Immunetics, Inc. is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its QualiCode™ Borrelia burgdorferi IgG and IgM Western Blot Kits. The kits are for in vitro diagnostic use in the detection of human antibodies specific to B. burgdorferi, the agent of Lyme disease. According to the protocol recommended by the Centers for Disease Control, all patient sera which test positive or indeterminate on an ELISA screening assay must be re-tested by Western Blot. The greater accuracy of the Western Blot test makes it possible to diagnose Lyme disease more definitively or rule it out in some cases.
"Our Western Blot test was able to detect antibodies in about 15% more of the samples that were tested than the FDA-approved test which we compared against in our clinical trials", said Dr. Andrew Levin, Scientific Director of Immunetics. "These results were obtained using serum samples from well-characterized Lyme patients. There is a well-recognized need in the medical community to improve the overall sensitivity of Lyme disease testing. The extra level of sensitivity demonstrated by our test will ultimately benefit the many Lyme disease patients for whom obtaining confirmation of infection has been a major hurdle."
Immunetics offers state-of-the-art assay technology for infectious disease research and diagnosis, and for over ten years has been a leading innovator of tests for HIV, Lyme and other infectious diseases. The company produces and markets a range of infectious disease immunoassay kits and instruments.