Rapid testing of coronavirus at home can help control the next epidemic in the US. U. S. , if corporations approaching testing can convince regulators that the public can accept them as true to use them correctly.
Many corporations compete to be the first to market a check that Americans can buy without a prescription with effects delivered in minutes by the bed or at the breakfast table. This can allow others to be screened before going to the workplace or school. , relieving tension in overloaded control laboratories and temporarily identifying new infections.
But considerations about test reliability, how consumers might react to their results, and how public fitness will monitor them have slowed their development.
Companies conducting such tests say they would possibly not seek emergency approval from the Food and Drug Administration until the end of this year or early next year, in the component because the company needs them so that adults of other ages, schooling and English professing can effectively use their products.
Public fitness experts say FDA caution is justified because unreliable or unusable verification can help spread the virus. There is also a threat that many others will interpret a negative result as a transparent outcome; In authenticity, even the most productive control will produce false negatives. And even a genuine negative does not guarantee that a user will rarely find the same in the early stages of infection.
“If it were a disease that only affected the individual, then it wouldn’t be a challenge,” said Georges Benjamin, executive director of the American Public Health Association. “The challenge is that there will be a cohort of other people who take the test, find out that they will most likely give negative results, but that is not the case, and they will infect other people. “
A false negative result can be simply harmful if “other people use it to go to parties,” said Heather Pierce, senior director of scientific policy at the Association of American Medical Colleges. “It has inflamed other people who feel they have been passported so that they have no interaction in the other public fitness measures we want to eliminate the virus. “
False positives are also a cause for concern, as some others may isolate themselves for up to two weeks, without paintings or without a school for no reason. But that threat can be reduced by follow-up laboratory tests, and alleviate the possibility of home testing to prevent the spread of Covid-19, Tsar Brett Giroir said.
There is little precedent for the detection of infectious diseases at home. The FDA has approved only one of these HIV tests, manufactured through OraSure Technologies, which requires follow-up through a fitness service provider. a quarter of a century of debate about the dangers posed by false negatives of HIV testing at home and whether users would get an appropriate recommendation on their results.
Still, FDA officials are keen for corporations to market Covid-19 tests at home, as they can help expand testing and shut down chains of transmission.
“We haven’t won a presentation for internal control, whether molecular or antigen, that we can’t even take a look at,” FDA diagnostic director Tim Stenzel said last Wednesday. “I’ve let them know that I’d be very interested in getting a smart review of the house as soon as possible. “
The firm said in July that any home check can diagnose at least 90% of infections in others with and without symptoms, and have a false positive rate of 1% or less. Companies will also have to go to regulators that others will be able to control themselves, without the help of a fitness professional, and provide consumers with transparent data on when and how to interpret controls.
Mark McClellan, former FDA commissioner George W. Bush, said the agency’s criteria would be “really difficult” to meet for brands in a single-use test.
But the firm told corporations that their accuracy criteria were a starting point. FDA officials have stated that they are open to approval of checks that meet the 90% detection threshold if check marks expand their strategies, such as repeated detection over an era of time. mitigating any accuracy.
The FDA’s willingness to be flexible is welcome, but not enough, says Michael Mina, epidemiologist at Harvard’s THChan School of Public Health and one of the leading advocates of common and immediate testing. Minina says home coronavirus tests will be used for surveillance, to stumble upon new infection equipment; however, other people don’t just rely on those tests to make medical decisions.
“We want the FDA to start thinking a little bit about how those tests are evaluated,” Mina said. “We continue to see that the FDA approves the tests only through a clinical diagnostic lens. “
He said the positive effects of home checks will show through an instant check that uses another technique to detect the virus: eliminating the threat of false positives that can erode public trust in home checks.
Another challenge for check developers is how to make home detection effects successful in state and local fitness services.
According to Mara Aspinall, a professor of biomedical diagnostics at Arizona State University, automatic electronic communication of the effects to the government of physical fitness during a home screening is ideal. “We want to focus as temporarily as possible on this interconnectivity so that we can get an accurate count of the positive and negative effects of those controls,” he said.
But while the FDA needs the effects of home checks to be easily reported, it does not require corporations conducting such checks to create automated systems to do so. “We know that there are internal and point-of-service check-in developers looking to integrate those reporting capabilities, and that’s their choice,” a firm official told POLITICO.
If home tests become widespread and effects are controlled, they may hinder the country’s fight against coronavirus, said Peter Lurie, president of the Center for Public Interest Science and a former FDA associate.
“If you become a major player in the market and we don’t have a concept of results, I think it can be a problem,” Lurie said.
If the FDA grants emergency approval to a home check that does not have an automated formula for reporting results, the federal government deserves to launch a public data crusade to inspire voluntary reporting to public fitness authorities, said Marcus Plescia, the leading medical officer of the Association of State and Territory Health Officials.
“We want to go beyond the FDA’s duty to factor regulations and the manufacturer’s duty to have written commands and warnings for the customer,” he said. “You want to be more proactive and have interaction with the public. “
Reeve Benaron, executive director of Intrivo Diagnostics, who distributes an immediate Covid-19 check that requires a prescription, said the FDA faces a complicated balancing exercise by setting its regulatory threshold, but believes that diagnostic corporations will succeed in the agency’s established standard.
“I think they’ll start seeing [the house tests allowed] next year,” Benaron said. “This calendar year will be difficult. We want very high quality testing. There has to be quality because when faced with a diagnosis, it’s life and death. “
But even if housing tests are widely available, they will be a panacea, APHA Benjamin warned.
“We want to start sending messages now that dressing up in a mask, washing your hands and social esttachment is the procedure we’ll go through in the next few years,” he said. “Our lives will be back to the way they used to be. “