A North Attleborough medical facility is offering coronavirus testing that in some cases can yield results in about 15 minutes, the chief executive officer said Thursday.
“We’re just trying to do our part,” said Dr. Ryan Welter, CEO of Tristan Medical North Attleborough, where dozens of people are being tested daily.
Asked if the rapid test had been approved by the FDA, Welter said his company is using a Hangzhou AllTest Biotech Co. product for the tests. The FDA website lists the Hangzhou product among a number of offerings from commercial manufacturers and labs whose tests have not been reviewed by the agency.
“The FDA has not reviewed the validation of tests offered by these developers ... and is including this list here to provide transparency regarding the notifications submitted to FDA," the agency website says.
The agency says it “does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories” of such tests “where the test has been validated” and notification has been provided to FDA. The Hangzhou company has notified the agency that it has validated its testing product and is offering the tests, according to the FDA site.
Welter entered into a voluntary agreement not to practice medicine in Massachusetts last May, according to the state Board of Registration in Medicine. He said Thursday that he’s not administering tests himself at Tristan Medical.
At the time he entered into the deal with the state, the Taunton Daily Gazette reported that the agreement was described as “non-disciplinary” in nature. Welter declined to discuss the agreement in detail Thursday since the matter is still pending.
He said Tristan Medical is offering two types of coronavirus tests. The first is the traditional nasal swab test, which delivers results within a day or two. Because there’s a shortage of traditional nasal swab tests available, Welter said, his company is reserving them for patients who are symptomatic and who have had exposure to COVID-19.
But there’s a second group of patients, he said, who can take the rapid test, which delivers results in about 15 minutes by drawing blood from a finger prick. These are people, he said, who have had community exposure and show mild symptoms such as a cough that could be attributed to allergies, or who had symptoms previously.
A negative reading on the rapid test shows the patient doesn’t have antibodies the body produces to fight COVID-19, after contracting the virus.
“The only problem with this test is that it’s not specific enough to tell us that they absolutely are negative to COVID," Welter said in a recent Facebook video. "Because they could still be in that early phase or not amounted enough antibody resistance to show up positive on this test. So a negative test cannot completely rule out COVID."
However, Welter said in the video, the test can be repeated in four to seven days.
“And if you’re asymptomatic and re-check, and again if you’re not positive again ... then that would be a very strong presumed negative,” he said. “Again, the problem is, we can definitely tell if you are positive, but we can’t 100 percent tell if you’re negative with this test. So it does have some limitations, but it does tell us a lot of valuable information."
He said if a patient with symptoms reads negative on the rapid test, they’re then given the traditional nasal swab to determine definitively whether they have COVID. If a patient without symptoms or a “suggestive history” of infection reads negative, Welter said, they’re asked to come back in a few days and repeat testing.
He said by phone that anyone seeking a test must first call the company for a pre-screening to determine whether they should take the traditional nasal swab test or rapid test. Then they drive to the facility, Welter said, and patients getting the nasal swab can have it done from their vehicle. Patients getting the rapid blood test have it done in a tent on the grounds of the facility.
Staff administering tests are equipped with personal protective gear including N95 masks, goggles, gloves and gowns, Welter said, and billing is currently being done the traditional way through patients’ insurance and any applicable co-pays.
Insurers haven’t yet provided a way to facilitate the free testing that President Trump has called for, Welter said, but “if there’s a reimbursement” coming to patients with out-of-pocket expenses, they’ll receive it at a later date.
“This has been a great benefit, I think, to the community,” he said of the testing.
Travis Andersen can be reached at travis.andersen@globe.com.