30995 - Lyme (Borrelia burgdorferi) VIsE pep C10 ELISA with Reflex to IgG and IgM
The Lyme (Borrelia burgdorferi) VIsE1 pepC10 ELISA with reflex to IgG and IgM may aid in the diagnosis of Lyme disease in at risk patients. The Lyme VIsE1 pepC10 ELISA assay provides presumptive detection of IgM and IgG antibodies to B. burgdorferi in human serum. Positive or equivocal results will automatically reflex to Lyme B. burgdorferi IgG and IgM testing. 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.
The ZEUS ELISA™ Borrelia VlsE1 pepC10 with reflex to IgG and IgM is for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The IgM Test is designed to detect IgM class antibodies to B. burgdorferi in human sera, and the IgG Test is designed to detect IgG class antibodies to B. burdgorferi in human sera. These assays have been cleared for diagnostic use by the U.S. Food and Drug Administration.
Specimens known to contain potentially cross reactive antibodies to B. burgdorferi with infections to tick-borne relapsing fever, rickettsial diseases, ehrlichiosis, babesiosis, and leptospirosis have not been tested, therefore the performance of this device is unknown if there is any cross-reactivity with these antibodies.
2-7 business days from receipt of specimen, Monday through Saturday.
|Specimen Type||Order Code||CPT Code||NY Approved||Volume||Assay Range||Special Instructions|
1 mL (0.2 mL min)
Qualitative, Positive / Equivocal / Negative
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 Eurofins test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 1001 NW Technology Dr, Lee's Summit, MO 64086.
Serum beyond it's acceptable length of time from collection as listed in the specimen handling, or specimen types other than serum. Hemolyzed, icteric or lipemic specimens.
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 Eurofins' 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 Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.
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