BOSTON — It was an idea born from the federal government’s initial breakdown on COVID-19 testing — and during a time when lockdowns were the norm.
Home test kits for the coronavirus were introduced last winter. But sales of the products were halted in March after the Food and Drug Administration warned consumers about “unauthorized” home-test products.
A month later, the FDA authorized the sale of the first home-collection test kit under an Emergency Use Authorization. Since then, several others have come on the market in the same manner.
All of are approved for use only in symptomatic patients who first must pass a symptom questionnaire on the test company website. If they do, a company physician ultimately decides whether enough evidence of infection exists to overnight a test kit.
"It provides a really convenient way that you can test and feel safe about testing," said Peter Foley, CEO of LetsGetChecked, which markets a kit using a nasal swab. "It's a nice, gentle, non-invasive process."
Foley presses a swab against the first inch or so of his nose to demonstrate how little penetration is needed to get a decent sample of the virus.
"It's a very straightforward process," he said. "It goes back into a small vial. In the vial we've got a deactivating buffer which actually kills the virus, which means that it's much safer for transport."
The sample is sent back to the company's lab in California, where it is processed within 24 to 48 hours.
"We did over 250,000 tests in July alone and it's continuing to grow at an exceptional rate," Foley said -- somewhat of a surprise, since there is an up-front out-of-pocket cost for at-home Covid tests ranging from $109 to $155. (The companies do expect health insurance plans will reimburse those costs.)
In Massachusetts, some COVID testing -- even for asymptomatic residents -- is free. And insurance companies generally cover tests for those with symptoms.
But Foley said much of what's fueling at-home testing is fear of infection at test sites. "It provides a really convenient way that you can test and feel safe by testing," he said. "I think that would probably be the primary driver for doing a home test. It's to cut down on potential exposure."
A home test from hims & hers uses a sample of saliva instead of a nasal swab. Basically, consumers spit into a vial, said company medical director, Dr. Patrick Carroll. He calls this sampling approach more customer-friendly than using a nasal swab. “Which is a tricky test to do,” he said.
Turnaround time on the saliva test can be up to five days, Carroll said.
“Our customers want something they can do at home... on their own schedule... and access a provider quickly,” he said, noting that a physician gets back with hims & hers customers within two hours.
One issue, yet to be resolved with home COVID testing, is patient limitations.
"If you're only having symptoms it does limit the number of customers qualifying for the test," Carroll said. "And I think the concern among physicians and epidemiologists is 20 to 40 percent of folks with the virus actually are asymptomatic. So there is some concern that we're missing asymptomatic patients in the testing because they don't qualify under the Emergency Use Authorization."
Carroll thinks that may change.
“I am sure the FDA is reviewing that,” he said. “I could see in the future that that may be opened up for asymptomatic folks. But for today we follow strictly to the guidelines that Rutgers (co-developer of the test) has received from the FDA.”
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