Guide For Using LOINC Microbiology Terms: Logical Observation Identifiers Names and Codes (LOINC )
Guide For Using LOINC Microbiology Terms: Logical Observation Identifiers Names and Codes (LOINC )
Website: loinc.org
3 Microscopic examination 16
3.1 Light microscopy 17
3.1.1 Microscopy to identify the characteristics or type of organism present 17
3.1.2 Microscopy to identify the presence or absence of a specific organism 18
3.2 Stains 18
3.2.1 Stains that help identify the characteristics or type of organism present 19
3.2.2 Stains that help identify the presence of a specific organism 20
3.3 Wet/KOH Preparations 21
3.3.1 Wet or KOH preparations that help identify the type of unknown organism 21
3.3.2 Wet or KOH preparations that help identify the presence of a suspected organism 22
3.4 Thick and thin films 23
3.5 Ova and parasite (O&P) 24
4 Cultures 26
4.1 Specimen-specific requirements 27
4.2 Routine culture to detect and identify an unknown organism 29
4.3 Organism-specific culture to identify the presence or species of a suspected organism 30
4.3.1 Presence or absence of a suspected genus or species 31
4.3.1.1 Screening cultures for drug-resistant organisms 31
4.3.2 Detecting and identifying the specific species of suspected organism 32
5 Susceptibility testing 35
5.1 Phenotypic susceptibility testing 35
5.1.1 Bacterial or fungal phenotypic susceptibility testing 37
5.1.2 Susceptibility testing for slow-growing bacteria 38
5.1.3 Viral phenotypic susceptibility testing 39
5.1.4 Susceptibility thresholds based on type of infection (“Breakpoints”) 40
5.2 Phenotypic testing for resistance enzymes 41
5.3 Genotypic resistance testing 42
5.3.1 Bacterial molecular resistance testing 44
5.3.1.1 Identifying the presence or absence of a resistance gene 44
5.3.1.2 Identifying the presence or absence of a resistance-conferring mutation 45
5.3.1.3 Identifying the specific resistance-conferring mutation found 46
5.3.2 Predicted susceptibility based on molecular testing 47
6 Antigen tests 48
6.1 LOINC Methods for antigen testing 48
6.2 Identifying the presence or absence of a suspected organism 49
6.3 Identifying the specific subtype of a suspected organism 50
6.4 Quantitative antigen tests 50
8 Serology testing 61
8.1 LOINC Components for antibody testing 62
8.1.1 Specifying the antibody class in the Component 62
8.1.2 Measuring acute and convalescent antibodies and vaccine efficacy 63
8.2 LOINC Methods for antibody testing 63
8.3 Testing for the presence or absence of antibodies to a specific organism 65
8.4 Quantitative antibody testing 66
LOINC was first published in 1995, and over the last 25 years has had significant growth and
adoption across domains including laboratory, physiological measurements, radiology, standardized
survey instruments, clinical documents, and nursing management and assessment. New LOINC
versions are published twice yearly, usually in June and December, and contain new content as well
as edits to previously published content.
At present, LOINC is used in more than 170 countries, and over 30 countries, including the United
States, have adopted LOINC as a national standard. U.S. federal regulations mandate the use of
LOINC codes through the "Promoting Interoperability" incentive programs for electronic health
records (formerly referred to as "meaningful use"), which require LOINC for laboratory test result
reporting. And in June 2018, the U.S. Food and Drug Administration (FDA) published Guidance
that supports the adoption of LOINC for in vitro diagnostic (IVD) tests, the distribution of LOINC
codes by IVD vendors, and the inclusion of LOINC codes for IVD tests in product labeling.1
1
Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests. Guidance for
Industry and Food and Drug Administration Staff. Silver Spring, MD: U.S. Food and Drug
Administration; 2018. Available from:
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm
610636.pdf
The primary focus of this mapping guide is observation values that are reported to a patient record;
limited information about mapping lab orders is also presented. Other use cases (e.g. specific
chemical tests or culture media used to identify isolates from a positive blood culture) are not fully
addressed at this time, but will likely be included in future versions. Next-generation sequencing
assays (which could be the subject of a whole guide itself) are out of scope.
This guide includes information about how to select LOINC terms for tests that detect a variety of
microorganisms (such as groups of bacteria, viruses and fungi as well as specific organisms) by
different methods, including culture, microscopy, immunoassay and molecular methods. It includes
tests that are resulted in different ways, including qualitative and quantitative measurements, as well
as those for which the result may evolve over time from preliminary to final. It also includes
serological testing for antibodies to microorganisms, even though such assays are not strictly in the
microbiology domain.
Lastly, LOINC continues to evolve following changes in laboratory medicine as well as lessons
learned regarding the best practices for reporting, storing, and aggregating laboratory data. In some
cases, LOINC terms that represented the preferred way of reporting 15 or 20 years ago may not
necessarily be the best concepts to use today based on current understanding. In such cases, we still
present information about mapping to such concepts in this guide, but with a usage note titled
“Evolving model” that describes the mapping strategy that is no longer preferred along with
recommendations for which codes to use based on current best practices.
In the assay-specific chapters, we include information about the specific methodology and how the
different LOINC axes (i.e., LOINC P arts) should be valued for various types of results. For different
types of assays and results, different P arts have specific values. For example, ordinal results are
represented using a LOINC term with Scale Ord, and specific stains have Method names that include
the type of stain. We also include examples of LOINC terms that represent each type of result within
that methodology, as well as example HL7 v2 OBX segments that demonstrate how the result could
be reported electronically. The HL7 v2 format is used for these examples because v2 is widely used in
laboratory result reporting and may be familiar to readers, whereas other standards such as Clinical
Document Architecture (CDA) and Fast Healthcare Interoperability Resources (FHIR) are not as
commonly used (in the United States) for laboratory reporting at this time.
This Guide also includes mapping and other information that are not assay-specific. Chapters 9
through 12 cover:
For readers who would like more information about LOINC or mapping principles, we have
provided several appendices at the end of this guide. Appendix A includes additional resources for
learning more about LOINC, mapping and validation, and related standards. Appendix B has
detailed information about requesting new LOINC terms. And Appendix C is a LOINC primer that
describes the 6 primary LOINC axes (Parts) , typical Component and Property/ S cale constructs for
microbiology, as well as the definitions and differences between orders, observations, and results.
KEY POINT
See Appendix A-C at the end of this guide for: A) recommended resources; B) how to
request new LOINC terms; and C) information about LOINC Parts, specific modeling for
microbiology and discussion about orders, observations, and results.
Lastly, LOINC content and documentation have been t ranslated into many languages, courtesy of
volunteer translators, which may help in mapping efforts outside of the U.S.
The table below illustrates this format using molecular microorganism detection as an example.
LOINC terms for molecular assays that detect whether or not a specific organism is present always
have P
rThr as the Property, Ord as the Scale, and one of the names shown in the M ethod row as the
Method, so the Property, Scale, and Method rows are blue. The Component a lways includes the words
gene, DNA, RNA, or rRNA but the microorganism name can vary, so this row is white, with the
variable part given in curly braces. The Time Aspect and S ystem can vary, so these rows are white and
contain the curly brace notation.
Property PrThr
Scale Ord
Probe
Probe.amp.sig
Probe.amp.tar
Non-probe.amp.tar
For more information about how to align the test results in your system with the correct LOINC
Part value, for example, which Property and S cale are appropriate for tests resulted as a titer versus
those resulted as ordinal strings (“Detected”, “Negative”), see Chapter 10 “Choosing the right LOINC
term (“mapping”)” and Appendix C “LOINC primer”.
The table below provides a brief overview of the field definitions in an HL7 OBX segment to help
you understand the examples in the guide. Note that the examples are simplified for readability and
do not represent the full OBX structure. For more information, please refer to the appropriate HL7
234
v2 and related specifications. , ,
The relevant fields for quantitative and qualitative results are as follows:
Quantitative result:
OBX|1|2|3.1^3.2^3.3^3.4^3.5^3.6|4|5|6|7|8|...
Qualitative result:
2
HL7 V2 Standard: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=185
3
HL7 V2 Lab Results Interface (LRI) for US Realm:
http://www.hl7.org/implement/standards/product_brief.cfm?product_id=329
4
Integrating the Healthcare Enterprise (IHE) Pathology and Laboratory Medicine (PaLM) Technical
Framework Supplement - Laboratory Analytical Workflow (LAW):
http://www.ihe.net/Technical_Frameworks/#PaLM
Table: OBX segment field definitions for both quantitative and qualitative results.
Data type of the result given in this segment. In this example, the
OBX-2 2
result is quantitative, so the data type is NM (numeric).
5 Quantitative result
OBX-5 carries either 5
a single quantitative 5.1 Qualitative result code
value or, if qualitative,
a triplet that can be 5.2 Qualitative result text
optionally repeated,
5.3 Qualitative result coding system
e.g., for reporting
observation values
5.4 Qualitative result code in a second coding system
using both the local
code system and a
5.5 Qualitative result text in a second coding system
standard code system
5.6 Second qualitative result coding system
5
All of the examples in this guide use LOINC Answer codes for qualitative results; due to licensing
restrictions, this guide does not yet include SNOMED CT codes. However, we recommend using
SNOMED CT codes for qualitative results in countries that are licensed to do so.
KEY POINT
In addition, information about specific LOINC models that have evolved or continue to evolve over
time will be offset using this style:
EVOLVING MODEL
LOINC terms with specific detection limit Methods are no longer recommended for use.
Instead, we encourage reporting individual results using a more generic code along with
a second LOINC (87706-8 Laboratory device Detection limit) to report the detection limit
as a separate observation.
2.6 Citations
We cite various articles, websites, and online resources in this guide. All citations and URLs were
verified at the time this guide was published. Scientific articles are referenced with their PubMed
identification numbers and linked to the entry at P ubMed.gov.
Table: Comparison of different microscopic exams and their LOINC naming patterns
O&P exam Ova & parasites Prid Nom {Name of stain or other
identified methodology}
KEY POINT
Property Prid
Scale Nom
Method Microscopy.light
Examples:
10729-2 Trypanosoma sp identified: Prid: Pt: Bld: Nom: Microscopy.light
LCN: Trypanosoma sp identified in Blood by Light microscopy
Property PrThr
Scale Ord
Method Microscopy.light
Example:
20457-8 Fungi.filamentous: PrThr: Pt: Urine sed: Ord: Microscopy.light
LCN: Fungi.filamentous [Presence] in Urine sediment by Light microscopy
3.2 Stains
LOINC includes terms for a variety of stains that aid in the identification of microorganisms. The
type of stain is indicated in the Method.
