Lyme IgM and IgG, Whole Cell Sonicate, ELISA, Serum
Use
The test is used as supplemental testing for samples with positive or equivocal first-tier test results for antibodies to Lyme disease causing Borrelia species. It should not be used as a screening procedure for the general population. Positive results by the modified 2-tier testing algorithm provide supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the causative agent of Lyme disease. The test utilizes the modified 2-tiered serologic testing algorithm (MTTTA), which involves initial enzyme immunoassay (EIA) screening for total antibodies against the Borrelia Vlse/pepC10 proteins, followed by IgM and IgG antibody testing for samples with positive or equivocal first-tier EIA results.
Special Instructions
Not provided.
Limitations
The performance characteristics of the test are not established for substituting other enzyme immunoassays in the modified 2-tiered serologic testing. False positives can occur due to cross-reactions with other spirochetal diseases or certain viral infections. True Borrelia burgdorferi infection-positive sera will generally be negative in rapid plasma reagin and treponemal antibody assays. False negatives may occur if the specimen is collected too soon after infection before significant antibody development.
FDA ApprovedNew York Approved
Methodology
Immunoassay (ELISA)
Biomarkers
Borrelia burgdorferi
Microorganism
LOINC Codes
- 34942-3 - B burgdor IgG+IgM Pnl Ser
- 40612-4 - B burgdor IgM SerPl Ql IA
- 16480-6 - B burgdor IgG SerPl Ql IA
- 46248-1 - B burgdor IgG+IgM Ser IA-Imp
Result Turnaround Time
1-5 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.6 mL
Minimum Volume
0.5 mL
Container
Sarstedt Aliquot Tube 5 mL
Collection Instructions
Centrifuge and aliquot serum into a plastic vial.
Causes for Rejection
Gross hemolysis, gross lipemia, gross icterus, heat inactivated
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 10 days |
| Frozen | 30 days |