The Centers for Disease Control and Prevention (CDC) have shipped coronavirus tests to more than 100 labs after getting emergency Food and Drug Administration (FDA) approval for the long-awaited diagnostic, officials said Wednesday.
Its test, previously only authorized for use at CDC’s own lab was green-lit last night for distribution to any CDC-authorized lab with a certain classification, though it’s unclear how many of these there are in the US.
Each of the first 100 or so labs will get two test kits, capable of screening 700 to 800 patient samples, said Dr Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases.
Kits are expected in time for broader testing to start next week.
‘The availability of this test is the starting place for greater commercial testing for [2019-nCoV],’ said Dr Messonnier, and suggested that states may start reporting more confirmations faster soon.
‘We’ve been preparing for an outbreak like this for years…[this is] the beginning of what could be a long response.’
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.’
Dr Messonnier said Wednesday there are no new cases confirmed in the US, but that she expects there will be.
A deluge of those diagnoses may be on its way soon, as four additional planes repatriate Americans who had been trapped in Wuhan and as the newly-approved tests reach more labs.
‘We should not be surprised if there are cases’ from the flights, said Dr Messonnier.
‘That being said, there’s a child with a fever,’ she added, referring to a minor who is among the 195 Wuhan evacuees at March Air Reserve, and who was taken to a hospital and quarantined with a fever on Tuesday.
‘Those of you that have children know there are many reasons that children develop fevers and, as far as I understand, the child is actually doing pretty well.’
She also noted that, of the 11 confirmed cases, most had been doing consistently well and even said that those who had been in somewhat worse shape – potentially a reference to a California couple hospitalized Sunday night – were improving.
According to Dr Messonnier, the quarantined flight passengers are ‘going on with daily life as best they can’ on March Air Reserve.
They are expected to be released by February 11.
‘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.
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.