
c Parainfluenza Virus 4A could not be tested at higher concentrations due to the relatively low titer of the stock viral culture.
The potential for the FilmArray RP to cross-react with non-FilmArray RP organisms was evaluated by testing an
exclusivity panel consisting of 26 bacteria, 6 viruses, and 1 yeast. These organisms were selected based on their
relatedness to FilmArray RP organisms, clinical relevance (cause respiratory symptoms or represent
nasopharyngeal flora), or high prevalence within the population (e.g. Herpes Simplex Virus). Negative sample
matrix was spiked with bacteria or fungi at a concentration of 106 CFU/mL and viruses at a concentration between
104 - 105 TCID50/mL, or the highest concentration possible. The FilmArray RP did not cross-react with the
exclusivity panel organisms listed in Table 42.
Table 42. Non-FilmArray RP Exclusivity Panel – No cross-reactivity was observed with the organisms listed
Virus Strain / Isolate
Bocavirus Clinical Specimen
Cytomegalovirus (CMV) AD-169 (VR-538)
Epstein-Barr Virus (EBV) B95-8
Herpes Simplex Virus Type 1
Measles Virus Edmonston
Mumps Zeptometrix # 0810079CF
Yeast Strain / Isolate
Candida albicans Zeptometrix #0801504
Bacterium Strain / Isolate
Bordetella bronchisepticaa clinical isolate
Bordetella holmesii F061
Bordetella parapertussisa A747
Chlamydia trachomatis D-UW3
Corynebacterium diptheriae ATCC14779
Escherichia coli O157:H7
Haemophilus influenzae MinnA
Lactobacillus acidophilus Type strain
Lactobacillus plantarum 17-5
Legionella longbeacheae Long Beach 4
Legionella micdadei Tatlock
Legionella pneumophilia Philadelphia
Moraxella catarrhalis Ne 11 (type strain)
Mycobacterium tuberculosis H37Ra-1
Mycoplasma hominis ATCC 23114
Mycoplasma genitalium ATCC 33530
Neisseria elongate type strain
Neisseria gonorrhoeae ATCC 700825
Neisseria meningitidis M1027 (type strain)
Pseudomonas aeruginosa Zeptometrix #0801519
Staphylococcus aureus COL
Staphylococcus epidermidis RP62A
Streptococcus pneumoniae type 59
Streptococcus pyogenes Zeptometrix #0801512
Streptococcus salivarius ATCC 13419
Ureaplasma urealyticum ATCC 27618
a Though not observed in this study, the FilmArray RP Bordetella pertussis assay can cross-react with strains of B.
bronchiseptica and B. parapertussis that carry a pertussis toxin pseudogene (see Limitations section).
Supplemental Analytical Exclusivity Testing for Influenza Strains of Avian Origin:

Additional analytical exclusivity testing was carried out (using the original FilmArray RP) with either live isolates or
purified genomic RNA of avian host influenza A strains with the following results:
Table 43. Results of Exclusivity Testing of Virus or Nucleic Acid from Cultures of Avian Isolates of Influenza A
Test FilmArray
Host Subtype Isolate / Strain
Concentrationa Result
A/Japan/305/57 3.3 ng RNA

H2N2
Kilbourne F38
6.3 ng RNA
A/Korea/426/68 (HA, NA) x A/Puerto Rico/8/34
H5N1 A/Vietnam/1203/2004 R-H5 N/Ab
Influenza A
Avian H5N2 A/duck/Pennsylvania/10218/84 2.5 ng RNA
(no subtype detected)
Kilbourne F181
H5N3 247 ng RNA
A/duck/Singapore/645/97
H7N2
A/NewYork/107/2003 N/Ab
H7N3
A/Mallard/Netherlands/12/2000 N/Ab
Test FilmArray
Host Subtype Isolate / Strain
Concentrationa Result
H10N7 A/chicken/Germany/N/49 68 ng RNA

a Purified and quantified RNA from Avian Influenza cultures was obtained from BEI Resources
b Stock virus HA titer from CDC = 128. Twenty microliters of virus stock tested.
Supplemental SARS Coronavirus Exclusivity Information:

In silico analysis of SARS virus sequence (GenBank ID NC_004718.3) against primers for each of the 4 FilmArray RP
Coronavirus assays was conducted. When the non-SARS Coronavirus assay primers were aligned with the
corresponding target sequence from SARS virus, each primer contained at least 6 mismatches. Based on alignments,
no reactivity was predicted between SARS virus and the 4 FilmArray RP Coronavirus assays.
Cross-Contamination and Carryover

To evaluate cross-contamination or carryover, high positive samples (Table 41) were loaded and tested back-to-back
with other high positive samples containing different organisms. No false positive results were observed, indicating
that the system design and recommended sample handling practices are effective in preventing carryover.
Reproducibility
A multicenter reproducibility study was performed to determine between-site and overall reproducibility of the
FilmArray RP. Reproducibility testing occurred at three test sites utilizing the original FilmArray RP and a panel of
twelve simulated NPS specimens spiked with various combinations of organisms at three different test levels: Medium
Positive (3X LoD), Low Positive (1X LoD), and High Negative (LoD/10). The High Negative test level was predicted to
generate positive results in approximately 20-80% of the samples tested. On each testing day, two operators at each
site tested two aliquots of specimens on two different FilmArray instruments (six specimens per operator per
instrument per day). Every specimen was tested four times a day on five days at the three testing sites, for a total of at
least 60 tests per organism per concentration. A total of 26 lots of reagents and 20 FilmArray instruments were utilized
in the reproducibility study.
Positive, Equivocal, Negative results and Tm data for each organism are summarized in the tables below:
Table 44. Summary of Positive Agreement, Negative Agreement, and Tm Results from Reproducibility Testing of Single Assay
Organisms
%
Agreement
Adenovirus
with
AdVC1
# # Expected 95% Mean %CV Observed
Positive Negative Result a CI Tm Tm Tm Range
Site A 20/20 0/20 100% 83.2% – 100% 83.74 0.24 83.33 - 84.26
Medium Positive
Site B 20/20 0/20 100% 83.2% – 100% 84.23 0.21 83.95 - 84.60
(3X LoD)c
Site C 20/20 0/20 100% 83.2% – 100% 83.76 0.28 83.03 - 84.13
900 TCID50/mL All
60/60 0/60 100% 94.0% - 100% 83.93 0.36 83.03 - 84.60
Sites
Site A 20/20 0/20 100% 83.2% – 100% 83.42 0.28 83.01 - 83.98
Low Positive
Site B 20/20 0/20 100% 83.2% – 100% 83.90 0.26 83.54 - 84.30
(1X LoD)c
Site C 20/20 0/20 100% 83.2% – 100% 83.62 0.38 83.05 - 84.64
300 TCID50/mL All
60/60 0/60 100% 94.0% - 100% 83.64 0.39 83.01 - 84.64
Sites
Site A 18/20 2/20 90.0% 68.3% – 98.8% 83.33 0.26 83.02 - 83.76
High Negativeb
Site B 16/20 4/20 80.0% 56.3% – 94.3% 83.71 0.30 82.93 - 84.29
(LoD/10)c
Site C 10/20 10/20 50.0% 27.2% – 72.8% 83.26 0.31 82.61 - 83.86
30 TCID50/mL All
44/60 16/60 73.3% 60.3% – 83.9% 83.43 0.38 82.61 - 84.29
Sites
Site A 0/180 180/180 100% 98.0% - 100%
Site B 0/180 180/180 100% 98.0% - 100%
Negative
Site C 0/180 180/180 100% 98.0% - 100%
All
0/540 540/540 100% 99.3% – 100%
Sites
a Expected results for the “Medium Positive”, the “Low Positive”, and the “High Negative” panel members are positive. Expected
result for the “Negative” panel member is negative.

b High negative samples are targeted to be positive 20-80% of the time.
c Reproducibility testing was performed prior to the modification of the panel to include a second Adenovirus assay. Test
concentrations and multiples of LoD reflect the Adenovirus LoD prior to panel modification (300 TCID50/mL).
%
Agreement
Coronavirus 229E
with
ATCC VR-740
Site A 20/20 0/20 100% 83.2% – 100% 81.20 0.20 80.81 - 81.47
Medium Positive Site B 20/20 0/20 100% 83.2% – 100% 81.80 0.32 81.35 - 82.18
(3X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 81.35 0.34 81.03 - 82.13
12 TCID50/mL
All 81.37 0.40 80.81 - 82.18
60/60 0/60 100% 94.0% - 100%
Sites
Site A 20/20 0/20 100% 83.2% – 100% 81.19 0.21 80.83 - 81.66
Low Positive Site B 20/20 0/20 100% 83.2% – 100% 81.62 0.25 81.12 - 82.08
(1X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 81.09 0.32 80.30 - 81.56
4 TCID50/mL
All 81.31 0.38 80.30 - 82.08
60/60 0/60 100% 94.0% - 100%
Sites
Site A 14/20 6/20 70% 45.7% - 88.1% 81.06 0.22 80.72 - 81.43
High Negativeb Site B 7/20 13/20 35% 15.4% - 59.2% 81.54 0.24 81.15 - 82.08
(LoD/10)
Site C 11/20 9/20 55% 31.5% - 76.9% 81.17 0.24 80.70 - 81.68
0.4 TCID50/mL
All 81.25 0.34 80.70 - 82.08
32/60 28/60 53.3% 40.0% - 66.3%
Sites
Site A 0/180 180/180 100% 98.0% - 100%
Site B 0/180 180/180 100% 98.0% - 100%
Negative
Site C 0/180 180/180 100% 98.0% - 100%
All
0/540 540/540 100% 99.3% – 100%
Sites

