Lyme Disease Test Cleared for Use By FDA

Wampole Laboratories, a division of Carter-Wallace Inc., today announced that the Food and Drug Administration (FDA) has cleared the 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. The company expects the product to be available for sale this spring.

The assay is a simple, two-step rapid membrane format test that provides visual color results using serum or whole blood samples. It uses unique recombinant antigens rather than the whole cell B. burgdorferi preparations used in current laboratory tests.