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.
"A single Solana instrument system performs up to twelve Solana Influenza A+B assays on almost any sample type or brand of viral transport media in under an hour, and up to 96 patient samples during an eight-hour shift, which is critical during an influenza epidemic when testing volumes are at their highest, and samples are coming from several different locations and often collected in a variety of different transported media," Quidel President and CEO Douglas Bryant said in a statement.
The FDA approval comes about a month after the agency cleared Quidel's Solana assay for the sexually transmitted disease trichomoniasis, and a little more than a year after it approved the firm's Solana Group A Streptococcus assay and the Solana platform.