Lyme Immunoassay, IgM and IgG

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Marshfield Clinic Public WebSite

Test Code: LYMG

Overview
Ordering
Specimen
Performing
Clinical/Interpretive
Contacts
Coding

Synonyms/Keywords

Lyme confirmation, Lyme IgM, Lyme IgG, B. burgdorferi

Test Components

IgM and IgG-class antibodies to B. burgdorferi (Lyme disease)

Useful For

Confirmation of Lyme serology positive and equivocal results.

Specimen Requirements

Fasting Required	Specimen Type	Preferred Container/Tube	Acceptable Container/Tube	Specimen Volume	Specimen Minimum Volume (allows for 1 repeat)	Pediatric Minimum Volume (no repeat)
No	Serum	Red Top Tube (RTT)	Serum separator tube (SST)	1 mL	0.5 mL	0.5 mL

Collection Processing Instructions

Separate serum from cells within 2 hours of collection

Acceptable Specimen Types

Serum

Specimen Stability Information

Specimen Type	Temperature	Time
Serum	Refrigerated	7 days
Serum	Frozen (-20 ^oC)	3 months

Rejection Criteria

Turbid sera, gross hemolysis, gross lipemia or bacterially contaminated samples

Performing Laboratory Information

Performing Location	Day(s) Test Performed	Analytical Time	Methodology/Instrumentation
Marshfield	Monday through Friday	1 day	Chemiluminescence immunoassay (Liaison XL)

Test Information

This assay is for confirmation of a Lyme screen, as part of a modified two-tier test (MTTT) algorithm for Lyme disease (LD) serological testing. A report of Negative, Equivocal, or Positive for IgM & IgG anti-B. burgdorferi antibodies together with an interpretive comment will be made. Please see the Table below for interpretation. Note that the MTTT still suggests that IgM results in patients with > 30 days of the infection be disregarded, since a detectable IgM titer after that time may be due to non-specific cross-reactions.

Reference Range Information

Performing Location	Reference Range
Marshfield	Negative

Interpretation

Table: Guidance for the Interpretation of Lyme Disease (LD) MTTT Results

Test Sequence			Interpretation for Providers
Lyme Screen	Confirmatory Lyme IgM	Confirmatory Lyme IgG
Lyme Screen	Confirmatory Lyme IgM	Confirmatory Lyme IgG
Negative	Testing Not Indicated	Testing Not Indicated	No laboratory evidence of infection with B. burgdorferi (Lyme disease). Negative results may occur in patients recently infected (< or = 14 days) with B. burgdorferi. If recent infection is suspected, repeat testing in 7-14 days.
Positive/Equivocal	Negative	Negative	No laboratory evidence of infection with B. burgdorferi (Lyme disease). Negative results may occur in patients recently infected (< or = 14 days) with B. burgdorferi. If recent infection is suspected, repeat testing in 7-14 days.
Positive/Equivocal	Equivocal	Negative	Infection with B. burgdorferi (Lyme disease) cannot be ruled in or ruled out. Equivocal results may occur in patients recently infected (< or = 14 days) with B. burgdorferi. If recent infection is suspected, repeat testing in 7-14 days.
Positive/Equivocal	Positive	Negative	Results are consistent with acute or recent infection with B. burgdorferi (Lyme disease). IgM results should ONLY be considered as indicative of recent infections in patients presenting within 30 days of symptom onset.
Positive/Equivocal	Negative	Equivocal	Infection with B. burgdorferi (Lyme disease) cannot be ruled in or ruled out. If clinically indicated, consider repeat testing in 7-14 days.
Positive/Equivocal	Negative	Positive	Results are consistent with B. burgdorferi (Lyme disease) infection in the recent or remote past.
Positive/Equivocal	Positive	Positive	Results are consistent with B. burgdorferi infection (Lyme disease).
Positive/Equivocal	Equivocal	Equivocal	Infection with B. burgdorferi (Lyme disease) cannot be ruled in or ruled out. Equivocal results may occur in patients recently infected ( < or =14 days) with B. burgdorferi. If recent infection is suspected, repeat testing in 7-14 days.
Positive/Equivocal	Equivocal	Positive	Results are consistent with B. burgdorferi infection (Lyme disease) in the recent or remote past.
Positive/Equivocal	Positive	Equivocal	Results are consistent with a new infection with B. burgdorferi (Lyme disease). IgM results should ONLY be considered as indicative of recent infections in patients presenting within 30 days of symptom onset.

