NEW YORK (GenomeWeb News) – The US Food and Drug Administration today said that it has issued an Emergency Use Authorization for another diagnostic test for the 2009 H1N1 flu virus, also known as the swine flu.
The test is made by Focus Diagnostics and uses real-time reverse transcription polymerase chain reaction. The EUA allows Focus, which is owned by clinical lab firm Quest Diagnostics, to distribute its molecular diagnostic assay to CLIA labs certified to perform high complexity tests.
Focus' test amplifies the viral genetic material obtained from swabs of the nose or throat, or from nasal discharges. A positive result indicates that the patient is infected with the 2009 H1N1 influenza virus, but it does not indicate the stage of infection. According to FDA, a negative result does not preclude influenza virus infection.
"This authorization will contribute to the nation's capacity for accurate testing for the 2009 H1N1 influenza virus," Daniel Schultz, director of FDA's Center for Devices and Radiological Health, said in a statement.
In late April, FDA issued an EUA for a US Centers for Disease Control and Prevention molecular diagnostic panel for identifying cases of 2009 H1N1 flu virus.
This past spring, FDA issued warning letters to three firms for allegedly marketing tests for the 2009 H1N1 flu virus that had not been cleared for marketing or authorized for emergency use by the agency. The three firms — Luminex, Becton Dickinson, and Prodesse — all complied with FDA's instructions following the warning letters.
Since that time, Luminex announced that FDA had cleared labeling updates for its xTAG Respiratory Viral Panel to include data about the performance of the test in humans infected with the pandemic A/H1N1 influenza virus.