Emergency status of H1N1 tests terminated

Molecular diagnostic tests used during the peak of the H1N1 outbreak in 2009 have officially had their emergency use statuses terminated last week.

The emergency use statuses were initially granted last year by the U.S. Food and Drug Administration after a state of emergency had been declared during the H1N1 outbreak, reports.

Working from a Centers for Disease Control and Prevention study, the U.S. Department of Health and Human Services decided the rate of 2009 H1N1 cases had fallen to those of normal rates and that the emergency status was no longer needed.

“The FDA is aware that a ;significant number; of labs have bought and are still using tests that were authorized for emergency use and that a number of these tests will be used after the EUA ended last week,” FDA spokeswoman Erica Jefferson wrote in an e-mail to

Jefferson said two tests for H1N1 have received FDA's 510(k) clearance for commercial sales, including a test developed by Focus Diagnostics and one developed by the CDC. Jefferson also told that test makers who had emergency-use tests approved are encouraged to work with the FDA to submit additional information in order to obtain clearance for their products.

Some of the products and tests authorized under the temporary emergency use status included a Cepheid Xpert Flu Panel, a kit made by Diagnostic Hybrids, an Epoch BioSciences RT-PCR test, a Diatherix Laboratories test and DxNA's GeneStat 2009 A/H1N1 Influenza test.