FDA Authorizes First Non-Prescription COVID-19 Test for Home Use

By Neil P. First Posted: Dec 10, 2020 09:34 AM EST

The U.S. Food and Drug Administration authorizes the first non-prescription or over-the-counter COVID-19 test kit for at-home use.

(Photo : Gareth Cattermole/Getty Images)

Determining the real number of COVID-19 infections in the country can only be determined through the COVID-19 test. Recently, the U.S Food and Drug Administration authorizes the use of non-prescription or over-the-counter COVID-19 test kit for at-home use.

FDA Authorizes Over-the-Counter COVID-19 Test Kit

The U.S. Food and Drug Administration announced on Wednesday that they now authorize the LabCorp Pixel COVID-19 Test Home Collection Kit that allows anyone 18 and older to buy the kit and collect nasal swab samples at home.

The samples collected will then be sent to a LabCorp facility for testing. According to a published article in CNN News, the result of the test either positive or invalid will be delivered back to the consumers. Their healthcare provider will notify them by phone.

Additionally, the users or consumers will also be notified through an email or an online portal if their COVID-19 tests are negative. This at-home diagnostic test will help the country and the CDC to determine the exact number of COVID-19 infections.

Dr. Jeff Shuren, the director of the FDA's Center for Devices and Radiological Health, said in a statement, "While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing."

How this COVID-19 Diagnostic At-Home Kit Help Individuals?

This COVID-19 diagnostic at-home kit will help many individuals in the country to determine if they test positive or negative for the virus. This is very helpful most especially during and after the holiday season where experts predicted a surge of COVID-19 infections.

This will also inform everyone if isolation or quarantine is necessary. Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics, said in a statement, "With this authorization, we can help more people get tested, reduce the spread of the virus, and improve the health of our communities."

Where and How to Use the Kit?

The company said through a news release that the new COVID-19 diagnostic test kit is now available through the Pixel by LabCorp website but they also added that it will be soon available in different stores across the country.

There are important steps that users or consumers should follow. After buying the test kit, users are instructed to register the kit on the website and follow the included instructions.

"Test results are securely delivered to the consumer via the Pixel by LabCorp portal. A healthcare provider will counsel consumers who test positive to assist with healthcare treatment and actions," Lab Corp said.

Moreover, the company also added that their COVID-19 test kit is not a substitute for a doctor's visit.

At present, there are currently two types of diagnostic tests and these are molecular tests, such as RT-PCR tests, that look for the virus's genetic material and antigen tests that detect specific proteins from the virus.