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# A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Lyme Disease Serology, Serum
Test Code: LYMPAN
Synonyms/Keywords
​Lyme Disease, Borrelia burgdorferi, Lyme EIA IgG and IgM, LYMSCR 
Test Components
​An EIA screen test will be performed on all specimens.  All specimens with a positive or equivocal screening result will reflex to Lyme Confirmatory IB, which will include both IgM and IgG immunoblot.  No immunoblot analysis willl be performed on samples with a negative EIA 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)​ ​3.0 mL ​1.5 mL ​0.5 mL
Specimen Stability Information
Specimen Type Temperature Time
​Serum ​ ​Refrigerate ​5 days
​Frozen ​> 5 days
Rejection Criteria
 
Hemolyzed, lipemic, bilirubinemic, or turbid sera
​CSF
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Marshfield
​Peak Season:
June through November
Lyme Screen: 
Monday through Friday
Confirmatory Immunoblot: 
Wednesday, Friday
​1 day
Lyme Screen:
Enzyme immunoassay
Lyme Confirmatory: Immunoblot
​Marshfield
​Off Season:
December through May
Lyme Screen:
Tuesday and Friday
Confirmatory Immunoblot: Friday
​1 day
Lyme Screen:
Enzyme immunoassay
Lyme Confirmatory: Immunoblot
Test Information

According to the Centers for Disease Control and Prevention, during the first month of acute illness, all positive and equivocal screening test results should be confirmed by IgM and IgG immunoblot or by IgG immunoblot alone.  After the first month of acute illness, all positive and equivocal screening test results should be confirmed by IgG immunoblot alone.

An EIA screening test (LYMSCR) will be performed on all specimens. All specimens with a positive or equivocal screening result will reflex to Lyme Confirmatory Immunoblot  (LYIBP), which will include both IgM and IgG immunoblot. 

 **Immunoblots will not be performed on sera with a negative EIA screening result without consulting a doctoral microbiologist or pathologist.
Reference Range Information
Performing Location Reference Range
​Marshfield ​Negative
Interpretation
These results have been interpreted using CDC criteria. Serological results must be correlated with clinical findings.
 
Serological studies are the primary means of Lyme disease (LD) diagnosis. The CDC recommends that all previously undiagnosed possible LD cases be tested by a two-tier algorithm:
1) All sera are to be initially tested with an anti-B. burgdorferi antibody enzyme immunoassay (EIA).
2) All EIA positive or equivocal sera are then confirmed with B. burgdorferi antibody immunoblot (IB) assays.
a) IgM & IgG IBs in first month of infection (i.e. during the EM period), or
b) IgG only thereafter.

The sensitivity of the CDC two-tier algorithm ranges from 40% in the first weeks of infection to nearly universal seropositivity in untreated Late LD. The IgM IB is necessary to maximize sensitivity early in the infection, but is prone to false positive results; a positive IgM IB alone after the first 1 – 2 months of illness is most likely a false positive result. (That is, the IgG IB should also be positive beyond Local Early LD.) When reviewing LD serology results, it is important to remember two things:
1) LD patients can remain seropositive for months or years, even after successful treatment. Repeat testing when reinfection is suspected is therefore of little clinical utility.
2) There are no published data that support the appearance and disappearance of individual bands on IBs as a tool in diagnosis. It is thus more useful to rely on the interpretation of an IB, and not on the individual bands reported.
 
Note that IgM IB data will now always be provided when the EIA is positive or equivocal regardless of the stage of infection. The clinician should therefore interpret positive IgM/negative IgG IB results carefully in cases clearly beyond the early erythema migrans phase.
When early LD (i.e. the erythema migrans phase) is suspected and the LD antibody screen test is negative, retesting once in 2-4 weeks is recommended: performance of IBs in this scenario offers little benefit. Beyond the early phase, a negative EIA result confidently rules out LD in the immunocompetent patient; IBs are of little benefit in this scenario and can lead to misdiagnosis and unneeded treatment.
Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
​86618 ​1 ​EIA
​86617 ​2 ​Immunoblot (if needed)
Synonyms/Keywords
​Lyme Disease, Borrelia burgdorferi, Lyme EIA IgG and IgM, LYMSCR 
Test Components
​An EIA screen test will be performed on all specimens.  All specimens with a positive or equivocal screening result will reflex to Lyme Confirmatory IB, which will include both IgM and IgG immunoblot.  No immunoblot analysis willl be performed on samples with a negative EIA 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)​ ​3.0 mL ​1.5 mL ​0.5 mL
Specimen Stability Information
Specimen Type Temperature Time
​Serum ​ ​Refrigerate ​5 days
​Frozen ​> 5 days
Rejection Criteria
 
