At-Home COVID-19 Test Gets Emergency Authorization From FDA

Unsplash, LapCorp / Twitter

The Food And Drug Administration has just given an Emergency Use Authorization (EUA) for the first at-home diagnostic test with a collection option for COVID-19.

The test, produced by Laboratory Corporation of America (LabCorp), is a COVID-19 RT-PCR Test called “Pixel by LabCorp.”

The test is an at-home collection kit, which provides sample collection materials including a nasal swab to the user, who then uses the included shipping package to return the sample to a lab for testing.

Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” said FDA Commissioner Stephen M. Hahn, M.D.

Since the coronavirus outbreak, testing has been somewhat limited, and if you could obtain a test, it had to be taken at a hospital or drive-thru testing site, which made people apprehensive because most states have stay-at-home orders.

Now, thanks to this emergency order, LabCorp’s at-home test is only available for healthcare workers and first responders, which they say is a CDC guideline. They are working on making these tests available to the public in the next few weeks.

A statement from LabCorp also says that “the EUA permits nasal swab specimens to be collected at home using the Pixel by LabCorp™ COVID-19 test home collection kit if recommended by a healthcare provider after completing a COVID-19 questionnaire.”

The test will include a specific cotton swab, much like a Q-tip, but the FDA advises to not use other cotton swabs you may have at home due to “sterility and cross-reactivity.”

As it states on their website, the at-home test kit costs $119 and the instructions are as follows:

LabCorp

LabCorp continues to develop new ways to help patients and healthcare providers fight the COVID-19 crisis through our leading testing capabilities and deep scientific and research expertise,” said Adam Schechter, president and CEO of LabCorp. “Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time.”

Once this is available to the public, would you take one? Let us know in the comments.