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Elecsys CMV IgM

cobas e 411
04784618190 04784618500 100 cobas e 601
cobas e 602

English combination with a low avidity index for IgG is a strong indication of a recent
primary CMV infection.4,5,12 Seroconversion to CMV IgM and IgG may also
System information indicate a recent CMV infection.2,3,4,5,12
For cobas e 411 analyzer: test number 580
For cobas e 601 and cobas e 602 analyzers: Application Code Test principle
Number 011 µ-Capture test principle. Total duration of assay: 18 minutes.
Intended use ▪ 1st incubation: 10 µL of sample are automatically prediluted 1:20 with
Immunoassay for the in vitro qualitative determination of IgM antibodies to Diluent Universal. Biotinylated monoclonal anti‑h‑IgM‑specific antibodies
cytomegalovirus in human serum and plasma. are added.
Results obtained with this assay are used as an aid in the diagnosis of ▪ 2nd incubation: CMV‑specific recombinant antigen labeled with a
recent CMV infections. ruthenium complexa) and streptavidin-coated microparticles are added.
The electrochemiluminescence immunoassay “ECLIA” is intended for use Anti‑CMV IgM antibodies present in the sample react with the
on Elecsys and cobas e immunoassay analyzers. ruthenium-labeled CMV‑specific recombinant antigen. The complex
becomes bound to the solid phase via interaction of biotin and
streptavidin.
Summary ▪ The reaction mixture is aspirated into the measuring cell where the
microparticles are magnetically captured onto the surface of the
Cytomegalovirus (CMV), a member of the herpes virus family, is ubiquitous electrode. Unbound substances are then removed with
in all human populations, causing infections which are followed by life-long ProCell/ProCell M. Application of a voltage to the electrode then induces
latency in the host with occasional reactivations.1,2 The seroprevalence of chemiluminescent emission which is measured by a photomultiplier.
antibodies in adults ranges from 40‑100 % with inverse correlation to
socioeconomic status.1,2,3 CMV is transmitted through body fluids, including ▪ Results are determined automatically by the software by comparing the
blood, genital secretions and breast milk. Saliva and urine of infected electrochemiluminescence signal obtained from the reaction product of
individuals also represent a prominent source of infection, and children, the sample with the signal of the cutoff value previously obtained by
especially those attending day care facilities, are an important vector for calibration.
viral spread.2,3,4,5,6 In immunocompetent individuals primary CMV infection is a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) )
usually mild or asymptomatic.2,5 Patients commonly present with a Reagents - working solutions
mononucleosis-like syndrome, including fever, sore throat, cervical The reagent rackpack (M, R1, R2) is labeled as CMVIGM.
lymphadenopathy, malaise, headache, muscle ache and joint pains.2,3,5,7
During pregnancy, CMV can cause congenital infection which may result in M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL:
permanent physical and/or neurological sequelae to the child.5 CMV
infection can be primary, i.e. newly acquired, or secondary, i.e. due to Streptavidin-coated microparticles 0.72 mg/mL; preservative.
reactivation of the latent virus or re-infection with a different viral strain.3,5
Primary CMV infection is reported in 1‑4 % of seronegative women during R1 Anti-h-IgM-Ab~biotin (gray cap), 1 bottle, 9 mL:
pregnancy and the risk of transmission to the fetus is estimated to be about Biotinylated monoclonal anti‑h‑IgM antibody (mouse) > 500 µg/L,
30‑40 %.3,4 Reactivation of CMV infection during pregnancy is reported in MES buffer 50 mmol/L, pH 6.5; preservative.
10‑30 % of seropositive women and, in this circumstance, the risk of
transmission of the virus is about 1‑3 %.3,4,5 Overall, prenatal CMV infection R2 CMV-Ag~Ru(bpy) (black cap), 1 bottle, 9 mL:
occurs in 0.6‑0.7 % of all life births in the developed world.4,5,8 The majority of
babies born with congenital CMV infection are asymptomatic at birth.8,9,10 Of CMV‑specific antigen (recombinant, E. coli) labeled with ruthenium
these 5‑15 % still develop irreversible impairments, most frequently hearing complex > 50 µg/L; MES buffer 50 mmol/L, pH 5.5; preservative.
