The FDA has issued an amended Emergency Use Authorization (EUA) for the OraRisk COVID-19 RT-PCR test (OralDNA Labs), allowing testing from a saline oral rinse collection.
This is the first EUA for a simple saline 30 second swish and gargle collection. It eliminates the need for a nasal swab, and avoids the difficulty some individuals have in providing sufficient saliva for saliva direct testing. Samples are viable for up to 72 hours and no longer require cold pack transportation.
The FDA’s initial EUA for OraRisk COVID-19 RT-PCR was granted on July 17, 2020 for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab and nasal swab specimens.
Food and Drug Administration (FDA). Emergency Use Authorization Amendment: OraRisk COVID-19 RT-PCR. September 25, 2020. Available at: click here. Accessed October 2, 2020.