Saline Oral Rinse COVID-19 RT-PCR Test Could Be a Game-Changer for Coronavirus Testing

This could make oral rinse collection a game-changer for COVID-19 testing.

OralDNA Labs (Eden Prairie, MN, USA) has been issued an amended Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its OraRisk COVID-19 RT-PCR test, allowing testing from a saline oral rinse collection. This marks the first EUA for a simple saline 30 second swish and gargle collection. The OraRisk COVID-19 RT-PCR test is meant 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. Samples are viable for up to 72 hours and no longer require cold pack transportation.

"Oral rinse collection will be a game-changer for COVID testing," said George Hoedeman, CEO of OralDNA Labs. "A 30 second convenient collection without a nasal swab will improve patient comfort, minimize exposure risk to frontline healthcare professionals, shorten collection time, and avoid supply chain bottlenecks. These improvements, along with our exceptional turnaround times generally being shorter than our advertised 24 to 48 hours from sample receipt, will allow for an overall enhanced testing experience."

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