%
Coronavirus HKU1 Agreement
Type B with
Clinical Specimen 6123 # # Expected 95% Mean %CV Observed
Site A 20/20 0/20 100% 83.2% – 100% 75.61 0.23 75.37 - 76.02
Medium Positive
(3X LoD) Site B 20/20 0/20 100% 83.2% – 100% 76.02 0.26 75.58 - 76.33
Site C 20/20 0/20 100% 83.2% – 100% 75.49 0.32 74.96 - 75.90
5.7 x 106 RNA
copies/mL All Sites 60/60 0/60 100% 94.0% - 100% 75.69 0.41 74.96 - 76.33
Low Positive Site A 20/20 0/20 100% 83.2% – 100% 75.47 0.22 74.96 - 75.79
(1X LoD)
Site B 20/20 0/20 100% 83.2% – 100% 75.89 0.20 75.59 - 76.12
1.9 x106 RNA Site C 20/20 0/20 100% 83.2% – 100% 75.35 0.30 74.83 - 75.81
copies/mL All Sites 60/60 0/60 100% 94.0% - 100% 75.55 0.40 74.83 - 76.12
High Negativeb Site A 15/20 5/20 75.0% 50.9% - 91.3% 75.51 0.28 75.06 - 75.90
(LoD/10)
Site B 17/20 3/20 85.0% 62.1% - 96.8% 75.85 0.22 75.26 - 76.23
1.9 x 105 RNA Site C 19/20 1/20 95.0% 75.1% – 99.9% 75.33 0.22 74.98 - 75.59
copies/mL All Sites 51/60 9/60 85.0% 73.4% – 92.9% 75.55 0.38 74.98 - 76.23
Site A 0/180 180/180 100% 98.0% - 100%
Site B 0/180 180/180 100% 98.0% - 100%
Negative
Site C 0/180 180/180 100% 98.0% - 100%
All Sites 0/540 540/540 100% 99.3% – 100%

%
Agreement
Coronavirus NL63
with
BEI Resources NR-470
Site A 20/20 0/20 100% 83.2% – 100% 80.21 0.31 79.64 - 80.90
Medium Positive
Site B 20/20 0/20 100% 83.2% – 100% 80.55 0.33 79.99 - 81.03
(3X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 80.04 0.25 79.67 - 80.62
15 TCID50/mL All
60/60 0/60 100% 94.0% - 100% 80.29 0.40 79.64 - 81.03
Sites
Site A 20/20 0/20 100% 83.2% – 100% 80.08 0.25 79.57 - 80.42
(1X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 79.88 0.27 79.36 - 80.40
5 TCID50/mL All
60/60 0/60 100% 94.0% - 100% 80.12 0.38 79.14 - 80.89
Sites
Site A 13/20 7/20 65.0% 40.8% - 84.6% 80.08 0.34 79.21 - 80.82
High Negativeb Site B 14/20 6/20 70.0% 45.7% - 88.1% 80.36 0.30 79.98 - 80.91
(LoD/10)
Site C 10/20 10/20 50.0% 27.2% - 72.8% 79.91 0.26 79.24 - 80.30
0.5 TCID50/mL All
37/60 23/60 61.7% 48.2% - 73.9% 80.11 0.39 79.21 - 80.91
Sites
Negative Site A 0/180 180/180 100% 98.0% - 100%
%
Agreement
Coronavirus NL63
with
BEI Resources NR-470
Site B 0/180 180/180 100% 98.0% - 100%
Site C 0/180 180/180 100% 98.0% - 100%
All
0/540 540/540 100% 99.3% – 100%
Sites

%
Agreement
Coronavirus OC43
with
ATCC VR-759
Site A 20/20 0/20 100% 83.2% – 100% 80.98 0.23 80.53 - 81.36
(3X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 81.20 0.26 80.60 - 81.55
1,800 TCID50/mL
All 81.17 0.32 80.53 - 81.82
60/60 0/60 100% 94.0% - 100%
Sites
Site A 20/20 0/20 100% 83.2% – 100% 80.82 0.26 80.29 - 81.25
(1X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 81.07 0.37 80.40 - 81.58
600 TCID50/mL
All 81.07 0.38 80.29 - 81.85
60/60 0/60 100% 94.0% - 100%
Sites
Site A 18/20 2/20 90.0% 68.3% - 98.8% 80.86 0.24 80.49 - 81.25
(LoD/10)
Site C 16/20 4/20 80.0% 56.3% - 94.3% 81.04 0.32 80.11 - 81.45
60 TCID50/mL
All 81.07 0.36 80.11 - 81.81
48/60 12/60 80.0% 67.7% - 89.2%
Sites
Site A 0/180 180/180 100% 98.0% - 100%
Site B 0/180 180/180 100% 98.0% - 100%
Negative
Site C 1/180 179/180 99.4% 96.9% - 100%
All
1/540 539/540 99.8% 99.0% - 100%
Sites

%
Agreement
with
hMPV-16 (Type A1)
Medium Positive Site A 20/20 0/20 100% 83.2% – 100% 77.61 0.23 77.06 - 77.90
(3X LoD)
Site B 20/20 0/20 100% 83.2% – 100% 78.07 0.28 77.67 - 78.61
6 TCID50/mL Site C 19/20 1/20 95.0% 75.1% - 99.9% 77.73 0.21 77.45 - 78.11
All
59/60 1/60 98.3% 91.1% - 100% 77.82 0.36 77.06 - 78.61
Sites
Site A 20/20 0/20 100% 83.2% – 100% 77.39 0.21 77.04 - 77.79
(1X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 77.60 0.24 77.16 - 77.99
2 TCID50/mL All
60/60 0/60 100% 94.0% - 100% 77.62 0.35 77.04 - 78.11
Sites
Site A 17/20 2/20 85.0% 62.1% - 96.8% 77.34 0.20 77.05 - 77.59
High Negativeb
Site B 19/20 6/20 95.0% 75.1% - 99.9% 77.76 0.22 77.06 - 78.11
(LoD/10)
Site C 12/20 4/20 60.0% 36.1% - 80.9% 77.37 0.29 76.74 - 77.79
0.2 TCID50/mL All
48/60 12/60 80.0% 67.7% - 89.2% 77.50 0.35 76.74 - 78.11
Sites
Site A 0/180 180/180 100% 98.0% - 100%
Site B 0/180 180/180 100% 98.0% - 100%
Negative
Site C 0/180 180/180 100% 98.0% - 100%
All
0/540 540/540 100% 99.3% – 100%
Sites

%
Agreement
Influenza B with
B/FL/04/06 # # Expected 95% Mean %CV Observed
Site A 20/20 0/20 100% 83.2% – 100% 80.47 0.26 79.88 - 80.93
Medium Positive
Site B 20/20 0/20 100% 83.2% – 100% 80.88 0.31 80.30 - 81.30
(3X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 80.36 0.32 79.78 - 80.80
180 TCID50/mL All
60/60 0/60 100% 94.0% - 100% 80.56 0.40 79.78 - 81.30
Sites
Site A 20/20 0/20 100% 83.2% – 100% 80.44 0.27 80.00 - 80.92
(1X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 80.34 0.22 79.77 - 80.81
60 TCID50/mL All
60/60 0/60 100% 94.0% - 100% 80.51 0.37 79.77 - 81.33
Sites
Site A 12/20 8/20 60.0% 36.1% - 80.9% 80.42 0.32 79.84 - 80.90
(LoD/10)
Site C 8/20 12/20 40.0% 19.1% - 64.0% 80.30 0.21 79.79 - 80.69
6 TCID50/mL All
30/60 30/60 50.0% 36.8% - 63.2% 80.50 0.36 79.79 - 81.17
Sites
Site A 0/180 180/180 100% 98.0% - 100%
Site B 0/180 180/180 100% 98.0% - 100%
Negative
Site C 0/180 180/180 100% 98.0% - 100%
All
0/540 540/540 100% 99.3% – 100%
Sites
b
High negative samples are targeted to be positive 20-80% of the time.
%
Agreement
with
Zeptometrix # 0810014CFN
Site A 20/20 0/20 100% 83.2% – 100% 78.86 0.26 78.42 - 79.25
Medium Positive
Site B 20/20 0/20 100% 83.2% – 100% 79.32 0.28 78.83 - 79.78
(3X LoD)
Site C 19/20 1/20 95.0% 75.1% - 99.9% 78.50 0.28 78.02 - 78.87
1,500 TCID50/mL All
59/60 1/60 98.3% 91.1% - 100% 78.91 0.50 78.02 - 79.78
Sites
Site A 20/20 0/20 100% 83.2% – 100% 78.60 0.31 77.99 - 79.05
(1X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 78.50 0.38 77.90 - 79.16
500 TCID50/mL All
60/60 0/60 100% 94.0% - 100% 78.67 0.40 77.90 - 79.36
Sites
Site A 15/20 5/20 75.0% 50.1% - 91.3% 78.54 0.25 78.10 - 78.94
(LoD/10)
Site C 13/20 7/20 65.0% 41.0% - 84.6% 78.41 0.35 77.87 - 79.02
50 TCID50/mL All
43/60 17/60 71.7% 58.6% - 82.6% 78.61 0.42 77.79 - 79.36
Sites
Site A 0/180 180/180 100% 98.0% - 100%
Site B 0/180 180/180 100% 98.0% - 100%
Negative
Site C 0/180 180/180 100% 98.0% - 100%
All
0/540 540/540 100% 99.3% – 100%
Sites

