August 18, 2019 – To perceive the strength of rapid and affordable testing to expand the COVID-19 epidemic in the United States, look no further than the existing home pregnancy test.
During a pregnancy test, you urinate on a cartridge that contains a strip of paper towels. This paper is coated with tiny Y-shaped antibodies that recognize and adhere to a hormone produced by pregnant women. In a life-changing chemical drama, if the hormone is detected, the band adjusts the color.
A new batch of COVID-19 tests in progression necessarily uses the same technology. If deployed broadly and frequently, some experts say, they can simply replace the pandemic course, even before there is a vaccine.
“We have a viable solution today,” says Michael Mina, MD, PhD, a diagnostic expert at Harvard University’s Center for Communicable Disease Dynamics.
Mina says that with enough government investment, that is, billions of dollars to be on the same scale as investment in vaccines or economic stimulus, millions of such tests can simply be published and distributed to each and every One of the Americans at a cost of about $1 according to test. Array thinks that if each and every one won a box of 50 tests and they made one every day, “how they put on their touch lenses,” america could see its epidemic disappear. Mina says she’s helping some of the corporations that expand immediate evidence, but has no monetary interest in any of them.
“If everyone does, or even an undeniable majority of people do, then the vast majority of transmission and those epidemics will be avoided in a matter of weeks. We don’t have to wait for a vaccine,” he said in a recent call with reporters.
A user spits on a test strip or mixes their saliva with a little saline and applies it to a strip of paper. As the solution is sucked through the paper towel, it flows against antibodies that recognize and attach to an express part of the virus that causes COVID-19. If the virus is provided in giant amounts, which is also the case of a user who is contagious to the maximum, the antibodies stick to it and cause a check indicator to replace the color.
No painful smears on the nose. No doctor visits or a site. And, above all, without long waits to get results.
When a user waits days for COVID-19 results, retention makes verification unnecessary for the pandemic.
Here’s why speed counts: when a virus invades the frame, it hijacks our cells and turns them into miniature virus factories. Very quickly, its production this way, so that in a few days, the picture will be complete copies of the COVID-19 virus.
After reading the dynamics of COVID-19 disease transmission in recent months, researchers now that a person’s viral load, i.e. the number of copies of the virus within its framework, is probably the highest at the time of birth of the infection, birth per day. two before the onset of symptoms, if they show symptoms. This is when they are best able to spread the disease.
To spread COVID-19, inflamed Americans must be discovered and removed at the same time that their viral load reaches or approaches this peak, and ideally, before they have the chance to infect another person.
If a user has to wait four or five days or even a week to recover the effects of their tests, they don’t get the effects temporarily enough to act accordingly. They don’t know they’ll have to stay home and restrict their contact with others. Public fitness staff do not receive an alert in time to touch and warn others who may have been infected.
Infected young people infect their peers and teachers. Workers take the virus to their offices. The spread of the virus continues.
A recent study published in The Lancet Public Health found that once the effects of control are delayed by more than 3 days, even the best contact search formula prevents the epidemic from spreading. The same study found that with a more moderate delay of 2 days in control effects, it needs a quick and complete touch to decrease transmission of the virus. This is something america’s high doesn’t have right now.
That’s why Microsoft founder Bill Gates recently told CNN that the U.S. check formula provides “the maximum effects of any country in the world.”
Many corporations have the immediate testing in development. Mina says she has some of her products on her desk.
These come with giant corporations like 3M, which he announced in a July 14 press release that he is running with scientists from the Massachusetts Institute of Technology to expand an immediate test. They also earned $500,000 in investment from an accelerator program of generation from the National Institutes of Health to help them boost their marketing.
There are also smaller corporations in the mix: E25Bio and Sherlock Biosciences, which are located in Cambridge, MA.
The Sherlock test, called INSPECTR, was developed at Harvard Wyss High School. The company says it expects to have it on the market during the first part of 2021.
All companies have a ready-to-use edition of those tests. The problem, Mina says, is that those tests are accurate enough to get the fda’s soft green.
The firm says over-the-counter diagnostic controls deserve to be sensitive enough to detect nine out of 10 people more inflamed with the virus that causes COVID-19. If a doctor has prescribed the check, you will need to be sensitive enough to report the positive effects of 8 out of ten people inflamed. The FDA’s needs for prescription checks through doctors are less stringent than for over-the-counter options. The firm believes that since doctors will interpret the effects of the controls, they will most likely know when they will want to re-verify the effects opposed to popular control sent to a lab for analysis.
To keep the value of fast home tests low, you’ll need to use easily available basic fabrics. Because they use low-quality fabrics, testing is not as effective at detecting other people with COVID-19 when the virus point in their frame is low. When the virus grades in the frame are higher, the tests are more accurate, Mina says.
This may not be the kind of control a doctor might need during flu season to find out why a person’s fever and pains, he says, however, those controls can also be just pandemic control paints because they locate other people. directly to the point that they are maximum likely to transmit the infection to another person.
Mina says the U.S. wants a new regulatory design that allows for cheaper, faster testing as a public fitness equipment than diagnostics.
“I think we’ve lost our minds in relation to this genuine analytical sensibility,” Mina said in a recent episode of the this Week in Virology podcast.
“We are so focused on expensive, high-end controls that we don’t review them because we focus on clinical quality controls.”
Mina estimates that, given that COVID-19 controls in the U.S. They want to be consulted by a doctor or sent to a lab for results, we will probably only detect about 5% of other people when they actively spread the infection. He thinks that if other people simply did a checkup each and every day or every day, at home, we could reach 85% of other people before they spread their disease.