Microorganisms are naturally colorless. By adding color to a fixed smear, specific characteristics of
the organism such as morphology or cell wall properties become visible. These characteristics help
to identify the organism that is present. Examples of common stains and how they are used include:
● Acid-fast stains i dentify bacteria with long-chain fatty acids that are resistant to crystal
violet stain and other basic dyes;
● Gram stains are used to classify bacteria as Gram positive or Gram negative based on their
cell wall staining pattern;
● Nucleic acid stains bind to DNA and/or RNA and, depending on the stain, may
distinguish between the two and also differentiate single-stranded from double-stranded
nucleic acids;
LOINC contains two primary types of stain terms: 1) those that utilize staining patterns to
determine the type of organism present, if any; and 2) those that identify the presence or absence of
a suspected organism.
Property Prid
Scale Nom
Examples:
11480-1 Microscopic observation:Prid:Pt:Urine:Nom:Acid fast stain
LCN: Microscopic observation [Identifier] in Urine by Acid fast stain
The Component for terms used to identify the characteristics or type of organism present
using a stain is always Microscopic observation.
Property PrThr
Scale Ord
Examples:
23597-8 Dermatophilus congolensis:PrThr:Pt:Exudate:Ord:Methylene blue
LCN: Dermatophilus congolensis [Presence] in Exudate by Methylene blue stain
Similar to staining tests, wet and KOH preparation terms fall into two categories: 1) nominal tests
that are looking for the absence or, if present, specific identity of an organism, and 2) ordinal tests
looking for the presence or absence of a specific organism.
LOINC naming patterns for both types of observations are given in the two tables below.
Property Prid
Scale Nom
KOH preparation
Property Prid
Scale Nom
Examples:
6470-9 Microscopic observation:Prid:Pt:Stool:Nom:Wet preparation
LCN: Microscopic observation [Identifier] in Stool by Wet preparation
Property PrThr
Scale Ord
KOH preparation
LOINC terms for thin and thick films are named with the following pattern:
Property Prid
Scale Nom
Thick film
Examples:
10664-1 Filaria identified:Prid:Pt:Bld:Nom:Thin film
LCN: Filaria identified in Blood by Thin film
Note that there are a few LOINC terms with the M ethods Malaria smear and M alaria thin smear
that we are in the processing of updating in order to align with the model described above. There are
also some parasitology terms that follow the general light microscopy model described above, such as
51587-4 Plasmodium sp [Presence] in Blood by Light microscopy, to report the presence of any
Plasmodium species, and 32206-5 Plasmodium sp identified in Blood by Light microscopy, to report the
specific species of Plasmodium that was identified, that may be used when the specific type of smear
is not specified.
Property Prid
Scale Nom
Examples:
43227-8 Ova & parasites identified:Prid:Pt:Stool:Nom:Trichrome stain
LCN: Ova and parasites identified in Stool by Trichrome stain
Cultures may be done for reasons outside of routine patient care, such as for propagating cell lines
and preservation for future research and quality control. Such use cases are outside of the scope of
this guide.
In the LOINC name, the type of culture is specified in the Method. Examples include:
Note that at the current time, a single code for a routine or organism-specific culture is
recommended for reporting the preliminary result (e.g., from a blood bottle culture or a plated
specimen) and identification. Historically, all of these steps have been included in the laboratory
workflow under the “culture” umbrella, and individual results for each step have not been reported
to or stored in the patient’s EHR record. LOINC does contain some concepts to represent these
individual steps; they are not included in the present version of this guide, but may be added in
future editions.
A single LOINC term for a routine culture is used to report the preliminary result (e.g., from
a blood bottle culture or a plated specimen) and organism identification as each of these
steps occurs. Separate terms are used for Gram stain and susceptibility results. See the
first sample scenario in Chapter 11 for an example.
In almost all cases, LOINC terms do not distinguish specimen-specific techniques in the M ethod,
because the S ystem provides information about the specimen for which the culture is optimized. For
example, the term 625-4 Bacteria identified in Stool by Culture is used to represent a culture optimized
for the growth of pathogens in stool, and 6331-3 C ampylobacter sp identified in Stool by Organism
specific culture f or a culture that specifically promotes the growth of Campylobacter species in stool.
In both cases, the LOINC M ethod does not specify the details of how the culture is optimized for such
growth, because these details are laboratory-specific and unnecessary for interpreting the culture
result. The one exception is certain respiratory cultures, a few of which have specific M ethods such as
Respiratory culture.
Although LOINC terms for different types of samples look similar in terms of the construction of
the C
omponent and Method, there are differences in the spectrum of suspected microorganisms named
in the C
omponent a nd the specific culture M
ethods a ssociated with each. The first table below provides
examples of various specimens and the typical LOINC culture Methods used with each; the second
includes specimens and the typical pathogens that may be isolated from each using organism-specific
culture.
Blood Culture
Aerobic culture
Anaerobic culture
Organism specific culture
Burn Culture
CSF Culture
Organism specific culture
Shell vial culture
Genital Culture
Aerobic culture
Organism specific culture
Stool Culture
Organism specific culture
Urine Culture
Organism specific culture
Wound Culture
Aerobic culture
Anaerobic culture
Routine cultures are commonly used to look for bacteria, and thus would be named with the
Component Bacteria identified. As discussed in the introduction to this Chapter, a single code for a
routine culture is used to report the results of the bottle culture, bacterial isolation, and
identification. Several results may be reported over time with changing statuses, such as
“Preliminary” and “Final”, but using a single code helps tie these results together. Gram stain and
susceptibility testing results are reported using separate LOINC codes but are typically linked to the
primary culture result, for example, by using the OBX-4 Observation sub-ID field in an HL7 v2
message. OBX-4 is also used when multiple organisms grow on a single culture to both distinguish
the individual results as well as link each organism to its associated Gram stain and susceptibility
results.
Sometimes fungi will grow on a routine culture. If so, most laboratories would report these results
under the same test name. The LOINC name simply reflects that such a culture is not optimized for
growing out fungi; having “bacteria” in the name does not prohibit reporting whatever organism
grows.
LOINC terms that represent cultures for detecting and identifying unknown organisms are named
with the following pattern:
Fungus identified
Virus identified
Property Prid
Examples:
17928-3 Bacteria identified:Prid:Pt:Bld:Nom:Aerobic culture
LCN: Bacteria identified in Blood by Aerobe culture
KEY POINT
The same principle applies for organism-specific cultures as for routine cultures when an unexpected
organism is found. The LOINC term reflects what a given culture is optimized for, but if a different
Property PrThr
Scale Ord
Examples:
45095-7 Chlamydia trachomatis:PrThr:Pt:Genital:Ord:Organism specific culture
LCN: Chlamydia trachomatis [Presence] in Genital specimen by Organism specific culture
LOINC terms for screening cultures are named with the following pattern:
Property PrThr
Prid
Scale Ord
Nom
Examples:
73834-4 Bacteria.carbapenem resistant identified:Prid:Pt:Anal:Nom:Organism specific
culture
LCN: Bacteria.carbapenem resistant identified in Anal by Organism specific culture
Property Prid
Scale Nom
Examples:
20955-1 Salmonella sp identified:Prid:Pt:Stool:Nom:Organism specific culture
LCN: Salmonella sp identified in Stool by Organism specific culture
LOINC terms for colony counts are named with the following pattern:
Property NCnc*
ACnc
Num
* most common
Method Culture
Examples:
19090-0 Colony count:NCnc:Pt:Urine:Qn
LCN: Colony count [#/volume] in Urine
6 7 8
Various agencies, including the FDA and CLSI in the U.S. and EUCAST in Europe, publish
guidelines for the threshold at which a given organism should be susceptible to a specific antibiotic
for the purpose of clinical care. Using a hypothetical example, consider that a particular antibiotic
kills a specific organism at a concentration of 100 ug/mL or above. If the highest safe concentration
for patient dosing is 5 ug/mL, then that antibiotic cannot be used because the organism is not
susceptible at a concentration of 5 ug/mL.
LOINC terms for susceptibility testing have the name of the antibiotic in the Component. Drug names
in LOINC are almost always specified with the generic name. To facilitate searching, the LOINC
database typically includes the brand name in its list of related names.
The following table lists the primary Methods used in susceptibility testing:
6
Microbiology Data for Systemic Antibacterial Drugs — Development, Analysis, and Presentation
Guidance for Industry. Silver Spring, MD: U.S. Food and Drug Administration; 2016. Available from:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM182288.pdf
7
M100: Performance Standards for Antimicrobial Susceptibility Testing, 27th Edition. Wayne, PA:
Clinical and Laboratory Standards Institute; 2017.
8
Clinical Breakpoints [Internet]. Basel (Switzerland): The European Committee on Antimicrobial
Susceptibility Testing. Available from: http://www.eucast.org/clinical_breakpoints/
Agar (Disc) diffusion A standardized inoculum density from a culture isolate is applied to an agar
plate. Discs of absorbent material to which specific concentrations of
(Kirby-Bauer) antibiotic have been added are placed on the agar. The agar plate is incubated
to allow the isolate to grow on the plate in the presence of the antibiotic. If an
area surrounds the disc where growth of the organism has been inhibited, the
organism may be susceptible to the antibiotic on the disc. The diameter of the
zone of inhibition surrounding the disc can be measured and compared to
standards to determine if the organism is susceptible, intermediate, or
9
resistant to the antibiotic.
Gradient strip A small strip is impregnated with an antimicrobial drug that has an increasing
concentration from one end of the strip to another. The concentrations of the
(e.g. E-test™) antibiotic are marked along the strip. The strip is placed on the agar surface
that has been inoculated by a standardized density of the isolated organism
being tested. The MIC of the antimicrobial is determined by the intersection of
the border where microbial growth is inhibited and the concentration of
10
antimicrobial designated on the strip. The gradient strip test is a form of MIC
testing.6
MLC (minimum The minimum lethal concentration (MLC) is used to determine the minimum
lethal concentration) bactericidal concentration (MBC) or the minimum fungicidal concentration
(MFC) of drugs in question. A precise aliquot of culture from the MIC wells or
tubes that exhibit no growth are sub-cultured onto a non-selective agar plate
and allowed to incubate for 24 hours. The number of colony-forming units per
milliliter (CFU/mL) is determined. The MBC is defined as the lowest
concentration of antibiotic that kills 99.9% of the final inoculum after a
24-hour incubation and in accordance with the standardized conditions stated
in document M26-A. The MFC is defined as the lowest concentration of an
antifungal drug that kills 98-99.9% when compared to the initial inoculum (the
sample in the clear wells or tubes).6
9
Balouiri M, Sadiki M, Ibnsouda SK. Methods for in vitro evaluating antimicrobial activity: A review.