%
Agreement
with
Zeptometrix #0810015CF
Site A 20/20 0/20 100% 83.2% – 100% 83.63 0.36 83.01 - 84.39
Medium Positive
Site B 20/20 0/20 100% 83.2% – 100% 84.06 0.40 83.44 - 84.79
(3X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 83.88 0.32 83.13 - 84.28
30 TCID50/mL All
60/60 0/60 100% 94.0% - 100% 83.85 0.42 83.01 - 84.79
Sites
Site A 20/20 0/20 100% 83.2% – 100% 83.56 0.28 82.94 - 84.08
(1X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 83.79 0.32 82.92 - 84.25
10 TCID50/mL All
60/60 0/60 100% 94.0% - 100% 83.78 0.37 82.92 - 84.63
Sites
(LoD/10)
Site B 12/20 8/20 60.0% 36.1% - 80.9% 83.91 0.31 83.43 - 84.56
%
Agreement
with
1 TCID50/mL Site C 11/20 9/20 55.0% 31.5% - 76.9% 83.71 0.36 82.91 - 84.30
All
35/60 25/60 58.3% 44.9% - 70.9% 83.69 0.41 82.71 - 84.56
Sites
Site A 0/180 180/180 100% 98.0% - 100%
Site B 0/180 180/180 100% 98.0% - 100%
Negative
Site C 0/180 180/180 100% 98.0% - 100%
All
0/540 540/540 100% 99.3% – 100%
Sites

%
Agreement
with
Site A 20/20 0/20 100% 83.2% – 100% 81.17 0.36 80.71 - 81.86
Medium Positive
Site B 20/20 0/20 100% 83.2% – 100% 81.48 0.35 81.03 - 81.89
(3X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 80.94 0.28 80.63 - 81.37
30 TCID50/mL All
60/60 0/60 100% 94.0% - 100% 81.22 0.41 80.63 - 81.89
Sites
Site A 20/20 0/20 100% 83.2% – 100% 80.97 0.36 80.36 - 81.52
(1X LoD)
Site C 17/20 3/20 85.0% 62.1% - 96.8% 80.86 0.28 80.10 - 81.21
10 TCID50/mL All
57/60 3/60 95.0% 86.1% - 99.0% 81.08 0.40 80.10 - 81.79
Sites
Site A 10/20 10/20 50.0% 27.2% - 72.8% 80.99 0.26 80.30 - 81.34
(LoD/10)
Site C 5/20 15/20 25.0% 8.7% - 49.1% 80.84 0.24 80.41 - 81.24
1 TCID50/mL All
22/60 38/60 36.7% 24.6% - 50.1% 81.05 0.34 80.30 - 81.77
Sites
Site A 0/180 180/180 100% 98.0% - 100%
Site B 0/180 180/180 100% 98.0% - 100%
Negative
Site C 0/180 180/180 100% 98.0% - 100%
All
0/540 540/540 100% 99.3% – 100%
Sites

%
Agreement
Parainfluenza Virus 4a
with
Site A 20/20 0/20 100% 83.2% – 100% 77.70 0.30 77.36 - 78.10
Medium Positive
(3X LoD) Site B 20/20 0/20 100% 83.2% – 100% 78.09 0.56 77.48 - 78.74
Site C 20/20 0/20 100% 83.2% – 100% 77.73 0.40 77.05 - 78.21
15,000
TCID50/mL All
60/60 0/60 100% 94.0% - 100% 77.82 0.47 77.05 - 78.74
Sites
Site A 20/20 0/20 100% 83.2% – 100% 77.11 0.28 76.64 - 77.68
(1X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 77.23 0.38 76.81 - 78.20
5,000 TCID50/mL All
60/60 0/60 100% 94.0% - 100% 77.33 0.46 76.64 - 78.71
Sites
Site A 4/20 16/20 20.0% 5.7% - 43.7% 77.07 0.26 76.63 - 77.58
(LoD/10)
Site C 11/20 9/20 55.0% 31.5% - 76.9% 77.24 0.30 76.62 - 77.84
500 TCID50/mL All
20/60 40/60 33.3% 21.7% - 46.7% 77.29 0.40 76.62 - 78.00
Sites
Site A 0/180 180/180 100% 98.0% - 100%
Site B 0/180 180/180 100% 98.0% - 100%
Negative
Site C 0/180 180/180 100% 98.0% - 100%
All
0/540 540/540 100% 99.3% – 100%
Sites

b
High negative samples are targeted to be positive 20-80% of the time.
%
Respiratory Syncytial Agreement
Virus with
Type A # # Expected 95% Mean %CV Observed
Site A 60/60 0/60 100% 94.0% - 100% 80.44 0.35 79.46 - 80.83
Medium Positive Site B 60/60 0/60 100% 94.0% - 100% 80.86 0.25 80.41 - 81.56
(3X LoD)
Site C 60/60 0/60 100% 94.0% - 100% 80.39 0.33 80.08 - 80.91
6 TCID50/mL All
180/180 0/180 100% 97.8% - 100% 80.58 0.40 79.46 - 81.56
Sites
Site A 40/40 0/40 100% 91.2% - 100% 79.82 0.50 78.93 - 80.62
Low Positive Site B 40/40 0/40 100% 91.2% - 100% 80.40 0.46 79.47 - 81.03
(1X LoD)
Site C 40/40 0/40 100% 91.2% - 100% 80.13 0.47 79.13 - 80.79
2 TCID50/mL All
120/120 0/120 100% 97.0% - 100% 80.10 0.57 78.93 - 81.03
Sites
(LoD/10)
Site B 17/20 3/20 85.0% 62.1% - 96.8% 80.12 0.50 79.26 - 80.89
0.2 TCID50/mL Site C 11/20 9/20 55.0% 31.5% - 76.9% 79.97 0.57 78.83 - 80.84
%
Respiratory Syncytial Agreement
Virus with
Type A # # Expected 95% Mean %CV Observed
All
46/60 14/60 76.7% 64.0% - 86.6% 79.90 0.58 78.72 - 80.89
Sites
Site A 0/120 120/120 100% 97.0% - 100%
Site B 0/120 120/120 100% 97.0% - 100%
Negative
Site C 0/120 120/120 100% 97.0% - 100%
All
0/360 360/360 100% 99.0% - 100%
Sites

%
Agreement
with
A639
Site A 20/20 0/20 100% 83.2% – 100% 88.36 0.36 87.46 - 89.05
(3X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 88.34 0.18 87.97 - 88.58
12,000 CFU/mL
All 88.50 0.38 87.46 - 89.20
60/60 0/60 100% 94.0% - 100%
Sites
Site A 20/20 0/20 100% 83.2% – 100% 88.39 0.28 87.73 - 88.96
(1X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 88.22 0.28 87.74 - 88.67
4,000 CFU/mL
All 88.42 0.34 87.73 - 89.20
60/60 0/60 100% 94.0% - 100%
Sites
Site A 16/20 4/20 80.0% 56.3% - 94.3% 88.41 0.34 87.86 - 89.36
(LoD/10)
Site C 12/20 8/20 60.0% 36.1% - 80.9% 88.26 0.28 87.52 - 88.71
400 CFU/mL
All 88.46 0.37 87.52 - 89.36
40/60 20/60 66.7% 53.3% - 78.3%
Sites
Site A 0/180 180/180 100% 98.0% - 100%
Site B 0/180 180/180 100% 98.0% - 100%
Negative
Site C 0/180 180/180 100% 98.0% - 100%
All
0/540 540/540 100% 99.3% – 100%
Sites

%
Chlamydophila Agreement
pneumoniae with
TW183 # # Expected 95% Mean %CV Observed
Site A 20/20 0/20 100% 83.2% – 100% 79.65 0.29 78.94 - 79.99
(3X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 79.73 0.23 79.42 - 80.09
9,000 copies/mL
All 79.92 0.45 78.94 - 80.82
60/60 0/60 100% 94.0% - 100%
Sites
Site A 20/20 0/20 100% 83.2% – 100% 79.63 0.27 79.03 - 80.09
Low Positive Site B 19/20 1/20 95.0% 75.1% - 99.9% 80.15 0.28 79.68 - 80.62
(1X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 79.61 0.30 78.84 - 80.09
3,000 copies/mL
All 79.79 0.42 78.84 - 80.62
59/60 1/60 98.3% 91.1% - 100%
Sites
Site A 11/20 9/20 55.0% 31.5% - 76.9% 79.55 0.25 79.25 - 80.08
(LoD/10)
Site C 10/20 10/20 50.0% 27.2% - 72.8% 79.61 0.29 79.16 - 80.21
300 copies/mL
All 79.72 0.38 79.16 - 80.72
35/60 25/60 58.3% 44.9% - 70.9%
Sites
Site A 0/180 180/180 100% 98.0% - 100%
Site B 0/180 180/180 100% 98.0% - 100%
Negative
Site C 0/180 180/180 100% 98.0% - 100%
All
0/540 540/540 100% 99.3% – 100%
Sites

