30995 - Lyme (Borrelia burgdorferi) VIsE pep C10 ELISA with Reflex to IgG and IgM

Test Code: 30995
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Clinical and Procedure
Clinical Utility

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.

Procedure

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.

Specificity

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.

Turnaround Time

2-7 business days from receipt of specimen, Monday through Saturday.

 

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
Serum (1) 30995 86618 Yes

1 mL (0.2 mL min)

 

Qualitative, Positive / Equivocal / Negative
  • Collect 4-5 mL whole blood in red top tube.
  • Centrifuge and transfer 1.0 mL serum to clean, screw top tube.
  • Can be shipped ambient, on cold pack, or frozen Monday through Friday.
  • Ambient: 14 days. Refrigerated and Frozen (-20 or below): 30 days.
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 Eurofins test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 18000 W 99th St. Ste, #10, Lenexa, KS 66219.

Causes for Rejection

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.

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 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.

References
  1. Steere AC, Taylor E, Willson ML, Levine JF, Spielman A. Longitudinal assessment of the clinical and epidemiological features of Lyme Disease in a defined population. J Infect Dis 1986; 154:295-300.
  2. Rosenfeld ME, Nowakowski J, McKenna DF, Carbonaro CA, Wormser GP. Serodiagnosis in early Lyme disease. J Clin Microbiol 1993; 31:3090-3095
  3. Steere AC, Grodzicki RL, Komblatt AN, Craft JE, Barbour AG, Burgdorfer W, Schmid GP, Johnson E, Malawista SE. The spirochetal etiology of Lyme disease. N Engl
    J Med 1983;308:733-740.
  4. Bakken LL, Callister SM, Wand PJ, and Schell RF. Interlaboratory Comparison of Test Results for Detection of Lyme Disease by 516 Patients in the Wisconsin State Laboratory of Hygiene/College of American Pathologists Proficiency Testing Program. J. Clin. Microbiol. 1997;35:537-543.
  5. U.S. Department of Labor, Occupational Safety and Health Administration: Occupational Exposure to Bloodborne Pathogens. Final Rule, Fed. Register 56:64175-64182, 1991.
  6. Procedures for the collection of diagnostic blood specimens by venipuncture. Second Edition; Approved Standard (1984). Published by National Committee for Clinical Laboratory Standards.
  7. Procedures for the Handling and Processing of Blood Specimens. NCCLS Document H18-A, Vol. 10, No. 12. Approved Guideline 1990.
  8. Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guidelines – 4th Edition (2010). CLSI Document GP44-A4 (ISBN 1-56238-724-3). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087.
  9. Branda JA, Linskey K, Kim YA, Steere AC, Ferrano MJ. Two-Tiered Antibody Testing for Lyme Disease With Use of 2 Enzyme Immunoassays, a Whole-Cell Sonicate Enzyme Immunoassay Followed by a VlsE C6 Peptide Enzyme Immunoassay. Clin Infect Dis 2011; 53:541–547.
  10. Mollins CR, Delorey MJ, Sexton C, Schriefer ME. Lyme Boreliosis Serology: Performance of Several Commonly Used Laboratory Diagnostic Tests and a Large Resource Panel of Well Characterized Patient Specimens. J Clin Microbiol 2016; 54:2726-2734.
  11. Branda JA, et al. Advances in Serodiagnostic Testing for Lyme Disease Are at Hand. Clin Infect Dis 2018 Mar 19;66(7):1133-1139
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