First COVID-19 and Flu Combination Test Authorized for Home-Use
The U.S. Food and Drug Administration authorized the first diagnostic test for at-home collection of patient samples to detect both COVID-19 and Influenza A and B.
The FDA announced on December 4, 2020, the Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu is authorized for individuals who are suspected of respiratory viral infection consistent with COVID-19 when a home collection is determined to be appropriate by an individual’s healthcare provider.
Patients can collect a sample at home under a healthcare provider's order and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit, stated the FDA’s press release.
“Today’s authorization for a COVID-19 plus flu test using samples collected at home is a significant step toward FDA’s nationwide response to COVID-19. With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19. At the same time, in the middle of the flu season, which is important for many, including the most vulnerable of Americans,” said FDA Commissioner Stephen M. Hahn, M.D.
“This is another example of the FDA working with test developers to bring important diagnostics to Americans.”
“With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results.”
“This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”
As of December 1, 2020, the FDA had authorized 295 coronavirus diagnostic tests, including 227 molecular tests, 61 antibody tests, and 7 antigen tests 2020.
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Previously, Quest Diagnostics stated on November 24, 2020: ‘Our average turnaround time for reporting test results is approximately 2-3 days for all patients and approximately 2 days for our priority patients.’
‘We continue to expand our physical capacity with additional testing equipment and platforms, add capacity through our lab referral partner program, and remain in close contact with our suppliers to acquire the supplies needed to provide testing.’
‘We also continue to work with healthcare providers to prioritize testing, including for patients who are hospitalized, awaiting surgery, or receiving care in congregate settings, such as nursing homes.’
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