Published: Fri, March 20, 2020
Sci-tech | By Patricia Wade

FDA releases approved Covid-19 test kits

FDA releases approved Covid-19 test kits

Plus, if people have the option of testing at home, they won't have to venture to the hospital and potentially expose people to COVID-19 while they're out, according to the paper.

Although this decision will help increase testing capacity for COVID-19, it is important to the clinical lab community that Congress amend language in the Families First Coronavirus Response Act that now does not provide coverage for COVID-19 tests without EUAs.

However, authorities are moving quickly to close that gap and ramp up testing capacity. However, if FDA, upon review of the EUA request, identifies a significant problem that can not be addressed in a timely manner, the laboratory may have to stop using the test and issue test reports indicating that prior tests may be unreliable.

The U.S. Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUA) for commercially distributed COVID-19 diagnostic tests at the end of last week.

Americans imprisoned in Iran, Lebanon released
Jeanne Shaheen, have been pressuring the Lebanese government to release Fakhoury, denying he was involved in alleged war crimes. Earlier this year, Shaheen introduced a sanctions bill to put additional pressure on Lebanon's government to release Fakhoury.

The second part of the new guidance lets commercial test developers sell their products on the market without the need for an emergency use authorization (EUA).

The clinical laboratory community has seen a major change in COVID-19 tests, with the EUA requirements for the tests lifted entirely. "We urge state authorities and commercial developers to take all necessary steps to ensure the availability of accurate tests". Thermo Fisher Scientific and Roche Molecular Diagnostics were the first commercial developers to receive the go-ahead late last week. Both tests are for the qualitative detection of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19).

The Logix Smart COVID-19 test kits are being shipped to Italy, Germany, the United Kingdom, Turkey, Greece, the Philippines, Thailand, Australia, Paraguay, Ecuador, Israel, South Africa and Canada, in addition to customers and research institutions in the U.S.

"These are PCR based kits used in laboratories, and not point-of-care kits", the agency said. Though manufacturers now have the go-ahead to develop serological tests, which measure the amount of proteins or antibodies responding to infection in a patient's blood, it's unclear how many developers will choose to do so. "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", he added. Finally, FDA recommends including a general statement in the test report that FDA review is pending, whenever that is the case.

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