Wallace, Inc. says the Food and Drug Administration has cleared for use its Wampole PreVue B. burgdorferi Antibody Detection Assay, the first rapid test available for the diagnosis of Lyme Disease. The test can be used in physician offices and other point of care settings and provides results in 20 minutes, as opposed to standard laboratory tests, which can take several days to obtain results. The company says it expects the product to be available for sale for the onset of Lyme season this spring. The burgdorferi assay is a simple, two-step rapid membrane format test which provides visually read color results using serum or whole blood samples. It utilizes unique recombinant antigens rather than the whole cell B. burgdorferi preparations used in current laboratory tests.
Antigenic proteins developed by recombinant DNA techniques allow for greater accuracy.
Using the assay, physicians will be able to make a probable diagnosis of Lyme disease more quickly and make antibiotic decisions immediately. Lyme disease is a bacterial infection spread to humans primarily by tick bite. The infectious agent is the spirochete Borrelia burgdorferi. Lyme disease is the most common insect-borne infectious disease in North America and is a significant public health concern. K Fl gstad .