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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“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 in a statement. The agency has previously authorized four other tests that use saliva for sampling, but these yielded varying results.

The authorization occurs amid ongoing disarray over Covid-19 testing. The U.S. has been plagued by an inconsistent strategy for detecting the virus, thanks in part to persistent shortages and the use of a variety of different tests that have sometimes yielded unreliable results.

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The inability to quickly and efficiently test Americans has, in turn, made it much harder for government officials and the medical community to accurately assess and predict the path of the virus. For this reason, the FDA move was greeted with enthusiasm by some public health experts, who have bemoaned the ongoing spread of Covid-19.

“This could be one the first major game changers in fighting the pandemic,” tweeted Andy Slavitt, a former acting administrator of the Centers for Medicare and Medicaid Services in the Obama administration, who expects testing capacity to be expanded significantly. “Rarely am I this enthusiastic… They are turning testing from a bespoke suit to a low-cost commodity.”

Yale’s saliva-based test also skirts a step that other Covid-19 tests require: extracting the virus’s genetic material. Extraction kits are one of many components of the existing diagnostic tests that have faced shortages. Supply issues have limited testing capacity overall, as well as slowed how quickly results can be returned.

“Widespread testing is critical for our control efforts,” Yale researcher Nathan Grubaugh said in a statement. Grubaugh added: “If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine.”

The research team validated SalivaDirect in part by testing NBA players, coaches, and staff, and Yale said the test is now being studied in asymptomatic people through the program with the NBA and its players union.

    • To: Zaccchaeus
      The NBA was involved in the study, so probably a big media draw. The night before during a PBS interview, NBA manager? mentioned something of the sort being in the works during an interview.

    • NBA participation in the trial makes it of wide public interest. The night before the news release, their General Manager? was interviewed on PBS/NewsHour and mentioned something in the works of benefit to players.

  • I have bad nose bleeds I’m afraid of taking the COVID test in the nose but want to take the salvia test is the test in Charlotte, nC

  • 1. It has not been demonstrated that we can do testing by saliva. There are sensitivity and reproducibility issues that need to be addressed. 2. Rapid turnaround for schools means testing can’t be mailed. 3. Given the recent attempts to kneecap the postal service, this is dubious at best. 4. Taking a test then partying while waiting for results defeats the purpose of the test! If a person is identified as positive later, the virus is going to be spread while waiting/partying.

    • SalivaDirect demonstrated well-enough to pass muster under the rule change. The change was necessary to increase the spread of testing. It will get the sickies out of circulation faster and slow the spread more quickly. There are drawbacks to all new developments. Onward.

  • If we’re able to do a Salva testing,
    why can’t some of the kits be mailed.
    We send a colon test by mail. This way we can cover more ground. You want a test right away, go to testing site. If your one who is willing to wait
    for results as you party , do it that way. At least they took a test. Label special tubes, which contains where you can be reach.

  • As an owner of a senior housing facility. This would sure help me. The facility is in Pocatello, Id when can I expect to be able to start testing my employees with this method. Thanks

  • Wake up!! Get real! The diagnostics industry has worked on such projects for years. EUA for unvalidated products as such should NOT be allowed. Such hype only adds to the dysfunction.

  • Briefly:
    1) Ms Potter, rapidtests.org is an interesting concept- it is not a test. I hope someone gets this approach built and approved, but there are no reported at-home saliva tests with immediate reporting which have even been submitted for FDA analysis.
    2) The reported testing “breakthrough” in the article above boils down to saliva test vs nasal swab. Both require a lab to evaluate which is THE bottleneck.
    Too much hype IMHO

  • The one of greatest interest is a rapid-result — estimated 15 mins. — saliva test. No labs involved! It analyzes saliva on a paper-strip to indicate contagion —
    i. e. positive or negative and that’s it! Up to the user to act responsibly, self-quarantine, call a doctor, and take the more definitive PCR swab-type tests that measure viral load, etc. important for tracing/tracking use. Here’s a link for the nitty-gritty: rapidtests.org. Estimated cost $1-$5. And FYI, Covid-19 exposure trackers have been added to our cell phones. Found it in my Android under Google settings; considering whether to activate it for the common good. Sure would’ve appreciated a by-your-leave. Understand that new phones will just be active; no choice. Brave New World.

    • To Edward Fotsch:The SalivaDirect product is on the market thanks to a rule change allowing it to pass FDA muster. The rapidtests.org site promotes an at-home test based on research done at Harvard and the U. of Colorado. Several articles are posted there and two non peer-reviewed papers. Primary investigator is Michael Mina. Unlike SalivaDirect, this test likely wouldn’t be approved even under the relaxed rules, thus reluctance to seek it. For obvious reasons, the argument is for further relaxation, thus your reaction that there is TMH; not so IMHO. Today I will seek an app in my area that tracks Covid exposure and turn it on and encourage others to do the same.

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