Journal of Pharmaceutical Analysis 2016;6:71-79.
10
CLSI, Methods for Determining Bactericidal Activity of Antimicrobial Agents. Approved Guideline,
CLSI document M26-A. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite
2500,Wayne, Pennsylvania 19087, USA, 1998.
KEY POINT
In LOINC, the Method Phenotyping is only used for viral susceptibility testing. For
microorganisms other than viruses, specific named Methods such as Agar diffusion, MIC,
and Gradient strip are used.
LOINC terms for bacterial and fungal susceptibility tests are named with the following pattern:
Property Susc
11
Wallace RJ Jr, Nash DR, Steele LC, Steingrube V. Susceptibility testing of slowly growing mycobacteria by a
microdilution MIC method with 7H9 broth. J Clin Microbiol. 1986 Dec;24(6):976-81. [PMID: 3097069]
12
Jorgensen JH, Carroll KC, Funke G, Pfaller MA, Landry ML, Richter SS, Warnock DW (Eds.).
Manual of Clinical Microbiology, 11th edition 2015;1220-1221,1286.
Scale Qn
Ord
OrdQn
Method MIC
Gradient strip
Agar diffusion
MLC
Examples:
7009-4 Erythromycin:Susc:Pt:Isolate:OrdQn:Gradient strip
LCN: Erythromycin [Susceptibility] by Gradient strip
As described above, the results for an MIC OrdQn assay can be reported either as quantitative in
OBX-5 with an interpretation in OBX-8 or ordinal in OBX-5 using the same LOINC, which is
illustrated in the following two OBX segment examples:
Property Susc
Scale OrdQn
Example:
20373-7 Amikacin:Susc:Pt:Isolate:OrdQn:Method for Slow-growing mycobacteria
LCN: Amikacin [Susceptibility] by Method for Slow-growing mycobacteria
The following table contains the naming pattern for viral phenotypic susceptibility terms in LOINC:
Property Susc
System Isolate
Scale OrdQn
Example:
72861-8 Ganciclovir: Susc: Pt: Isolate: OrdQn: Phenotyping
LCN: Ganciclovir [Susceptibility] by Phenotype method
Route of administration and type of infection are two independent parameters: there are cases where
one antibiotic could have multiple breakpoints depending on the combination of route and type of
infection, and others where one antibiotic will have a single breakpoint regardless of route and type
13
of infection. For example, there are two different breakpoints for parenteral penicillin: one for
meningitis and one for everything else. But, there is a single breakpoint for vancomycin. The
susceptibility test is carried out exactly the same way regardless of the breakpoint. It is only for the
final step of assigning a susceptibility result that the specific breakpoint becomes important.
LOINC terms for susceptibility testing based on different breakpoints for different infection types
contain the infection type in the System, for example, Isolate.meningitis, Isolate.pneumonia and
Isolate.UTI.
Note that I solate.meningitis (or “.pneumonia”, “.UTI”) indicates that the particular susceptibility
result being reported is for an antibiotic that has a meningitis breakpoint. It does not imply that the
patient has or is suspected to have meningitis. For the same patient, the result for the same antibiotic
based on the non-meningitis breakpoint may also be reported with a term that simply has I solate as
the S ystem, and the result for an antibiotic that only has a single published breakpoint will also be
13
In veterinary medicine susceptibility thresholds are critically dependent on host species. When
reporting susceptibility by threshold the host species must always be reported elsewhere in the
message.
The following table contains the naming pattern for these susceptibility threshold LOINC terms:
Property Susc
Scale OrdQn
Method MIC
Example:
31138-1 Cefotaxime: Susc: Pt: Isolate.meningitis: OrdQn: MIC
LCN: Cefotaxime [Susceptibility] for meningitis by Minimum inhibitory concentration
Gradient strip ARD is a reagent strip impregnated with a predefined concentration gradient of a
specific antibiotic or combination of antibiotics. The difference between this M ethod and Gradient
strip in LOINC is that Gradient strip is used for susceptibility testing, while G
radient strip ARD
is used for antimicrobial resistance detection and is reported as the presence or absence of a specific
enzyme or other mechanism that confers resistance. ARD is determined by comparing the inhibitory
concentration (IC) of a specific antimicrobial with the IC of that antimicrobial plus a resistance
inhibitor.
Property PrThr
System Isolate
Scale Ord
Example:
85046-1 AmpC beta-lactamase by cefoTEtan to cefoTEtan+cloxacillin inhibitory
concentration ratio:PrThr:Pt:Isolate:Ord:Gradient strip ARD
LCN: AmpC beta-lactamase by cefoTEtan to cefoTEtan+cloxacillin inhibitory concentration ratio
[Presence] by ARD gradient strip
14
The table below describes some of the resistance mechanisms and their associated genes.
14
Jia et al. 2017. CARD 2017: expansion and model-centric curation of the Comprehensive Antibiotic
Resistance Database. Nucleic Acids Research, 45, D566-573. Available from:
https://card.mcmaster.ca/ontology/36006
Alteration of antibiotic target Antibiotic target altered by rpoB, mcr-1, vanA, ermA
mutation or enzyme
modification
The resistance mechanisms above are all dependent on the ability of the organism to create or not to
create proteins that determine whether or not an antibiotic is lethal to the organism. The genes
responsible for the resistance proteins can be acquired either by genetic mutation or nucleic acid
transfer from another organism that carries the gene. As specified above, the genetic alterations can
change, replace, or cover up the protein to which the antibiotic attaches. Resistance genes can also
encode efflux pumps that move the antibiotic out of the microorganism. The antibiotic may be
inactivated, or the organism may become markedly less permeable to the drug, all due to genetic
15
changes in the microorganism.
Various M ethods are available to test for the genetic information (e.g., specific resistance genes or
nucleotide alterations in native genes) that encodes resistance mechanisms, including
Probe.amp.tar, N on-probe.amp.tar, and Sequencing (see Chapter 7 for definitions of these
Methods). Until 2018, LOINC bacterial genotypic susceptibility testing terms used the specific
Methods named above; however, moving forward we are recommending using the Molgen Method
for all bacterial molecular resistance testing to obviate the need to create different terms for different
molecular M ethods (Probe.amp.tar, S equencing, etc.). Terms that were previously created with a
Method other than M olgen are described below but their usage is not recommended.
Historically, susceptibility testing was always phenotypic and therefore was always performed on an
Isolate, which is a microorganism from a patient specimen that is grown and isolated on culture
media. However, with new molecular techniques, genotypic testing can be performed directly on
patient specimens without isolating the organism. Rather than creating separate terms for every
possible patient specimen that can be tested, single terms for each resistance gene or
resistance-conferring mutation will be created with the S ystem Isolate/Specimen, meaning that the
assay can be done using a traditional isolated colony or on a direct specimen. This does NOT imply
that every manufacturer’s genotypic assay is approved for testing on an isolate or any type of
specimen. Existing terms with I solate or other specific specimens as the S ystem may be updated over
time but are presented below in their present state.
15
Antibiotic Resistance [Internet]. Salt Lake City, Utah: University of Utah Genetic Science Learning
Center. Available from: http://learn.genetics.utah.edu/content/microbiome/resistance/
The specific Methods f or bacterial genotypic resistance testing such as Probe.amp.tar and
Sequencing are no longer recommended for use; the Method for existing bacterial molecular
resistance terms may be updated over time to Molgen.
EVOLVING MODEL
LOINC terms with specific Systems such as Bld or Isolate/Anorectal will no longer be created for
terms representing molecular resistance assays. Instead, the Isolate/Specimen System will be used
since newer molecular techniques can be used with a variety of specimens. Existing terms with more
specific Systems may be updated over time.
Property PrThr
System Isolate/Specimen
{Specimen type}*
Scale Ord
Method Molgen
Probe.amp.tar*
Non-probe.amp.tar*
*Going forward terms with these Methods may
be updated to the Molgen Method (see
discussion above)
Examples:
72421-1 Bacterial vancomycin resistance vanB
gene:PrThr:Pt:Isolate/Specimen:Ord:Molgen
LCN: Vancomycin resistance vanB gene [Presence] by Molecular method
Property PrThr
{Specimen type}*
Isolate*
*Going forward terms with these Systems may
be updated to the Isolate/Specimen System ( see
discussion above)
Scale Ord
Method Molgen
Probe*
Probe.amp.tar*
Non-probe.amp.tar*
*Going forward terms with these Methods may
be updated to the Molgen Method (see
discussion above)
Examples:
89372-7 Mycobacterium tuberculosis complex rpoB gene rifAMPin resistance
mutation:PrThr:Pt:Isolate/Specimen:Ord:Molgen
LCN: Mycobacterium tuberculosis complex rpoB gene rifAMPin resistance mutation [Presence]
by Molecular method
Property Prid
System Isolate/Specimen
Isolate*
*Going forward terms with these Systems may
be updated to the Isolate/Specimen System ( see
discussion above)
Scale Nom
Method Molgen
Probe.amp.tar*
Non-probe.amp.tar*
*Going forward terms with these Methods may
be updated to the Molgen Method (see
discussion above)
Property Susc
System Isolate
Scale Ord
Method Genotyping
Examples:
89488-1 Isoniazid:Susc:Pt:Isolate/Specimen:Ord:Genotyping
LCN: Isoniazid [Susceptibility] by Genotype method
72854-3 Ganciclovir:Susc:Pt:Isolate:Ord:Genotyping
LCN: Ganciclovir [Susceptibility] by Genotype method
(null) No method specified. Laboratory tests often do not include the Method as part of the
name for common tests when different methods produce clinically equivalent
results, which is a common situation in antigen testing.