%
Agreement
with
Type 1 - M129
Site A 20/20 0/20 100% 83.2% – 100% 77.42 0.29 77.04 - 77.71
(3X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 77.83 0.28 77.44 - 78.12
90 TCID50/mL
All 77.75 0.38 77.04 - 78.30
60/60 0/60 100% 94.0% - 100%
Sites
Site A 19/20 1/20 95.0% 75.1% - 99.9% 77.55 0.30 77.05 - 78.00
Low Positive Site B 17/20 3/20 85.0% 62.1% - 96.8% 77.96 0.33 77.36 - 78.37
(1X LoD)
Site C 20/20 0/20 100% 83.2% – 100% 77.68 0.39 76.65 - 78.10
30 TCID50/mL
All 77.73 0.40 76.65 - 78.37
56/60 4/60 93.3% 83.8% - 98.2%
Sites
(LoD/10)
Site B 4/20 16/20 20.0% 5.7% - 43.7% 78.01 0.27 77.67 - 78.45
3 TCID50/mL Site C 11/20 9/20 55.0% 31.5% - 76.9% 77.76 0.34 77.04 - 78.09
All 77.78 0.38 76.72 - 78.45
20/60 40/60 33.3% 21.7% - 46.7%
Sites
Site A 0/180 180/180 100% 98.0% - 100%
Site B 0/180 180/180 100% 98.0% - 100%
Negative
Site C 0/180 180/180 100% 98.0% - 100%
All
0/540 540/540 100% 99.3% – 100%
Sites

Table 45. Summary of Positive Agreement, Negative Agreement, and Tm Results from Reproducibility Testing of Multi-
Assay Organisms
Reproducibility Agreement Summary for Enterovirus (Human Rhinovirus/Enterovirus)

%
Enterovirus
# # Agreement with 95%
Echovirus 6 (Species B)
Positive Negative Expected Result a CI
Site A 20/20 0/20 100% 83.2% – 100%
Medium Positive Site B 20/20 0/20 100% 83.2% – 100%
(3X LoD)
Site C 20/20 0/20 100% 83.2% – 100%
90,000 TCID50/mL
All Sites 60/60 0/60 100% 94.0% - 100%
Site A 20/20 0/20 100% 83.2% – 100%

Low Positive Site B 20/20 0/20 100% 83.2% – 100%
(1X LoD)
Site C 20/20 0/20 100% 83.2% – 100%
30,000 TCID50/mL
All Sites 60/60 60/60 100% 94.0% - 100%
Site A 20/20 0/20 100% 83.2% – 100%

High Negativeb
Site B 20/20 0/20 100% 83.2% – 100%
(LoD/10)
Site C 20/20 0/20 100% 83.2% – 100%
3,000 TCID50/mL
All Sites 60/60 0/60 100% 94.0% - 100%
Site A 0/60 60/60 100% 94.0% - 100%

Site B 0/60 60/60 100% 94.0% - 100%
Negative
Site C 0/60 60/60 100% 94.0% - 100%
All Sites 0/180 180/180 100% 97.8% - 100%

Reproducibility Tm Summary (by assay) for Enterovirus
Enterovirus Mean % CV Observed
Assay
Echovirus 6 (Species B) Tm Tm Tm Range
Site A 87.12 0.24 86.79 - 87.73
Medium Positive
3x LoD Site B 87.51 0.30 86.99 - 88.05
Site C 86.98 0.33 86.37 - 87.64
90,000 TCID50/mL
All Sites 87.18 0.39 86.37 - 88.05
Site A 87.00 0.33 86.17 - 87.64
Low Positive
1x LoD Site B 87.36 0.29 86.80 - 87.85
Entero 1
Site C 86.81 0.35 86.15 - 87.41
30,000 TCID50/mL
All Sites 87.05 0.42 86.15 - 87.85
Site A 86.89 0.29 86.06 - 87.40
High Negative
0.1x LoD Site B 87.34 0.31 86.67 - 87.86
Site C 86.67 0.29 85.97 - 87.30
3,000 TCID50/mL
All Sites 86.96 0.44 85.97 - 87.86
Site A 87.09 0.28 86.68 - 87.73
Medium Positive
3x LoD Site B 87.47 0.30 86.82 - 88.00
Site C 86.93 0.36 86.16 - 87.64
90,000 TCID50/mL
All Sites 87.14 0.41 86.16 - 88.00
Site A 86.98 0.30 86.28 - 87.53
Low Positive
1x LoD Site B 87.34 0.28 86.89 - 87.82
Entero 2
Site C 86.77 0.35 86.05 - 87.52
30,000 TCID50/mL
All Sites 87.02 0.41 86.05 - 87.82
Site A 86.86 0.29 86.17 - 87.54
High Negative
0.1x LoD Site B 87.26 0.35 86.59 - 87.94
Site C 86.65 0.27 86.27 - 87.20
3,000 TCID50/mL
All Sites 86.92 0.42 86.17 - 87.94
Medium Positive Site A 85.70 0.31 85.21 - 86.18

3x LoD Site B 86.19 0.30 85.35 - 86.77
Site C 85.59 0.34 84.91 - 86.19
90,000 TCID50/mL All Sites 85.81 0.44 84.91 - 86.77
Site A 85.45 0.26 84.81 - 86.06
Low Positive
1x LoD Site B 85.87 0.24 85.44 - 86.36
HRV4
Site C 85.32 0.40 84.69 - 86.26
30,000 TCID50/mL All Sites 85.54 0.40 84.69 - 86.36
High Negative Site A 85.37 0.26 84.80 - 86.04

0.1x LoD Site B 85.82 0.23 85.43 - 86.23
Site C 85.22 0.22 84.82 - 85.58
3,000 TCID50/mL All Sites 85.46 0.39 84.80 - 86.23
Reproducibility Agreement Summary for Rhinovirus (Human Rhinovirus/Enterovirus)
%
Human Rhinovirus
# # Agreement with 95%
A1
Positive Negative Expected Result a CI
Site A 60/60 0/60 100% 94.0% - 100%
Medium Positive Site B 60/60 0/60 100% 94.0% - 100%
(3X LoD)
Site C 60/60 0/60 100% 94.0% - 100%
3 TCID50/mL
All Sites 180/180 0/180 100% 97.8% - 100%
Site A 20/20 0/20 100% 83.2% – 100%

Low Positive
Site B 20/20 0/20 100% 83.2% – 100%
(1X LoD)
Site C 20/20 0/20 100% 83.2% – 100%
1 TCID50/mL
All Sites 60/60 0/60 100% 94.0% - 100%
Site A 40/40 0/40 100% 91.2% - 100%

High Negativeb Site B 40/40 0/40 100% 91.2% - 100%
(LoD/10)
Site C 32/40 8/40 80.0% 64.4% - 91.0%
0.1 TCID50/mL
All Sites 112/120 8/120 93.3% 87.3% - 97.1%
Site A 0/60 60/60 100% 94.0% - 100%

Site B 0/60 60/60 100% 94.0% - 100%
Negative
Site C 0/60 60/60 100% 94.0% - 100%
All Sites 0/180 180/180 100% 97.8% - 100%

Reproducibility Tm Summary (by assay) for Rhinovirus
Human Rhinovirus Mean % CV Observed

Assay A1 Tm Tm Tm Range
Site A 83.79 0.44 83.25 - 85.09
Medium Positive
3x LoD Site B 84.06 0.31 83.43 - 84.56
Site C 83.68 0.23 83.22 - 84.09
3 TCID50/mL All Sites 83.84 0.38 83.22 - 85.09
Site A 83.71 0.29 83.07 - 84.35
Low Positive
1x LoD Site B 84.07 0.34 83.44 - 84.66
HRV1
Site C 83.93 0.34 83.24 - 84.71
1 TCID50/mL All Sites 83.90 0.37 83.07 - 84.71

0.1x LoD Site B 83.91 0.34 83.22 - 84.52
Site C 83.76 0.31 83.04 - 84.48
0.1 TCID50/mL All Sites 83.74 0.36 83.02 - 84.52

HRV2 3x LoD Site B 83.65 0.29 83.11 - 84.17
Site C 83.30 0.28 82.70 - 83.77
Human Rhinovirus Mean % CV Observed
Assay A1 Tm Tm Tm Range
3 TCID50/mL All Sites 83.42 0.41 82.55 - 84.67
Site A 83.28 0.31 82.57 - 83.86
Low Positive
1x LoD Site B 83.66 0.36 83.02 - 84.37
Site C 83.52 0.39 82.82 - 84.29
1 TCID50/mL All Sites 83.48 0.40 82.57 - 84.37

0.1x LoD Site B 83.58 0.36 82.80 - 84.31
Site C 83.37 0.33 82.51 - 83.92
0.1 TCID50/mL All Sites 83.37 0.40 82.42 - 84.31