loss, that can occur several months or even years after birth.5,8,9,10 For babies
symptomatic at birth, prognosis is very poor, and the vast majority will CMVIGM Cal1 Negative calibrator 1 (white cap), 2 bottles of 1.0 mL
develop severe mental impairment and/or hearing loss.5,8,9,10 Different studies each:
have shown that the risk of symptomatic congenital disease in the fetus or
newborn infant is high, when maternal primary infection takes place in early Human serum, negative for anti‑CMV IgM; preservative.
pregnancy before week 20 of gestation, and lower thereafter.4,5 The CMVIGM Cal2 Positive calibrator 2 (black cap), 2 bottles of 1.0 mL each:
congenital CMV infection caused by recurrent maternal infection seldom
leads to symptomatic disease at birth.4,5 Anti‑CMV IgM (human serum) in HEPES buffer, pH 7.4;
At risk for CMV infection and disease are also immunocompromised bovine albumin; preservative.
patients such as transplant recipients and HIV infected patients where the
virus can cause life-threatening diseases.11,12 The CMV status of transplant Precautions and warnings
donors and recipients is very important, as it will determine prophylactic and For in vitro diagnostic use.
pre-emptive treatment strategies against CMV. CMV‑negative transplant Exercise the normal precautions required for handling all laboratory
recipients should receive donations from CMV‑negative individuals or reagents.
leukocyte depleted blood products. CMV can reside in latency in infected Disposal of all waste material should be in accordance with local guidelines.
cells and free viral DNA load is usually low. The CMV status can still be Safety data sheet available for professional user on request.
determined by testing for CMV IgG antibodies. This kit contains components classified as follows in accordance with the
Within the appropriate clinical context, the first step in diagnosing acute Regulation (EC) No. 1272/2008:
primary CMV infection is most commonly made by the detection of
anti‑CMV‑specific IgG and IgM antibodies.5 Samples being reactive for IgM
antibodies indicate an acute, recent or reactivated infection.2,4,5,12 For further
analysis of a primary CMV infection the determination of the
CMV IgG avidity is used as an aid.2,4,5,12 A positive IgM result in
Warning

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Elecsys CMV IgM
H317 May cause an allergic skin reaction. Stability of the reagent rackpack
Prevention: on cobas e 2 weeks or
6 weeks if stored alternately in the
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
refrigerator and on the analyzers
P272 Contaminated work clothing should not be allowed out of (up to 80 hours on the analyzer)
the workplace.
Stability of the calibrators
P280 Wear protective gloves. unopened at 2‑8 °C up to the stated expiration date
Response: after opening at 2‑8 °C 8 weeks
P333 + P313 If skin irritation or rash occurs: Get medical on cobas e 411 at 20‑25 °C up to 5 hours
advice/attention. on cobas e 601 and cobas e 602 use only once
at 20‑25 °C
P362 + P364 Take off contaminated clothing and wash it before reuse.
Store calibrators upright in order to prevent the calibrator solution from
Disposal: adhering to the snap‑cap.
P501 Dispose of contents/container to an approved waste Specimen collection and preparation
disposal plant. Only the specimens listed below were tested and found acceptable.
Product safety labeling follows EU GHS guidance. Serum collected using standard sampling tubes or tubes containing
separating gel.
Contact phone: all countries: +49-621-7590
Li‑heparin, Na‑heparin, K2‑EDTA, K3‑EDTA, ACD, CPD, CP2D, CPDA and
All human material should be considered potentially infectious. Na‑citrate plasma.
All products derived from human blood (CMVIGM Cal1, CMVIGM Cal2) are Criterion: Mean recovery of serum value: negative samples ± 0.2 COI
prepared exclusively from the blood of donors tested individually and shown (cutoff-index); boderline/reactive samples: 80‑120 %.
to be free from HBsAg and antibodies to HCV and HIV.
Sampling devices containing liquid anticoagulants have a dilution effect
The serum containing anti‑CMV IgM (CMVIGM Cal2) was sterile filtrated. resulting in lower COI values for individual patient specimens.
The testing methods used assays approved by the FDA or cleared in In order to minimize dilution effects it is essential that respective sampling
compliance with the European Directive 98/79/EC, Annex II, List A. devices are filled completely according to manufacturer’s instructions.
However, as no testing method can rule out the potential risk of infection Stable for 4 weeks at 2‑8 °C, 7 days at 25 °C, 3 months at ‑20 °C (± 5 °C).
with absolute certainty, the material should be handled with the same level The samples may be frozen 5 times.
of care as a patient specimen. In the event of exposure, the directives of the The sample types listed were tested with a selection of sample collection
responsible health authorities should be followed.13,14 tubes or systems that were commercially available at the time of testing, i.e.
