FDA Gives Emergency Approval to Sell At-Home Virus Tests

"Authorising additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for Covid-19", FDA commissioner Stephen Hahn said in a statement.

The FDA released a EUA late last month, for example, for a self-collected at-home coronavirus diagnostic test using LabCorp's Pixel by LabCorp COVID-19 Test home collection kit. Once patients collect their saliva sample, they return it to the lab in a sealed package for testing, the FDA added.

"If people are committed to do self-collection and can facilitate that collection at home, certainly with a prescription under medical care, we can get to those that are quarantined, don't have the means for transportation or are too scared to go outside", Brooks said.

The science behind the detection of COVID-19 in saliva testing is the same as conventional swab tests, using molecular analysis in a process known as polymerase chain reaction, or PCR, which amplifies tiny bits of genetic material to pick up the virus.

"And importantly, this new approval will help the Rutgers community directly by allowing for convenient and precision testing of faculty, students and staff when the time comes for Rutgers to reopen the campus", he added.

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The Emergency Use Authorization was issued to Rutgers Clinical Genomics Laboratory for its Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. Beyond the rapid, accurate and broad testing for COVID-19 that is critically necessary, this test has other crucial benefits: it expands the availability of testing across the US, decreases the risk to medical professionals who are now directly exposed to the virus when performing a nasal swab-based sample collection, and preserves precious personal protective equipment (PPE) which is in limited supply.

Strom said the test was also being provided at University Hospital, RWJBarnabas Health, Hackensack Meridian Health, Atlantic Health System and other hospitals, and various drive-through testing sites across the state.

The saliva tests are already basically self-administered. "Protecting both patients and healthcare professionals from any unnecessary exposure is of paramount importance and saliva home collection addresses nearly all issues around testing quality, safety and availability", Andrew Brooks, chief operating officer and director of technology development at RUCDR, said in the statement. One simply spits into a tube with a funnel attached, and hands it over for processing.

According to Rutgers, more than 60,000 saliva tests have been performed since the test system was approved last month. Physicians, they said, should make patients aware of the limitations.

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