2009 H1N1 Flu Test Kit Launched in USA

In combination with clinical and epidemiological assessments, the test aids physicians in differentiating between the pandemic virus and other Influenza A strains.

This is the first test for detecting the new virus to be authorized by United States Food and Drug Association (FDA; Silver Springs, MD, USA) for use by Clinical Laboratory Improvement Amendments (CLIA) high-complexity labs during pandemic emergency.

The Focus Diagnostics test uses reverse transcriptase polymerase chain reaction (RT-PCR) to amplify viral RNA to make it detectable in a specimen. It targets two separate regions of the hemagglutinin (H1) gene of the 2009 H1N1 influenza virus to differentiate the presence of the pandemic virus from seasonal  Influenzavirus A. If RNA of Influenza A virus and the 2009 Influenza H1 gene are detected, then the specimen is reported as positive for 2009 H1N1 influenza infection. The expected turnaround time for reporting a result is within approximately 24 hours of receipt of a specimen by the Focus Diagnostics laboratory.

On July 24, 2010, the FDA announced it had granted emergency use authorization (EUA) to the Focus Diagnostics (Cypress, CA, USA) test, the first granted to a commercial test for detecting the 2009 H1N1 influenza virus.

In its EUA application to the FDA, Focus Diagnostics presented data involving more than 100 clinical specimens indicating that the Focus Diagnostics test agreed 100% with the U.S. Center for Disease Control and Prevention (CDC; Atlanta, GA, USA) test in identifying specimens as positive or negative for the pandemic virus.

On August 17, 2010, the FDA informed Focus Diagnostics that it had issued an amended EUA for the company's test to reflect labeling clarifications regarding the contents of the test kit. According to the EUA, the test may now be performed in laboratories certified under the U.S. Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity tests and operating certain equipment.

John Hurrell, Ph.D., vice president and general manager, Focus Diagnostics noted, "Expanded testing for this new virus could be critically important in aiding clinicians in determining which influenza A virus is causing a patient's illness should there be a surge in testing demand during the [2010, 2011] fall and winter flu season."

Related Links:
United States Food and Drug Association
U.S. Center for Disease Control and Prevention
Focus Diagnostics
Quest Diagnostics