Avoid foam formation in all reagents and sample types (specimens, not all available tubes of all manufacturers were tested. Sample collection
calibrators and controls). systems from various manufacturers may contain differing materials which
Reagent handling could affect the test results in some cases. When processing samples in
primary tubes (sample collection systems), follow the instructions of the
The reagents in the kit are ready‑for‑use and are supplied in bottles tube/collection system manufacturer.
compatible with the system.
Specimens should not be subsequently altered with additives (biocides,
cobas e 411 analyzer: The calibrators should only be left on the analyzer anti‑oxidants or substances that could possibly change the pH of the
during calibration at 20‑25 °C. After use, close the bottles as soon as sample) in order to avoid erroneous findings.
possible and store upright at 2‑8 °C.
Pooled samples and other artificial material may have different effects on
Due to possible evaporation effects, not more than 5 calibration procedures different assays and thus may lead to discrepant findings.
per bottle set should be performed.
Centrifuge samples containing precipitates and frozen samples before
cobas e 601 and cobas e 602 analyzers: Unless the entire volume is performing the assay. Lyophilized samples can be used.
necessary for calibration on the analyzers, transfer aliquots of the
reconstituted calibrators into empty snap‑cap bottles (CalSet Vials). Attach Do not use heat‑inactivated samples.
the supplied labels to these additional bottles. Store the aliquots at 2‑8 °C Ensure the samples, calibrators and controls are at 20‑25 °C prior to
for later use. measurement.
Perform only one calibration procedure per aliquot. Due to possible evaporation effects, samples, calibrators and controls on
All information required for correct operation is read in from the respective the analyzers should be analyzed/measured within 2 hours.
reagent barcodes. The performance of the Elecsys CMV IgM assay has not been established
Please note for cobas e 602 analyzers: Both the vial labels, and the with cadaveric samples or body fluids other than serum and plasma.
additional labels (if available) contain 2 different barcodes. Please turn the Materials provided
vial cap 180° into the correct position so that the barcode between the See “Reagents – working solutions” section for reagents.
yellow markers can be read by the system. Place the vial on the analyzer
as usual. Materials required (but not provided)
Storage and stability ▪ 04784626190, PreciControl CMV IgM, 16 x 1.0 mL
Store at 2‑8 °C. ▪ 11732277122, Diluent Universal, 2 x 16 mL sample diluent or
Do not freeze. 03183971122, Diluent Universal, 2 x 36 mL sample diluent
Store the Elecsys reagent kit upright in order to ensure complete ▪ 11776576322, CalSet Vials, 2 x 56 empty snap-cap bottles
availability of the microparticles during automatic mixing prior to use. ▪ General laboratory equipment
Stability of the reagent rackpack ▪ cobas e analyzer
unopened at 2‑8 °C up to the stated expiration date Additional materials for the cobas e 411 analyzer:

after opening at 2‑8 °C 12 weeks ▪ 11662988122, ProCell, 6 x 380 mL system buffer


▪ 11662970122, CleanCell, 6 x 380 mL measuring cell cleaning
solution

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Elecsys CMV IgM
▪ 11930346122, Elecsys SysWash, 1 x 500 mL washwater additive limits. Each laboratory should establish corrective measures to be taken if
▪ 11933159001, Adapter for SysClean values fall outside the defined limits.
If necessary, repeat the measurement of the samples concerned.
▪ 11706802001, AssayCup, 60 x 60 reaction cups
Follow the applicable government regulations and local guidelines for
▪ 11706799001, AssayTip, 30 x 120 pipette tips quality control.
▪ 11800507001, Clean‑Liner Note: The controls are not barcode-labeled and therefore the controls must
Additional materials for cobas e 601 and cobas e 602 analyzers: run on all instruments as non-Roche controls. The control values and
ranges have to be entered manually (except for the cobas e 602 analyzer).
▪ 04880340190, ProCell M, 2 x 2 L system buffer Please refer to the corresponding section in the operator’s manual.
▪ 04880293190, CleanCell M, 2 x 2 L measuring cell cleaning The exact lot-specific target values and ranges are printed on the value
solution sheet which is included in the control kit or reagent kit (or electronically
▪ 03023141001, PC/CC‑Cups, 12 cups to prewarm ProCell M and available).
