NEW YORK – The U.S. Meals and Drug Administration on Friday night granted Emergency Use Authorization for the primary time to a diagnostic check for at-home, self-collection of affected person samples for the detection of SARS-CoV-2 and influenza A/B.
The FDA licensed Quest Diagnostic’s RC COVID-19 +Flu RT-PCR check for prescription use with the corporate’s Self-Assortment Package for COVID-19 +Flu by people suspected of getting a respiratory an infection in line with the coronavirus. If a healthcare supplier determines that self-collection is acceptable to be used with the check and self-collection equipment, a affected person can accumulate the pattern at house and ship it to a Quest laboratory for evaluation.
The check is for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, and/or influenza B virus in nasal swab specimens, the FDA stated. Testing is restricted to labs designated by Quest which might be CLIA licensed and may carry out high-complexity exams.
“With the authorization of this check, the FDA helps to deal with the continuing struggle towards COVID-19 whereas in the midst of the flu season, which is vital for a lot of, together with essentially the most weak of Individuals,” FDA Commissioner Stephen Hahn stated in an announcement.
This article was initially revealed in GenomeWeb.