FDA+Approves+an+At-Home+COVID+Test

Hannah Waskiewicz

FDA Approves an At-Home COVID Test

When the COVID-19 pandemic began, there was little to no testing readily available. Fast forward about 10 months later,  there is now a new and improved way of testing. 

An Emergency Use Authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home, which provides rapid results, was released on November 17 by the U.S Food and Drug Administration.

This all-in-one test kit is a molecular single use test that is intended to detect COVID. Inside of this kit is a self-collected nasal swab sample used for a person aged 14 and older who are suspected of COVID-19 by their healthcare provider. It is also authorized for use in point-of-care settings, doctor’s offices, hospitals, urgent care centers and emergency rooms, for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only and reserved for individuals experiencing symptoms or those who have been recommended for testing by a healthcare provider, public health department, and/or contact investigator.  

This test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. The results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative depending on the test and lab you send it to, but in this case, it is the Lucira COVID-19-All-In-One Test Kit.   

How can you secure this test after talking with a health care provider? According to LabCorp, you can start off by completing an eligibility survey. Following this step, you will choose your billing option. They can bill it to your insurance, utilize federal funds to cover the cost of this test on your behalf if you’re uninsured, or you can pay with a credit card. Your sample collection kit will then be given to you via FedEx. For the actual LabCorp test, collect your sample and send it back to their world-class lab for testing. You can access your results online. 

As of right now, nine at-home COVID-19 tests are currently available for purchase. The Everlywell test however, is not available in New York, New Jersey, or Rhode Island and the hims & hers test availability varies by state.

This new discovery of at-home tests could possibly resolve many of the problems caused by COVID and could eventually help limit state guidelines. Why may you ask? Well, you don’t even need to leave your house to risk other people’s safety out in public. We can only hope cases begin to decrease and bring the pandemic to an end.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-self-testing-home

https://www.pixel.labcorp.com/at-home-test-kits/covid-19-test-home-collection-kit

https://www.everlywell.com/products/covid-19-test/

https://www.goodrx.com/blog/coronavirus-at-home-tests/

 

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