The Food and Drug Administration has given the nod to a novel new COVID-19 test. The regulator announced Monday that it granted an emergency use authorization (EUA) for SalivaDirect, a diagnostic solution developed by the Yale School of Public Health.
In contrast to most tests currently in use to detect active cases of the SARS-CoV-2 coronavirus, SalivaDirect does not require any kind of swab. Additionally, it does not necessitate a specialized container to hold the harvested sample. As its name implies, it's a saliva test, and the sample can be stored in any type of sterile container.
"It is also unique because it does not require a separate nucleic acid extraction step," involving additional chemicals, the FDA wrote in its daily round-up of COVID-19 and coronavirus-related news on Monday. "This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past."
SalivaDirect is the result of research into the coronavirus that indicated it could remain stable in saliva at warm temperatures. The Yale team developed a diagnostic solution around that property. Research indicates that SalivaDirect tests are similar in accuracy and sensitivity to those that use fairly uncomfortable nasopharyngeal swabbing to harvest test samples from within the nose.
In an article on SalivaDirect's receipt of the EUA, YaleNews quoted research team member Chantal Vogels, Ph.D., as saying that with its advantages, "it has the potential to be used on a large scale to help protect public health."
There are various COVID-19 testing products on the market that emphasize convenience and speed. Becton, Dickinson (BDC 1.03%), for one, has a blood testing kit for coronavirus antibodies that it says can deliver results in 15 minutes, while Abbott's (ABT 0.29%) five-minute ID NOW COVID-19 test received its EUA relatively early in the pandemic.