A: It’s called SalivaDirect, and it was developed by researchers at the Yale School of Public Health with funding from the NBA. And it’s good news!
On Saturday, the FDA granted an Emergency Use Authorization (EUA) for the new test, which has some distinct advantages over the more common PCR (polymerase chain reaction) tests currently in use:
1. It requires only a saliva sample (no nasal swab!) and readily-available lab supplies and equipment (no scarce reagents or fancy proprietary machines!).
2. Labs can run the test quickly and at high volumes — that translates to faster turnaround times for results.
3. Testing materials cost only about $4-5 per test, suggesting a likely consumer price of around $10 — way less than the $100 and up that most PCR tests cost now.
How does the test achieve all this? Unlike PCR, the SalivaDirect test doesn’t have to extract RNA from virus particles. The catch? The saliva test is much less *sensitive.* That’s epidemiology speak for how well a test does at identifying positive cases. Yes, this means that a SalivaDirect test has a higher chance of a giving a “false negative” result, meaning the test says you don’t have COVID-19 even when you do.
Nathan Grubaugh, one of the Yale researchers who led the development of the test, thinks that tradeoff is worth making. A cheap, easy, rapid test allows for widespread and frequent testing, an approach called “surveillance testing.” Even with a lower sensitivity test, surveillance testing can pick up most of the contagious cases in a community quickly enough to isolate cases and prevent further disease spread.
And the NBA connection? The NBA and the National Basketball Players Union invested about $500,000 in the development of the test, after hearing about promising preliminary results earlier in the year. The league was so eager to have a cheap, rapid testing option for players that they were willing to support diagnostics research.
Neither Yale, the NBA, or the players union plan to earn royalties from the sale or licensing of the testing technology, and Yale will make the testing protocol freely available to interested labs.
Grubagh’s lab appropriately named the testing project SWISH: the Surveillance with Improved Screening and Health study.
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