NEW YORK (GenomeWeb) – Quidel announced today that it has received US Food and Drug Administration 510(k) approval for its Solana assay for the diagnosis influenza A and B.
The test uses the helicase-dependent amplification technology that underpins Quidel's AmpliVue line of molecular assays, and is designed to detect nucleic acids isolated from nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. It is intended for use only with the company's Solana instrument.