Lyme Disease Serology, Serum
Use
This test is intended for diagnosing Lyme disease, which is caused by infection with a member of the Borrelia burgdorferi sensu lato complex. The most frequent cause in North America is Borrelia burgdorferi. This test applies a two-tiered serologic testing algorithm to detect antibodies to Lyme disease-causing Borrelia species. If the initial screening assay shows positive or equivocal results, a reflex test for confirmation using a Western blot is performed. Serologic testing may be negative in the early stages post-infection, but over 90% of patients with later-stage infections are seropositive.
Special Instructions
This test should not be used as a screening test for the general population nor for treatment monitoring. Instead, its supportive evidence and positive predictive value depend on a physician-suspected diagnosis and the presence of antibodies to VlsE1 and pepC10 antigens in the patient's demographic region. Proper handling requires centrifugation and serum aliquoting into a plastic vial. Ensure adequate volume and avoid hemolyzed or lipemic samples.
Limitations
A negative result does not rule out Lyme disease, especially in early-stage patients or those treated with antibiotics. False positives can occur due to other diseases like infectious mononucleosis or syphilis. A positive or equivocal result is not definitive and requires supplementing with an immunoblot test as per CDC guidelines. Testing cannot differentiate between different Borrelia strains, nor should it be used for treatment monitoring as IgG antibodies may persist post-infection resolution.
Methodology
Immunoassay (ELISA)
Biomarkers
LOINC Codes
- 20449-5
- 20449-5
Result Turnaround Time
1-4 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.5 mL
Minimum Volume
0.4 mL
Container
Plastic vial
Collection Instructions
Centrifuge and aliquot serum into a plastic vial.
Causes for Rejection
Gross hemolysis, Gross lipemia, Heat inactivated
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 10 days |
| Frozen | 30 days |
