Approved: Saliva-based COVID-19 test
This column is provided by the ONU HealthWise Pharmacy.
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for a saliva test for SARS-CoV-2, the virus that causes COVID-19 infection.
This approval was granted to the Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test.
The SalivaDirect test is a new method for processing saliva samples. Because the test is saliva-based and does not need reagents (critical test components for other tests that have been prone to shortages in the past), this new approval may allow for increased COVID-19 testing, according to the FDA.
As of the publication date, SalivaDirect is the fifth saliva-based test the FDA has authorized.
No nasal swab is needed. Instead, the patient self-collects a saliva sample under the observation of a health care professional.
“The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game changer that will reduce the demand for scarce testing resources,” said Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, MD, in a press release.
Unlike other recently approved COVID-19 tests, SalivaDirect does not require specific swab or collection devices. In fact, to collect the saliva sample, all you need is any sterile container.
This test has been shown to work with a variety of commonly used reagents and instruments. That means it can be used in other labs across the nation — not just in Yale's lab.
Interested labs can receive the SalivaDirect protocol from Yale and obtain the required components to perform the test on their own.
The labs will need to follow Yale’s instructions for use and comply with the conditions of authorization in the FDA's EUA.
Stories Posted This Week
Sunday, July 13, 2025
Saturday, July 12, 2025
Friday, July 11, 2025
Thursday, July 10, 2025
Wednesday, July 9, 2025
- Home cooling assistance program through Sept. 30
- Alfes named Women's Golf Coaches Association All-American Scholar for 2024-25
- Library staff will kiss a frog if patrons check out 1,000 books
- Red, White, Woof pup adoption party on July 12
- Expectations, communication feature in public meeting about N. Gilbert St. parking
- Ada Athletic Boosters prepare for 2025-2026 sports programs
- The Icon's menu mission