3x LoD Site B 83.25 0.36 82.49 - 83.88
Site C 82.89 0.43 82.10 - 83.88
3 TCID50/mL All Sites 82.96 0.51 81.99 - 83.94
Site A 82.67 0.49 81.76 - 83.65
Low Positive
1x LoD Site B 83.24 0.44 82.40 - 84.08
HRV3
Site C 83.07 0.41 82.13 - 83.76
1 TCID50/mL All Sites 82.98 0.54 81.76 - 84.08
Site A 82.68 0.50 81.78 - 83.67
High Negative
0.1x LoD Site B 83.21 0.46 82.18 - 84.37
Site C 82.97 0.42 81.85 - 83.64
0.1 TCID50/mL All Sites 82.96 0.52 81.78 - 84.37
Site A 83.81 0.38 83.28 - 84.98
Medium Positive
3x LoD Site B 84.14 0.34 83.43 - 84.83
Site C 83.80 0.25 83.44 - 84.20
3 TCID50/mL All Sites 83.90 0.37 83.28 - 84.98
Low Positive Site A 83.79 0.31 83.18 - 84.45

1x LoD Site B 84.08 0.31 83.55 - 84.61
HRV4
Site C 84.04 0.38 83.35 - 84.93
1 TCID50/mL All Sites 83.94 0.37 83.18 - 84.93
Site A 83.58 0.26 83.11 - 84.05
High Negative
0.1x LoD Site B 83.88 0.31 83.34 - 84.49
Site C 83.86 0.27 83.24 - 84.58
0.1 TCID50/mL All Sites 83.76 0.33 83.11 - 84.58
Reproducibility Agreement Summary for Influenza A H1
%
Influenza A H1N1
# # # Agreement with 95%
A/Brisbane/59/07
Positive Equivocal Negative Expected Result a CI
Medium Site A 20/20 0/20 0/20 100% 83.2% – 100%
Positive Site B 20/20 0/20 0/20 100% 83.2% – 100%
(3X LoD)
Site C 20/20 0/20 0/20 100% 83.2% – 100%
600
TCID50/mL All Sites 60/60 0/60 0/60 100% 94.0% - 100%
Site A 20/20 0/20 0/20 100% 83.2% – 100%

Low Positive
(1X LoD) Site B 19/20 1/20 0/20 95.0% 75.1% - 99.9%
Site C 17/20 2/20 1/20 85.0% 62.1% – 96.8%
200
TCID50/mL All Sites 56/60 3/60 1/60 93% 83.8% – 98.2%
High Site A 20/20 0/20 0/20 100% 83.2% – 100%

Negative Site B 17/20 2/20 1/20 85.0% 62.1% – 96.8%
(LoD/10)b
Site C 14/20 5/20 1/20 70.0% 45.7% - 88.1%
20
TCID50/mL All Sites 51/60 7/60 2/60 85.0% 73.4% - 92.9%
Site A 0/180 0/180 180/180 100% 98.0% - 100%

Site B 0/180 0/180 180/180 100% 98.0% - 100%
Negative
Site C 0/180 0/180 180/180 100% 98.0% - 100%
All Sites 0/540 0/540 540/540 100% 99.3% – 100%

Reproducibility Tm Summary (by assay) for Influenza A H1

Influenza A H1N1 Mean % CV Observed
Assay A/Brisbane/59/07 Tm Tm Tm Range
Site A 84.67 0.24 84.27 - 85.12
Moderate Positive
3x LoD Site B 85.10 0.24 84.78 - 85.56
Site C 84.64 0.34 83.76 - 85.23
600 TCID50/mL
All Sites 84.80 0.37 83.76 - 85.56
Site A 84.57 0.27 84.17 - 85.31
Low Positive
FluA- 1x LoD Site B 85.01 0.28 84.59 - 85.75
pan1 Site C 84.68 0.26 84.16 - 85.18
200 TCID50/mL
All Sites 84.75 0.34 84.16 - 85.75
Site A 84.27 0.26 83.85 - 84.81
High Negative
0.1x LoD Site B 84.75 0.23 84.29 - 85.32
Site C 84.46 0.35 83.89 - 85.48
20 TCID50/mL
All Sites 84.48 0.37 83.85 - 85.48
Site A 80.42 0.25 79.78 - 80.63
Moderate Positive
FluA- 3x LoD Site B 80.85 0.27 80.39 - 81.26
pan2 Site C 80.31 0.28 79.89 - 80.72
600 TCID50/mL
All Sites 80.52 0.39 79.78 - 81.26
Assay A/Brisbane/59/07 Tm Tm Tm Range
Site A 80.36 0.23 79.99 - 80.73
Low Positive
1x LoD Site B 80.80 0.21 80.42 - 81.15
Site C 80.52 0.22 80.19 - 80.89
200 TCID50/mL
All Sites 80.57 0.32 79.99 - 81.15
Site A 79.91 0.37 79.15 - 80.41
High Negative
0.1x LoD Site B 80.49 0.30 79.67 - 80.83
Site C 80.10 0.35 79.56 - 80.73
20 TCID50/mL
All Sites 80.17 0.45 79.15 - 80.83
Site A 78.79 0.25 78.31 - 79.25
Moderate Positive
3x LoD Site B 79.20 0.31 78.30 - 79.57
Site C 78.76 0.39 77.79 - 79.25
600 TCID50/mL
All Sites 78.91 0.42 77.67 - 79.57
Site A 78.77 0.25 78.42 - 79.34
Low Positive
FluA- 1x LoD Site B 79.20 0.27 78.72 - 79.67
H1-pan Site C 78.80 0.25 78.30 - 79.26
200 TCID50/mL
All Sites 78.93 0.36 78.30 - 79.67
Site A 77.65 0.33 77.15 - 78.21
High Negative
0.1x LoD Site B 78.18 0.45 77.47 - 79.26
Site C 77.93 0.49 77.43 - 79.04
20 TCID50/mL
All Sites 77.92 0.51 77.15 - 79.26
Reproducibility Agreement Summary for Influenza A H1-2009

%
Influenza A H1-2009
A/Swine NY/03/2009
Site A 20/20 0/20 0/20 100% 83.2% – 100%
Medium Positive
Site B 20/20 0/20 0/20 100% 83.2% – 100%
(3X LoD)
Site C 20/20 0/20 0/20 100% 83.2% – 100%
300 TCID50/mL
All Sites 60/60 0/60 0/60 100% 94.0% - 100%
Site A 20/20 0/20 0/20 100% 83.2% – 100%

Low Positive Site B 20/20 0/20 0/20 100% 83.2% – 100%
(1X LoD)
Site C 20/20 0/20 0/20 100% 83.2% – 100%
100 TCID50/mL
All Sites 60/60 0/60 0/60 100% 94.0% - 100%
Site A 20/20 0/20 0/20 100% 83.2% – 100%

High Negativeb Site B 19/20 1/20 0/20 95.0% 75.1% - 99.9%
(LoD/10)
Site C 20/20 0/20 0/20 100% 83.2% – 100%
10 TCID50/mL
All Sites 59/60 1/60 0/60 98.3% 91.1% – 100%
Site A 0/180 0/180 180/180 100% 98.0% - 100%

Negative Site B 0/180 0/180 180/180 100% 98.0% - 100%
Site C 0/180 0/180 180/180 100% 98.0% - 100%
%
Influenza A H1-2009
A/Swine NY/03/2009
All Sites 0/540 0/540 540/540 100% 99.3% – 100%
Reproducibility Tm Summary (by assay) for Influenza A H1-2009
Influenza A H1-2009 Mean % CV Observed

Assay A/Swine NY/03/2009 Tm Tm Tm Range
Moderate Site A 84.67 0.24 84.27 - 85.12
Positive Site B 85.10 0.24 84.78 - 85.56
3x LoD
Site C 84.64 0.34 83.76 - 85.23
300 TCID50/mL All Sites 84.80 0.37 83.76 - 85.56
Site A 84.57 0.27 84.17 - 85.31
Low Positive
FluA- 1x LoD Site B 85.01 0.28 84.59 - 85.75
pan1 Site C 84.68 0.26 84.16 - 85.18
100 TCID50/mL
All Sites 84.75 0.34 84.16 - 85.75
Site A 84.27 0.26 83.85 - 84.81
High Negative
0.1x LoD Site B 84.75 0.23 84.29 - 85.32
Site C 84.46 0.35 83.89 - 85.48
10 TCID50/mL
All Sites 84.48 0.37 83.85 - 85.48
Moderate Site A 80.62 0.20 80.31 - 80.83
Positive Site B 81.01 0.17 80.70 - 81.36
3x LoD
Site C 80.69 0.23 80.19 - 81.02
300 TCID50/mL All Sites 80.81 0.32 80.19 - 81.36
Site A 80.39 0.29 79.87 - 80.73
Low Positive
FluA- 1x LoD Site B 80.91 0.27 80.20 - 81.24
pan2 Site C 80.30 0.17 80.05 - 80.61
100 TCID50/mL
All Sites 80.62 0.44 79.87 - 81.24
Site A 80.43 0.27 80.08 - 81.03
High Negative
0.1x LoD Site B 80.72 0.27 80.11 - 81.14
Site C 80.41 0.34 79.86 - 80.82
10 TCID50/mL
All Sites 80.54 0.34 79.86 - 81.14
Moderate Site A 78.87 0.40 78.20 - 79.56
Positive Site B 79.44 0.35 78.94 - 79.99
3x LoD
Site C 78.62 0.43 77.92 - 79.44
300 TCID50/mL All Sites 78.97 0.58 77.92 - 79.99
FluA- Site A 78.37 0.30 77.89 - 79.24
Low Positive
H1-pan Site B 78.90 0.37 78.21 - 79.76
1x LoD
Site C 78.16 0.25 77.83 - 78.69
100 TCID50/mL
All Sites 78.47 0.51 77.78 - 79.76
0.1x LoD Site B 78.83 0.37 77.99 - 79.68
Influenza A H1-2009 Mean % CV Observed
Assay A/Swine NY/03/2009 Tm Tm Tm Range
Site C 78.08 0.27 77.68 - 78.51
10 TCID50/mL
All Sites 78.40 0.53 77.68 - 79.68
Moderate Site A 78.73 0.24 78.31 - 79.14
Positive Site B 79.20 0.24 78.84 - 79.67
3x LoD
Site C 78.54 0.30 77.89 - 78.92
300 TCID50/mL All Sites 78.81 0.44 77.89 - 79.67
Site A 78.64 0.26 78.10 - 79.14
Low Positive
FluA- 1x LoD Site B 79.03 0.25 78.53 - 79.48
H1-2009 Site C 78.49 0.24 78.12 - 78.82
100 TCID50/mL
All Sites 78.71 0.39 78.10 - 79.48
Site A 78.60 0.28 77.90 - 79.04
High Negative
0.1x LoD Site B 79.00 0.23 78.52 - 79.36
Site C 78.52 0.28 78.10 - 78.93
10 TCID50/mL
All Sites 78.70 0.38 77.90 - 79.36
Reproducibility Agreement Summary for Influenza A H3