16
Darwish IA. Immunoassay Methods and their Applications in Pharmaceutical Analysis: Basic
Methodology and Recent Advances. Int J Biomed Sci. 2006 Sep;2(3):217-35. [PMID: 23674985]
Immune stain An immune stain method is one where an antibody with an attached label reacts to
an antigen on cells within a tissue section. The labeled antibody produces a signal
when it binds to the antigen that can be detected by the assay instrument. In
LOINC, the Immune stain M ethod does not encompass Immunofluorescence, which
has its own Method type.
LA Latex agglutination is a method for detecting antigens using antibodies that are
attached to latex particles. When the antibody and antigen bind together, clumps
of latex particles are easily visible.
Property PrThr
Scale Ord
Examples:
31754-5 Brucella sp Ag: PrThr: Pt: Placenta: Ord:
LCN: Brucella sp Ag [Presence] in Placenta
Property Prid
Scale Nom
Example:
72366-8 Influenza virus A & B Ag: Prid: Pt: Nose: Nom: IA.rapid
LCN: Influenza virus A and B Ag [Identifier] in Nose by Rapid immunoassay
Property ACnc
Titr
Scale Qn
Example:
9817-8 Cryptococcus sp Ag: Titr: Pt: CSF: Qn: IA
LCN: Cryptococcus sp Ag [Titer] in Cerebral spinal fluid by Immunoassay
For example, Neisseria meningitidis is identified by the presence of the sodC gene. Different
serogroups of N. meningitidis can be identified based on the presence of additional genes: N.
meningitidis serogroup A contains the sacB gene, serogroup B contains synD, and serogroup Y
contains synF. By first testing for the sodC gene, the presence or absence of N. meningitidis can be
determined, and if it is found to be present, further testing for serogroup-specific genes can identify
the serogroup.
There are different types of nucleic acid tests, including individual tests that look for one specific
microorganism, and multiplex tests which simultaneously look for many different organisms based
on their individual genetic targets. Such multiplex tests are often represented in LOINC as panels,
such as 8 2159-5 Respiratory pathogens DNA and RNA panel – Nasopharynx by NAA with non-probe
detection, where the panel code is used for the order and the individual children to report the result
for each specific pathogen.
When selecting the best LOINC term for the nucleic acid test you are mapping, it is important to
review the manufacturer’s package insert or test specification document mentioned in section 3.2 to
determine: 1) the specific target, such as the name of the gene, or an unnamed segment of DNA or
RNA; and 2) the M ethod being used. Be careful when choosing terms for PCR-based tests, because, as
described further in Section 10.2, two LOINC Methods include a PCR step: Probe.amp.tar and
Non-probe.amp.tar.
As genetic testing continues to evolve, distinguishing the specific analyte (i.e. the genetic target) will
be important for understanding the differences between tests, interpreting the results, and guiding
further testing. Therefore, LOINC will continue to add new terms that specify the gene targets.
When mapping genetic tests, be sure to choose a LOINC term with the same specificity as the assay
you are mapping.
For tests that specify an individual genetic target, look for LOINC terms with a C
omponent
containing that specific target. For example:
For tests that do not specify the specific gene target, look for LOINC terms with a Component that
contains the more generic DNA or RNA. For example:
● Adenovirus 3 DNA
● Bordetella pertussis DNA
● Chikungunya virus RNA
Probe A test that detects a specific nucleic acid sequence by using a segment of genetic
material (the probe) that is known to bind to that sequence. This Method does not
include nucleic acid amplification.
Probe.amp.sig A test that uses a probe (see description of Probe above) to detect a specific target,
followed by amplification of the signal attached to that probe, which makes the
signal easier to detect. This Method does not include nucleic acid amplification.
Non-probe.amp.tar This Method begins with PCR-based amplification of the genetic material in the
specimen, but instead of using probes to identify the targets of interest, other
techniques, such as melt curve analysis or turbidity, are used to detect and identify
the target.
Property PrThr
Scale Ord
Method Probe
Probe.amp.sig
Probe.amp.tar
Non-probe.amp.tar
Examples:
87376-0 Escherichia coli stx1 gene:PrThr:Pt:Isolate:Ord:Probe.amp.tar
LCN: Escherichia coli stx1 gene [Presence] in Isolate by NAA with probe detection
KEY POINT
Remember the difference between Prid and Type is that Prid is used when the presence of the
organism is not certain, so either the absence (if it was not detected) or the specific subtype or strain
is reported, while Type is used when the organism is known to be present and the test is being done
to determine the specific subtype or strain.
Property Prid
Type
Scale Nom
Method Probe.amp.tar
Non-probe.amp.tar
Examples:
72483-1 BK virus subtype:Type:Pt:Ser/Plas:Nom:Probe.amp.tar
LCN: BK virus subtype in Serum or Plasma by NAA with probe detection
1. S yndromic, which include the most common organisms known to be associated with a
particular condition that are likely to be tested together. One example is a multiplex panel of
bacteria, viruses, and parasites that are common etiologic agents of diarrhea, such as the
following:
2. Pathogen class, which also include groups of organisms associated with a specific
condition, but only those within a single class of either bacterial, viral, fungal, or parasite,
such as the following viral causes of diarrhea: Rotavirus, Norovirus, Sapovirus, Astrovirus,
and Adenovirus.
Such multiplex tests are often represented in LOINC as panels, where the panel contains individual
children for reporting the individual result for each specific pathogen. LOINC code 82159-5, shown
below, is an example of a code that represents a multiplex panel.
Historically, multiplex tests that produced two or three individual results but where the individual
results were reported together in one field were modeled in LOINC by a single term (not a panel),
where all of the analytes were named and separated by ampersands (&) in the Component and “and” in
the Long Common Name (see the “Part-specific mapping principles” section in Chapter 9 for the
usage of & versus + in the Component). However, going forward, the panel model is recommended so
that each result can be reported in a separate field.
EVOLVING MODEL
Older LOINC terms for assays that produce individual results for two or three analytes were
sometimes modeled in LOINC as a single term with multiple analytes specified in the Component and
separated by “&”, and the Answer List a
ssociated with such terms would include combinatorial results.
Moving forward, only assays that truly produce a single result will be modeled this way; otherwise, a
panel will be created with individual children for each result.
Following is an example of an older LOINC term representing a multiplex assay that produces
individual results that are reported together as one:
51668-2 Streptococcus pneumoniae DNA & Haemophilus influenza DNA & Pseudomonas
aeruginosa DNA:Prid:Pt:XXX:Nom:Probe.amp.tar
LCN: Streptococcus pneumoniae DNA and Haemophilus influenzae DNA and Pseudomonas aeruginosa
DNA [Identified] in unspecified specimen by NAA with probe detection
LOINC terms for real-time PCR assays use the following naming pattern:
Property ThreshNum
Scale Qn
Method Probe.amp.tar
Examples:
74424-3 Enterovirus RNA:ThreshNum:Pt:Stool:Qn:Probe.amp.tar
LCN: Enterovirus RNA [Cycle threshold #] in Stool by NAA with probe detection
EVOLVING MODEL
Using LOINC terms with specific detection limit Methods is no longer recommended, and we
will likely not create any more terms that specify specific limits. Instead, we encourage
reporting viral load results using a term with Method Probe.amp.tar along with a second
LOINC term (87706-8 Laboratory device Detection limit) to report the detection limit as a
separate observation.
The following tables are a quick reference for determining the appropriate P roperty and Method for
viral load tests.
No Probe.amp.tar
Property NCnc
LnCnc
Scale Qn
Method Probe.amp.tar
Examples:
20447-9 HIV 1 RNA:NCnc:Pt:Ser/Plas:Qn:Probe.amp.tar
LCN: HIV 1 RNA [#/volume] (viral load) in Serum or Plasma by NAA with probe detection
LaCnc
Scale Qn
Method Probe.amp.tar
Examples:
43730-1 Epstein Barr virus DNA:ACnc:Pt:Ser/Plas:Qn:Probe.amp.tar
LCN: Epstein Barr virus DNA [Units/v olume] (viral load) in Serum or Plasma by Probe and target
amplification method
8 Serology testing
When a microorganism invades a host organism, its antigen(s) stimulate the production of
antibodies in the host and initiate a cascade of immune responses against it. As described above in
the chapter about antigen testing, the combination of the direct effect of the microorganism on the
host (e.g., via toxins) and the immune response to that microorganism often results in a
characteristic pattern of signs and symptoms that helps narrow down the potential list of causative
agents. Targeted antibody testing can be done based on this list of suspected organisms to identify
the single pathogen responsible. Tests for antibodies against infectious agents are useful for
Several classes of antibodies are produced by the human immune system, including IgA, IgD, IgE,
IgG, and IgM, all of which have a specific function. The most common types related to infectious
diseases are IgG and IgM. IgM antibodies are the first ones produced in response to a foreign
antigen, and the presence of IgM antibodies usually indicates acute infection (either active or recent).
IgG antibodies provide long-term immunity, and indicate previous, convalescent, or chronic
infection. IgG antibodies are also indicative of an immune response to vaccination.
Ab Antibody, which encompasses any of the specific antibodies and is used when the
assay does not specify which antibodies it is detecting
Ab.IgG+IgM Both IgG and IgM antibody can be detected, but not distinguished
Ab.IgG & IgM Both IgG and IgM can be detected and distinguished, and results are reported
separately for each
KEY POINT
Pay attention to the class(es) of antibody targeted by your test when choosing the
appropriate LOINC term. Often, the only distinguishing attribute of several LOINC terms is
that they differ in the specification of the antibody class.
For example, the following term represents the test for Epstein-Barr virus in the acute phase of the
illness:
32843-5 Epstein Barr virus capsid Ab.IgG^1st specimen: ACnc: Pt: Ser: Qn:
LCN: Epstein Barr virus capsid IgG Ab [Units/volume] in Serum --1st specimen
32844-3 Epstein Barr virus capsid Ab.IgG^2nd specimen: ACnc: Pt: Ser: Qn:
LCN: Epstein Barr virus capsid IgG Ab [Units/volume] in Serum --2nd specimen
(null) No method specified. Laboratory tests often do not include the Method as part of
the name for common tests when different methods produce clinically equivalent
results, which is a common situation in antibody and antigen testing. In these cases,
LOINC creates terms without a Method to allow laboratory professionals the
freedom to choose how the test is run.
IA.rapid LOINC defines rapid immunoassays as those producing results within 30 minutes.
Aggl Agglutination tests detect antibodies to antigens. When antibodies and their
corresponding antigens are mixed together, clumps are easily visible, which
indicates the presence of antibodies to the specific antigen.
