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FDA Okays Faster Covid-19 Test, Nixes Home Tests

Coronavirus graphic

(Pete Linforth, Pixabay)

23 Mar. 2020. The Food and Drug Administration granted an emergency clearance for a point-of-care test to detect for the virus causing novel coronavirus or Covid-19 infections. The agency also put a hold for now on authorizations for home testing or sample collection kits.

FDA on Saturday cleared the Xpert Xpress Sars-CoV-2 test made by Cepheid, a molecular diagnostics company in Sunnyvale, California. The Xpert Xpress Sars-CoV-2 test reads a person’s nose swab specimen taken by a clinician. The specimen is then mixed with reagents in a cartridge that fits into Cepheid’s GeneXpert analysis system. The GeneXpert system conducts a reverse transcription-polymerase chain reaction, or RT-PCR analysis that identifies and quantifies messenger RNA in the sample, in this case RNA signatures indicating the presence of Sars-CoV-2 viruses responsible for Covid-19 infections.

Cepheid says its system can return results in 45 minutes, once the GeneXpert system runs the test. “Cepheid currently has nearly 5,000 GeneXpert systems in the U.S. capable of point-of-care testing and for use in hospitals,” says company president Warren Kocmond in a company statement. “Our automated systems do not require users to have specialty training to perform testing. They are capable of running 24/7, with many systems already doing so today.”

FDA cleared the Xpert Xpress Sars-CoV-2 test under an emergency use authorization, an exemption from normal review procedures employed by the agency during public heath emergencies. The authorization clears the test when analyzed in labs certified for high and moderate complexity testing under the Clinical Laboratory Improvement Amendments process, and specifically allows for use in patient-care settings. Most other Covid-19 virus tests require shipping the samples to separate labs for analysis.

The lack of rapid and widespread Covid-19 testing is hampering the U.S. response to the pandemic. As of this morning (23 Mar.) the U.S. and its territories conducted 236,006 patient tests, with 32,617 testing positive and 203,389 negative, according to the Covid Tracking Project, a volunteer web site. The worldwide Covid-19 tracking dashboard hosted by Johns Hopkins University shows 35,225 cases in the U.S., about 10 percent of the worldwide total, responsible for 473 deaths.

FDA, however, is not authorizing tests for Covid-19 viruses at home, at least for now. On Thursday, 20 Mar., the agency issued a warning about fraudulent home testing kits being marketed in the U.S. “We want to alert the American public,” says the FDA statement, “that at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19.”

An agency FAQs page on diagnostic testing posted over the weekend also notes, “At this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19. The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.”

FDA’s policy puts on hold for now plans by a few home test kit developers for other conditions to immediately offer home sample collection or point-of-care tests for the Covid-19 virus. The technology news service TechCrunch reports that one company already collecting nasal swab samples from customers is destroying those samples.

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