%
Influenza A H3N2
A/Wisconsin/67/2005
Site A 20/20 0/20 0/20 100% 83.2% – 100%
Medium Positive
Site B 20/20 0/20 0/20 100% 83.2% – 100%
(3X LoD)
Site C 20/20 0/20 0/20 100% 83.2% – 100%
15 TCID50/mL
All Sites 60/60 0/60 0/60 100% 94.0% - 100%
Site A 20/20 0/20 0/20 100% 83.2% – 100%

Low Positive
Site B 20/20 0/20 0/20 100% 83.2% – 100%
(1X LoD)
Site C 20/20 0/20 0/20 100% 83.2% – 100%
5 TCID50/mL
All Sites 60/60 0/60 0/60 100% 94.0% - 100%
Site A 3/20 11/20 6/20 15.0% 3.2% - 37.9%

High Negativeb
Site B 4/20 12/20 4/20 20.0% 5.7% - 43.7%
(LoD/10)
Site C 3/20 8/20 9/20 15.0% 3.2% - 37.9%
0.5 TCID50/mL
All Sites 10/60 31/60 19/60 16.7% 8.3% - 28.5%
Site A 0/180 0/180 180/180 100% 98.0% - 100%

Site B 0/180 0/180 180/180 100% 98.0% - 100%
Negative
Site C 0/180 0/180 180/180 100% 98.0% - 100%
All Sites 0/540 0/540 540/540 100% 99.3% – 100%

Reproducibility Tm Summary (by assay) for Influenza A H3
Assay A/Wisconsin/67/2005 Tm Tm Tm Range
Site A 85.33 0.26 84.79 - 85.73
Moderate Positive
3x LoD Site B 85.48 0.42 84.91 - 86.27
Site C 85.06 0.38 84.50 - 85.40
15 TCID50/mL
All Sites 85.36 0.38 84.50 - 86.27
Site A 84.95 0.41 84.19 - 86.03
Low Positive
FluA- 1x LoD Site B 85.31 0.31 84.79 - 86.02
pan1 Site C 84.83 0.26 84.37 - 85.25
5 TCID50/mL
All Sites 85.03 0.41 84.19 - 86.03
Site A 84.91 0.39 84.22 - 85.60
High Negative
0.1x LoD Site B 85.24 0.30 84.78 - 85.77
Site C 84.86 0.27 84.48 - 85.33
0.5 TCID50/mL
All Sites 85.01 0.37 84.22 - 85.77
Site A 79.75 0.25 79.51 - 79.99
Moderate Positive
3x LoD Site B 79.94 0.30 79.40 - 80.37
Site C 79.60 0.24 79.14 - 79.86
15 TCID50/mL
All Sites 79.81 0.33 79.14 - 80.37
Site A 79.42 0.31 79.00 - 80.30
Low Positive
FluA- 1x LoD Site B 79.69 0.35 79.14 - 80.29
pan2 Site C 79.25 0.20 78.82 - 79.59
5 TCID50/mL
All Sites 79.45 0.37 78.82 - 80.30
Site A 79.22 0.35 78.64 - 79.75
High Negative
0.1x LoD Site B 79.59 0.29 79.05 - 79.99
Site C 79.24 0.20 78.84 - 79.54
0.5 TCID50/mL
All Sites 79.35 0.36 78.64 - 79.99
Site A 82.58 0.35 81.87 - 83.01
Moderate Positive
3x LoD Site B 82.89 0.19 82.60 - 83.11
Site C 82.44 0.33 81.98 - 82.81
15 TCID50/mL
All Sites 82.62 0.39 81.87 - 83.11
Site A 82.32 0.29 81.88 - 82.69
Low Positive
FluA- 1x LoD Site B 82.69 0.34 82.16 - 83.32
H3 Site C 82.21 0.25 81.76 - 82.73
5 TCID50/mL
All Sites 82.39 0.41 81.67 - 83.32
Site A 82.28 0.36 81.71 - 82.91
High Negative
0.1x LoD Site B 82.61 0.29 82.17 - 83.05
Site C 82.20 0.23 81.87 - 82.57
0.5 TCID50/mL
All Sites 82.37 0.36 81.71 - 83.05
Repeatability
The repeatability of the FilmArray RP results was evaluated with the original FilmArray RP by repeated testing the same
12 specimens tested in the Reproducibility study while minimizing as many sources of variability as possible. The in-
house Repeatability testing was performed at Site C over the course of 12 testing days. On each day, all 12 specimens
were tested 4 times by 2 operators on 2 FilmArray instruments.
Table 46. Summary of Positive Agreement Results for Repeatability Testing
Moderate Positive Low Positive High Negative
(3x LoD) (1x LoD) (0.1x LoD)
Organism Result
# Positive / % Positive # Positive / % Positive # Positive / % Positive
Total Results Total Results Total Results
Adenovirusa 48/48 100% 48/48 100% 34/48 70.8%
Coronavirus 229E 48/48 100% 48/48 100% 19/48 39.6%
Coronavirus HKU1 48/48 100% 48/48 100% 44/48 91.7%
Coronavirus NL63 48/48 100% 48/48 100% 27/48 56.3%
Coronavirus OC43 48/48 100% 47/48 97.9% 33/48 68.8%
Human Metapneumovirus 47/48 97.9% 48/48 100% 32/48 66.7%
Enterovirus 48/48 100% 48/48 100% 48/48 100%
Human Rhinovirus 144/144 100% 47/48 97.9% 83/96 86.5%
Influenza A H1 48/48 100% 43/48b 89.6%b 39/48c 81.3%c
Influenza A H1-2009 48/48 100% 48/48 100% 47/48d 97.9%d
Influenza A H3 48/48 100% 48/48 100% 7/48e 14.6%e
Influenza B 48/48 100% 48/48 100% 25/48 52.1%
Parainfluenza Virus 1 47/48 97.9% 48/48 100% 32/48 66.7%
Parainfluenza Virus 2 48/48 100% 47/48 97.9% 27/48 56.3%
Parainfluenza Virus 3 48/48 100% 41/48 85.4% 14/48 29.2%
Parainfluenza Virus 4 48/48 100% 48/48 100% 26/48 54.2%
Respiratory Syncytial Virus 144/144 100% 96/96 100% 32/48 66.7%
Bordetella pertussis 48/48 100% 48/48 100% 27/48 56.3%
Chlamydophila pneumoniae 48/48 100% 46/48 95.8% 18/48 37.5%
Mycoplasma pneumoniae 48/48 100% 47/48 97.9% 19/48 39.6%
% positive (all organisms) 1102/1104 942/960 599/960

per test level 99.8% 98.1% 62.4%
a Repeatability testing was performed prior to the modification of the panel to include a second Adenovirus assay. Test
concentrations and multiples of LoD reflect the Adenovirus LoD prior to panel modification (300 TCID 50/mL).
b The five (5) non-positive results for Influenza A H1 at LoD include: (1) Negative, (1) Influenza A H1 Equivocal and (3) Influenza A
Equivocal results.
c The nine (9) non-positive results for Influenza A H1 at 0.1 x LoD include: (1) Negative, (3) Influenza A (no subtype detected), (1)
Influenza A H1 Equivocal, and (4) Influenza A Equivocal results.

