The U.S. Food and Drug Administration is under fire for setting what critics say are near-impossible standards for quick, at-home Covid-19 tests that could provide a breakthrough in stemming the spread of the virus.
The rapid home tests are not as accurate as the common lab tests done now, but can usually detect when an individual has enough of the virus to be contagious. Perhaps most importantly, experts say, the rapid tests could be mass-produced cheaply, allowing many people to test themselves frequently and get results in minutes, before venturing out to schools and workplaces.

A line of motorists waiting for Covid-19 testing in Michigan. (Michigan National Guard/Creative Commons)
Officials and public health experts, including White House advisors Dr. Anthony Fauci and Dr. Deborah Birx, have supported the development of rapid tests that can be conducted either at home or in places like schools, offices, pharmacies and nursing homes. Last week, a bipartisan group of governors from Maryland, Louisiana, Virginia, Massachusetts, Michigan, and Ohio announced they were teaming up with the Rockefeller Foundation to scale up to 30 million tests per week with the rapid tests.
Most of the rapid home tests look for a virus protein called an antigen, instead of replicating virus DNA like the standard lab test that can take several days to report results. These lab tests are highly sensitive, and can detect even a small amount of the virus—but are expensive and time-consuming, requiring labs and technicians. Rapid at-home antigen tests would allow individuals to spit in a tube and wait just 15 or 20 minutes for a result.
Two companies have so far received FDA approval for faster tests, though these still require machine readers to be interpreted. So far, however, no tests have been approved for at-home use, and a growing number of critics say the FDA has put up hurdles to approval that have delayed their wide availability.
After months of vocal, high-level support for cheap, accessible tests, the FDA announced on July 29 that it would consider authorizing rapid home tests, acknowledging that they could be “a game changer.” But it required these tests to be at least 90% as accurate as the standard lab tests, and also include a means to report results to public health agencies.

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“Pretty much what they have done is taken five steps backwards towards the use of these as a public health tool,” Michael Mina, a Harvard University epidemiologist and immunologist, said in a conference call with reporters.
“The FDA has put two daggers in the heart of this test, unless they change their diagnostic guidelines for home testing,” said Laurence Kotlikoff, an Boston University economist who has written extensively on the issue, including a New York Times op-ed co-authored with Mina.
An FDA official, who would not speak if identified, said the agency based its requirements on various factors, including lessons learned from testing during the swine flu pandemic in 2009. But the official acknowledged expert opinion is evolving, and said the agency is open to alternative proposals, including people taking and repeating less-sensitive tests over a period of days.
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The problem, critics argue, comes with viewing rapid tests as primarily diagnostic tools for individuals, instead of as public health tools that can help on a larger scale. Because public health officials lack the means to know in real time who has the virus and can give it to others, they say, even a lower-sensitivity test could provide a significant benefit.
Antigen tests in particular are considered highly effective at detecting virus positives, but less accurate when they show negative results. Rapid test advocates say that a 50 to 60 percent accuracy rate would still be useful.
“If it means we could even just catch 50% of people that are transmissible we would immediately drop incidents across the whole population and that makes everyone safer,” Mina said.
According to Kotlikoff, “For the purpose of finding if you yourself have just become infected and need to be on top of this, that’s fine, PCR’s [the lab test is] better than anything. If we’re trying to protect the whole country, this is not what we need.”
Creating an at-home rapid test that is 90% as accurate as a standard lab test, “is like comparing apples to oranges,” said Bobby Brooke Herrera, co-founder and CEO of biotech company E25Bio, which has developed two rapid antigen tests. He said the FDA accuracy requirement has added months to development.
“We’ve had a test on our laboratory benches that should have been distributed with FDA approval back in April,” he said. “It’s the frequency and coverage that matters more so than sensitivity.”
And for biotech firms to ensure results are reported to health agencies, Kotlikoff said, “requires basically setting up a software company”—which could make the test much more expensive and hard to make widely available.
“Imagine how much a pregnancy test would cost if it had to be connected to the Department of Health,” said Mina. “It has to come with a WiFi signal.”
The requirements have created a dampening effect on biotech companies and the development of the tests in general, Kotlikoff says.
“They’re all scared to death of the FDA,” he said. “They don’t want to have a black stain from the FDA because it says their tests are insensitive.”
While Herrera said his team at E25Bio is still attempting to meet requirements and polish its application for approval while “also trying to educate many people in the FDA,” other biotech companies developing rapid home tests were more cautious in their remarks.
“We’re all trying to get to a point of confidence to say that less sensitivity is OK,” Rahul Dhanda, co-founder and CEO of Sherlock Biosciences, especially given that at-home testing is even more effective at detecting a contagious case of coronavirus when done daily.
Dhanda’s company is developing quick tests for homes and other non-lab settings that don’t look for antigens, but use gene editing and synthetic biology technology to detect the virus at the molecular level.
Another company, Quidel, which has developed a rapid antigen test for use in hospitals and doctors’ offices that was approved by the FDA—and is in talks with the group of six governors—said through a spokesperson that it has “no information on future self-testing product development at this time.”
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What do we need to know to stop the spread of the deadly COVID-19 virus? We need to know who is infectious.
Precisely because the PCR test is so sensitive that it picks up traces of the virus before and after the victim’s infectious period, the PRC test cannot give us the needed information – and when the result arrives in an untimely manner, it’s meaningless in any case.
An antigen test that is cheap, easy to use at home every single day to trace the user’s infectious state is perfect. When the user is infectious, he stays home. When he’s not, he goes out to meet the world.
Further, because the infectious period may actually be much shorter than the time he feels sick, once the test tells him he is no longer infectious, he can go about his business.
The test can be used not only at home, but also by employers to test employees, by nursing homes, by schools, etc. It can return us to our world and restore our economy.
Keep the PRC test in hospitals and doctors’ offices for onsite immediate use.
And put the at-home antigen test to work- now and start saving lives.
What are we waiting for?
New to your site- thanx to Michael Connolly’s book. Has there been any investigation into the questionable results of COVID-19 & Rapid tests? The numbers in Florida supposedly been proven that in many areas of the state all results come back positive; not one negative result; and now I find it even more unbelievable that suddenly children, who were reported to be fairly immune to the virus for the past 5 months, are suddenly testing positive when the schools are trying to reopen.
I know I am not alone in believing that all figures are over- inflated politically. Can someone prove it?
https://youtu.be/qKM4MIrfr4k
It is a concept that is not that difficult to comprehend, even for FDA lawyers. It is wrong to measure sensitivity comparing it with the PCR test. PCR test is so sensitive that it detects numbers of virus well below the number when people are infectious. PCR test therefore is misleading when it comes to finding people who can infect others: it is too sensitive. This home test is almost hundred percent sensitive for very high numbers, for people who are infectious, with many millions of the virus copies in the sample. Lawyers in FDA still don’t want to comprehend this simple notion and compare it with PCR test. That failure of understanding of simple scientific principles is why FDA has failed us since February. FDA should be fired and replaced with people who understand science. They allowed too many people to die. And yet still as of today that test still not allowed by FDA. All of us should contact their representatives, media, and governors today. We should have done it in February.