September 3, 2020
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1:53Now PlayingCOVID-19 widespread testing is crucial to fighting the pandemic, but is there enough testing? The answer is in the positivity rates.
Federal regulators are investigating a Texas laboratory that a Florida hospital chain dropped last week because of delayed and unreliable COVID-19 test results.
AdventHealth, which has 45 hospitals in nine states, terminated its Florida contract with MicroGen DX due to concerns about the validity of some of the 60,000 tests MicroGen had processed for the system because the lab left them at room temperature for days, according to an AdventHealth statement. MicroGen promotes shipping COVID-19 sputum (mucus) samples through FedEx on its website.
The company is also selling a saliva-only test that can be administered in a "hospital, clinic, drive-thru clinic or at-home," in all 50 states without an Emergency Use Authorization from the Food and Drug Administration, said MicroGen spokeswoman Ashley Moore. An authorized Emergency Use Authorization is required in a public health emergency, according to the Food and Drug Administration, for "any COVID-19 test for at-home testing, with or without the use of telemedicine."
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