d One (1) Influenza A H1-2009 Equivocal result at the 0.1 x LoD test level.
e The 42 non-positive results for Influenza A H3 at 0.1 x LoD include: (18) Negative, (2) Influenza A (no subtype detected) (15)
Influenza A H3 Equivocal, and (7) Influenza A Equivocal results.
Interference
Substances that could be present in NPS samples or introduced during sample handling were evaluated for their
potential to interfere with assay performance. Four different mixes containing FilmArray RP organisms were spiked
into a simulated NPS (sNPS) sample matrix (human epithelial cells in VTM) at 5x their respective LoDs. The 5x LoD
organism concentration was chosen to be near the LoD but also to provide consistent results for sample-to-sample
comparison. Each sample was tested with the original FilmArray RP in the presence of each potentially interfering
substance listed in Table 47. None of the substances tested were found to compete or interfere with the control or
organism assays in the FilmArray RP.
Table 47. List of Potentially Interfering Substances Evaluated (No Interference or Inhibition Observed)
Endogenous Substances Competing / Interfering Microorganisms
Human Blood (with Na Citrate) (1% v/v) Respiratory Syncytial Virus A 2.8 x 104 TCID50/mL
Mucin (bovine submaxillary gland) (1% v/v) Human Rhinovirus 1.1 x 104 TCID50/mL
Human Genomic DNA: 0.2 ng/L Influenza A H1-2009 1.0 x 105 TCID50/mL
2 ng/L Staphylococcus aureus 1.0 x 106 CFU/mL
20 ng/L Neisseria meningitidis 1.0 x 106 CFU/mL

Corynebacterium diptheriae 1.0 x 106 CFU/mL
Exogenous Substances
Saline Nasal Spray with Preservatives (1% v/v) Analgesic ointment (1% w/v)
Nasal Decongestant Spray (Oxymetazoline HCl) (1%v/v) Petroleum Jelly (1% w/v)
Tobramycin (0.6 mg/mL) Smokeless Tobacco (1% w/v)
Mupirocin (2% w/v) FluMist® Nasal Influenza Vaccine (2009-2010)
Technique Specific Substances
Laboratory Reagents: Viral Transport Media: Swabs:

Bleach (1%, 2%, 5% v/v) Remel M4 Copan 168C (rayon / twisted aluminum shaft)
Disinfecting wipes Remel M4-RT Copan FloQ (flocked nylon / plastic shaft)
Ethanol (7% v/v) Remel M5 Copan 175KS01 (polyester / aluminum shaft)
DNAzap (1% v/v) Remel M6 Millipore 519CS01M (flocked nylon / plastic shaft)
RNaseOut (1% v/v) Copan UTM
Evaluation of the FilmArray RP was not performed using clinical NPS specimens obtained from individuals who had
recently received the FluMist® nasal influenza vaccine (MedImmune, Gaithersburg, MD). However, analytical testing
was performed (using the original FilmArray RP) with simulated samples containing various concentrations of the
2009-2010 formulation of the vaccine material. The FilmArray RP assays react with the Influenza A H1, Influenza A
H3 and Influenza B viral material contained in the vaccine (Table 48). No cross-reactivity was observed with other,
non-influenza FilmArray RP assays.
Table 48. Evaluation of FluMist® Nasal Vaccine as a Potentially Interfering Substance
Respiratory Syncytial
Human Rhinovirus /
Coronavirus OC43
Coronavirus NL63
Metapneumovirus
Coronavirus 229E
Coronavirus HKU
Chlamydophila
Mycoplasma
pneumoniae
pneumoniae
Enterovirus
Adenovirus
Influenza B
FluMist
2009-2010 Influenza A
Human
Virus
H1-
(% v/v) H1 2009 H3
10% - - - - - - - + - + + - - - - - - - -
1% - - - - - - - + - + + - - - - - - - -
0.1% - - - - - - - + - + + - - - - - - - -
0.01% - - - - - - - + - + + - - - - - - - -
0.001% - - - - - - - + - + + - - - - - - - -
Equiv
a
0.0001% - - - - - - - - - + - - - - - - - -
0.00001% - - - - - - - - - - + - - - - - - - -
0.000001% - - - - - - - - - - - - - - - - - - -
a Influenza A H3 Equivocal result
Analysis of Potential Interference from Medications
The clinical dataset from the original FilmArray RP was analyzed for evidence of the effects of potentially interfering
medications (prescription and over-the-counter; OTC) administered to or taken by the study population. If clinically
significant interference from medications had occurred, it would be expected that the organism detection rate in the
medicated population would be lower than that in the non-medicated population. This effect was not observed in the
clinical dataset. One or more organisms was detected by the reference/comparator methods in 118 of 257 (45.9%) non-
medicated individuals. The FilmArray RP correctly identified all organisms in 112 (94.9%) of these individuals. One or
more organisms were detected by the reference/comparator methods in 342 of 596 (57.4%) medicated individuals. The
FilmArray RP correctly identified all organisms in 331 (96.8%) of these individuals. Table 49 lists the medications
administered to or taken by the enrolled study population (self-reported and/or recorded from patient charts).
Table 49. List of Medications Administered/Taken During the FilmArray RP Clinical Evaluation
Acetaminophen Clindamycin Lansoprazole Phenobarbital
Albuterol Co-trimoxazole Levalbuterol Phenylephrine
Cough drops/syrups
Alendronate Levothyroxine Pilocarpine
(various OTC)
Alprazolam Cyproheptadine Lisinopril Pravachol (Pravastatin)
Amoxicillin Deferasirox Loperamide Prednisolone
Amoxicillin Clavulanate Dextromethorphan Loratadine Prednisone
Dextromethorphan
Azithromycin Lorazepam Propranolol
hydrobromide
Baclofen Diphenhydramine Metoclopramide Pseudoephedrine
Benzonatate Doxylamine succinate Metolazone Ranitidine
Electrolyte solutions Saline Nasal Drops/Sprays
Betamethasone Metoprolol
(rehydration salts) (various OTC)
Brimonidine Enoxaparin Midazolam Salmeterol
Budesonide Eszopiclone Montelukast Simethicone
Budesonide/Formoterol
Fentanyl Naproxen Sirolimus
Fumarate Dihydrate
Bupropion hydrochloride Fluticasone Nizatidine Spironolactone
Carvedilol Furosemide Omeprazole Temazepam
Cefdinir Gabapentin Oseltamivir Tiotropium
Cefepime Gemfibrozil Oxybutynin Ursodiol
Ceftriaxone Guaifenesin Pancrelipase Valacyclovir
Cephrazole Hydrocodone Pantoprazole Vancomycin
Vitamins/Multivitamins/
Cetirizine Ibuprofen Penicillin
Minerals (various OTC)
Chlorpheniramine maleate Inderal (Propranolol) Pentamidine Voriconazole
Ciprofloxacin Isosorbide
PERFORMANCE CHARACTERISTICS OF FILMARRAY RP ON FILMARRAY 2.0 AND FILMARRAY TORCH
Clinical and non-clinical studies have established that the performance characteristics of the FilmArray RP, including
LoD (see Limit of Detection section above), positive percent agreement and negative percent agreement, and
reproducibility are equivalent on FilmArray and FilmArray 2.0 systems. Other non-clinical studies demonstrate similar
performance characteristics on FilmArray Torch systems.
NOTE: FilmArray Torch Modules are FilmArray 2.0 instruments that have been re-configured into a stacked system
for higher-throughput in a smaller workspace.
Clinical Comparison
A clinical comparison study was performed using specimens previously obtained during the FilmArray RP prospective
clinical evaluation and supplemented with other archived specimens collected from external medical facilities and
reference laboratories to increase the number of specimens being tested for low prevalence analytes. A total of 102
specimens were selected such that each analyte was represented 3-5 times. Each specimen was thawed and tested
using the FilmArray and FilmArray 2.0 systems. Overall positive percent agreement (PPA) between systems was
96.8% with the lower bound of the two-sided 95% confidence interval (95% CI) at 92.0%. Overall negative percent
agreement (NPA) was 99.8% with the lower bound of the two-sided 95% CI at 99.5%.
Table 50. Analyte Results from FilmArray System Clinical Comparison Study
FilmArray 2.0 / FilmArray
Analyte
PPA % 95% CI NPA % 95% CI
Viruses
Adenovirus 5/5 100% 47.8-100% 97/97 100% 96.3-100%
Coronavirus 229E 5/5 100% 47.8-100% 97/97 100% 96.3-100%
Coronavirus HKU1 6/6 100% 54.1-100% 95/96 99% 94.3-100%
Coronavirus NL63 6/6 100% 54.1-100% 96/96 100% 96.2-100%
Coronavirus OC43 4/5 80% 28.4-99.5% 97/97 100% 96.3-100%
Human Metapneumovirus 5/5 100% 47.8-100% 97/97 100% 96.3-100%
Human Rhinovirus/Enterovirus 9/10 90% 55.5-99.7% 91/92 98.9% 94.1-100%
Influenza A 16/16 100% 79.4-100% 86/86 100% 95.8-100%
FilmArray 2.0 / FilmArray
Analyte
PPA % 95% CI NPA % 95% CI
Influenza A H1 3/3 100% 29.2-100% 99/99 100% 96.3-100%
Influenza A H1-2009 6/6 100% 54.1-100% 96/96 100% 96.2-100%
Influenza A H3 7/7 100% 59-100% 95/95 100% 96.2-100%
Influenza B 5/5 100% 47.8-100% 97/97 100% 96.3-100%
Parainfluenza Virus 1 7/7 100% 59-100% 95/95 100% 96.2-100%
Parainfluenza Virus 2 6/6 100% 54.1-100% 95/96 99% 94.3-100%
Parainfluenza Virus 3 6/6 100% 54.1-100% 96/96 100% 96.2-100%
Parainfluenza Virus 4 5/6 83.3% 35.9-99.6% 96/96 100% 96.2-100%
Respiratory Syncytial Virus 8/8 100% 63.1-100% 94/94 100% 96.2-100%
Bacteria
Bordetella pertussis 4/4 100% 39.8-100% 97/98 99% 94.4-100%
Chlamydophila pneumoniae 3/3 100% 29.2-100% 99/99 100% 96.3-100%
Mycoplasma pneumoniae 5/6 83.3% 35.9-99.6% 96/96 100% 96.2-100%
Overall agreement 121/125 96.8% 92.0-99.1% 1911/1915 99.8% 99.5-99.9%
System performance for testing of 102 specimens on each platform was calculated. For the FilmArray, a total of 108
runs were attempted, 104 of which were completed (96.3%; 104/108). There were two run failures each for software
(1.9%) and instrument (1.9%) errors. No control failures were observed. Two specimens were retested due to
Influenza A ‘equivocal’ results. For the FilmArray 2.0, a total of 103 runs were attempted, all of which completed
(100%; 103/103). No control failures were observed. One specimen was retested due to an Influenza A ‘equivocal’
result.
Reproducibility
A multicenter reproducibility study was performed to determine between-site and overall reproducibility of the
FilmArray RP on FilmArray 2.0 systems. Reproducibility testing occurred at three test sites using contrived NPS
samples, each spiked with various combinations of four different RP analytes representing the types of organisms
detected by the panel (bacteria, DNA viruses and RNA viruses). Each analyte was evaluated at three different
concentrations (Negative, Low Positive and Moderate Positive). Negative results for each assay were obtained from
samples that were not spiked with a corresponding organism (analyte not in the sample).
The data include 90 replicates per analyte and incorporate a range of potential variation introduced by 8 different
operators, 3 different pouch lots, and 11 different FilmArray 2.0 instruments configured on 3 different multi-instrument
systems. Similar to the reproducibility of the FilmArray RP on the FilmArray (Tables 44-45 above), percent (%)
agreement with the expected Detected, Not Detected or N/A result was 95.6% or better and the standard deviation in
Tm was 0.5˚C or less for all assays.
Table 51. Summary of Reproducibility Results on the FilmArray 2.0
% Agreement with Expected Result
Expected Site/System Total
Analyte Tested Concentration Tested Test Result A B C (95% Confidence Interval)
Moderate Positive 89/90
30/30 29/30 30/30
3× LoD Detected 98.9%
100% 96.7% 100%
1.2x104 CFU/mL (94.0-100%)
Bordetella pertussis Low Positive 90/90
Strain A639 30/30 30/30 30/30
1× LoD Detected 100%
Zeptometrix 0801459 100% 100% 100%
4x103 CFU/mL (96.0-100%)
90/90
30/30 30/30 30/30
Negative Not Detected 100%
100% 100% 100%
(96.0-100%)
Moderate Positive 89/90

