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Thursday, June 30, 2022
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FDA Authorizes At-Home PCR Tests

Featured, Health

At-home COVID-19 test | Image by Ink Drop

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The U.S. Food and Drug Administration authorized the first at-home COVID-19 test.

Considered a step closer to a “Holy Grail” of sorts, the Seasonal Respiratory Virus RT-PCR DTC Test developed by Labcorp can be obtained without a prescription and administered at home without the assistance or supervision of a healthcare professional.

It can detect COVID-19, influenza A and B, and RSV.

While researchers consider current variants of COVID-19 to be milder than previous iterations, many Americans, especially those with comorbidities, remain at risk of severe injury or death if infected with the virus.

Early detection remains key to limiting the spread of COVID-19, but when symptoms appear, it is difficult to distinguish between COVID-19, the flu, and other similarly-presenting sicknesses.

Before Labcorp’s new SRV Test, a visit to the doctor was required to have a test administered to determine infection from a respiratory virus. The doctor would then send that test to a laboratory for analysis.

According to the FDA, the SRV Test “allows an individual to self-collect a nasal swab sample at home and then send that sample to Labcorp for testing. The test can identify and differentiate multiple respiratory viruses at the same time, detecting influenza A and B, commonly known as the flu, respiratory syncytial virus, commonly known as RSV, along with SARS-CoV-2, the virus that causes COVID-19. Results are delivered through an online portal, with follow-up from a health care provider for positive or invalid test results.”

The SRV Test removes a sometimes costly and time-consuming obstacle to testing for severe respiratory illnesses by eliminating a doctor’s prescription and visit as a requirement.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, stated, “The rapid advances being made in consumer access to diagnostic tests, including the ability to collect your sample at home for flu and RSV without a prescription, brings us one step closer to tests for these viruses that could be performed entirely at home.”

Speaking with NBC News, clinical virologist Matthew Binnicker of the Mayo Clinic said he wouldn’t be surprised if “a true ‘at-home’ molecular test targeting Covid-19, influenza and RSV is available within the next 12 months.”       

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