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Quidel's Lyme disease detection test gets US FDA clearance

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.