WASHINGTON — The FDA authorized the first at-home testing option for Covid-19 to LabCorp. The home RT-PCR testing kit will enable self-swabbing of a patient’s nose via nasal swabs and saline.
“Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing,” according to the FDA’s statement. The test kits, which will be available in most states within the coming weeks, will require a doctor’s order.
This is a re-issued emergency-use authorization for the Laboratory Corporation of America (LabCorp), that amended the original EUA for their Covid-19 RT-PCR test for use by healthcare providers and extends it to the new home-use kit.
As previously reported by BreakingMED, while there are many Covid-19 test kits available, the quality of these tests is not known since all have been pushed through with an EUA. Proper specimen collection by experienced people is key, but that may not be happening with drive-thru testing.
Given the art of sample collection, how the home tests will fare in providing an accurate picture of Covid-19 cases is not known, but they might help make up for the shortfall states are facing in getting test kits in the clinical arena.
An alarming story in the New York Times reported that tests originally rolled out by the CDC were contaminated. The Times noted that the FDA said two of the three CDC labs “violated their own manufacturing standards, resulting in the agency sending tests that did not work to nearly all of the 100 state and local public health labs.”
“Problems ranged from researchers entering and exiting the coronavirus laboratories without changing their coats, to test ingredients being assembled in the same room where researchers were working on positive coronavirus samples, officials said. Those practices made the tests sent to public health labs unusable because they were contaminated with the coronavirus, and produced some inconclusive results,” the Times reported.
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 125
Topic ID: 79,125,730,933,125,190,520,926,192,927,151,928,925,934