But so far he’s been happy with the progress. On Wednesday, his team hauled the equipment to his 11-year-old son’s school, where a group of 28 teachers and staff volunteered to come in to try out the tests—a trial run for what a school reopening might look like. Surveillance testing, O’Connor notes, will work only if the virus is largely brought under control first. It’s designed to catch asymptomatic people before they spark new outbreaks, not stop those that are already raging.
Right now, Wisconsin is in a gray area. A month ago, schools seemed poised to reopen in the fall, but with cases now spiking again, the outlook is uncertain. “The ideal thing would be to have kids here safely. But some of that is out of my control, because it’s a community function,” says Andy Wright, principal of the Eagle School, where O’Connor’s son is a student. “Can I push it further than other places if we have testing like this? I think I can, and I think parents and teachers would feel much safer.” Ideally, O’Connor would test the kids too, if they can get approval from both parents and the University of Wisconsin’s research board. (Kids, he notes, bring their own challenges to saliva-based sampling.)
In the end, the primary barrier for surveillance testing is not likely to be technological, or a matter of getting supplies. (The biggest challenge O’Connor has had obtaining materials, he says, is getting ahold of Lysol to wipe the outsides of the saliva vials.) It’s regulatory and logistical. The key benefit of LAMP—that the recipe is modular and easily adapted to different settings—puts it at a potential disadvantage with regulators. While the Food and Drug Administration has approved some so-called point-of-care tests for Covid-19, they’re typically well-packaged: They run on proprietary machines, usually found only in hospitals, and rely on single-use cartridges that cost as much as $40. So far, the FDA has authorized LAMP-based tests as well as Crispr-based tests, which layer the gene editing technology on top of LAMP procedures to improve the specificity of the test, but only within the context of certified labs.
“In practice, it’s going to be very, very difficult to conform to the current regulatory standards,” O’Connor says. One strategy would involve seeking clinical certification for a mobile lab that could provide diagnoses using a standardized set of instruments and procedures. Another would involve testing that does not involve a diagnosis but serves instead as screening for who should get a PCR test for the final word. But neither case has a clear regulatory framework to follow. “We need this to be part of a coordinated organized response,” he says. “I don’t believe we lack the logistical wherewithal to develop a plan for a test where you spit into a tube and you heat it up and wait for an hour. I could train my 11-year-old to do this in a day.”
For now, the experiments in Madison and Racine are being done as research; the teams will generate data to validate the tests, not provide diagnoses. But in practice, they’ll offer a form of screening. In Racine, if a sample turns yellow—positive—Kriegel calls the person at work and tells them they have a result of “potential clinical significance.” She asks them to come back to the Annex as soon as possible for a nasal swab, which the firefighters perform and then ship off to a lab in Chicago for PCR analysis, to confirm the result. Some people take the news in stride. One worker arrived in fretful tears. “That’s the whole challenge,” Kriegel says. “How do you do this kind of testing without making people constantly fearful?”
But Wolf, the fire chief, says he sees signs that the city is getting more comfortable. Word is getting around, and more volunteers among the city staff are showing up to be tested; Mason’s hope is to open the tests to Racine’s 77,000 residents soon, if they can sort the logistics and funding. In the meantime, Wolf and his crew are trying to get better at their pipetting—and at assuaging the public’s fears. “I just try to reassure them: Wear a mask, isolate as best they can,” he says. “If they’re careful around others, everyone will be OK.”
Updated Friday, July 24 1pm ET to correct the temperature at which LAMP reactions occur. It is 65 degrees Celsius, not 95.
More From WIRED on Covid-19
Source: A Wisconsin City Experiments With a Faster, DIY Covid-19 Test
By Gregory Barber
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