29/30 30/30 28/30
3× LoD Detected 98.9%
96.7% 100% 93.3%
3.0x102 TCID50/mL (94.0%-100%)
Adenovirus
Low Positive
Species C 89/90
1× LoD 30/30 30/30 29/30
Serotype 1 Detected 98.9%
1.0x102 TCID50/mL 100% 100% 96.7%
Zeptometrix (94.0%-100%)
0810050CF
90/90
30/30 30/30 30/30
100% 100% 100%
(96.0-100%)
Moderate Positive
3× LoD 90/90
30/30 30/30 30/30
3.0x102 TCID50/mL Detected 100%
100% 100% 100%
(96.0-100%)
Influenza A H1N1-
2009 Low Positive
A/SwineNY/03/2009 1× LoD 90/90
30/30 30/30 30/30
Zeptometrix 1.0x102 TCID50/mL Detected 100%
100% 100% 100%
0810109CFN (96.0-100%)
90/90
30/30 30/30 30/30
100% 100% 100%
(96.0-100%)
90/90
Moderate Positive 100%
30/30 30/30 30/30
3× LoD Detected (96.0-100%)
100% 100% 100%
6.0 TCID50/mL
Respiratory Syncytial
Virus Type A Low Positive 90/90
30/30 30/30 30/30
Zeptometrix 1× LoD Detected 100%
100% 100% 100%
0810040ACF 2.0 TCID50/mL (96.0-100%)
90/90
30/30 30/30 30/30
100% 100% 100%
(96.0-100%)
A FilmArray RP reproducibility evaluation was performed on FilmArray Torch systems. Contrived samples containing each
FilmArray RP analyte at low positive levels (1x LoD based on FilmArray 2.0) were tested on three complete FilmArray
Torch systems (12 FilmArray Torch Modules per system) over five days (30 replicates per analyte per system for 90 total
replicates per analyte). Agreement with the expected Detected results on FilmArray Torch systems was ≥95.6% for each
FilmArray RP analyte and agreement with the expected negative results (Not Detected) was 100% for each analyte.
REFERENCES
1. Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, National Center for
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virus infection and asthma. Clin Microbiol Rev, 2008. 21(3): p. 495-504.
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Chlamydophila pneumoniae Web Site . http://www.cdc.gov/ncidod/dbmd/diseaseinfo/chlamydiapneumonia_t.htm.
Accessed October 6, 2011.
16. Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, Disease Listing:
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WARRANTY INFORMATION
Product warranty information is available online at:
http://www.biofiredx.com/support/
For warranty information for customers outside the United States, contact the local bioMérieux sales representative or an
authorized distributor.
For additional information regarding our
products and applications, please contact
BioFire Diagnostics Customer Support
Department, local bioMérieux sales representative
or an authorized distributor.

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RFIT-ASY-0124

FilmArray® Respiratory Panel (RP)

Reach Us on the Web Reach Us by Phone

Customer and Technical Support outside of the U.S.

BioFire Diagnostics, LLC

5.2.8 Do Not Use if 5.3.2 5.3.7

5.4.2 5.4.3 Consult 5.5.1

Acute toxicity, cat. 4 & Skin irritation,

European Union Conformity

Manufacture Symbols (BioFire Diagnostics, LLC)

Use of Symbols in Labeling – 81 FR 38911, Docket No. (FDA-2013-N-0125)

Rx Only Prescription Use Only

SYMBOLS GLOSSARY .........................................................................................................................................................................II

E-LABELING ..................................................................................................................................................................................... III

TABLE OF CONTENTS ....................................................................................................................................................................... IV

NAME AND INTENDED USE ................................................................................................................................................................2

FILMARRAY RESPIRATORY PANEL ................................................................................................................................................................... 2

SUMMARY AND EXPLANATION OF THE TEST .....................................................................................................................................3

SUMMARY OF DETECTED ORGANISMS ............................................................................................................................................................ 4

MATERIALS PROVIDED ......................................................................................................................................................................7

MATERIALS REQUIRED BUT NOT PROVIDED ......................................................................................................................................7

WARNINGS AND PRECAUTIONS ........................................................................................................................................................7

GENERAL PRECAUTIONS ............................................................................................................................................................................... 7

REAGENT STORAGE, HANDLING AND STABILITY ................................................................................................................................9

SPECIMEN COLLECTION AND PREPARATION .................................................................................................................................... 10

PREPARE POUCH ...................................................................................................................................................................................... 10

QUALITY CONTROL .......................................................................................................................................................................... 14

INTERPRETATION OF RESULTS ......................................................................................................................................................... 15

ASSAY INTERPRETATION ............................................................................................................................................................................. 15

LIMITATIONS OF THE PROCEDURE ................................................................................................................................................... 20

EXPECTED VALUES ........................................................................................................................................................................... 22

PERFORMANCE CHARACTERISTICS .................................................................................................................................................. 26

PERFORMANCE CHARACTERISTICS OF FILMARRAY RP ON FILMARRAY 2.0 AND FILMARRAY TORCH .............................................. 76

WARRANTY INFORMATION ............................................................................................................................................................. 80

Human Rhinovirus (HRV) Picornavirus (RNA) Fall, spring[6] All ages[6]

Fall, periodicity of 1-2 Infants, young children,

Fall, periodicity of 1-2 Infants, young children,

Infants, young children,

Parainfluenza Virus 4 (PIV4) Paramyxovirus (RNA) Unknown All ages[11]

Older children, young adults,

Outbreaks most common

2008-2009 89.4% 13.2 79.9 6.9 10.6%

2007-2008 71% 26.2 0.0 73.8 29%

2006-2007 79.2% 62.3 0.0 37.7 20.8%

2005-2006 79.7% 8.1 0.0 91.9 20.3%

Mycoplasma pneumoniae is a causative agent of community-acquired atypical pneumonia, frequently in outbreak

Principle of the Procedure

7. View results on the test report at the completion of the run.

MATERIALS REQUIRED BUT NOT PROVIDED

WARNINGS AND PRECAUTIONS

WARNING: Bleach should never be added to Sample Buffer or sample waste.

 Specimens and pouches should be handled one-at-a-time.

2. Preventing amplicon contamination

Precaution Related to Public Health Reporting in the United States

REAGENT STORAGE, HANDLING AND STABILITY

SPECIMEN COLLECTION AND PREPARATION

Prepare Sample Mix

FilmArray and FilmArray 2.0

1. Ensure that the FilmArray system is on and the software is launched.