CleanCell M before use Calculation
▪ 03005712190, ProbeWash M, 12 x 70 mL cleaning solution for run The analyzer automatically calculates the cutoff based on the measurement
finalization and rinsing during reagent change of CMVIGM Cal1 and CMVIGM Cal2. The result of a sample is given either
▪ 12102137001, AssayTip/AssayCup, 48 magazines x 84 reaction as reactive or non-reactive as well as in the form of a cutoff index (signal
cups or pipette tips, waste bags sample/cutoff).
▪ 03023150001, WasteLiner, waste bags Interpretation of the results
▪ 03027651001, SysClean Adapter M Results obtained with the Elecsys CMV IgM assay can be interpreted as
follows:
Additional materials for all analyzers:
Non-reactive: < 0.7 COI
▪ 11298500316, ISE Cleaning Solution/Elecsys SysClean,
5 x 100 mL system cleaning solution Indeterminate: ≥ 0.7 - < 1.0 COI
Reactive: ≥ 1.0 COI
Assay
For optimum performance of the assay follow the directions given in this Samples with a cutoff index < 0.7 are non-reactive in the Elecsys CMV IgM
document for the analyzer concerned. Refer to the appropriate operator’s assay.
manual for analyzer‑specific assay instructions. Samples with a cutoff index between ≥ 0.7 and < 1.0 are considered
Resuspension of the microparticles takes place automatically prior to use. indeterminate. The sample should be retested. In case the result is still
Read in the test-specific parameters via the reagent barcode. If in indeterminate, a second sample should be tested e.g. within the following
exceptional cases the barcode cannot be read, enter the 15-digit sequence 2‑3 weeks.
of numbers. Samples with a cutoff index ≥ 1.0 are reactive in the Elecsys CMV IgM
Bring the cooled reagents to approximately 20 °C and place on the reagent assay.
disk (20 °C) of the analyzer. Avoid foam formation. The system The magnitude of the measured result above the cutoff is not indicative of
automatically regulates the temperature of the reagents and the the total amount of antibody present in the sample.
opening/closing of the bottles. The anti‑CMV IgM results in a given specimen, as determined by assays
Place the calibrators in the sample zone. from different manufacturers, can vary due to differences in reagents and
All the information necessary for calibrating the assay is automatically read assay methods.
into the analyzer. Limitations - interference
After calibration has been performed, store the calibrators at 2‑8 °C or A negative CMV IgM test result, also in combination with a positive
discard (cobas e 601 and cobas e 602 analyzers). CMV IgG result, does not completely rule out the possibility of an acute
infection with cytomegalovirus:
Calibration
Traceability: This method has been standardized against a Roche standard. ▪ Individuals at the early stage of acute infection may not exhibit
The units have been selected arbitrarily. detectable amounts of CMV IgM antibodies. In some of these individuals
an indeterminate or low positive result with the Elecsys CMV IgG assay
Calibration frequency: Calibration must be performed once per reagent lot may be found and indicate an early acute infection. A second sample
using CMVIGM Cal1, CMVIGM Cal2 and fresh reagent (i.e. not more than should be tested e.g. within 2 weeks. The detection of CMV IgM and/or
24 hours since the reagent kit was registered on the analyzer). a significant increase of the Elecsys CMV IgG antibody titer in the
Renewed calibration is recommended as follows: second sample supports the diagnosis of acute CMV infection.15,16
Calibration interval may be extended based on acceptable verification of ▪ The individual immune response following CMV infection varies
calibration by the laboratory. considerably.
▪ after 1 month (28 days) when using the same reagent lot In some individuals non‑reactive results may occur in the late phase of
▪ after 7 days (when using the same reagent kit on the analyzer) acute infection by the Elecsys CMV IgM assay.
The detection of IgM antibodies against CMV in a single sample is not
▪ as required: e.g. quality control findings with PreciControl CMV IgM sufficient to prove an acute CMV infection. In single cases elevated IgM
outside the defined limits antibody levels may persist even for years after initial infection. For further
▪ more frequently when this is required by pertinent regulations clarification additional laboratory tests (e.g. CMV IgG and IgG avidity) or
Range for the electrochemiluminescence signals (counts) for the combination of tests should be performed and results should be assessed
calibrators: in conjunction with the patient’s medical history and clinical symptoms.
