C6 Borrelia burgdorferi IgM and IgG (Lyme) ELISA
Test Code: 30150
Cpt Code:86618 (x1)
The C6 Borrelia burgdorferi IgM and IgG (Lyme) ELISA may aid in the diagnosis of Lyme disease in at risk patients. The assay provides presumptive detection of IgM and IgG antibodies to B. burgdorferi in human serum. Positive or equivocal results should be supplemented by testing with a standardized Western Blot method. Positive Western Blot results provide evidence for exposure to or infection with B. burgdorferi. The diagnosis of Lyme disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results should not be used to exclude Lyme disease.
C6 Borrelia burgdorferi IgM and IgG (Lyme) ELISA is based on a synthetic peptide antigen (C6 peptide) in microwell enzyme-linked immunosorbent assay (ELISA) format. The antigen is derived from the V1sE protein of B. burgdorferi. The assay has been cleared for diagnostic use by the U.S. Food and Drug Administration.
The C6 Borrelia burgdorferi IgM and IgG (Lyme) ELISA detects the synthetic peptide antigen (C6 peptide) derived from the V1sE protein of B. burgdorferi, which has been shown to be both specific and highly immunogenic.
The assay measurement range is 0.1 to 10.0 Lyme Index units. Reference values from apparently healthy subjects were ≤ 0.9.
|≤0.90||Negative result. No antibody to B. burgdorferi detected in the present assay. This result does not exclude the possibility of B. burgdorferi infection, and where early Lyme disease is suspected, a second sample should be tested 2-4 weeks later.|
|0.91 - 1.09||Equivocal result. The imprecision inherent in any method implies a lower degree of confidence in the interpretation of samples values very close to the calculated cutoff value. For this reason an equivocal category has been designated. Equivocal samples should be tested with a supplemental assay such as a standardized Western Blot test in accordance with CDC recommendations.|
|≥1.10||Positive result. Antibody to B. burgdorferi detected in the present assay. All positive results should be supplemented by re-testing the corresponding serum samples on a standardized Western Blot test in accordance with CDC recommendations.|
Causes For Rejection
Specimens other than serum, specimens that been stored at ambient temperature, or stored at 2 to 8°C longer than 10 days are not accepted and cause for rejection.
2-7 days from receipt of specimen. Assay performed on Thursday.
Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086.
NY approved. Collect 3-5 mL blood specimen in a gel separator tube (SST) without anti-coagulants. Allow specimen to clot, then centrifuge specimen within 2 hours of draw to pellet cells below the gel. Minimum volume is 1.0 mL serum following centrifugation. Specimen can be stored refrigerated at 2 to 8°C for up to 10 days or preferably stored frozen in a non-self defrosting freezer and shipped on dry ice for overnight delivery.
Specimens are approved for testing in New York only when indicated in the Specimen Information field above.
The CPT codes provided are based on Viracor-IBT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for general informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.
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