The Food and Drug Administration has cleared Quidel’s Sofia Lyme FIA test for use with the Sofia 2 Fluorescent Immunoassay analyzer to aid in the diagnosis of Lyme disease. The test rapidly detects and differentiates between human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens taken from patients suspected of B. burgdorferi infection. The Sofia 2 Fluorescent Immunoassay analyzer on which the test runs is Quidel’s next-generation version of its Sofia instrument system, for which the Sofia Lyme FIA test previously received clearance. The Sofia 2 uses the original Sofia’s fluorescent chemistry design while improving upon the graphical user interface and optics system to provide results in as little as 3 minutes. Sofia 2 also integrates wireless connectivity and its bar-code scanner within a smaller footprint than the legacy Sofia instrument, and comes connected to Virena, Quidel’s data management system that provides aggregated, de-identified testing data in near real-time.