NEW YORK (GenomeWeb) – Quidel has received clearance from the US Food and Drug Administration for two assays, the firm announced late yesterday. An assay to detect Group B Strep (GBS) using the firms Solana molecular system received 510(k) clearance from the FDA, while an assay to detect Group A Strep on its Sofia 2 fluorescent immunoassay analyzer received simultaneous 510(k) clearance and CLIA waiver.
The Solana test is designed for direct, qualitative detection of GBS in pregnant women using enriched broth cultures of rectovaginal swabs. The US Centers for Disease Control and Prevention guide that all pregnant women be tested for Group B Strep toward the end of pregnancy to prevent transmission to babies during delivery.
The Solana molecular platform processes up to 12 different assays or samples in each batched run, and the menu for the instrument also includes Quidel's Influenza A+B, Strep Complete (Groups A+C/G), RSV+hMPV, HSV 1+2/VZV, Trichomonas, and C. difficile tests.
The Group A Strep immunoassay test detects one of the most common infections of the upper respiratory tract, particularly in children, and the cause of "strep throat." The test is a 5-minute immunoassay that runs on Quidel's Sofia2 platform — a next-generation Sofia instrument for the decentralized point-of-care market, with a smaller footprint and improved user interface and optics systems.
The test is the third on the Sofia2 system, with tests for influenza A and B as well as respiratory syncytial virus cleared and CLIA waived by the FDA earlier this year.