Quidel has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Solana Influenza A+B assay.
The assay has been developed to identify nucleic acids isolated from nasal and nasopharyngeal swabs from patients with indications and symptoms of respiratory infection to help in the the diagnosis of Influenza A and B infections.
It is intended for use only with the Solana instrument. The assay, which requires no upfront extraction of RNA, is said to generate an accurate result in around 45 minutes.
By using novel reverse-transcriptase helicase-dependent amplification (HAD) techlogy, the assay will generate test results.
Solana enables healthcare professionals to process up to 12 patient samples in each 45-minute run in moderately complex settings.
Quidel president and CEO Douglas Bryant said: "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 8 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."
Last month, the company received CE mark approval for the assay.