Comp fix The presence or absence of either antigens (or antibodies) is determined by
whether complement is fixed as a result of the formation of antigen-antibody
complexes. If no complexes are formed, the unfixed complement will attach to the
indicator red blood cells and lyse them. Lysis indicates that no antibody (or antigen)
is present in the patient’s serum. If no lysis occurs, the antigen-antibody complexes
have used up the available complement, so no lysis will occur. No lysis indicates the
presence of antigen (or antibody). 15
17
Darwish IA. Immunoassay Methods and their Applications in Pharmaceutical Analysis: Basic
Methodology and Recent Advances. Int J Biomed Sci. 2006 Sep;2(3):217-35. [PMID: 23674985]
18
Pedersen JC. Hemagglutination-inhibition assay for influenza virus subtype identification and the
detection and quantitation of serum antibodies to influenza virus.Methods Mol Biol.
2014;1161:11-25. [PMID: 2 4899416]
Neut Neutralization is used to detect antibody to a virus in patient serum. The virus and
serum are combined and allowed to incubate. Next, indicator cells are added
followed by a second incubation. After the second incubation, the indicator cells
are examined microscopically for evidence of visible cellular changes known as
viral cytopathic effect (CPE) or for immunofluorescent staining of the viral antigen.
If the virus was not neutralized by antibody in the serum, it will infect the indicator
cells that will then display CPE, or, if fluorescent stain was applied, will emit visible
fluorescence. If antibody is present, the virus will not invade the cells, and no CPE
19
will be observed or no fluorescence will be visible.
KEY POINT
If the test you are mapping is performed by one of these methods, be sure to choose a LOINC
term with a matching Method specification. If the precise method is not specified for your
test, choose the methodless LOINC term, unless the specific Method has a clinically
significant effect on the result. In this case, we recommend that you request a new,
method-specific LOINC code.
Property PrThr
Scale Ord
19
VNT (Virus Neutralisation Tests) [Internet]. Glasgow (Scotland): Biobest Laboratories Ltd. Available
from: h
ttp://www.biobest.co.uk/diagnostics/techniques/vnt-virus-neutralisation-tests.html
Examples:
81097-8 West Nile virus Kunjin strain Ab: PrThr: Pt: Ser: Ord:
LCN: West Nile virus Kunjin strain Ab [Presence] in Serum
Property Acnc
Titer
Scale Qn
Examples:
80618-2 Zika virus Ab.IgM: ACnc: Pt: CSF: Qn: IA
LCN: Zika virus IgM Ab [Units/volume] in Cerebral spinal fluid by Immunoassay
24176-0 Adenovirus Ab^2nd specimen: Titr: Pt: Ser: Qn: Comp fix
LCN: Adenovirus Ab [Titer] in Serum by Complement fixation --2nd specimen
Interpretation terms in LOINC have the Property Imp and the Scale Nom or Nar. Many Components
include a keyword such as “pattern”. In the case of impressions covering IgG and IgM, the LOINC
term name includes “&”, which indicates that different results that can be distinguished are being
compared.
Property Imp
Scale Nom
Nar
Examples:
23979-8 Borrelia burgdorferi Ab.IgG band pattern: Imp: Pt: CSF: Nom: IB
LCN: Borrelia burgdorferi Ab.IgG band pattern [Interpretation] in Cerebral spinal fluid by Immunoblot
73560-5 Mumps virus Ab.IgG & IgM: Imp: Pt: Ser: Nom:
LCN: Mumps virus IgG and IgM [Interpretation] in Serum
Note that some laboratories use the same general term to report an interpretation across
organism-specific panels. In this case, the meaning of the result is understood in the context of the
panel. Examples of these general codes include 5 6850-1 Interpretation and review of laboratory results,
59464-8 M
icrobiologist review of results, and 69048-7 Immunologist review of results.
Qualitative result values are non-numeric and can be either ordinal or nominal. Ordinal result values
can be ranked, such as Detected/Not detected, Low/Medium/High,
Susceptible/Intermediate/Resistant, and Positive/Negative. Nominal result values cannot be ranked,
and include concepts such as the specific Streptococcus pneumoniae serotype that is detected, or the
species of bacteria identified in a blood culture. Nominal result values can be thought of as “short
answer” or those coming from a pick-list. Narrative result values, which consist of longer, free-text
entries, are not drawn from a formal vocabulary or terminology standard and are out of scope for
this chapter.
In the context of data exchange using HL7 v2, both the observation and the observation result
value(s) are reported in the OBX segment, with the observation in OBX-3 and the qualitative result
value(s) in OBX-5. More specifically, OBX-5.1 contains the code, 5.2 the text, and 5.3 the coding
system. Remember that in specific cases where the P roperty is O rdQn, such as antimicrobial
susceptibility testing, result values can be reported e ither as: 1) a quantitative value in OBX-5 with
an interpretation in OBX-8; or 2) as an ordinal result value in OBX-5 using the same LOINC. In this
chapter we are addressing the second reporting style; however, example OBX segments for both are
shown below for comparison. For more details, see the “OBX segments” section in Chapter 2 and/or
the “Phenotypic susceptibility testing” section in Chapter 5.
As part of the LOINC distribution, we provide structured lists of possible result values for nearly
every ordinal qualitative LOINC observation term as well as many nominal terms. These LOINC
Answer Lists are sets that organize a collection of LOINC Answer strings and codes. LOINC Answer
Lists illustrate the possible result values associated with an observation, and LOINC Answer codes
KEY POINT
Local result values for qualitative tests can be mapped to LOINC Answer codes that
represent the equivalent string.
Different IVD manufacturers may recommend different result values, such as Detected/Not detected
versus Present/Absent, for similar assays. Users should always follow local reporting regulations, for
example, reporting qualitative results according to the IVD vendor’s package insert for the assay that
was used. There are ongoing efforts in the U.S. by the FDA’s Systemic Harmonization and
Interoperability Enhancement for Lab Data (SHIELD) initiative, the I VD Industry Connectivity
Consortium (IICC), and other collaborators to create constrained, publicly-available lists of answer
sets and/or equivalence mappings for result values that share the same meaning. Such constrained
answer sets, once approved by stakeholders, have the potential to make reporting across different
IVD assays more consistent, or at least comparable by way of equivalence mappings. When the
SHIELD initiative participants define such sets, this chapter will be updated to include information
about the appropriate use of manufacturer or public-health recommended coding sets and/or
equivalence mappings, their impact on LOINC Answer Lists, and how they will be made available.
In the microbiology domain, nearly all of the LOINC Answer Lists are Example type lists. They are
meant to give users an idea of the types of results associated with a particular LOINC observation.
For example, a list that contains result values such as “Detected” and “Not detected” is indicative of an
ordinal result representing the presence or absence of an analyte.
A LOINC term is typically bound to an Answer List based on information from the package insert
and sample report(s) for the original IVD test that term was created for. When new LOINC terms
are requested, we ask for supporting documentation in part to understand how the observation is
KEY POINT
Example Answer Lists include Answer codes and strings that are meant to be illustrative of
possible result values. Answer Lists are typically bound to a particular LOINC term based on
the IVD test upon which that term was originally modeled. Depending on their reporting
needs, users may add or subtract result values from an Example LOINC Answer List if they
remain consistent with that term’s Scale ( i.e., ordinal or nominal).
A handful (less than 20) of LOINC microbiology terms are bound to Preferred Answer Lists. These
are primarily observations with a finite set of result values, such as the type of Clostridium
botulinum toxin present. In such cases, the result values that were known to exist at the time the
term was created are all included in the associated LOINC Answer List. As of version 1.1 of this
guide, only a single LOINC microbiology term (LOINC: 5 5463-4 I nfluenza virus A swine origin RNA
[Identifier] in Unspecified specimen by NAA with probe detection) is bound to a N
ormative list
(LL745-1), where the result values in that Answer List must be used as specified by the Centers for
Disease Control and Prevention (CDC).
The LOINC Answer List bound to a particular term is shown in the Answer List section of the
detailed display page for that term. Display pages are available in the online LOINC search
application (https://search.loinc.org) and the Regenstrief LOINC Mapping Assistant (RELMA).
The Answer List section will clearly indicate the linkage type, i.e. E xample, Preferred, or
Normative. (For more information about the online search application and RELMA, see the
“Choosing the right LOINC term” chapter.) In addition, the linkages from LOINC terms to Answer
Lists are available in the LOINC Answer File that is available for d ownload from the LOINC
website.
Some LOINC Answer Lists include a mapping between the LOINC Answer codes and
corresponding SNOMED CT codes, though this is a work in progress and a given list may only
contain mappings for a subset of the answers it contains. Note that due to licensing restrictions, this
guide does not yet include SNOMED CT codes, though the mappings are available in the LOINC
Answer File that is available for download from the LOINC website. The mappings are also shown
on detailed display pages associated with each term.
Negative LA6577-6
Absent LA9634-2
20
SNOMED CT [Internet]. London (England): SNOMED International. Available from:
http://www.snomed.org/snomed-ct
KEY POINT
Result value mapping should be done at the level of the Answer code and Answer string, not
at the level of the Answer List.
For instance, suppose two different assays, “Assay A” and “Assay B”, produce ordinal result values for
whether or not IgM antibody to Legionella species is present in a serum specimen. The package
insert for Assay A recommends reporting result values as Detected/Not detected, whereas the
package insert for Assay B recommends reporting Present/Equivocal/Absent. Laboratories using
Assay A would use Answer codes LA11882-0 (Detected) and LA11883-8 (Not detected), and
laboratories using Assay B would use LA9633-4 (Present), LA11885-3 (Equivocal), and LA9634-2
(Absent). Both laboratories would map to the same LOINC term:
The above LOINC term happens to be associated with Example LOINC Answer List L L744-4,
which contains LA11882-0 (Detected) and LA11883-8 (Not detected), but the same term can be used
with result values LA9633-4 (Present), LA11885-3 (Equivocal), and LA9634-2 (Absent), or any
other ordinal values that have the same meaning.
KEY POINT
The primary characteristics of an assay should determine which LOINC term to map to,
NOT the Answer List associated with that term. Result value mapping is an independent
process.
