FDA authorizes first COVID-19 and flu combination test for use with home-collected samples
FDA authorized (PDF) the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider.
Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit. Read the FDA news release (December 4, 2020)
FDA authorizes first ultraviolet-C (UV-C) light based bioburden reduction system
FDA authorized (PDF) the Lumin LM3000 Bioburden Reduction UV System, the UV-C light based bioburden reduction system for emergency use in bioburden reduction of certain N95 respirators when there are insufficient supplies of filtering facepiece respirators resulting from the COVID-19 pandemic.
The system, manufactured by 3B Medical Inc., is a Tier 3 system intended for bioburden reduction (or reduction of microorganisms) of 3M Model 1860 N95 respirators only, and only for single-user reuse, as a supplement to the Centers for Disease Control and Prevention (CDC) reuse recommendations. Tier 3 bioburden reduction systems are intended to be used in addition to and not in lieu of CDC reuse recommendations. In evaluating the EUA request, the FDA reviewed available scientific evidence, including scientific literature, performance testing, and other information related to bioburden reduction and the use and reuse of filtering facepiece respirators as described in the FDA guidance. (December 3, 2020)
Diagnostic test EUAs
As of today, 297 tests and sample collection devices are authorized by FDA under EUAs; these include 228 molecular tests and sample collection devices, 61 antibody tests, and 8 antigen tests. Also see: Coronavirus Testing Basics
|