A Harvard professor who has been an outspoken advocate for cheap, rapid, at-home coronavirus testing hailed a new test that will be sold over the counter and can provide results to the user in about 15 minutes.
The new test, made by Australian company Ellume, is a “major boon,” said Dr. Michael Mina, a professor at the T.H. Chan School of Public Health. Mina is among a group of experts who have argued that at-home testing could offer a way out of the pandemic.
“An over-the-counter rapid test is a tremendous advance. It means that some people will have ready access to a much needed test to help know their status, without having to go through a physician,” Mina said Tuesday in a statement.
But he also said he had reservations. He noted that the test, which involves a nasal swab, processing fluid, and a small electronic analyzer that sends test results to a person’s smartphone, will cost about $30 for one use.
“This is not the public health screening device I have been discussing,” said Mina, who has advocated for simple, low-cost paper strip testing that would be as easy to conduct as pregnancy tests are.
He noted that the US Food and Drug Administration recently approved over-the-counter sale of another coronavirus test, though that test requires the person to send the sample to a lab for testing. He called for more over-the-counter approvals, but at the same time expressed concerns that if the tests are approved, the “rich and powerful” would hoard them. He said on Twitter Tuesday he would keep pushing for cheaper tests.
Thanks Michael - we understand access to rapid #hometesting is a critical component of the #pandemic response & want to be part of the solution.— Ellume (@EllumeHealth) December 16, 2020
Home testing reduces the strain on #pointofcare settings and lowers the #risk of infecting others while seeking testing.
The FDA on Tuesday issued an emergency authorization for the Ellume test. It can be taken by people as young as 2, and it is authorized for people with or without symptoms.
The test requires people to swab their noses, place the swab in processing fluid, and then put five drops of the fluid into the analyzer, which does the test and sends the results to the smartphone.
Ellume chief executive Sean Parsons told 7News Australia, “The objective is to test and screen as many people in the population as possible to decrease the transmission of COVID while we’re looking to vaccinate the population.”
The test detects bits of coronavirus proteins called antigens. It’s slightly less accurate than gold standard laboratory tests designed to look for coronavirus genetic material with a technique called polymerase chain reaction, or PCR. But in a clinical study of nearly 200 people, Ellume’s product was able to detect 95 percent of the coronavirus infections found by PCR, regardless of whether the infected people felt sick. It also correctly identified 97 percent of the people who received negative laboratory test results.
Ellume, which was awarded a $30 million grant from the National Institutes of Health, said it planned to manufacture and deliver about 20 million of the tests to the United States within the first half of 2021.
In a statement, FDA Commissioner Stephen Hahn called Ellume’s authorization “a major milestone in diagnostic testing for COVID-19” in light of the coronavirus’s persistent grip on the nation. The product will be available in drugstores, Hahn noted, and gives Americans “more testing options from the comfort and safety of their own homes.”
Other experts also hailed the Ellume test -- and the prospect of other tests eventually entering the market.
“It’s a big deal, and a huge step for efforts to take back control from the virus,” Mara Aspinall, a biomedical diagnostics professor at Arizona State University, told the Washington Post.
She said questions remain about how much of a difference it would make unless it’s available in large quantities, and how to prevent people and companies from hoarding such a test.
Susan Butler-Wu, a clinical microbiologist at the University of Southern California’s Keck School of Medicine, told The New York Times the test’s price tag and limited availability will likely restrict it from very frequent use. But in single-use contexts, “what’s really exciting is, it allows me to get a really quick answer if I’m feeling unwell. To me, that’s the most powerful thing.”
Tests that cost $5 or $10 “are possible and coming, and I’d love to see them, because you need both a low price point so lots of people use it and you need plenty of production,” said Ashish Jha, dean of the Brown University School of Public Health.
Still, “we should have had this in May, June,” Jha told Bloomberg News. “We could have ended this pandemic in America. We could have brought this under control if we had decided to pick a different approach.”
Material from Globe wire services was used in this report.
Martin Finucane can be reached at firstname.lastname@example.org.