(Adapted from APHL Suggested Reporting Language, Interpretation and Guidance Regarding Lyme disease Serologic Test Results.

https://www.aphl.org/aboutAPHL/publications/Documents/ID-2021-Lyme-Disease-Serologic-Testing-Reporting.pdf. Accessed 12/11/2023

Outreach CPTs

CPT	Modifier (if needed)	Quantity	Description	Comments
86617		2	Lyme Confirmatory Immunoassay, IgM and IgG

Synonyms/Keywords

Lyme confirmation, Lyme IgM, Lyme IgG, B. burgdorferi

Test Components

IgM and IgG-class antibodies to B. burgdorferi (Lyme disease)

Ordering Applications

Ordering Application	Description

If the ordering application you are looking for is not listed, contact your local laboratory for assistance.

Specimen Requirements

Fasting Required	Specimen Type	Preferred Container/Tube	Acceptable Container/Tube	Specimen Volume	Specimen Minimum Volume (allows for 1 repeat)	Pediatric Minimum Volume (no repeat)
No	Serum	Red Top Tube (RTT)	Serum separator tube (SST)	1 mL	0.5 mL	0.5 mL

Collection Processing

Separate serum from cells within 2 hours of collection

Acceptable Specimen Types

Serum

Specimen Stability Information

Specimen Type	Temperature	Time
Serum	Refrigerated	7 days
Serum	Frozen (-20 ^oC)	3 months

Rejection Criteria

Turbid sera, gross hemolysis, gross lipemia or bacterially contaminated samples

Useful For

Confirmation of Lyme serology positive and equivocal results.

Test Components

IgM and IgG-class antibodies to B. burgdorferi (Lyme disease)

Reference Range Information

Performing Location	Reference Range
Marshfield	Negative

Interpretation

Table: Guidance for the Interpretation of Lyme Disease (LD) MTTT Results

Test Sequence			Interpretation for Providers
Lyme Screen	Confirmatory Lyme IgM	Confirmatory Lyme IgG
Lyme Screen	Confirmatory Lyme IgM	Confirmatory Lyme IgG
Negative	Testing Not Indicated	Testing Not Indicated	No laboratory evidence of infection with B. burgdorferi (Lyme disease). Negative results may occur in patients recently infected (< or = 14 days) with B. burgdorferi. If recent infection is suspected, repeat testing in 7-14 days.
Positive/Equivocal	Negative	Negative	No laboratory evidence of infection with B. burgdorferi (Lyme disease). Negative results may occur in patients recently infected (< or = 14 days) with B. burgdorferi. If recent infection is suspected, repeat testing in 7-14 days.
Positive/Equivocal	Equivocal	Negative	Infection with B. burgdorferi (Lyme disease) cannot be ruled in or ruled out. Equivocal results may occur in patients recently infected (< or = 14 days) with B. burgdorferi. If recent infection is suspected, repeat testing in 7-14 days.
Positive/Equivocal	Positive	Negative	Results are consistent with acute or recent infection with B. burgdorferi (Lyme disease). IgM results should ONLY be considered as indicative of recent infections in patients presenting within 30 days of symptom onset.
Positive/Equivocal	Negative	Equivocal	Infection with B. burgdorferi (Lyme disease) cannot be ruled in or ruled out. If clinically indicated, consider repeat testing in 7-14 days.
Positive/Equivocal	Negative	Positive	Results are consistent with B. burgdorferi (Lyme disease) infection in the recent or remote past.
Positive/Equivocal	Positive	Positive	Results are consistent with B. burgdorferi infection (Lyme disease).
Positive/Equivocal	Equivocal	Equivocal	Infection with B. burgdorferi (Lyme disease) cannot be ruled in or ruled out. Equivocal results may occur in patients recently infected ( < or =14 days) with B. burgdorferi. If recent infection is suspected, repeat testing in 7-14 days.
Positive/Equivocal	Equivocal	Positive	Results are consistent with B. burgdorferi infection (Lyme disease) in the recent or remote past.
Positive/Equivocal	Positive	Equivocal	Results are consistent with a new infection with B. burgdorferi (Lyme disease). IgM results should ONLY be considered as indicative of recent infections in patients presenting within 30 days of symptom onset.

(Adapted from APHL Suggested Reporting Language, Interpretation and Guidance Regarding Lyme disease Serologic Test Results.

https://www.aphl.org/aboutAPHL/publications/Documents/ID-2021-Lyme-Disease-Serologic-Testing-Reporting.pdf. Accessed 12/11/2023

For more information visit:

http://labtestsonline.org

Performing Laboratory Information

Performing Location	Day(s) Test Performed	Analytical Time	Methodology/Instrumentation
Marshfield	Monday through Friday	1 day	Chemiluminescence immunoassay (Liaison XL)

For billing questions, see Contacts

Outreach CPTs

CPT	Modifier (if needed)	Quantity	Description	Comments
86617		2	Lyme Confirmatory Immunoassay, IgM and IgG

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For most current information refer to the Marshfield Laboratory online reference manual.

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26526 Lyme Immunoassay, IgM and IgG