The U.S. Food and Drug Administration granted 510(k) clearance to Quidel Corp.'s Sofia Lyme Fluorescent Immunoassay to detect certain antibodies to a bacteria in serum or plasma samples.
The test detects Immunoglobulin M and Immunoglobulin G antibodies to Borrelia burgdorferi, a bacteria that causes Lyme disease, with samples from patients suspected of B. burgdorferi infection. It can either be used with Sofia or Sofia 2 analyzer to help in the diagnosis of Lyme disease.
Lyme disease is caused by bacteria of the Borrelia type which is spread by ticks.
