Dental testing specialist OralDNA Labs has received an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its saline oral rinse COVID-19 test.
The OraRisk test is the first saline 30-second swish-and-gargle collection COVID-19 test to get an EUA, according to the company. The test is intended for the detection of nucleic acid from SARS-CoV-2, the virus that causes COVID-19.
This type of test eliminates the need for a nasal swab and avoids the challenge of patients not being able to provide adequate amounts of saliva for direct testing. Results are available in 24 to 48 hours.
The test is for use by certified lab professionals; the company would need to seek a new approval from the FDA for use by others. In May, a bill passed in North Carolina allowing dentists to administer tests that have been approved or authorized by the FDA.
