Lyme serology panel

Message

Testing performed at Va Connecticut. The Lyme Serology panel is performed using FDA approved ZEUS Borrelia VlsE1/pepC10 IgG/IgM Test System EIA. SUPPLEMENTAL TESTING: All equivocal and positive results will automatically be reflexed to the ZEUS ELISA B. burgdorferi IgM and the ZEUS ELISA B. burgdorferi IgG assays.

Test Code

LYME SEROLOGY PANEL(WH)

Includes

Tier 1 screen, Tier 2 Lyme IgG, Tier 2 Lyme IgM, and interpretation.

Preferred Specimen

serum from a gold top tube

Minimum Volume

1 mL

Instructions

Centrifuge and ship an aliquot in a 12X75 mL tube refrigerated.

Transport Temperature

Refrigerated.

Methodology
Zeus Scientific EIA-MTTT-IVD

Setup Schedule

Variable - 2 or more runs per week.

Report Available

3-8 days

Reference Range

Negative

Clinical Significance

VA CT Molecular Diagnostics Laboratory announces a methodology change for Lyme antibody testing to the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. This enzyme immunoassay (EIA) is intended for testing serum samples from symptomatic patients or those suspected of having Lyme disease.
Specimens with positive or equivocal test results will undergo supplemental testing using a Modified Two-Tier Test (MTTT) approach. This modified methodology uses supplemental EIAs in place of western immunoblot assays. The FDA has determined that MTTT is “substantially equivalent to or better than” STTT and meets CDC guidelines for Lyme disease testing. Second tier testing at VA CT will utilize the ZEUS ELISA B. burgdorferi IgM Test System and the ZEUS ELISA B. burgdorferi IgG Test System. In a VA CT verification study, the MTTT and STTT showed 100% agreement in a comparison of 50 positive and 74 negative samples.
Positive or equivocal test results in the first “tier” screening EIA (which detects both IgG and IgM) plus a positive result on either or both of the second tier EIAs (which each detect either IgG or IgM) constitute an overall positive result. A positive result is supportive evidence for the presence of antibodies and exposure to B. burgdorferi, the cause of Lyme disease, but should not be used as a sole criterion for diagnosis. The diagnosis of Lyme disease must also be based on the patient’s exposure history, signs/symptoms, and other laboratory data.

Performing Laboratory
Test performed at the VA Connecticut Molecular Diagnostics Laboratory
Contact: Tricia Cavallaro 203-932-5711

Last Updated: April 12, 2021

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.