For months ago, US public health experts asked the federal government to approve and fund inexpensive and quick home tests of Covid-19 to help control the spread of the infection. But when the Biden government this week announced a $ 231.8 million deal to increase production from the first test entirely at home, the experts’ response was, to say the least, unenthusiastic. One dismissed it as “saliva in the ocean.”
It’s not that the home test with a 15 minute response time is not a good idea, they said, it’s just that the launch of this starter kit is too small and too late, and the test too expensive and complicated to help extinguish the violent pandemic fire. Several experts asked the Biden administration to subsidize home testing for consumers, and said the Food and Drug Administration needs to do more to make these tests widely available.
Covid’s first completely over-the-counter test, a rapid antigen test produced by Australian company Ellume, received an emergency use authorization in December. On Monday, the government said it would provide funding to build a factory in the United States that will eventually run millions of tests every month, but will take time to expand.
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“Making testing easier for all Americans is a high priority with obvious benefits,” said Andy Slavitt, senior adviser to the White House to Covid-19’s response, at a news conference where the deal was announced.
A year after the virus arrived in the United States, Covid testing remains difficult to do for many Americans, with tests restricted to doctors’ offices and other settings administered by healthcare professionals. For many, waiting for results takes days, which is very slow to detect active and contagious infections, especially in asymptomatic people who may have been exposed to someone with an infection.
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It is an ongoing disaster fueled, critics say, by the Trump administration’s failure earlier last year to develop and implement a national testing strategy. While the government has spent billions to develop, buy and distribute free of charge the most promising vaccines, the tests have largely been passed on to the private sector, which has developed hundreds of different tests, many of them put to use without government verification.
Even with the launch of mass vaccines, easy and affordable testing, along with the use of a mask, will continue to be key components to curb the spread of infection, said Atul Gawande, surgeon, professor at the Harvard School of Public Health TH Chan and former Covid Advisor -19 to the Biden transition team. Although he said that the deal with Ellume is a good step, technology and price barriers mean that it is not enough.
Gawande said the new government has committed to a national testing strategy, which is important. The challenge now is to publicize the tests to the public and communicate the importance of regular testing.
“We came back repeatedly, the most powerful tool in the public health grant is communications,” said Gawande. “When we had inconsistent communications from the top, a lack of commitment to widespread testing, even [President Trump] discouraging the test, it’s no surprise that we’re where we are. “
This week’s news is unlikely to change much, at least immediately. The Ellume agreement will send 100,000 test kits to US families each month from February to July and will eventually increase production to 19 million tests per month.
In January, about 1.8 to 2 million Covid tests were performed every day in the United States. The testing scenario is a mix of PCR tests, which show high accuracy rates, but generally take longer to generate results, and rapid antigen tests that have been shown to be less accurate but provide quick responses. Public health experts say many of the tests are reactive – used to help diagnose individuals who have possible symptoms or may have been exposed to the virus – rather than being widely implanted 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, assistant professor of epidemiology at the Harvard School of Public Health TH Chan, is among the loudest voices calling for federal funding and distribution of cheap and fast strip test antigens as a means of controlling the pandemic. In an ideal world, Mina said, every American could test for Covid twice a week at home, with supplies paid for and distributed by the federal government.
Mina and others said they were concerned about the fairness of Ellume’s test. It costs $ 30, too expensive for most Americans to have regular home exams. And the test is linked to a smartphone app that requires some technology knowledge and steps that Mina and others said added difficulty and confusion for most potential users. The test kit transmits the results to users through the app and transmits the data to local public health agencies to allow tracking of case and contact counts.
“It is not going to be an effective tool to really stop the spread,” said Mina. “I see this decision as more of an attempt to put the cards on the table”, signaling that the administration is “willing to support rapid testing and at home”.
Mina said widespread home testing would help keep the spread of the virus under control. Even assuming that a fraction of the results are inaccurate, he said, frequent, free tests detect undetected infections and help people make informed choices about their behavior. Ellume sent 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 provide a small percentage of false-positive readings when patients are not really infected, or false-negative results when they do have Covid. He warned that for patients without symptoms, the positive results must be confirmed by further testing and that the negative results do not prevent an infection.
Eric Topol, president 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 testing, it will do nothing to address the inequality of the testing landscape.
“It is a waste of money. It’s throwing money away, ”he said.
The Ellume test is a good test, he added, but it is not what Americans need now, which is a free, very basic and easy to use home test. He called the number of tests that Ellume will provide “saliva 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 is approved for use from 2 years onwards.”
Other tests have received emergency FDA approval, but LabCorp’s Abbott, Pixel, and BinaxNOW home antigen tests, both of which are increasing production, still require telemedicine consultations. Mina said that adding technology and medical involvement further slows down the process in what should be an easy, inexpensive and affordable test for all Americans. Critics say the FDA must act quickly to grant emergency clearance for cheap and fast strip tests.
Gawande criticized the agency’s approach to regulating home antigen testing, saying that it should consider approving low-sensitivity tests with faster response times to encourage the production of easy and inexpensive tests – even if they may pass some infections.
“When the FDA wants to encourage certain types of testing resources, it can do that,” he said. “At the moment, it is still in the individual diagnostic approach.”
A senior FDA official said that home testing will play an important role in responding to the pandemic. 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 companies to develop them and apply for regulatory approval.
There are tradeoffs between test performance and speed when comparing rapid home tests with PCR tests done under medical supervision, said Shuren, noting that the FDA has set slightly lower precision limits for rapid tests. Home tests “will play an increasingly important role,” he added. “In part, this will be about production.”
This story is part of a project funded by the NIHCM Foundation. The foundation played no role in reporting, editing or presenting this work.