C6 B. burgdorferi (Lyme) ELISA

Peptide ELISA eliminates vaccine cross-reactivity

CAMBRIDGE, Mass.....May 31, 2001…..This new Lyme ELISA was recently cleared for in vitro diagnostic use by the FDA.  The kit is the first to detect human antibodies to B. burgdorferi using the C6 peptide antigen, recently shown to be a highly accurate marker for Lyme disease.  In a comparative study, the C6 ELISA yielded a 10-fold reduction in the number of false positive results, while demonstrating sensitivity of 100% in early Lyme disease (up to 1 month after onset) and 98% in late stage disease (1 year or more after onset).  Overall, concordance of C6 ELISA with Western Blot results was 97%.  Unlike many other Lyme screening tests, this test does not yield false positive results on individuals vaccinated with the Lymerix^® vaccine^*.  These advantages will enable clinicians to diagnose or rule out the disease more quickly, with less re-testing.  As an added benefit, the C6 test detects infection with European Lyme strains B. garinii and B. afzelii.  The kit includes a 96-well breakaway microplate, ready to use reagents and controls.

^* Recombinant OspA vaccine against Lyme disease, manufactured by GlaxoSmithKline Biologicals