Lyme IgM and IgG, Whole Cell Sonicate, ELISA, Serum

Casandra

Casandra Test Code MC30299Version 1 (DRAFT)

Performing Lab

Lab Mayo Clinic LabLab Test ID TLYMECPT Code 86617

Lyme IgM and IgG, Whole Cell Sonicate, ELISA, Serum

Clinical Use

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

The test should only be ordered on specimens that have tested positive or equivocal by a first-tier Lyme disease antibody test. Proper forms such as the Infectious Disease Serology Test Request (T916) should be completed if not ordering electronically. Ensure the collection and handling procedures align with the guidelines to prevent false positives or negatives.

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.

Test Details

FDA Approved