Focus Diagnostics, Inc. (Focus Diagnostics), has launched the Influenza A H1N1 (2009) Real Time RT-PCR test kit for use by high complexity clinical laboratories in the US. The test intended to qualitatively detect the RNA of the 2009 H1N1 influenza virus (pandemic virus) from a patient's nasal, nasopharyngeal or throat specimen. The test, in combination with clinical and epidemiological assessments, helps in diagnosing patients infected with the pandemic virus rather than other influenza A strains.
The availability of a quality test kit authorized by FDA for use during the pandemic emergency will contribute to the nation’s capacity for accurate testing for the 2009 H1N1 influenza virus, said John Hurrell, Ph.D., vice president and general manager, Focus Diagnostics. 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 fall and winter flu season.
On July 24, the US Food and Drug Administration (FDA) announced it had granted emergency use authorization (EUA) to the Focus Diagnostics test, the first granted to a commercial test for detecting the 2009 H1N1 influenza virus. On August 17, 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 be performed in laboratories certified under the US Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity tests and operating certain equipment.
In April 2009, the FDA granted two EUAs in connection with the CDC’s RT-PCR diagnostic panel used by public health labs in the US to detect the 2009 H1N1 influenza virus infection. 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 CDC’s RT-PCR test in identifying specimens as positive or negative for the pandemic virus.
The Focus Diagnostics test uses reverse transcriptase polymerase chain reaction, or 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 human influenza A virus. If RNA of Influenza A virus and the 2009 Influenza H1 gene are detected, 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 in Cypress, California.
The FDA has only authorized the Influenza A H1N1 (2009) Real Time RT-PCR to use for the duration of the declaration of emergency, which is currently set to expire on April 26, 2010, unless it is terminated, revoked sooner or renewed. Only CLIA high-complexity laboratories operating certain equipment are permitted to perform the test under the EUA.