No longer will health professionals have to send samples of potential novel coronavirus cases to the Centers for Disease Control and Prevention (CDC) for testing — beginning this week, diagnostic test kits allowing qualified labs to test themselves are out for shipping.
This, the CDC says, will expand the ability to detect 2019-nCoV throughout the world, as the kits will be provided to both U.S. and international laboratories. Known as the CDC 2019-nCov Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel, the tool can be paired with an existing RT-PCR testing tool more traditionally used to test for seasonal cases of the flu. This test will allow professionals to investigate both upper and lower respiratory specimens for potential 2019-nCoV infection within four hours. Each kit can test between 700-800 patient specimens.
“Our goal is early detection of new cases and to prevent further spread of the coronavirus,” Dr. Robert Redfield, CDC Director, said. “Distribution of these diagnostic tests to state laboratories, U.S. government partners and more broadly to the global public health community will accelerate efforts to confront this evolving global public health challenge.”
While the test kits have not been cleared by the U.S. Food and Drug Administration (FDA), the Emergency Use Authorization issued by the FDA this week allows for their use. Around 200 test kits will go out in the initial batch to U.S. domestic laboratories and about the same to certain international labs, through the International Reagent Resource mechanism. More will follow, per orders, in the days to come.
Only certain labs can order the 2019-nCoV tests, though. This includes approximately 115 labs in the U.S. and 191 international labs, including those of the World Health Organization Global Influenza Surveillance Response System. The test will no longer be usable as soon as the Emergency Use Authorization is revoked