Quidel’s Lyme Fluorescent Immunoassay Cleared by FDA

Quidel received FDA clearance for its Sofia 2 lyme fluorescent immunoassay, used in conjunction with its fluorescent immunoassay analyzer to detect human IgM and IgG antibodies.

The assay is used to rapidly diagnose Borrelia burgdorferi — lyme disease — from finger-stick whole blood specimens.

The device integrates wireless connectivity with an updated graphical user interface and optic system.