Pharmaceutical Returns

Over-The-Counter Home Test For COVID-19 Gets US Green Light

1 year ago  •  Add Comment  •  by Amanda Alfredson

After over 90 million confirmed cases worldwide, a new over the counter (OTC) Covid-19 test has been introduced. The FDA has issued an Emergency Use Authorization (EAU) for the first at-home COVID-19, rapid test. “Receiving an EUA does not mean that the product is officially FDA-approved. It is an authorization that allows unapproved products to be used during the public health crisis”.

How Does it Work?

This COVID-19 test is not like any other. This test can be completed at home without sending the sample to a lab. The at-home kit includes a nasal swab, a dropper, processing fluid and a Bluetooth-connected analyzer that sends the results straight to an app on your smartphone. The consumer swabs the inside of their nose, places the swab into the analyzer, and then wait roughly 15 minutes for the results. Through the app, you results can sent to employers, educators, and even public health authorities to ensure the accuracy of case statistics.

How Does it Compare?

Compared to the standard PCR tests which detect viral genetic material, the OTC version, successfully identified 96% of PCR-confirmed COVID-19 positive cases in people with symptoms and 91% of PCR-confirmed cases in people without symptoms.

Covid At Home Test in a Nutshell

While there are many pros to this test, the goal production of 20 million test by mid-2021 is still not enough to meet the overall need in the U.S. to bring control over the pandemic. Additionally, the cost can be a barrier for people choosing this at-home test over the free test at a doctor’s office or clinic. Either way, it is another tool in the arsenal to fight the pandemic.


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