LYMEX LYMEX

Synonyms

Allscripts (AEHR) Order Name

Lyme Vise IgG/IgM AB Reflex MTTT

Sunrise Clinical Manager (SCM) Order Name

Lyme Vise IgG/IgM AB Reflex

EPIC Order Name

Clinical Info

For more information on the interpretation of Lyme disease serology, please visit:https://www.youtube.com/watch?v=Dei-8na9wZUhttps://www.youtube.com/watch?v=LhF7vX5RynAhttps://www.aphl.org/aboutAPHL/publications/Documents/ID-2021-Lyme-Disease-Serologic-Testing-Reporting.pdf

Specimen Type

Blood

Container

Gold Top Tube

Collection Instructions

Container/Tube: Gold-top tube(s)
Specimen: 1 mL of serum
Transport Temperature: Refrigerate

Transport Instructions

Refrigerate

Specimen Stability

3 days Room Temperature
14 Days Refrigerated
30 Days Frozen

Methodology

Chemiluminescence Immunoassay (CLIA) with reflex to Modified Two Tier Testing (MTTT)
for Equivocal and Positive CMIA results

Days Performed

Monday through Saturday

Performing Laboratory

Northwell Health Laboratories

CPT

86617 x 2

PDM

5304324

Result Interpretation

Negative 0.01 - 0.89 Index
Equivocal 0.90 - 1.09 Index
Positive ≥ 1.10 Index

Suggested Interpretation of Lyme Disease Serologic Test Results using the Modified Two-Tiered Testing Algorithm

Test Sequence			Interpretation for Laboratories	Interpretation for Providers	Comments / Further Actions
Tier 1	Tier 2a	Tier 2b
Lyme VlsE IgM/IgG Total Immunoassay	Lyme IgM Immunoassay	Lyme IgG Immunoassay
Negative	Testing Not Indicated	Testing Not Indicated	Negative for antibodies to B. burgdorferi (Lyme disease).	No laboratory evidence of infection with B. burgdorferi (Lyme disease).	Negative results may occur in patients recently infected (≤14 days) with B. burgdorferi. If recent infection is suspected, repeat testing on a new sample collected in 7–14 days is recommended.
Positive/ Equivocal	Negative	Negative	Antibodies to B. burgdorferi (Lyme disease) not confirmed.	No laboratory evidence of infection with B. burgdorferi (Lyme disease).	Negative results may occur in patients recently infected (≤14 days) with B. burgdorferi. If recent infection is suspected, repeat testing on a new sample collected in 7–14 days is recommended.
Positive/ Equivocal	Positive/ Equivocal	Negative	IgM-class antibodies to B. burgdorferi (Lyme disease) detected.	Results are consistent with acute or recent infection with B. burgdorferi (Lyme disease).	IgM immunoassay results should only be considered as indicative of recent infections in patients presenting within 30 days of symptom onset. Consideration of IgM immunoblot results in patients with symptoms lasting >30 days is discouraged due to the risk of false positive IgM immunoblot results or prolonged IgM seropositivity following disease resolution. Testing of a new specimen collected in 7–14 days to demonstrate IgG seroconversion may be considered to confirm infection. If both tests are equivocal consider repeat testing in 7-14 days if clinically warranted.
Positive/ Equivocal	Negative	Positive/ Equivocal	IgG-class antibodies to B. burgdorferi (Lyme disease) detected.	Results are consistent with B. burgdorferi (Lyme disease) infection in the recent or remote past. IgG-class antibodies may remain detectable for months to years following resolution of infection.	Results should not be used to monitor or establish adequate response to therapy. Response to therapy is confirmed through resolution of clinical symptoms; additional laboratory testing should not be performed. If both tests are equivocal consider repeat testing in 7–14 days if clinically warranted.
Positive/ Equivocal	Positive/ Equivocal	Positive/ Equivocal	IgM and IgG-class antibodies to B. burgdorferi (Lyme disease) detected.	Results are consistent with B. burgdorferi infection (Lyme disease) in the recent or remote past. Antibodies may remain detectable for months to years following resolution of infection.	Results should not be used to monitor or establish adequate response to therapy. Response to therapy is confirmed through resolution of clinical symptoms; additional laboratory testing should not be performed. If both tests are equivocal consider repeat testing in 7–14 days if clinically warranted.

NOTE: Testing for IgM antibodies to B. burgdorferi is not indicated in patients presenting >30 days post-symptom onset.

Adapted from APHL Suggested Reporting Language, Interpretation and Guidance Regarding Lyme Disease Serologic Test Results

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