30-Second Swish and Gargle Coronavirus Collection Authorized

Minnesota based OralDNA Labs announces on September 30, 2020, that the U.S. FDA has issued an amended Emergency Use Authorization (EAU) for the OraRisk® COVID-19 RT-PCR test allowing testing from a saline oral rinse collection. This is the 1st EAU for a simple saline 30-second swish and gargle collection.

This process eliminates the need for a nasal swab and avoids the difficulty some individuals have in providing sufficient saliva for saliva direct testing. Collected samples are viable for up to 72-hours and just as important, the samples no longer require cold pack transportation.

This test is for the qualitative detection of nucleic acid from SARS-CoV-2 in oral saline rinse specimens, nasopharyngeal swab, and nasal swab specimens collected in universal transport media, and nasal swabs collected in oral saline rinse, from individuals suspected of COVID-19 by their healthcare provider.