Negative calibrator (CMVIGM Cal1): 500‑1600 The results in HIV patients, in patients undergoing immunosuppressive
Positive calibrator (CMVIGM Cal2): 2800‑16000 therapy, or in patients with other disorders leading to immune suppression,
Quality control should be interpreted with caution.
For quality control, use PreciControl CMV IgM. Specimens from neonates, cord blood, pretransplant patients or body fluids
other than serum and plasma, such as urine, saliva or amniotic fluid have
Controls for the various concentration ranges should be run individually at not been tested.
least once every 24 hours when the test is in use, once per reagent kit, and
following each calibration. The assay is unaffected by icterus (bilirubin ≤ 342 µmol/L or ≤ 20 mg/dL),
hemolysis (Hb ≤ 0.310 mmol/L or ≤ 0.500 g/dL), lipemia (Intralipid
The control intervals and limits should be adapted to each laboratory’s ≤ 1500 mg/dL) and biotin (≤ 410 nmol/L or ≤ 100 ng/mL).
individual requirements. Values obtained should fall within the defined
Criterion: Mean recovery of positive samples within ± 20 % of serum value.

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Elecsys CMV IgM
Samples should not be taken from patients receiving therapy with high biotin **** Rubella: 2 discordant samples were found.
doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin ***** Autoantibodies: 7 discordant samples were found out of 73 samples.
administration. An overall agreement of 92.3 % (381/413) was found in these specimens
No interference was observed from rheumatoid factors up to a concentration with the Elecsys CMV IgM assay and the comparison test. 377 samples
of 2000 IU/mL. were found concordantly negative and 4 samples were found positive.
In vitro tests were performed on 18 commonly used pharmaceuticals and in 20 samples were found indeterminate either with the Elecsys CMV IgM
addition on ganciclovir and valganciclovir. No interference with the assay assay or the comparison test.
was found. Clinical sensitivity
Sera from patients with primary EBV infections can demonstrate positive Sensitivity in primary infections
results in the Elecsys CMV IgM assay. This is not unexpected as both A total of 365 frozen samples from pregnant women with primary CMV
viruses belong to the herpes virus family and this potential interference is infection including sequential and single samples analyzed by commercially
known for CMV IgM assays.16 As with many μ‑capture assays, an available CMV IgM assays were tested with the Elecsys CMV IgM assay at
interference with unspecific IgM is observed. Increasing amounts of 4 different sites. For calculation of sensitivity confirmed positive samples
unspecific IgM may lead to a decrease in the recovery of positive samples had a low avidity index or were clinically characterized. Indeterminate
with the Elecsys CMV IgM assay. samples were counted as positives. Samples with a high avidity index and
In rare cases, interference due to extremely high titers of antibodies to all discrepant samples or concordant negative samples with a moderate
analyte‑specific antibodies, streptavidin or ruthenium can occur. These avidity index were excluded.
effects are minimized by suitable test design.
For diagnostic purposes, the results should always be assessed in Site N Sensitivity (%)
conjunction with the patient’s medical history, clinical examination and other Elecsys CMV IgM assay Comparison CMV IgM test
findings.
1d) 180 93.0 (106/114) 94.7 (108/114)
Specific performance data
2 57 96.5 (55/57) 96.5 (55/57)
Representative performance data on the analyzers are given below. Results
obtained in individual laboratories may differ. 3 39e) 91.2 (31/34) 79.4 (27/34)
Precision 35f) 93.1 (27/29) 100 (29/29)
Precision was determined using Elecsys reagents, human sera and controls
in a protocol (EP5‑A2) of the CLSI (Clinical and Laboratory Standards 4g) 54 92.3 (48/52) 98.1 (51/52)
Institute): 2 runs per day in duplicate each for 21 days (n = 84); repeatability
d) 66 samples were excluded due to high/moderate avidity.
n = 21. The following results were obtained:
e) 5 samples were excluded due to moderate avidity and concordant negative results for CMV
IgM.
cobas e 411 analyzer
f) 6 samples were excluded due to moderate/high avidity and concordant negative results for
Repeatability Intermediate precision CMV IgM.
Sample Mean SD CV Mean SD CV g) 2 samples were excluded due to moderate avidity and discrepant CMV IgM results.

