Second H1N1 virus detection test authorized for use

New test is enhanced by large amount of 2009 H1N1 genetic information CDC received throughout pandemic.

A CDC-developed test for diagnosing presence of 2009 H1N1 influenza virus has been authorized for use by FDA. The test is the second cleared by FDA for detecting the H1N1 virus; the first test was cleared in late May.

The test, named CDC Influenza 2009 A (H1N1)pdm Real-Time RT-PCR Panel (IVD), will help ensure accurate results among laboratories qualified to conduct influenza subtype testing in the United States and abroad. A molecular biology technique is used to detect influenza A viruses and the 2009 H1N1 virus specifically. The test replaces the previous real-time RT-PCR diagnostic test that received an emergency use authorization by FDA during the 2009 H1N1 pandemic.

According to CDC, the new test has been improved by the considerable amount of 2009 H1N1 genetic information the agency received throughout the pandemic. As a result, CDC said that the new test can detect human infections with 2009 H1N1 virus with sensitivity and specificity greater than 96% for upper respiratory specimens.

Posted by Joe Sheffer (jsheffer@aphanet.org)
June 22, 2010