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25226 Lyme Disease Serology, Serum

Lyme Disease Serology, Serum
Test Code: LYMPAN
Synonyms/Keywords
​​​Lyme Disease, Borrelia burgdorferi, Lyme​ IgG and IgM, LYMSCR 
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. 
Useful For
​The primary lab diagnostic test for Lyme disease.
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


Performing Laboratory 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)
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.

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
​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 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 (< 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
​86618 ​ ​1
​Lyme Immunoassay Screen
 ​
​86617 ​ ​2 ​Lyme Confirmatory Immunoassay, IgM and IgG
 ​Performed only if needed
Synonyms/Keywords
​​​Lyme Disease, Borrelia burgdorferi, Lyme​ IgG and IgM, LYMSCR 
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. 
Ordering Applications
Ordering Application Description
​Centricity ​Lyme Disease Serology, Serum
​Cerner ​Lyme Disease Serology, Serum (COMMON)
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)​ ​1.0 mL ​0.5 mL ​0.5 mL
Collection Processing

​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


Useful For
​The primary lab diagnostic test for Lyme disease.
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. 
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
​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 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 (< 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:
Performing Laboratory 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)
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​86618 ​ ​1
​Lyme Immunoassay Screen
 ​
​86617 ​ ​2 ​Lyme Confirmatory Immunoassay, IgM and IgG
 ​Performed only if needed
For most current information refer to the Marshfield Laboratory online reference manual.