"We ask the public and stakeholders to be analytical of COVID-19 test kits that they may encounter as we have identified some applications which appear to be suspicious and unauthorized", he said. 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.
However, authorities are moving quickly to close that gap and ramp up testing capacity.
A health and wellness company will release the first U.S.at-home coronavirus tests soon, the firm said. The Guidance contains policies regarding (i) laboratories' development and use of certain tests prior to or without an Emergency Use Authorization (EUA), (ii) commercial manufacturers' development and distribution of certain tests prior to an EUA, and (iii) development, use, and distribution of serological tests without an EUA.
The new rules will allow private companies to immediately begin marketing test kits to the public before getting permission from the FDA, as previously required. Under the February 29 guidance, the FDA granted EUA waivers to labs that are certified to perform high-complexity testing, but commercial vendors were not covered by that policy.
But to help address the urgent need for more tests, the U.S. Food and Drug Administration (FDA) announced an "unprecedented" move on Monday. Thermo Fisher Scientific and Roche Molecular Diagnostics were the first commercial developers to receive the go-ahead late last week.
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.
He also said that these test kits were polymerase chain reaction-based reagent kits used in laboratories and not point-of-care or do-it-yourself kits.
Tests can be requested online for those experiencing COVID-19 symptoms. In their March 16 statement, the FDA admitted these tests "are less complex than molecular tests and are exclusively used to identify antibodies, which limits their effectiveness for diagnosis".