COI COI % COI COI % Specificity in past infection


A total of 158 frozen samples from pregnant women with past CMV
HSb), negative 0.188 0.004 2.1 0.175 0.004 2.4 infection, analyzed by commercial CMV assays, were tested with the
HS, low positive 1.52 0.032 2.1 1.62 0.056 3.4 Elecsys CMV IgM assay at 4 different sites. All samples were pre‑selected
positive for CMV IgG, negative for CMV IgM and a high avidity index
HS, high positive 14.2 0.295 2.1 13.9 0.438 3.2 showing absence of acute infection.
PCc) CMV IgM 1 0.185 0.006 3.1 0.171 0.005 2.8 Relative specificity in past infections
PC CMV IgM 2 2.04 0.052 2.6 1.98 0.103 5.3 Site N Relative specificity (%)
b) HS = human serum Elecsys CMV IgM assay Comparison CMV IgM test
c) PC = PreciControl
1h) 48 98 100
cobas e 601 and cobas e 602 analyzers 2 30 100 100
Repeatability Intermediate precision 3i) 50 84 86
Sample Mean SD CV Mean SD CV 4 30 100 100
COI COI % COI COI %
h) 1 sample was found indeterminate with the Elecsys CMV IgM assay and negative with the
HS, negative 0.172 0.004 2.0 0.184 0.010 5.2 comparison assay.
HS, low positive 1.17 0.027 2.3 1.68 0.082 4.9 i) 8 samples were positive with the Elecsys CMV IgM assay; 7 samples were equivocal with the
comparison assay.
HS, high positive 15.0 0.297 2.0 14.0 0.524 3.8 Capability to discriminate the persisting IgM after CMV infection
PC CMV IgM 1 0.164 0.003 1.8 0.182 0.010 5.2 A total of 68 frozen samples from pregnant women analyzed by commercial
CMV IgM assays were tested with the Elecsys CMV IgM assay at 3
PC CMV IgM 2 1.97 0.033 1.7 1.96 0.119 6.1 different sites. All samples were pre‑selected positive for CMV IgG and
CMV IgM and a high avidity index showing absence of acute infection.
Analytical specificity
Capability to discriminate the persisting CMV IgM
433 potentially cross reacting samples were tested with the Elecsys
CMV IgM assay and a comparison CMV IgM assay comprising the following Site N Elecsys CMV IgM assay Comparison CMV IgM test
specimens:
tested/reactive tested/reactive
▪ containing antibodies against HBV, HAV, HCV, HIV*, HTLV, EBV**,
HSV***, VZV, Parvo B19***, Rubella****, Treponema pallidum, 1j) 20 20/6 20/20
Toxoplasma gondii 2k) 28 28/4 28/28
▪ containing autoantibodies***** (ANA, anti-tissue, RF) 3l) 20 20/7 20/20
* HIV: 8 discordant samples were found out of 70 samples.
j) 14 samples were discrepant negative with the Elecsys CMV IgM assay.
** EBV: 13 discordant samples were found out of 48 samples.
*** HSV, Parvo B19: 1 discordant sample was found in each group. k) 24 samples were discrepant negative with the Elecsys CMV IgM assay.

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Elecsys CMV IgM
l) 12 samples were discrepant negative with the Elecsys CMV IgM assay. 11 Plosa EJ, Esbenshade JC, Fuller MP, et al. Cytomegalovirus infection.
Specificity in pre‑selected negative samples Pediatr Rev 2012;33:156-163.
A total of 173 frozen samples from pregnant women in which a CMV 12 Ross SA, Novak Z, Pati S, et al. Overview of the diagnosis of
infection was excluded and analyzed by commercial CMV IgM assays were cytomegalovirus infection. Infect Disord Drug Targets 2011;11:466-474.
tested with the Elecsys CMV IgM assay at 4 different sites.
13 Occupational Safety and Health Standards: Bloodborne pathogens.
Site N Specificity (%) (29 CFR Part 1910.1030). Fed. Register.
Elecsys CMV IgM assay Comparison CMV IgM test 14 Directive 2000/54/EC of the European Parliament and Council of
18 September 2000 on the protection of workers from risks related to
1 50 100 100 exposure to biological agents at work.
2m) 50 98 100 15 Revello MG, Gerna G. Diagnosis and Management of Human
3n) 23 100 95.7 Cytomegalovirus Infection in the Mother, Fetus, and Newborn Infant.
