New coronavirus saliva test gets emergency approval from FDA

COVID-19 pandemic has pushed the world into unknown territory, and the only way to understand the widespread of the disease is through testing. But the painful nasal swab hasn't been the easiest, not to mention it's expensive and takes time. The call for a faster, cheaper and less painful COVID-19 test has finally been answered as the Food and Drug Administration on Saturday granted emergency approval for a new saliva test.

SalivaDirect does not require any special type of swab or collection device, Xinhua news agency reported citing the FDA as saying on Saturday. A saliva sample can be collected in any sterile container. The test is also unique because it does not require a separate nucleic acid extraction step.

How does it work?

The saliva test for COVID-19 can get results in less than a second. Patients just need to rinse their mouth with a saline wash and spit into a vial. The sample is then put in an AI-based device to get the results.

Courtesy: Reuters

Researchers have been able to get accurate results for 95 percent of the time. They are using machine learning so the results are bound to get more accurate over time. The researchers estimate the cost of the test to be less than 25 US cents and the device will cost less than $200. The device can be operated anywhere, at home, airports, malls, etc.


This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past, said the FDA in a release. Being able to perform a test without these kits enhances the capacity for increased testing while reducing the strain on available resources, said the release.

"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 Giroir.

"Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents," said FDA Commissioner Stephen Hahn.

This is the fifth test the FDA has authorized that uses saliva as a sample for testing.