When Patrick Sullivan, the founder and chief executive of the Hawaii technology company Oceanit, spoke to the Honolulu City Council last week, a big part of the presentation focused on a strategy for protecting the public from COVID-19 that’s picking up steam.
The approach might be called “The Fast and the Frequent.” The idea: to use a lot of rapid-results, cheap and easy-to-use tests as an initial screening in settings where people congregate, like a school, workplace or care home. The tests are cheap enough that they can be taken frequently.
Oceanit has one such test in the works. It’s called the ASSURE-19 test. It involves spitting in a cup, then applying the spit to a plastic device that looks a bit like a home pregnancy test. Results come in about 10 minutes.
“We’re going to live with the virus for a while, until everybody is vaccinated,” Sullivan said. “That’s just the state of the world.”
And the company’s fast spit test could help people live with it more safely. Sullivan is pushing something he calls “The Aloha Protocol” for tourists: a fast-action, self-administered test taken for the first six days people are here.
Workplaces or schools could use the tests to sustain COVID-free bubbles, he says. People who test positive in the morning would stay home and follow-up with a standard test administered by a professional.
Lt. Gov. Josh Green, a medical doctor who is helping lead the state’s response, agrees – but with caveats.
Green said rapid, frequent tests — not just Oceanit’s but others already on the market — could be useful as a complement to the more sensitive tests that are the gold standard for COVID-19. He also said they will not replace tools like masks and social distancing.
Part of the appeal of the fast tests is that they are inexpensive, he said, but they’re not a panacea.
“As I often say, when it comes to health care, you get what you pay for,” he said.
The fast-and-frequent strategy is gaining traction partly because federal regulators are fast-tracking approvals for the tests.
For example, Abbott’s fast-action test, called the BinaxNOW COVID-19 Ag Card, has gotten emergency use approval from the FDA. The company touts the $5 test as “a rapid, reliable, highly portable, and affordable tool for detecting active coronavirus infections at massive scale.”
Tests like Abbott’s are called antigen tests.
They’re different from other fast, saliva-based tests that also have gotten emergency approval from the FDA, along with widespread publicity, even in the sports pages. Used by NBA teams, and developed at universities like Rutgers and Yale – the basketball players union helped pay to develop the tests – the saliva tests are sensitive enough to detect minute amounts of the virus’ RNA sequence.
These are called reverse transcriptase-polymerase chain reaction tests. Scientists also call them PCR tests. It’s the same type of testing done in hospitals and labs requiring a long swab stuck way up into the patient’s sinus cavity.
While PCR tests are considered the gold standard, they take time to get results back and are expensive enough that most people can’t use them very often, unless you’re maybe an NBA player. The take-at-home saliva PCR test developed by Rutgers, for example, costs individual consumers $150 and gets results back in 24 to 48 hours, ESPN reported. Given the costs, it wouldn’t make sense for most people to take such a test every day before going to work.
Antigen tests are faster and cheaper. Most use nasal swabs, but don’t have to be shoved as far up the nose as standard PCR tests, so they’re easier to administer. They detect antigens, which are substances the body creates to help fight the virus.
The Oceanit test uses yet another technology: chemically engineered molecules to detect the virus. But the resulting application is the same, a test that’s easy enough to do at home, and cheap enough to do frequently.
Even proponents of these alternative tests acknowledge that they’re not as sensitive as PCR tests. But the argument is that the alternatives are accurate enough if used daily or every other day. And the tests are cheap enough to do that.
Although the tests can produce false negatives, indicating the person is not infected when they actually are carrying the virus, advocates of fast testing say the issue is not whether the person is carrying some amount of the virus but whether they are contagious.
For example, Dr. Michael Mina, a professor at Harvard’s school of public health who is a leading proponent of the fast and frequent strategy, says that the rapid antigen tests are more than adequate because they’re sensitive enough to detect when a person has enough of the virus to shed it to other people.
What’s more, proponents like Mina say, the fast, cheap tests are even better because the PCR tests can show people testing positive even when the amount of virus in their bodies is so low that they aren’t contagious.
Sullivan says the same principle applies to Oceanit’s spit test. He said there’s a problem with a test that shows someone is positive when they have no symptoms and such as a small amount of the virus that it can’t be spread.
“I call that a false positive,” he said.
It might be a question of when, not if, fast and frequent testing will become widespread for certain situations.
The New York Times recently published an article quoting a dozen scientists skeptical of the whole fast and frequent strategy. Among other things, the article noted, there’s not yet an at-home fast antigen test on the market.
But even some skeptics agreed the tests could be useful in certain situations, like group settings such as schools, universities and workplaces.
The CDC also says the tests can be a good screening tool in group settings.
“Rapid antigen tests can be used for screening testing in high-risk congregate settings in which repeat testing could quickly identify persons with a SARS-CoV-2 infection to inform infection prevention and control measures, thus preventing transmission,” the center says. “In this case, there may be value in providing immediate results with antigen tests even though they may have lower sensitivity than RT-PCR tests, especially in settings where a rapid turnaround time is required.”
But when Hawaii will start using the tests on a large scale isn’t clear. Green notes that private parties, such as companies, could already use FDA-approved tests like Abbott’s test to screen employees, the same as NBA teams.
Green said as more rapid tests are approved, there will be more options, and he said there is a committee continually assessing available tests to see what’s appropriate to use, and how. The idea of “serial tests every 24 or 48 hours” could be a viable solution for places like fire stations and schools.
Sullivan said he’s discussed a deal with the state to provide 400,000 ASSURE-19 tests in exchange for $10 million in seed money to set up a manufacturing facility in Hawaii. That cost, $25 per test, is much more than the $5 for Abbott’s test. But Sullivan said the price will come down as the company scales up production.
According to Sullivan, for its investment of federal CARES Act money, the state would get 400,000 rapid-action tests and 50 new jobs, many suitable for displaced hospitality workers, and a medical manufacturing facility in the state.
“If we’re going to build a diverse economy, then we’ve got to do things like this,” he said.
Sullivan could not say for sure when the product will be approved, but he said he’s certain that’s a question of when not if. He said it’s best to get started standing up a manufacturing facility sooner rather than later, even as it’s going through testing needed to get approvals.
“All of these things take time,” he said. “It doesn’t happen overnight.”
Sullivan said shipping costs shouldn’t be much of a barrier. A single test, he said, weighs about the same as a coffee bean, one of the state’s top cash crops.
“It’s mostly paper and plastic and a whole lot of science and chemistry,” he said.
Getting the state to commit to buy a test that doesn’t have regulatory approval is another issue. Sullivan said he had met with Gov. David Ige, but the governor wanted approvals first. Ige’s spokeswoman said she couldn’t comment on Sullivan’s account.
Sullivan said he could understand the governor being reluctant to commit $10 million in taxpayer money to something that hadn’t been approved. But Sullivan said the state should also weigh the costs and benefits and not be afraid to act.
“To start with, people are just nervous and don’t want to make a bad decision,” he said. “Sometimes not making a decision is a way to cope with that.”
From the state’s view, Green said, it’s a matter of making sure the tests are approved by the FDA and accurate enough to use for particular situations.
“As these things improve, we want to quickly be able to strike,” he said.
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