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FDA Clears CDC's MDx Test for H1N1 Virus

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared a test developed by the US Centers for Disease Control and Prevention for the diagnosis in humans of the 2009 H1N1 Influenza, making it the second to receive clearance, CDC said on Tuesday.

The test, called the CDC Influenza 2009 A (H1N1) pdm Real-Time PCR Panel, replaces an earlier test by CDC, also based on real-time RT-PCR technology, which received emergency authorization by the FDA in April, 2009.

The earlier test was developed based on the limited number of H1N1 specimens that were available at the early onset of the pandemic last year. Using the "vast amount" of 2009 H1N1 genetic data CDC received through the pandemic, the agency has optimized the new test, CDC said in a statement. As a result, sensitivity and specificity is now greater than 96 percent for upper respiratory specimens.

The test is used to isolate and amplify viral genetic material in secretions taken from a patient's upper and lower respiratory tract. Results can be obtained within four hours, and multiple samples can be tested simultaneously.

CDC said the test will become available soon to CDC-qualified laboratories.

This week's approval of the CDC's test comes on the heel of the FDA's 510(k) clearance of Quest Diagnostics' Simplexa Influenza A H1N1 test in late May. That test and CDC's are the only ones to receive clearance from the FDA for the virus.

Previously, tests for 2009 H1N1 Influenza were available only through Emergency Use Authorization, which allows the FDA to authorize unapproved or uncleared medical products, or unapproved or uncleared uses of approved or cleared medical products, while a medical emergency is in effect.

CDC's test uses molecular biology to detect influenza A and specifically the 2009 H1N1 virus. According to CDC, an estimated 43 million to 88 million cases of 2009 H1N1 occurred between April 2009 and March 13, 2010.

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