F.For months, U.S. public health experts have been calling on the federal government to approve and fund low-cost and rapid Covid-19 home tests to help control the spread of the infection. But when the Biden administration announced a $ 231.8 million deal this week to ramp up production of the first full home test, the response from the experts was unenthusiastic, to say the least. One of them dismissed it as “a spit in the ocean”.
It’s not that home testing with a 15-minute turnaround time isn’t a good idea, they said, it’s just that the rollout of this first kit is too little and too late, and the test too expensive and complicated for the raging pandemic fire. A number of experts called on Biden’s administration to subsidize the home test for consumers, saying the Food and Drug Administration needs to do more to make such tests widely available.
The first fully over-the-counter Covid test, a rapid antigen test from Australian company Ellume, was licensed for emergency use in December. On Monday, the government said it would provide funding to build a plant in the US that will eventually run millions of tests each month, but it will take time to scale up.
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“Making easier tests available to every American is a high priority with clear benefits,” Andy Slavitt, senior White House adviser on Covid-19 response, said at a news conference where the deal was announced.
A year after the virus hit the United States, Covid tests remain difficult for many Americans to come by, with tests limited to doctor’s offices and other settings staffed by health professionals. For many, waiting for results takes days, which is too slow to catch active, contagious infections, especially in asymptomatic people who may have been exposed to someone with an infection.
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Critics say it is an ongoing debacle fueled by the Trump administration’s failure early last year to develop and implement a national testing strategy. While the government spent billions to develop, purchase and distribute the most promising vaccines for free, testing was largely turned over to the private sector, which developed hundreds of different tests, many of which were put into use without government control.
Even with massive vaccine rollouts, easy, accessible testing, along with the use of masks, will remain important components to curb the spread of infection, said Atul Gawande, a surgeon, professor at Harvard TH Chan School of Public Health, and former Covid. -19 advisor to the Biden transition team. While he said the Ellume deal is a good move, technology and price barriers mean it’s not enough.
Gawande said the new government has committed to a national testing strategy, which is important. Now the challenge is to bring tests to the public and communicate the importance of regular tests.
“We come back time and again to the most powerful tool in the public health bag is communication,” said Gawande. “If we’ve had inconsistent communication from the top, even a lack of commitment to widespread testing [President Trump] testing is discouraging, it’s no surprise that we are where we are. “
This week’s news probably won’t change much right away. The deal with Ellume will ship 100,000 test kits per month to US households from February to July, eventually scaling production to 19 million tests per month.
In January, approximately 1.8 million to 2 million Covid tests were conducted daily in the United States. The test landscape is a mix of PCR tests, which have high accuracy but often take longer to generate results, and fast antigen tests that have been shown to be less accurate but give fast answers. Public health experts say too many of the tests are reactive – used to help diagnose individuals who have potential symptoms or who may have been exposed to the virus – rather than being widely used to prevent spread and protect the general public. That’s where the call for cheap home tests comes in.
Dom Smith for STAT
Michael Mina, an assistant professor of epidemiology at Harvard TH Chan School of Public Health, is one of the loudest voices calling for federal funding and distribution of cheap, high-speed antigen tests on paper strips as a means of controlling the pandemic. In an ideal world, Mina said, every American could test for Covid at home twice a week, with supplies paid for and distributed by the federal government.
Mina and others said they were concerned about the fairness of the Ellume test. It costs $ 30, far too expensive for most Americans to screen regularly at home. And the test is tied to a smartphone app that requires some technical knowledge and steps that Mina and others say are more difficult and confusing for most potential users. The test kit sends results to users through the app and sends data to local public health authorities to track the number of cases and contacts.
“It’s not going to be an effective tool to really stop the spread,” Mina said. “I see this decision more as laying the cards on the table,” indicating that the administration is “willing to support rapid tests and home tests.”
Mina said large-scale home tests would help control the spread of the virus. Even if a fraction of the results are inaccurate, he says, frequent, free tests will detect undetected infections and help people make informed choices about their behavior. Ellume submitted data to the FDA describing the test as 95% accurate. In its approval, the agency warned that, as with all antigen tests, the test can give a small percentage of false positive results when patients are actually uninfected, or false negative results when they actually have Covid. It cautioned that for patients without symptoms, positive results should be confirmed by further testing and that negative results do not rule out infection.
Eric Topol, chairman of innovative medicine at Scripps Research, said the government’s deal with Ellume will make a “zero” difference and without the government subsidizing the cost of tests, it will do nothing to resolve the inequality of the testing landscape .
‘It’s a waste of money. It’s throwing money away, ”he said.
The Ellume test is a good test, he added, but it’s not what Americans need right now, which is free, very simple, easy-to-use home tests. He cited the number of tests that will give Ellume “a spit in the ocean.”
Ellume said in a statement that his home test is “a critical part of the US COVID-19 response because it is the only rapid test currently approved for asymptomatic use, and it is approved for use in children as young as 2 years old.”
Other tests have been approved by the FDA, but LabCorp’s Pixel and Abbott’s BinaxNOW home antigen tests, both of which ramp up production, still require telemedicine consultation. Mina said adding technology and doctor involvement further slows the process in what should be easy, inexpensive, and accessible testing for all Americans. Critics say the FDA must act quickly to grant emergency authorization for low-cost, high-speed tests on paper strips.
Gawande was critical of the agency’s approach to regulating home antigen testing and said it should consider approving tests with lower sensitivity and faster turnaround times to encourage the production of low-cost, easy-to-use tests – even though they may be missing some infections.
“When the FDA wants to encourage certain types of testing opportunities, it has been able to do so,” he said. “At the moment it is still in the individual diagnostic approach.”
A senior FDA official said home tests will play an important role in the pandemic response. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, told STAT in an interview that the agency sees a greater role for home testing in the future, but it is up to the companies to develop them and seek regulatory approval. ask.
There are tradeoffs between test performance and speed when comparing the rapid home tests with PCR tests performed under medical supervision, Shuren said, noting that the FDA has set slightly lower accuracy thresholds for the rapid tests. Home testing “will play an increasingly important role,” he added. “In part, that comes down to production.”
This story is part of a project funded by the NIHCM Foundation. The foundation played no role in the reporting, editing or presentation of this work.