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C6 Borrelia burgdorferi IgM and IgG (Lyme) ELISA

Test Code: 30150

Cpt Code:

86618 (x1)

Clinical Utility

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.

Procedure

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.

Specificity

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.

Assay Range

The assay measurement range is 0.1 to 10.0 Lyme Index units. Reference values from apparently healthy subjects were ≤ 0.9.

Lyme Index Interpretation
≤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.

Turnaround Time

2-7 days from receipt of specimen. Assay performed on Thursday.

Shipping

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.

Specimen Information

serum

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.

Disclaimer

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.

References

Burgdorfer W, Barbour AG, Hayes SF, et al. Lyme disease-a tick borne spirochetosis? Science. 1982 Jun 18;216:1317-9.

Steere AC. Lyme Disease. N Engl J Med. 1989 Aug 31;321(9):586-96.

Steere AC, Malawista SE. Cases of Lyme disease in the United States: locations correlated with distribution of Ixodes dammini. Ann Intern Med. 1979 Nov;91(5):730-3.

Levine JF, Wilson ML, Spielman A. Mice as reservoirs of the Lyme disease spirochete. Am J Trop Med Hyg. 1985 Mar;34(2):355-60.

Burgdorfer W, Lane RS, Barbour AG, Gresbrink RA, Anderson JR. The western black-legged tick, Ixodes pacificus: a vector of Borrelia burgdorferi. Am J Trop Med Hyg. 1985 Sep;34(5):925-30.

Barbour AG, Hayes SF. Biology of Borrelia species. Microbiol Rev. 1986 Dec;50(4):381-400.

Dattwyler RJ. Lyme borreliosis: an overview of clinical manifestations. Lab Med. 1990;21:290-2.

Dattwyler RJ. Immunodiagnosis of Lyme borreliosis. Rheum Dis Clin N Am. 1989 Nov;15(4):727-34.

Szczepanski A, Benach J. Lyme borreliosis: host responses to Borrelia burgdorferi. Microbiol Rev. 1991 Mar;55(1):21-34.

Craft JE, Grodzicki RL, Steere AC. Antibody response in Lyme disease; evaluation of diagnostic tests. J Inf Dis. 1984 May;149(5):789-95.

Craft JE, Fischer DK, Shimamoto GT, Steere AC. Antigens of Borrelia burgdorferi recognized during Lyme disease. Appearance of a new immunoglobulin M response and expansion of the immunoglobulin G late in the illness. J Clin Invest. 1986 Oct;78(4):934-9.

Centers for Disease Control and Prevention. Recommendations for test performance and interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease. MMWR. 1995 Aug 11;44(31):590-1.

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