The BBI Borrelia burgdorferi IgM and IgG Western Blot Test Kit has received 510(K) clearance from the US Food and Drug Administration (FDA) to be marketed and sold in the US for in vitro diagnostic use. The test kit is intended for use in testing human serum samples that have been found positive or equivocal using a first-line test (enzyme immunoassay or immunofluorescence assay) for B. burgdorferi antibodies. B. burgdorferi is the infectious tick-borne bacteria that causes Lyme disease.

The Western blot method identifies specific antibodies, and according to Centers for Disease Control guidelines, a supplementary test such as the Western blot should be used to provide additional information following a positive or equivocal result with the first-line Lyme test.

Boston Biomedica Inc