Hemolyzed, lipemic, bilirubinemic, or turbid sera
​CSF
Useful For
​The primary lab diagnostic test for Lyme disease.
Test Information

According to the Centers for Disease Control and Prevention, during the first month of acute illness, all positive and equivocal screening test results should be confirmed by IgM and IgG immunoblot or by IgG immunoblot alone.  After the first month of acute illness, all positive and equivocal screening test results should be confirmed by IgG immunoblot alone.

An EIA screening test (LYMSCR) will be performed on all specimens. All specimens with a positive or equivocal screening result will reflex to Lyme Confirmatory Immunoblot  (LYIBP), which will include both IgM and IgG immunoblot. 

 **Immunoblots will not be performed on sera with a negative EIA screening result without consulting a doctoral microbiologist or pathologist.
Reference Range Information
Performing Location Reference Range
​Marshfield ​Negative
Interpretation
These results have been interpreted using CDC criteria. Serological results must be correlated with clinical findings.
 
Serological studies are the primary means of Lyme disease (LD) diagnosis. The CDC recommends that all previously undiagnosed possible LD cases be tested by a two-tier algorithm:
1) All sera are to be initially tested with an anti-B. burgdorferi antibody enzyme immunoassay (EIA).
2) All EIA positive or equivocal sera are then confirmed with B. burgdorferi antibody immunoblot (IB) assays.
a) IgM & IgG IBs in first month of infection (i.e. during the EM period), or
b) IgG only thereafter.

The sensitivity of the CDC two-tier algorithm ranges from 40% in the first weeks of infection to nearly universal seropositivity in untreated Late LD. The IgM IB is necessary to maximize sensitivity early in the infection, but is prone to false positive results; a positive IgM IB alone after the first 1 – 2 months of illness is most likely a false positive result. (That is, the IgG IB should also be positive beyond Local Early LD.) When reviewing LD serology results, it is important to remember two things:
1) LD patients can remain seropositive for months or years, even after successful treatment. Repeat testing when reinfection is suspected is therefore of little clinical utility.
2) There are no published data that support the appearance and disappearance of individual bands on IBs as a tool in diagnosis. It is thus more useful to rely on the interpretation of an IB, and not on the individual bands reported.
 
Note that IgM IB data will now always be provided when the EIA is positive or equivocal regardless of the stage of infection. The clinician should therefore interpret positive IgM/negative IgG IB results carefully in cases clearly beyond the early erythema migrans phase.
When early LD (i.e. the erythema migrans phase) is suspected and the LD antibody screen test is negative, retesting once in 2-4 weeks is recommended: performance of IBs in this scenario offers little benefit. Beyond the early phase, a negative EIA result confidently rules out LD in the immunocompetent patient; IBs are of little benefit in this scenario and can lead to misdiagnosis and unneeded treatment.
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Marshfield
​Peak Season:
June through November
Lyme Screen: 
Monday through Friday
Confirmatory Immunoblot: 
Wednesday, Friday
​1 day
Lyme Screen:
Enzyme immunoassay
Lyme Confirmatory: Immunoblot
​Marshfield
​Off Season:
December through May
Lyme Screen:
Tuesday and Friday
Confirmatory Immunoblot: Friday
​1 day
Lyme Screen:
Enzyme immunoassay
Lyme Confirmatory: Immunoblot
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
​86618 ​1 ​EIA
​86617 ​2 ​Immunoblot (if needed)
For most current information refer to the Marshfield Laboratory online reference manual.