FDA approves new, inexpensive saliva-based COVID-19 testing
At the order of the US Food and Drug Administration, a new way of testing patients for COVID-19 is now available.
This new fifth testing option is a saliva-based procedure that was given Emergency Use Authorization this week.
Saliva may not engender the most pleasant images in one's mind, but the test might be preferable to the currently popular nasal swab, which can be uncomfortable.
In contrast to the awkward nasal swab test, the saliva test is inexpensive, noninvasive, requires minimal processing, and retains much of the accuracy of traditional nasopharyngeal (relating to the upper part of the pharynx, connecting with the nasal cavity above the soft palate) swabs.
The new procedure was developed by the Yale School of Public Health and Yale is offering SalivaDirect’s protocol open source, meaning researchers worldwide can take and adapt the method for use in their own labs depending on what resources they have available.
The authors say they engineered their protocol to be as adaptive as possible to different PCR kits already on the market.
“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,” Food and Drug Administration (FDA) Commissioner Stephen Hahn says in a press release announcing the emergency use authorization.
This same flexibility and relatively streamlined protocol also make SalivaDirect a cheaper alternative to traditional PCR tests, the authors say. The total cost of the reagents needed for one test is roughly $5, meaning it could be offered to the public for much less, perhaps as little as $10.
“This could be one the first major game changers in fighting the pandemic,” Andy Slavitt, a former acting administrator of the Centers for Medicare and Medicaid Services, tweeted in response to the news. “Rarely am I this enthusiastic . . . [With] a $10 test, you can test every day or every couple days.”
BREAKING: Great news.— Andy Slavitt @ ?? (@ASlavitt) August 15, 2020
SalivaDirect received approval this morning from the @US_FDA.
This could be one the first major game changers in fighting the pandemic. Rarely am I this enthusiastic. Here’s why.
Follow if interested.
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