CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Sept. 6, 2018—Quidel has received 510(k) clearance and Clinical Laboratory Improvement Amendments waiver from the FDA to market its Sofia 2 Lyme FIA to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from fingerstick whole blood specimens from patients suspected of B. burgdorferi infection. The test is intended for use with the Sofia 2 analyzer to aid in the diagnosis of Lyme disease.
The Sofia 2 Lyme FIA uses a bi-directional test strip format to detect both IgM and IgG antibodies to B. burgdorferi from a single fingerstick whole blood sample—one side of the test strip detects IgM antibodies to B. burgdorferi and the other side detects IgG antibodies to B. burgdorferi.