FDA clears saliva test for Covid-19, opening door to wider testing (statnews.com)
The Food and Drug Administration on Saturday authorized emergency use of a new and inexpensive saliva test for Covid-19 that could greatly expand testing capacity.
The new test, which is called SalivaDirect and was developed by researchers at the Yale School of Public Health, allows saliva samples to be collected in any sterile container. It is a much less invasive process than the nasal swabs currently used to test for the virus that causes Covid-19, but one that has so far yielded highly sensitive and similar results. The test, which also avoids a key step that has caused shortages of chemical reagents used in other tests, can run approximately 90 samples in fewer than three hours in a lab, although the number can be greater in big labs with automation.
Moreover, Yale intends to provide its “open source” testing protocol to laboratories around the country. Other labs can now adopt the method while using a variety of commercially available testing components that can reduce costs, speed turnaround times and increase testing frequency, according to the FDA. And because the reagents for the test cost less than $5, the Yale researchers estimated labs should charge about $10 per sample, although that remains to be seen. The testing method is available immediately, but the researchers added it can be scaled up quickly for use in the coming weeks.
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