Lyme Antibody Modified 2-Tier with Reflex, Serum
Use
The test is used for the diagnosis of Lyme disease, which is caused by infection with a member of the Borrelia burgdorferi sensu lato complex. These tick-borne spirochetes are transmitted to humans through the bite of Ixodes species ticks. The modified two-tiered serologic testing algorithm includes an initial enzyme immunoassay screen for total antibodies against the Borrelia VlsE/pepC10 proteins. If positive or equivocal, it reflexes to supplemental EIAs for detection of IgM and IgG antibodies against Borrelia burgdorferi whole cell sonicate material.
Special Instructions
This test should not be used as a screening procedure for the general population. Instead, clinical evidence should suggest the diagnosis of Borrelia infection or related conditions before testing. If not ordering electronically, complete, print, and send the Infectious Disease Serology Test Request form with the specimen.
Limitations
A negative result does not exclude infection with Borrelia species causing Lyme disease, especially in early stages or after antibiotic treatment. False positive results can occur with other conditions like infectious mononucleosis and syphilis. The assay detects infections from other members of the Borrelia burgdorferi sensu lato complex but does not differentiate between them. Lyme serology is not suitable for treatment monitoring, as IgG can persist post-resolution of infection.
FDA ApprovedNew York Approved
Methodology
Immunoassay (ELISA)
Biomarkers
LOINC Codes
- 83081-0
- 83081-0
Result Turnaround Time
1-4 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.6 mL
Minimum Volume
0.5 mL
Container
Plastic vial
Collection Instructions
Centrifuge and aliquot serum into a plastic vial.
Causes for Rejection
Gross hemolysis, gross lipemia, gross icterus, heat-inactivated specimen
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 10 days |
| Frozen | 30 days |