First at-home rapid COVID-19 test gets emergency use OK

Critic says it’s the wrong test for the times

BOSTON — With COVID-19 testing sites across the country swamped, including a site at the TJX building in Framingham, it is a solution that seems to have come at exactly the right time. But one critic suggests the FDA’s emergency authorization of the first at-home rapid COVID-19 testing kit brings to the market a clunky version of what’s really needed.

“This is not really the test we need,” said Dr. Michael Mina of Harvard’s School of Public Health. “The test is a very expensive test. It’s an extremely manufactured test. It’s a test that simply cannot scale.”

The test, made by California start-up Lucira Health, will retail for about $50. It contains an electronic base into which the nasal swab sample is inserted. The company was not available Wednesday to talk about their product.

Dr. Mina is all for home testing, but he said it would have been better to approve the kind of home tests already in use in other countries: simple strips that can be mass-produced for little money.

“Slovakia’s doing it at a massive scale, they’re trying to test around half their population, once a week, which is essentially what I’ve been calling for,” Dr. Mina said. “And within a week, truly within a week, they stopped their virus from exponentially growing on a country level.”

As it is, Dr. Mina doesn’t think Lucira can ramp up production sufficiently for significant quantities to be available by spring. And even when tests are available, consumers face an obstacle.

“It still requires a doctor’s note, a doctor’s prescription,” Dr. Mina said. “Why, why, in the middle of November does anyone need a doctor’s prescription to get a COVID test?”

>>>MORE: More than 100 Mass. schools to try COVID-19 rapid-testing program

Clearly, many this November are looking to get COVID-19 tests in Massachusetts. Public health officials fear some may be trying to ‘test’ their way to a safe Thanksgiving gathering.

The problem is, COVID-19 tests examine only a point in time. And with so much COVID-19 around, a negative result one day could mean nothing the next if, for example, someone were to subsequently gather in a group or be part of a crowd.

And not every test is equal. PCR tests take a day or two to come back, but are considered highly accurate. Rapid antigen tests were never designed to pick up infections in asymptomatic people who could still be transmitting virus, said Dr. George Abraham, the Chief of Medicine at St. Vincent Hospital in Worcester; so, they can give false negatives.

“Even with the PCR test, that would only tell us that, at that point in time, we don’t have infection but in no way predicts that down the road we won’t get it,” Dr. Abraham said. “In other words, a day later, two days later, three days later we have no guarantees that we will not get an infection.”

At St. Vincent, Dr. Abraham and other staffers put together a public service announcement to dissuade residents from organizing large gatherings during the holidays. It urges use of technology to virtually link families.

“You can set a time for everyone to connect and all households can eat dinner at the same time from your respective locations,” suggested one participant.

Dr. Abraham and others in the medical community suspect some will ignore such advice and travel anyway. That could result in major issues next month.

“The reality is we are expecting to see a surge post-holiday,” Dr. Abraham said. “So the first couple of weeks of December we may see an increase.”

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