Lyme Disease Serology
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Lyme Disease Serology, Serum
Test ID: LYME
Orderable by Ontario ND
Test
Method
ELISA
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)
Platform
Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system
Report Includes
Specimens
Serum
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.
Test Location
Mayo Clinical Labs, Minnesota USA
Test Version
7-Nov-2019
Specimen
Specimens
Serum
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 | 10 days |
|---|---|
| Frozen | 30 days |
Rejection Criteria
| Hemolysis | Gross |
|---|---|
| Lipemia | Gross |
Test Version
7-Nov-2019
Performance / Interpretation
Method
ELISA
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)
Platform
Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system
Turnaround Time
6 days
Results
| Name | Units | Reference Range | Conversion Factor | |
|---|---|---|---|---|
| Lyme Disease Serology |
|
|||
Test Location
Mayo Clinical Labs, Minnesota USA
Test Version
7-Nov-2019
Interface / Setup
Test Version
7-Nov-2019