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FDA gives emergency green light for the CDC’s coronavirus test

The US Food and Drug Administration on Tuesday extended the use of a coronavirus detection tool to Centers for Disease Control and Prevention (CDC)-qualified laboratories across the country.

The authorization was until recently limited to CDC laboratories, of which the agency’s site says there are some 200 nationwide. 

An FDA spokesperson declined to answer when asked how many labs would now be permitted to use and analyze the test.  

Under the emergency use authorization, the 2019-nCoV Real-Time RT-PCR diagnostic panel can be used in patients who meet the CDC criteria for coronavirus testing.

So far, 11 US coronavirus patients have been confirmed, 167 have tested negative, 82 tests are pending, and the CDC is following 36 ‘people under investigation.’ 

The move is meant to speed diagnosis and containment of coronavirus patients to control its spread in the US, but without a specific number of authorized labs, it’s unclear how much the authorization will do to expedite the process.  

‘Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions,’ the FDA said in a Tuesday evening statement. 

Dr Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases, said Monday that she expects there will be more cases diagnosed in the US. 

Only one of the 11 identified cases so far was someone detected in airport screening. 

One of the patients was diagnosed after the CDC traced close contacts of another person confirmed to have the coronavirus. 

The other nine confirmed patients were detected by non-CDC doctors, suggesting that if there was a shorter pipeline between state health care professionals and testing, diagnoses would move more quickly. 

This may become increasingly important now that more than one instance of person-to-person transmission has been reported in the US. 

What’s more, CDC officials said Monday that four more flights have been scheduled to evacuate Americans from Wuhan, the epicenter of the outbreak. 

Secretary Alex Azar of the Department of Health and Human Services also announced that flights from China would be redirected to 11 US airports. 

These locations, according to the White House, will be equipped to screen passengers and quarantine them if necessary – although many local authorities have said they were not prepared to do so, the Washington Post reported. 

The more labs have access to the diagnostic test, the greater the odds that the held passengers can be diagnosed or cleared of cornavirus more quickly, hopefully easing the burden of screening on citizens, state officials and facilities.  

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