Much remains unknown about the novel coronavirus that has so far killed more than 238,000 people in the U.S., including 17,000 in Florida. But by now, we do know that the virus spreads through respiratory droplets from an infected person's nose or mouth when they talk, cough, or sneeze.
With that in mind, UM researchers recruited more than 1,000 subjects to take part in a pilot program that could help make COVID screening faster for the public and cheaper for labs to process. Last month, UM became the first college in the nation to participate in the clinical research study.
The new test works something like a breathalyzer test, but instead of measuring blood-alcohol levels, it determines whether someone has contracted a potentially deadly contagion. One of the doctors leading the study, Roy Weiss, calls the new method a potential "game changer."
Weiss' team will forward its findings in the coming weeks to BioSafety Technologies, which is collecting data from other pilot test sites. If the results show promise, it's possible the new testing method might obtain emergency-use authorization from the U.S. Food and Drug Administration for use across the nation, he says.
Right now, Weiss tells New Times, the gold standard for COVID testing is the PCR (polymerase chain reaction) test, which detects the RNA and nucleic acid of the virus in a sample. That's the method that involves the so-called brain swab that's likely the most invasive and uncomfortable way to test.
"So now comes along the need for a test that would be very sensitive and specific, very rapid in terms of being able to give you on the spot — not in five minutes, not in thirty minutes, but in one minute — the ability to say whether or not you're likely to have the virus," says Weiss, who also is a professor and chairs UM's Department of Medicine. "And be, at the same time, economically feasible and cheap."
A standard PCR test costs the government upward of $130 to process in a laboratory and usually takes between one to three days to produce a result, Weiss says. The new breath test will cost, on average, $4 — the cost of the tube you blow into — and deliver a result in minutes.
"It's not a nasal swab, it's not saliva, but it's actually measuring whether there are any viral particles that are being spewed out during your exhalation," Weiss says.
At the university's Coral Gables campus, Weiss and his team collected over 1,000 samples from trial participants. Students and staff at UM's Coral Gables and Virginia Key campuses already are required to be tested for COVID every two weeks. Weiss says students "love the idea" of the noninvasive test.
"They don't like having anything stuck up their nose. So just taking three breaths into a tube? That's a piece of cake, and can be done very quickly," he says.
Weiss adds that the breath test would be ideal for on-campus events that draw a high volume of students, like a Hurricanes game.
"This would be something that we could have stationed in front of the football stadium," Weiss says. "So in order to see whether or not it's OK to go in and be an observer in the game, you blow in, and one minute later the test result is there in front of you, and you can get a green light and go."
That idea assumes the study will demonstrate that the test is effective and its results reliable. Weiss' team has yet to reach any conclusions one way or the other, he says. Now that enough samples have been collected from the participants in the blind study, Weiss and his team will sit down with the data to formulate their report for the FDA. Weiss says it's not immediately clear when the findings can be peer-reviewed.
"We hope this will move very quickly," he says. "We don't know what the results of the study will show, but assuming the results are positive, we would hope that within a month or so there should be emergency-use authorization permitted."