FDA Authorizes First Saline Oral Rinse Collection Test for COVID-19
The test provides qualitative detection of nucleic acid from SARS-CoV-2 in oral saline rinse specimens, nasopharyngeal swab, and nasal swab specimens in a universal transport media, as well as nasal swabs collected in oral saline rinse.
The US Food and Drug Administration (FDA) has amended the Emergency Use Authorization (EUA) for the OraRisk COVID-19 RT-PCR test, allowing for users of the device to be tested for coronavirus 2019 (COVID-19) via saline oral rinse collection.
With the amended indication, the OralDNA Labs product becomes the first device with an EUA for a saline 30-second swish and gargle collection, eliminating need for nasal swab and saliva direct testing.
According to the company, the samples are viable for up to 72 hours, and no longer require cold pack transportation.
The test provides qualitative detection of nucleic acid from SARS-CoV-2 in oral saline rinse specimens, nasopharyngeal swab, and nasal swab specimens in a universal transport media, as well as nasal swabs collected in oral saline rinse. The test is designed for collection conducted by healthcare providers.
George Hoedeman, chief executive officer of OralDNA Labs, suggested oral rinse collection could be a “game-changer” in COVID-19 testing.
"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,” Hoedeman said. “These improvements, along with our exceptional turnaround times generally being shorter than our advertised 24-48 hours from sample receipt, will allow for an overall enhanced testing experience."
