FDA Announces Authorization of First At-Home Coronavirus Test

Nick Kangadis | April 21, 2020

The U.S. Food and Drug Administration (FDA) announced on Tuesday the authorization of the first diagnostic COVID-19 test that people can take at home and picked up to be tested by the Laboratory Corporation of America (LabCorp). 

The FDA announced the following in statement:

This reissued EUA [emergency use authorization] for LabCorp’s molecular test permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing.  LabCorp intends to make the Pixel by LabCorp COVID-19 Test home collection kits available to consumers in most states, with a doctor’s order, in the coming weeks.

The LabCorp home self-collection kit includes a specific Q-tip-style cotton swab for patients to use to collect their sample. Due to concerns with sterility and cross-reactivity due to inherent genetic material in cotton swabs, other cotton swabs should not be used with this test at the present time. The FDA continues to work with test developers to determine whether or not Q-tip-style cotton swab can be used safely and effectively with other tests.

The FDA went on to note that authorization for at-home testing is only applicable to the LabCorp test mentioned above.

H/T: Fox News