Borrelia burgdorferi Antibodies, Total by ELISA with Reflex to IgG and IgM by Immunoblot (Early Disease)
Ordering Recommendation
Preferred reflex test to detect Lyme disease in individuals with ≤4 weeks of clinical symptoms or exposure to tick. Positive/equivocal screen confirmed by immunoblot.
Mnemonic
Methodology
Semi-Quantitative Enzyme-Linked Immunosorbent Assay/Qualitative Immunoblot
Performed
Sun-Sat
Reported
1-3 days
New York DOH Approval Status
Specimen Required
Serum separator tube.
Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.15 mL)
Refrigerated.
CSF or plasma. Contaminated, heat-inactivated, hemolyzed, or severely lipemic specimens.
After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)
Reference Interval
Test Number |
Components |
Reference Interval |
---|---|---|
Borrelia burgdorferi Abs, Total by ELISA | Less than or equal to 1.20 LIV |
Interpretive Data
Refer to report.
Component | Interpretation |
---|---|
Borrelia burgdorferi Antibodies, Total by ELISA | 0.99 LIV or less: Negative - Antibody to B. burgdorferi not detected. 1.00-1.20 LIV: Equivocal - Repeat testing in 10-14 days may be helpful. 1.21 LIV or greater: Positive - Probable presence of antibody to B. burgdorferi detected. |
FDA
Note
This panel is appropriate for Lyme disease testing less than 4 weeks from erythema migrans or onset of disease symptoms.
A negative result indicates the immunoblot evaluation for B. burgdorferi antibody demonstrates no antibodies unique to B. burgdorferi and is, therefore, not supportive of Lyme disease.
A positive result indicates that the immunoblot evaluation for B. burgdorferi antibody is consistent with the presence of antibody produced by patients in response to infection by B. burgdorferi and suggests the presence of Lyme disease. Although the test has been shown to have a high degree of reliability for diagnostic purposes, laboratory data should always be correlated with clinical findings.
Current CDC recommendations for the serological diagnosis of Lyme disease are to screen with a polyvalent ELISA test and confirm equivocals and positives with immunoblot. Both IgM and IgG immunoblots should be performed on specimens obtained less than 4 weeks after appearance of erythema migrans. Only IgG immunoblot is to be performed on specimens greater than 4 weeks after disease onset. IgM immunoblot in the chronic stage is not recommended and does not aid in the diagnosis of neuroborreliosis or chronic Lyme disease.
If ELISA result is 1.00 LIV or greater, then IgG and IgM immunoblot will be added. Additional charges apply.
Hotline History
CPT Codes
86618; if reflexed, add 86617 x2
Components
Component Test Code* | Component Chart Name | LOINC |
---|---|---|
0050216 | Borrelia burgdorferi Abs, Total by ELISA | 34148-7 |
Aliases
- Early Lyme Disease Ab Reflex
- Lyme Disease
- Lyme Disease Ab, ELISA to Western Blot
- Lyme Disease Reflex Panel, Early Disease
- Lyme Disease, Acute Reflexive Panel