Roche receives emergency FDA approval for their new COVID-19 PCR test. — But the FDA approved test is adjusted to return some false negatives in order to avoid false positives. - cdc.gov
The FDA gave Roche approval to pre-position their PCR test kits at Reference Labs across America prior to approval, but . . .
. . . there still won't be enough to test all Americans with COVID-19 exposure or symptoms.
> > > Smart, well-run nations like Germany, Australia, Taiwan, and South Korea bought similar PCR test kits early in the epidemic. < < < Ooga Boogas claimed the pandemic is a hoax.
FDA Issues Emergency Use Authorization for Roche SARS-CoV-2 Test - Mar 13, 2020 - genomeweb.com
NEW YORK – Roche said on Friday that the US Food and Drug Administration has issued Emergency Use Authorization for the Cobas SARS-CoV-2 Test.
The test, which is also CE-IVD marked, is for patients who show signs and symptoms of the disease COVID-19, caused by the SARS-C0V-2 coronavirus. It is for the qualitative detection of SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet the clinical and epidemiological criteria for testing, and can be used with Roche's fully automated Cobas 6800 and Cobas 8800 systems.
The Cobas SARS-CoV-2 Test is a real-time, reverse transcriptase PCR test. The single-well, dual target assay includes specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes the novel coronavirus that has infected nearly 133,000 people worldwide. Almost 5,000 people have died from COVID-19.
Roche noted that negative results with the Cobas SARS-CoV-2 Test does not preclude infection and such results must be combined with clinical observations, patient history, and epidemiological information.
"Over the last weeks, our emergency response teams have been working hard to bring this test to the patients," Roche Diagnostics CEO Thomas Schinecker said in a statement. "CE-mark certification and the FDA’s granting of EUA supports our commitment to give more patients access to reliable diagnostics which are crucial to combat this serious disease."
Roche said that upon the authorization it will have millions of tests each month for use on the two Cobas systems and "Roche is working to the limits of our production capacity." |