Equivocal LA11885-3
Indeterminate LA11884-6
Inconclusive LA9663-1
Invalid LA15841-2
Undetermined LA14100-4
Uncertain LA12719-3
Within LOINC, we do not want to make different Answer Lists that vary only by the inclusion or
exclusion of certain null flavors. Thus, our policy is to add specific null flavors as entries in the
Unknown LA4489-6
KEY POINT
The vendor’s package insert and laboratory’s Standard Operating Procedure for commercial
and laboratory-developed tests, respectively, are the best starting point for mapping.
KEY POINT
The analyte, specimen(s) that can be analyzed, qualitative sample results, units of measure for
quantitative results, and, if relevant, the Method of analysis, are essential for choosing a LOINC
term.
RELMA is highly recommended for mapping anything more than just a handful of terms, because it
stores your data and provides features that will help you with the mapping process. RELMA’s main
limitation is that it only runs on the Microsoft Windows operating system, so Mac or Linux users
will have to configure a virtual machine with Windows in order to use RELMA. (Instructions for
how to do this are available on the LOINC website). A new version of RELMA is released twice a
year in June and December, and must be downloaded after each release in order to stay current with
software updates.
Although this may seem like a lot of results, do not panic! Also, do not pick the first LOINC term
just because it’s at the top! Focusing on a few key details can make it easy to narrow down the list of
candidates. First of all, in this case, the test is specifically looking for IgG antibodies. So, you can
narrow your search results by including the search term “IgG”:
With that level of specificity, we now have a single, precise matching LOINC term for your test.
KEY POINT
Using combinations of multiple, specific search terms will return a smaller set of results to
review and will make your mapping more efficient and accurate.
Equally important, however, is not over-specifying your mapping by guessing about information
that you do not have. As you saw from the previous example, LOINC has a lot of seemingly similar
terms for the same analyte that vary by subtle distinctions. Mapping accurately requires attention to
those details and not making assumptions about the test you are trying to map.
For example, searching RELMA for the test name “Rotavirus Ab Ser IA Titer” will return:
If all of the other microorganism antibody titer tests in the group you are mapping are for IgG (and
say so in the name), it may be tempting to map to the IgG term, but since IgG is NOT specified in
your Rotavirus test name, mapping to the IgG term would be over specifying based on the
information you have available.
You need to keep the constraints of your LIS or LIMS in mind. If the local system has a common
name of STAIN for all stains and CULT for all culture results, those two tests have to be mapped to
the most generic LOINC terms for those concepts: 11546-9 Microscopic observation [Identifier] in
Unspecified specimen by Other stain and 1 1475-1 Microorganism identified in Unspecified
specimen by Culture, respectively. The specific LOINC mapping for urine culture, stool culture,
Giemsa stain, etc. will take place at the order level.
KEY POINT
Map to the most specific LOINC term possible based on the information you have available,
but do not over specify by making assumptions about test characteristics that you do not
have.
LOINC labels tests that detect a microorganism’s genetic material with “DNA”, “RNA” or “gene”,
depending on whether the assay has a specific, named target or is for an unnamed or undisclosed
portion of the DNA or RNA.
For example, the C omponent Neisseria meningitidis DNA represents any fragment of DNA from
N. meningitidis, and N eisseria meningitidis serogroup w135 synG is used for assays that are
specifically looking for the serogroup w135 synG gene.
For example, HIV 1+2 Ab indicates a test that can detect both HIV 1 and HIV 2 antibodies but
cannot distinguish between them. In contrast, Chlamydia trachomatis & Neisseria gonorrhoeae
DNA indicates a test that can detect both C
hlamydia trachomatis and N
eisseria gonorrhoeae AND can
distinguish between the two. In these cases, the result distinguishes the different entities. For
example the answer values might be “Chlamydia trachomatis not detected” and/or “Neisseria
gonorrhoeae detected”.
KEY POINT
Analytes separated by & are distinguished in the result while those separated by + are not.
When reviewing a large list of candidate LOINC terms for mapping, it is often easier to narrow
down your choices by looking at the S cale first. Applying the coarser filter first will help focus in on
the fine grained distinctions in the P roperty.
The following table illustrates how the P roperty and S cale differ for different types of results.
20447-9 HIV 1
RNA:NCnc:Pt:Ser/Plas:Qn:Probe.amp.tar
Example result: 2,000 copies/mL
86701-0 Rotavirus A
RNA:ThreshNum:Pt:XXX:Qn:Probe.amp.ta
r
Example result: 26 cycles
For quantitative tests, the reporting units of measure will determine the correct LOINC P roperty
and are essential for choosing the correct LOINC term. In the LOINC Users’ Guide, the “ Property”
section of Chapter 2 contains a list of the LOINC Properties that are available, and Appendix E
“Examples for LOINC Property M atching” includes detailed examples for matching units and
Properties.
Before you start mapping, a useful exercise would be to determine which P roperty corresponds to the
units associated with each of your tests.
Adding a P roperty to your search query is an easy way to narrow down the list of candidate LOINC
terms. For example, if the test’s units of measure are mg/dL, searching for LOINC terms with the
Cnc (mass concentration) will significantly narrow the number of terms returned.
Property M
To illustrate further, consider the two searches in the images below. The first image shows the
search query “CSF Influenza virus Ab” and the second shows “CSF Influenza virus Ab MCnc”. The
second search returns less than half of the candidate LOINC terms than the first. Although you must
still choose between six candidate terms, the mapping will be straightforward if you know whether
the test measures Influenza virus A versus Influenza virus B and IgA, IgG and IgM.
10.5.4 System
The LOINC S ystem represents the specimen, e.g. blood or urine. The most common laboratory
specimens in microbiology are blood (Bld), serum or plasma (Ser/Plas), urine, various respiratory
specimens, and cerebrospinal fluid (CSF). However, LOINC microbiology terms exist for many
other specimens as well, such as stool, tissue, pleural fluid, and urethral swab.
Note that some LOINC terms contain a S ystem with several specimen types separated by a slash (“/”).
The slash indicates that any of these specimen types are suitable for that test. It does NOT mean that
a specific manufacturer’s assay has to be approved for all of the specimens listed; it simply means that
the results are expected to be clinically equivalent regardless of which of the two (or three)
specimens are used, and the assay should be approved for at least one of the given specimens.
For example, the S er/Plas System in LOINC is used for assays where the analyte can be measured in
either serum or plasma. This is common, for example, in antibody tests. LOINC does not have
separate terms for tests on serum and plasma, unless there is a compelling reason to do so. One such
example is for ammonia assays, where the preferred specimen is plasma, and the results in serum
compared to plasma are significantly different. LOINC will never have a test with the S ystem
Ser/Plas as well as the exact same test but with the S ystem S er or the System Plas. Over time as
testing methods have evolved, by policy, LOINC has added P las to many LOINC terms that
originally had a System of Ser. LOINC will continue to do so moving forward as new approaches are
developed and either specimen is approved by the laboratory or manufacturer.
KEY POINT
Mapping a particular manufacturer’s assay to a Ser/Plas term does NOT imply that the
specific assay is approved for both specimens. Laboratories do not need to run the test on
both serum and plasma in order to use a LOINC code with a System of Ser/Plas.
10.5.5 Method
LOINC includes terms that specify a particular laboratory M ethod as well as those that do not (i.e.,
methodless terms). In general, when the specific Method used has a clinically significant impact on
interpreting the results for a particular analyte, LOINC will specify the M ethod in its term name. On
the other hand, if the result is the same clinically regardless of the methodology used, then the
LOINC name will generally be methodless.
Even when the Method is included in the term name, LOINC specifies the Method at a general level.
For example, Immunoassay (IA) includes enzyme immunoassay and chemiluminescence.
The same principle of mapping to the most specific term possible without over-specifying, applies to
choosing LOINC terms with the appropriate Method. If the assay you are mapping has a specific
methodology that is important for interpreting the result, then map to a LOINC term with that
specific Method. If such a term does not exist, you may need to request a new one (see this guide’s
Appendix B “Requesting new LOINCs”).
The same mapping principles described earlier apply for each approved specimen and reporting
format. For example, if an assay is approved for use with either serum or CSF, then the vendor
should provide two LOINC codes, one with System Ser or Ser/Plas, and one with C
SF. Similarly, if a
single assay can be configured to result an ordinal qualitative response or a numeric titer, then a
vendor should again provide two different LOINC codes, one for each type of result. It is up to each
downstream client to determine the best LOINC codes for their specific implementation of the test
and to select it from the options proposed. The lab may also decide to follow another mapping
strategy as shown for “Laboratory C” in the table below, but note the limitation presented in the
footnote for that strategy.
IVD vendors should map to all of the LOINC codes that support the range of specimens and
reporting options approved for a single test kit.
Laboratories should map to the subset of LOINC codes that are appropriate for the
specimens and reporting options they have implemented for that test kit.
The following table illustrates the sets of LOINC codes that IVD vendors could provide for various
hypothetical assays based on the information in the package insert along with the subset(s) of codes
that downstream laboratories would use depending on their individual LIS implementations.
Package insert assay IVD Vendor provided LOINC codes LOINC codes used by downstream
information clients for individual implementations
Adenovirus DNA PCR, 21055-9 Adenovirus DNA: PrThr: Laboratory A: only using the assay to
approved for serum, Pt: Ser/Plas: Ord: Probe.amp.tar test CSF specimens
CSF, and urine, may 38375-2 Adenovirus DNA: PrThr: 38375-2 Adenovirus DNA: PrThr: Pt:
only be reported as a Pt: CSF: Ord: Probe.amp.tar CSF: Ord: Probe.amp.tar
qualitative ordinal 86512-1 Adenovirus DNA: PrThr:
result Pt: Urine: Ord: Probe.amp.tar Laboratory B: using the assay for all
three approved specimens, with three
individual test builds
21055-9 Adenovirus DNA: PrThr: Pt:
Ser/Plas: Ord: Probe.amp.tar
38375-2 Adenovirus DNA: PrThr: Pt:
CSF: Ord: Probe.amp.tar
86512-1 Adenovirus DNA: PrThr: Pt:
Urine: Ord: Probe.amp.tar
21
Using a single build for a generic specimen is not recommended as it results in a loss of information,
and the list of codes provided by the vendor should not include the generic LOINC code when more
specific ones are available (note that 39528-5 is not listed in the second column)
Adenovirus DNA PCR, 21055-9 Adenovirus DNA: PrThr: Laboratory G: only using the assay to
approved for serum, Pt: Ser/Plas: Ord: Probe.amp.tar test CSF specimens, reporting result
CSF, and urine, may be 38375-2 Adenovirus DNA: PrThr: as a qualitative ordinal
reported as a Pt: CSF: Ord: Probe.amp.tar 38375-2 Adenovirus DNA: PrThr: Pt:
qualitative ordinal 86512-1 Adenovirus DNA: PrThr: CSF: Ord: Probe.amp.tar
result, quantitative viral Pt: Urine: Ord: Probe.amp.tar
load in copies/volume Laboratory H: testing CSF and urine
or log copies/volume, or 49334-6 Adenovirus DNA: NCnc: specimens, reporting results as
both an ordinal result Pt: Ser/Plas: Qn: Probe.amp.tar copies/mL
and if positive, a 49338-7 Adenovirus DNA: NCnc: 49338-7 Adenovirus DNA: NCnc: Pt:
quantitative viral load Pt: CSF: Qn: Probe.amp.tar CSF: Qn: Probe.amp.tar
48609-2 Adenovirus DNA: NCnc: 48609-2 Adenovirus DNA: NCnc: Pt:
Pt: Urine: Qn: Probe.amp.tar Urine: Qn: Probe.amp.tar
KEY POINT
⚠
Note that these scenarios are meant to illustrate the use of LOINC codes for test results
across microbiology domains and are not guaranteed to be completely accurate in terms of
clinical care.