Clin Microbiol Rev 2002;15(4):680-715.
4 50 100 100 16 Genser B, Truschnik-Wilders M, Stünzner D, et al. Evaluation of Five
m) 1 sample was found positive with the Elecsys CMV IgM assay. Commercial Enzyme Immunoassays for the Detection of Human
n) 1 sample was found equivocal with the comparison assay.
Cytomegalovirus-Specific IgM Antibodies in the Absence of a
Commercially Available Gold Standard. Clin Chem Lab Med
Clinical specificity 2001;39(1): 62-70.
A total of 1646 fresh samples from clinical routine (blood donors, site 1) For further information, please refer to the appropriate operator’s manual for
were tested at 3 different sites (pregnancy testing, site 2 and 3) with the the analyzer concerned, the respective application sheets and the Method
Elecsys CMV IgM assay in comparison to competitor assays. The Sheets of all necessary components (if available in your country).
IgG avidity test was used to resolve discrepant results.
A point (period/stop) is always used in this Method Sheet as the decimal
Relative specificity after resolution separator to mark the border between the integral and the fractional parts of
Site N Relative Lower Relative Lower a decimal numeral. Separators for thousands are not used.
specificity confidence specificity confidence Symbols
Elecsys limit Comparison limit Roche Diagnostics uses the following symbols and signs in addition to
CMV IgM % CMV IgM test % those listed in the ISO 15223‑1 standard (for USA: see dialog.roche.com for
definition of symbols used):
assay %
% Contents of kit
1o) 511 98.8 (495/501) 97.4 96.6 (484/501) 94.6 Analyzers/Instruments on which reagents can be used
2p) 616 97.1 (574/591) 95.4 93.4 (552/591) 91.1 Reagent
3q) 519 97.0 (492/507) 95.2 92.9 (471/507) 90.3 Calibrator
o) 10 samples were excluded due to moderate avidity or missing avidity result. Volume for reconstitution
p) 10 samples were confirmed positive by low avidity index; 15 samples were excluded due to
moderate or missing avidity result. GTIN Global Trade Item Number
q) 3 samples were confirmed positive by low avidity index; 9 samples were excluded due to
moderate or missing avidity result. COBAS, COBAS E, ELECSYS and PRECICONTROL are trademarks of Roche. INTRALIPID is a trademark of
Fresenius Kabi AB.
References
All other product names and trademarks are the property of their respective owners.
1 Cannon MJ, Schmid DS, Hyde TB. Review of cytomegalovirus Additions, deletions or changes are indicated by a change bar in the margin.
seroprevalence and demographic characteristics associated with © 2021, Roche Diagnostics
infection. Rev Med Virol 2010;20:202-213.
2 Johnson J, Anderson B, Pass RF. Prevention of maternal and
congenital cytomegalovirus infection. Clin Obstet Gynecol
2012;55:521-530.
Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim
3 Yinon Y, Farine D, Yudin MH. Screening, diagnosis, and management www.roche.com
of cytomegalovirus infection in pregnancy. Obstet Gynecol Surv
2010;65:736-743.
4 Buonsenso D, Serranti D, Gargiullo L, et al. Congenital
cytomegalovirus infection: current strategies and future perspectives.
Eur Rev Med Pharmacol Sci 2012;16:919-935.
5 Coll O, Benoist G, Ville Y, et al. WAPM Perinatal Infections Working
Group. Guidelines on CMV congenital infection. J Perinat Med
2009;37:433-445.
6 Joseph S, Beliveau C, Muecke C, et al. Cytomegalovirus as an
occupational risk in daycare educators. Paediatr Child Health
2006;11:401-407.
7 Lazzarotto T, Guerra B, Lanari M, et al. New advances in the diagnosis
of congenital cytomegalovirus infection. J Clin Virol 2008;41:192-197.
8 Lombardi G, Garofoli F, Stronati M. Congenital cytomegalovirus
infection: treatment, sequelae and follow-up. J Matern Fetal Neonatal
Med 2010;23Suppl3:45-48.
9 Elliott SP. Congenital cytomegalovirus infection: an overview. Infect
Disord Drug Targets 2011;11:432-436.
10 Lazzarotto T, Guerra B, Gabrielli L, et al. Update on the prevention,
diagnosis and management of cytomegalovirus infection during
pregnancy. Clin Microbiol Infect 2011;17:1285-1293.

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