The Yale School of Public Health conducted its own study of 44 inpatients and 98 health-care workers and found that saliva samples taken from just inside the mouth provided greater detection and consistency than the nasal swab approach. The study also concluded there was less variability in results with the self-sample collection of saliva.
Two of the health-care workers had traces of the virus in the saliva test that did not show up in the test based on nasopharyngeal swabs. They were quarantined to avoid infecting others at the hospital. Yale is still awaiting an emergency use authorization from the FDA.
In another advantage, saliva tests bypass the need for one part of the supply chain that has caused so many bottlenecks during the pandemic. The Rutgers patients spit into a 2 milliliter cup that has already been manufactured. A chemical solution in the cup preserves the genetic material of the virus so it can be shipped to a laboratory for analysis.
“We scoured what was already commercially available so as not to create more problems,” Brooks said.
The drawback of saliva testing is that it depends on the untrained patient to administer, but Brooks said the challenges were no greater than in other testing devices.
Other entities working on saliva testing lag behind Rutgers, whose tests, like others, are reimbursed by the Centers for Medicare and Medicaid Services at $100 each. Darwin Biosciences, the start-up firm founded by professors from the University of Colorado at Boulder, has said it needs months to finish work and approvals for what they call the “SickStick.”
“Our device acts at the earliest stage of infection. It knows you’re sick before you do,” said Nicholas Meyerson, a scientist in the department of molecular, cellular and developmental biology and chief executive of Darwin Biosciences. But Meyerson told the university online publication CU Boulder Today that the group needs more time; its device might be helpful if a second wave of infections hits.
In Connecticut, another group called Homodeus has also been working on a saliva test that could be done as easily as a home pregnancy test. Jonathan Rothberg, one of the lead researchers, said the test could be made for a dollar or less and scaled into the millions. The goal would be to have results in half an hour, and an iPhone app would enable patients to analyze the data themselves, and then share that data widely and quickly in the event of a breakout.
“So you can spit into a tube. And get results. No lab. No technician. No expensive machines. No wait. The designer enzymes do all the work,” Rothberg said in an email last month. In a tweet this week, he said the company was still “preparing for validation studies for regulatory agencies.”
Rothberg remained optimistic, though. He recently tweeted that for less than going to the moon, America could go to work. And for less than they spend on 80 billion sodas, Americans could do universal testing.
“We’re looking for geniuses to come up with good solutions,” said Harlan Krumholz, a cardiology professor, and public health expert at Yale medical school. “They all need to be tested rigorously, but quickly. That’s the balance.”
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