The following tables contain a variety of lab tests, the LOINC term(s) that correspond to those tests,
and sample results over a series of time points. The specific time intervals are less important than the
order in which the tests occur and results are reported. Each row also contains the specific chapter
and section in this guide that corresponds to the test in that row for easy reference.
CSF HSV PCR 7.3 32141-4 Herpes simplex virus LA11883-8 Final
1+2
DNA [Presence] in Not detected
Cerebral spinal fluid by Probe
and target amplification
method
Skin lesion HSV 4.2.2 5858-6 Herpes simplex virus LA21123-7 No Preliminary
culture identified in Skin by Organism growth
specific culture
Time period 2
Lab test Related LOINC term(s) Result(s) Result status
chapter and (LOINC Answer
section codes are
included where
available)
Skin lesion HSV 4.2.2 5858-6 Herpes simplex virus LA21123-7 No Preliminary
culture identified in Skin by growth
Organism specific culture
Time period 3
Lab test Related LOINC term(s) Result(s) Result status
chapter and (LOINC Answer
section codes are
included where
available)
Skin lesion HSV 4.2.2 5858-6 Herpes simplex virus LA21123-7 No Preliminary
culture identified in Skin by growth
Organism specific culture
Time period 4
Lab test Related LOINC term(s) Result(s) Result status
chapter and (LOINC Answer
section codes are
included where
available)
Skin lesion HSV 4.2.2 5858-6 Herpes simplex virus LA21123-7 No Final
culture identified in Skin by growth
Organism specific culture
In this scenario, the tables are organized by test rather than time periods in order to illustrate specific
information about LOINC panels and multiplex testing.
In this scenario, the stool pathogen profile shown in the table below contains 10 elements out of the
22 in LOINC panel 82195-9 Gastrointestinal pathogens DNA and RNA panel - Stool by Target
amplification with non-probe based detection. Since the 10 elements match the panel in terms of S ystem
and M ethod, and none of the elements in the LOINC panel are required, this example stool pathogen
panel may be mapped to 8 2195-9, and 82195-9 can be used as the order code. However, if the
example stool pathogen profile contained 15 elements, 3 of which were not contained in 8 2195-9, or
if the M
ethod for the example profile was P robe.amp.tar, then it could not be mapped to the existing
LOINC panel.
KEY POINT
⚠
Note that these examples do not represent any particular manufacturer or test kit, and we
recommend that you always follow the result reporting requirements as stated in the
manufacturer’s package insert or test specification document as well as local regulations.
2 - Report 13503-8 Borrelia burgdorferi Ab.IgM band pattern [Interpretation] in IgM to the
the band Serum by Immunoblot following two
pattern bands detected,
supporting a
diagnosis of Lyme
disease: 39, 41
For higher confidence in the accuracy and consistency of your mappings, multiple experts should be
involved. To minimize the potential for bias, each expert could independently map each test,
followed by a comparison and reconciliation of discrepancies. Resources may not support this level
of mapping redundancy, in which case we still recommend having at least one other reviewer
confirm the LOINC choices. This review could be performed across all mappings, or even for a
subset of tests with different analytes, methods, and units of measure.
Of special note is that the Regenstrief Institute offers a service called the Mapping Validity Checker,
which is a semi-automated algorithm that checks the LOINC mappings for each test in a test catalog.
The algorithm looks for inconsistencies and probable errors in the mappings and returns a detailed
report highlighting areas that need further review. Where possible, the report provides suggestions
for choosing the correct LOINC code. The Mapping Validity Checker is available for a small fee as
part of the L
OINC Premium Membership program. The detailed feedback and consistency checking
represents an exceptional value, even for expert mappers. (Regenstrief hasn’t yet seen a mapping file
completely free of issues).
22
Lin MC, Vreeman DJ, McDonald CJ, Huff SM. Correctness of Voluntary LOINC Mapping for
Laboratory Tests in Three Large Institutions. AMIA Annu Symp Proc. 2010 Nov 13;2010:447-51.
[PMID: 21347018]
LOINC terms may be edited for a variety of reasons, but Regenstrief’s policy is to not modify any
term in a way that would change its fundamental meaning. Terms can be updated for a variety of
reasons without changing the meaning, including modeling changes, nomenclature updates,
corrections, and changes in status.
A LOINC term can have one of four different statuses as described in the following table. If a LOINC
term is discovered to be erroneous or ambiguous, its status is set to “Deprecated”, but it is not
removed from the database.
Trial Concept is experimental in nature. Use with caution as the concept and associated
attributes may change.
Discouraged Concept is not recommended for current use. New mappings to this concept are
discouraged; existing mappings may continue to be valid in context.
Deprecated Concept is deprecated. Concept should not be used, but it is retained in LOINC for
historical purposes.
For more details regarding statuses and other editorial policies, see the “Editorial policies and
procedures” chapter in the LOINC Users’ Guide.
Users should review each release for changes in status for all LOINC terms they are using. If a
previously active LOINC term you mapped to has now become discouraged or deprecated, users
should review the documented rationale for that change and update the mapping to an appropriate
Users should also review edits to any terms they are using. For example, updates to the LOINC Long
Common Name are quite common in subsequent LOINC versions as we refine our naming
conventions. If you are using this attribute in your system, it should be updated with each release.
In addition, many users would benefit from reviewing the new LOINC terms published in each
release to see if new terms are available for tests previously unmapped or if there are now more
suitable matches for underspecified mappings.
The two main ways to find newly edited LOINC terms are:
1. Filter on the current version number in the VersionLastChanged field in the LOINC Table
(either the .csv or .mdb version), which can be downloaded from the L OINC download page
of the LOINC website. Once you have filtered on this field, the value in the CHNG_TYPE
field will indicate whether the term is new, discouraged, deprecated, or updated (see
“Appendix A LOINC Database Structure” in the LOINC Users’ Guide for descriptions of the
CHNG_TYPE values).
2. Download the L OINC Table Changes File, which is available as an independent download
from the LOINC website.
KEY POINT
We recommend updating your local system with the latest version of LOINC within 90
days of each release, which occurs twice a year in June and December.
From the local database maintenance standpoint, consider the following recommendations:
1. Anytime there is a change in the display name, specimen type, reporting format, units of
measure, workstation assignment or interpretive data, there is a potential for a LOINC
attribute change, so the existing mapping should be reviewed any time such a change is
implemented;
2. If instrument downtime or a kit change occurs, the LOINC mappings for the tests run by
the substitute bench or referral lab performing the temporary downtime runs should be
reviewed. If the LOINC is “stamped” on an open result field and a different LOINC is going
to be used, the pre-determined override procedure (which varies from LIS to LIS) will need
to be invoked;
3. If any local tests are mapped to a LOINC term with System XXX or no Method ( i.e.,
methodless), consider looking for new codes with a more accurate S ystem or M
ethod w ith
each new LOINC release.
First, recognize that you will almost inevitably have to inactivate some mappings and update to
superseding codes. Consider where the history logs of those mappings should be stored. (In the
source systems that use them? Offline in your mapping environment?) Next, consider what the
optimal communication and approval process should be when the mappings are finalized and ready
for publication to downstream recipients. You’ll also want to determine what the format should be
of the mapping file, including its structure and contents (e.g. which data fields). RELMA has a highly
configurable set of features for exporting mappings (See the “Exporting Local Terms and their
LOINC Mappings” section in the RELMA Manual).
If you are an IVD vendor, we strongly recommend that you publish the mappings of your test codes
to LOINC codes for your customers using the newly developed LIVD specification (described
below).
The LIVD specification was created for publishing and exchanging mappings of LOINC terms for
IVD test results as a resource for downstream users such as clinical laboratories. IVD vendors are
well positioned to identify the appropriate LOINC terms for their test results because they possess all
of the relevant information about the test. When paired with expert LOINC knowledge and review,
IVD vendors have the opportunity to create high quality mappings that can then be used by their
customers to achieve more consistent coding choices across the industry. As IVD vendors make
these mappings available in the LIVD format, the reduced effort and expense of choosing the correct
LOINC term will dramatically boost the ability of labs to implement standard terminology.
If you are an IVD vendor mapping your tests to LOINC, we recommend that you publish
your mappings using the LIVD format.
For several reasons, it could be advantageous if a trusted, neutral third party such as the Regenstrief
Institute or IICC, would serve as an expert curator and central repository of mappings between IVD
assays and LOINC. In addition to its role as the developer of LOINC, Regenstrief could help provide
a single point of contact for all vendor-mapped codes in a common format (e.g. LIVD) and make
them broadly available from a central location for downstream users such as laboratories, EHR
systems, public health departments, and health information exchanges (HIEs). In general, by
minimizing the number of times each test has to be mapped, the risk of incorrect mappings will be
reduced. However, it is also important to keep in mind that ultimately, it is the laboratory
professionals’ responsibility to determine which LOINC terms are most appropriate for the tests
they perform.
Such an approach is not without issues, including synchronization between the many IVD vendors
and the source; business, legal, and IP issues with publication outside of the organization’s control;
and the resources it would take to maintain such a service. Nevertheless, Regenstrief would welcome
feedback (pros, cons, suggestions) about such an approach at https://loinc.org/contact/.
