A new COVID-19 detection test that can be completed in just a few hours is authorized for use by the US Food and Drug Administration (FDA). The test has several advantages over traditional nasal swab tests: It is inexpensive, less invasive and can be performed without the need for certain test components that have run short during the pandemic.
What’s more, the test, known as SalivaDirect, does not require any proprietary equipment or technology; and instructions for the test will be made immediately available to laboratories around the country, the FDA said in a statement.
SalivaDirect “is yet another test change for innovation games that will reduce the demand for rigorous resource testing,” said adm. Brett P. Giroir, the U.S. Assistant Secretary of Health and the COVID-19 test coordinator, in the statement.
Developed by researchers at Yale School of Public Health, the test was recently given to NBA players and staff to help validate its effectiveness.
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Unlike nasal swab tests, which require a special swab to be inserted deep into the nose, the saliva test simply requires a person to inject into a collection container, which is a less invasive (and probably less painful) process. In addition, the spit samples can be collected with any sterile container, the FDA said.
“We’ve simplified the test so that it only costs a few dollars … and we expect labs to only pay about $ 10 per sample,” said Nathan Grubaugh, assistant professor of epidemiology at Yale School of Public Health. said in a statement. “If cheap alternatives like SalivaDirect can be implemented nationwide, we can finally get a grip on this pandemic, even for a vaccine.”
So far, studies by SalivaDirect have found that the accuracy of the test is similar to that of nasal swab tests, the researchers said. A first SalivaDirect study was published August 4 on the preprint server medRxiv, but the results have yet to be published in a peer-reviewed journal. The test can provide results in less than three hours, according to CNN.
Yale does not seek to commercialize the test, the statement said. After all, the university will provide instructions for the test as an “open source” protocol, which means designated labs can follow Yale’s protocol to perform their own tests, the FDA said. Labs could use a number of commercially available components, including just chemical reagents, to perform the test.
The researchers said that SalivaDirect could be scaled up rapidly across the US in the coming weeks.
Another benefit of the new test is that it prevents a test step, known as “nucleic acid extraction,” which requires other COVID-19 tests, the FDA said. This step requires special “extraction kits” that have been in short supply in recent months. “It can perform a test without these kits increasing the capacity for increased testing, while reducing the pressure on available resources,” the FDA said.
The FDA on Saturday (August 15) approved emergency use for SalivaDirect. It is the fifth speech test for COVID-19 to receive this authorization. Earlier detective tests, such as one developed by Rutgers University researchers, require a special collection container to perform, Live Science reported earlier.
Originally published on Live Science.
