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Test ID: LYME

Lyme Disease Serology, Serum

Orderable by Ontario ND

Test Overview

Clinical Utility

Diagnosis of Lyme disease. If Lyme disease serology is positive, then Lyme disease antibody confirmation (by immunoblot) will be performed at an additional charge.

Method

Enzyme-linked immunosorbent assay (ELISA)

Analytical Platform

Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system

Method Description

The first-tier Lyme disease screening enzyme-linked immunosorbent assay (ELISA) used is the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system (Branchburg, NJ) The Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system is designed to detect IgG- and IgM-class antibodies (not differentiated by the assay in the final result) in human sera to VlsE1 and pepC10 antigens. Diluted test sera are incubated in antigen coated microwells. Any antigen-specific antibody in the sample will bind to the immobilized antigen. The plate is washed to remove unbound antibody and other serum components. Peroxidase conjugated goat antihuman IgG and IgM are added to the wells and the plate is incubated. The conjugate will react with IgG and IgM antibodies immobilized on the plate. The wells are washed to remove unreacted conjugate. The microwells containing immobilized peroxidase conjugate are incubated with peroxidase substrate solution. Hydrolysis of the substrate by peroxidase produces a color change. After a period of time the reaction is stopped and the color intensity of the solution is measured photometrically. The color intensity of the solution depends upon the antibody concentration in the original test sample.(Package insert: Borrelia VlsE1/pepC10 IgG/IgM Test System, Zeus Scientific, Inc., Branchburg, NJ. Rev. Date 12/18/2017; package insert: Immunetics C6 B burgdorferi [Lyme] ELISA Kit, Immunetics, Inc, Boston, MA 02210-2377, 2013)

Result Included

Lyme Disease Serology

Specimen

Specimen Type

Serum

Volume

Sample Volume

1.5 mL

Minimum Volume

1.0 mL

Specimen Comment

Gel-separator tubes are acceptable.

Collection & Handling

Handling Information

Store and send cold or frozen. Specimen volume requested reflects possible reflex immunoblot assay (separate test listing).

Stability

Refrigerated Frozen
10 days 30 days

Rejection Criteria

Criteria Specification
Hemolysis Gross
Lipemia Gross

Performance & Interpretation

Turnaround Time

6 days

Results

Name
Units
Reference Range
Conversion
  1. Lyme Disease Serology
    Negative

Referral Location

Out-of-Country

Test Version

Last Updated

2019-11-07