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HelpTest Code LYMPAN Lyme Disease Serology, Serum
Useful For
The primary lab diagnostic test for Lyme disease.
Synonyms/Keywords
Lyme Disease, Borrelia burgdorferi, Lyme IgG and IgM, LYMSCR
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) | 1.0 mL | 0.5 mL | 0.5 mL |
Collection/Processing Instructions
Separate serum from cells within 2 hours of collection.
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated | 7 days |
| Frozen (-20 o C) | 3 months |
Rejection Criteria
| Gross hemolysis |
| Gross lipemia |
| Bacterially contaminated |
Test Components
A chemiluminescence immunoassay screen test will be performed on all specimens. All specimens with a positive or equivocal screening result will reflex to Lyme Confirmatory Immunoassay, IgM and IgG. No confirmatory analysis will be performed on samples with a negative screening result.
Test Information
This assay is for screening and confirmation (as-needed), as part of a modified two-tier test (MTTT) algorithm for Lyme disease (LD) serological testing.
A chemiluminescence immunoassay screening test will be performed on all specimens. All specimens with a positive or equivocal screening result will reflex to the confirmatory test Lyme Immunoassay, IgM and IgG on the same day of testing.
For the confirmation test, 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 with > 30 days of the infection be disregarded, since a detectable IgM titer after that time may be due to non-specific cross-reactions.
Interpretations
Table: Guidance for the Interpretation of Lyme Disease (LD) MTTT Results
| Test Sequence | Interpretation for Providers | ||
|---|---|---|---|
| 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 (≤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 (≤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 (≤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 new or recent infection with B. burgdorferi (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 (≤ 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
Reference Range Information
Negative
Marshfield Labs Performing Department
Marshfield Labs Microbiology
Performing Information
| Performing Location | Day(s) Test Performed | Analytical Time | Methodology/Instrumentation |
|---|---|---|---|
| Marshfield | Lyme Screen and Confirmation: Monday through Friday | 1 day | Chemiluminescence immunoassay (Liaison XL) |
CPT Codes
| CPT | Modifier (if needed) |
Quantity | Description | Comments |
|---|---|---|---|---|
| 86618 | 1 | Lyme Immunoassay Screen | ||
| 86617 | 2 | Lyme Confirmatory Immunoassay, IgM and IgG | Performed only if needed |
Outreach CPT Codes
| CPT | Modifier (if needed) |
Quantity | Description | Comments |
|---|---|---|---|---|
| 86618 | 1 | Lyme Immunoassay Screen | ||
| 86617 | 2 | Lyme Confirmatory Immunoassay, IgM and IgG | Performed only if needed |
Ordering Applications
| Ordering Application | Description |
|---|---|
| Cerner | Lyme Disease Serology, Serum (COMMON) |