LOINC website
The LOINC® website has multiple resources available for new and experienced LOINCers. From the
home page, you can click “Get Started” for a quick tour. Dig a little deeper and you will find domain
specific information, videos, details on available downloads, events and community activities, and
information on submitting new LOINC terms.
https://loinc.org
Through the Premium Membership program, you can gain access to real-time and archived
LOINCinars (webinars). Past topics have included a tour of the new LOINC artifacts, tips for
searching in LOINC, and the lifecycle of a submission.
https://loinc.org/members/webinar/
Journal publications
Forrey AW, McDonald CJ, DeMoor G, Huff SM, Leavelle D, Leland D, Fiers T, Charles L, Griffin B,
Stalling F, et al. Logical observation identifier names and codes (LOINC) database: a public use set of
codes and names for electronic reporting of clinical laboratory test results. Clin Chem. 1996 Jan;
42(1):81-90. [PMID: 8565239]
LOINC Essentials
A thorough, detailed step-by-step guide for getting your local terms mapped to LOINC written by
LOINC Director Dr. Daniel Vreeman. Available for $39, this eBook will help you learn LOINC fast.
https://danielvreeman.com/loinc-essentials/
Journal Publications
Abhyankar S, Demner-Fushman D, McDonald CJ. Standardizing clinical laboratory data for
secondary use. Journal of biomedical informatics. 2012;45(4):642-650. doi:10.1016/j.jbi.2012.04.012.
[PMID: 2 2561944]
Kim H, El-Kareh R, Goel A, Vineet F, Chapman WW. An Approach to Improve LOINC Mapping
through Augmentation of Local Test Names. Journal of biomedical informatics. 2012;45(4):651-657.
doi:10.1016/j.jbi.2011.12.004. [PMID: 2 2210167]
Related standards
UCUM
The Unified Code for Units of Measure (UCUM) is a code system intended to include all units of
measures being contemporarily used in international science, engineering, and business. The
purpose is to facilitate unambiguous electronic communication of quantities together with their
units.
http://unitsofmeasure.org
HL7 v2
http://www.hl7.org/implement/standards/product_brief.cfm?product_id=185
HL7 CDA
http://www.hl7.org/implement/standards/product_brief.cfm?product_id=7
HL7 FHIR
http://www.hl7.org/implement/standards/product_brief.cfm?product_id=449
Regenstrief balances the desire to respond quickly to new term submissions with the review
processes necessary for a high quality standard. We can only be quick if the requesters provide clear
and comprehensive information about the terms they are submitting. A list of information required
for a submission is provided below.
How to submit
The information you provide about your local test/measurement and how it is used is more
important than the proposed LOINC name you come up with. Having complete information about
your local test makes the review process much smoother and helps us create clear term definitions as
well as verifying and enhancing other accessory content, which benefits everyone.
Required information
The set of information required for a particular submission depends on the content of the request. In
order for us to process your request, we need:
Regardless of format, we ask that users submit no more than 50 proposed terms at a time.
See the sections below for more details about each of the three submission formats.
For detailed instructions on how to use RELMA to propose a term, please see Appendix A of the
RELMA manual. You can download the RELMA Manual here:
http://loinc.org/downloads/files/RELMAManual.pdf.
http://loinc.org/submissions/new-terms
Other formats (e.g. distributed database fields, exported internal/local formats) will not be accepted.
● Component
● Property
● Time Aspect
● System
● Scale
● And where relevant, the M
ethod.
No single attribute (Part) alone can completely describe a given measurement; only when they are
taken together do six attribute names define a single LOINC concept. Each type of Part is briefly
described in Table 1 and in more detail in later chapters when relevant. In addition, you can find a
thorough description of each P art in the LOINC Users’ Guide “Major Parts of a test or observation
name” chapter.
LOINC does not include information about certain parameters that either are not relevant for
interpreting the result or are expected to be reported elsewhere in the context of the test result. Such
attributes include the specific manufacturer or instrument used for testing, the specific anatomic site
of blood collection, such as “right antecubital fossa”, testing priority, such as “stat”, information about
who collected the specimen or verified the result, and the place of testing.
Property The dimension of the analyte that is being ● Mass concentration (MCnc)
measured
● Presence or Threshold (PrThr)
● Type
● Titer (Titr)
● Aspirate (Asp)
● Nasopharynx (Nph)
● Cervix (Cvx)
● Unspecified specimen
(XXX)
Method How the analyte was measured. The Method ● No method specified (no value
is the only major axis that does not have to for the Method)
be populated for every LOINC term.
● Immunoassay (IA)
● Agglutination (Aggl)
23
Note that a slash (/) in the System means “or”, indicating that any of the specimen types included are
suitable for that test. It does NOT mean that a specific manufacturer’s assay is approved for both
specimens; it simply means that results are expected to be clinically equivalent regardless of which of
the two (or three) specimens are used.
KEY POINT
Definitions
An order (“battery” or “profile”) is a request for a single test or group of tests to be
performed
An observation (“test result”) is a single resultable test
A result (“test result value”) is a quantitative or qualitative value produced by the test
For example, Borrelia burgdorferi IgG+IgM with reflex to immunoblot panel - Serum is an order, but it is
not an observation because it does not represent a single test that can be resulted. The OrderObs
value for such a term is O rder. On the other hand, Borrelia burgdorferi IgG Ab [Presence] in Serum by
Immunoblot is a single test that could be ordered and resulted individually, so in LOINC, its OrderObs
value is B
oth (meaning that the same term can function as both the order and observation). Finally,
some observations are such that they would never be ordered by themselves, and these have an
OrderObs value of O bservation. Examples include the presence or absence of IgG antibodies to
various Borrelia protein bands (e.g., 23 kDa), which would not be ordered in isolation.
The concepts of orders and observations are closely related to the panel and panel children
constructs in LOINC. LOINC “panels” are always order-only terms that contain a discrete set of
enumerated child elements (children), corresponding to what is typically called a “Battery” or
“Profile” in the laboratory setting. A given panel term does not represent a single resultable test;
rather, it represents an order for a set of tests. Panel terms often have a dash (-) for the Property and
Scale since the child terms may not all have the same values for these attributes. In addition, although
in almost all cases the child elements within a LOINC panel are enumerated, they are not necessarily
all required; rather, some may be optional or conditional, and the same LOINC panel term may be
LOINC terms that are observations only are, by definition, children or resultable tests within an
orderable panel and cannot be ordered by themselves. In contrast, those classified as both an order
and an observation may be included in a panel but also have to be orderable (and resultable) on their
own.
KEY POINT
OrderObs values
LOINC panel terms = Order
LOINC terms that only exist within panels = Observation
LOINC terms that can be ordered singly or as part of a panel = Both
Following is an example of a LOINC Borrelia burgdorferi panel showing the order-only panel term
and its children:
As part of the LOINC distribution, we provide lists of LOINC Answer codes for nearly every
qualitative LOINC observation term. Where possible, we also publish a mapping between LOINC
answer codes and corresponding SNOMED CT codes, though this is a work in progress. Note that
due to licensing restrictions, this guide does not yet include SNOMED CT codes.
In the laboratory domain, nearly all of the LOINC Answer lists are EXAMPLE type lists that are
meant to give users an idea of the types of results associated with a particular LOINC. Users should
always follow local reporting regulations, for example, reporting qualitative results according to the
vendor’s package insert.
Component
The Component part of a LOINC term describes what is being measured. For assays such as cultures
or stains when the purpose is to identify whether or not a microorganism is present and if yes,
which type, the Component name is usually general, such as Bacteria identified (for cultures) or
24
SNOMED CT [Internet]. London (England): SNOMED International. Available from:
http://www.snomed.org/snomed-ct
Qualitative results
LOINC Microbiology terms include two types of qualitative results: those that represent the
presence or absence of an analyte (Scale Ord), and those that represent the identity of an analyte
(Scale N
om). LOINC terms with an ordinal Scale are used for categorical results that can placed in an
order, such as Detected/Not detected, Low/Medium/High, and Positive/Negative. All tests that are
reported in this manner are labeled as ordinal because the result categories can be ranked. The
Property for ordinal terms is typically PrThr, which stands for “Presence or Threshold”, meaning
either the actual presence or absence of an analyte or that the amount of analyte detected is over
some predetermined threshold.
Terms with the Property of Type are used for assays that identify the specific analyte in cases when
the baseline presence of the analyte is known. For example, if an isolate known to contain
Streptococcus pneumoniae is further analyzed to determine the specific serotype, the serotype assay
would have a Property of Type, not P
rid, because the presence of the Streptococcus is already
known.
KEY POINT
Property Prid + Scale Nom = absence of an analyte, or, if present, the type of analyte found;
the result is often selected from a list of organisms
Example results: Not detected, Leptospira biflexa, Leptospira interrogans, Leptospira
kirschneri
Property Type + Scale Nom = type of analyte found, when the presence is already known;
the result is often selected from a list of organisms
Example results: Leptospira biflexa, Leptospira interrogans, Leptospira kirschneri
Note that the example answers for a Type/Nom term are the same as the Prid/Nom term,
except the Prid/Nom term includes another choice for “Not detected”
Quantitative results
Assays that measure the amount of analyte present have a S cale of Q n. These terms can vary in the
specification of their P roperty, depending on the specific characteristic that is being measured, such
as titer, mass concentration, or number per area. The LOINC P roperty is closely related to the units
of measure; the Property determines the kind of units that are reportable with that term. LOINC has
different Properties for analytes measured in mass units versus substance units (e.g. milligrams versus
millimoles), but does not have different P roperties to represent different orders of magnitude, such as
milligram versus gram. Thus, when mapping, users must choose a LOINC term with a P roperty that
The ACnc P roperty represents the number of arbitrary units in a volume (arbitrary concentration).
Immunoassay results that are based on optical densities are commonly represented in LOINC with
this Property. Because the units are truly arbitrary, they may be represented in a variety of ways by
different laboratories and also within LOINC, as shown in the table below.
#/area Naric Qn
The package insert will tell you whether a particular assay is approved for quantitative and/or
qualitative reporting; some assays are approved for both and may map to two LOINC codes. For
assays that map to two LOINC codes, the code that is appropriate for the result being reported in a
particular instance should be used.
KEY POINT