The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Diatherix Laboratories for its rapid H1N1-09 influenza test.
Under the EUA, the Diatherix H1N1-09 test has not been approved by the FDA, but has been sanctioned for use during the duration of the declaration of emergency for the H1N1 flu pandemic.
The test uses the company’s proprietary molecular technology, known as Target Enriched Multiplex Polymerase Chain Reaction (Tem-PCR), to detect the viral RNA of the H1N1-09 pandemic influenza strain.
The test allows clinicians to quickly and definitively identify H1N1-09 patients from other flu sufferers who have similar symptoms within 24 hours.
The test is intended to be used on nasopharyngeal swabs, nasal swabs, throat swabs and nasal aspirates from patients with signs and symptoms of respiratory infection.