FDA creates template for emergency clearance of at-home COVID-19 tests

By LabPulse.com staff writers

May 29, 2020 -- The U.S. Food and Drug Administration (FDA) has created a template to clarify and smooth the way toward obtaining emergency use authorization (EUA) for at-home sample collection kits for COVID-19.

While there are authorized COVID-19 tests for use with at-home collection of samples that may be sent to a lab for processing and test reporting, there are currently no tests authorized to be used completely at home. All tests that have received an EUA, including any authorizations for home collection of a specimen, can be found on the FDA's website page on EUAs.

AMP survey shows labs' struggles with COVID-19 supply shortages
A survey conducted by the Association for Molecular Pathology (AMP) illustrates the challenges clinical labs have faced in securing supplies for COVID-19...
Quest readies launch of nasal specimen self-collection kits for coronavirus
Quest Diagnostics announced plans to make more than a half million nasal specimen self-collection kits for coronavirus testing available by the end...
FDA offers reference panel to help validate COVID-19 diagnostics
The U.S. Food and Drug Administration (FDA) is now offering a reference panel that will help labs evaluate new molecular diagnostic tests for detection...
AACC objects to FDA's at-home virus kit clearance, following go-ahead for Everlywell
The American Association for Clinical Chemistry (AACC) has notified the U.S. Food and Drug Administration (FDA) that it objects to the agency's recent...
FDA updates guidance on coronavirus tests
The U.S. Food and Drug Administration (FDA) has released an updated guidance document on coronavirus testing for clinical laboratories and commercial...

Copyright © 2020 LabPulse.com

Last Updated ls 5/29/2020 1:10:41 PM

Register below for our weekly Letter from the Editor to receive the latest Clinical Lab news and insights.