“Maybe we just want a shit check if it’s reasonable enough to use it very often,” he says.
Other experts agree with him.
“I think it’s a very, very smart idea,” says Arthur Caplan, PhD, director of the Medical Ethics Division at Langone Medical Center at New York University. “We are sinking under the weight of approved testing. We don’t have enough evidence. They’re too slow. Chemicals are depleted. Return times are too long and not working.”
Caplan says he recently consulted through a Seattle school formula that he needs to check for quick tests like this with his students.
“It’s time to move on to a formula that, less accurate and more error-prone, may still provide us with data that would be useful, that is, useful and affordable. They also deserve to add, especially if you do, you know, over a period of time. long was time, ” he says.
But the FDA is convinced.
“When evaluating the known and potential benefits and dangers of a check, the FDA considers the probability of a false result and the result of a false result. For example, a false result in a circle of close family members for over-the-counter monitoring is not mitigated by seeing a fitness care professional who takes into account other symptoms and symptoms and would possibly advise the person based on the medical judgment of the fitness care professional. As such, for example, a user with a false negative result in an over-the-counter diagnostic control would probably be less likely to be quarantined despite the symptoms, which would put other members of the network at risk,” the signature said in an emailed statement.
They are the only ones beyond this approach.
Peter Lurie, MD, is the president of the Center for Science in the Public Interest. Prior to this position, he was the FDA’s Associate Commissioner for Public Health Strategy.
He thinks it may be disastrous for the FDA to reduce its testing accuracy standards.
Lurie states that even very accurate verification can provide a higher percentage of results. In fact, the functionality of the control is based not only on the characteristics of the control, but also on the extent of a disease within a population.
Let’s say you have a control with a sensitivity of 95% and a specificity of 95%. In medical terms, the sensitivity of control is the ability of a control to trip over a user who actually has the disease. Control specificity is the ability of control to exclude others who are not infected.
This means that 95% of the time, the check detects others with COVID-19 and identifies others who are not inflamed 95% of the time. This is quite reliable, but in a population where only 5% of other people are inflamed, this can be a problem.
Here’s why: let’s say you have a population of a hundred people. Five of them have COVID-19. If you give a check with a 95% sensitivity to the hundred people, you’ll probably stumble across the five genuine positives, which is excellent. But with a specificity of 95%, the check will also make some mistakes.
From another hundred people who take it, 5%, or five other people, will get a false positive result. A false positive is when the check indicates they have an infection, but this is not the case. In this example, some of the positive effects (five out of 10 positive effects in total) returned through verification would be false. Such verification can generate 50,000 false positives consistent with the day for every million people who delight in it. There would be an equally giant number of other people who would get false negative effects.
And the maximum home tests lately to achieve this level of sensitivity and specificity of 95%.
“The functionality of the maximum home controls was well below the 80% threshold,” Admiral Brett Giroir, MD, undersecretary of fitness at the U.S. Department of Health and Human Services, said in a statement to WebMD. Giroir is also the tsar of COVID-19 control.
Lurie emphasizes that all of these positives undergo additional control, the slowest type that is sent to a lab, to verify their results.
“It turns out it creates a lot of extra work,” he says. “You’re going to spend a lot of time chasing your tail.”
Lurie says he’s also involved with the anxiety those false positives would create on other people before they can be corrected. And there is a danger that other people will act on the basis of false information: go checkered when they think they are negative, for example.
“An unfunded check is anything with an insignificant result,” he says.
And then the precedent I’d set. Lurie believes that if the FDA relaxes its criteria to fit a type of test, the market may be flooded with low-quality testing.
“If you allow testing in the market with poor functionality features, it’s an incentive for other people to be smart because the incentive is for brands to be smart enough to reach the market,” he says.
Lurie says this has already happened with the antibody tests. The FDA narrowed its criteria to allow brands to bring their tests to market faster, and many of them didn’t work. The firm has now disposed of more than a hundred of those market tests.
“It will be the wild west of other people with very bad evidence. That’s what’s happening,” he says.
At a press conference on 16 May, the Director-General of the World Health Organization warned that without an effective vaccine, there is a way to prevent the spread of COVID-19.
“You can’t fight a blindfolded chimney. And we prevent this pandemic if we don’t know who’s infected,” Tedros Adhanom Ghebreyesus said. “We have an undeniable message for all countries: test, test, test.”
From the outset, the United States has struggled to provide an effective testing program. Mina believes rapid testing can give Americans a way back to a more general life.
It recognizes that such prompt and reasonable evidence may simply be wrong. A lot. But the tests would also catch many more people and detect them while they are contagious. And he says there are tactics for this kind of test.
On the one hand, we want to advise others to treat the effects as preliminary, “just as we treat HIV control. We won’t tell all those other people who are HIV positive after a fast HIV test “We do a confirmation check first.”
Mina says this is a smart explanation for why to allow various types of immediate verification to be put on the market. Because they all work in a slightly different way, they may be exchanged with each other. “Maybe their bodies will produce proteins that stick to control in a way that makes them positive,” Mina says. “So what someone can do is open their 30-check package that they gave you at the pharmacy, and with those checks, there would be five confirmation checks,” he says.
Other experts think it can work.
“These tests just want to be smart enough to trip over other people with many viruses and identify other people with the maximum threat of transmitting the infection, so they don’t want to be perfect. They just have to be pretty smart,” Isaac says. Bogoch, MD, which specializes in infectious diseases at the Research Institute at Toronto General Hospital and the University of Toronto.
And that means some of the checks will be wrong. People will miss and other people will get positive effects when they are not infected. Bogoch says this kind of control will force us to think a little more about the effects and what to do with them.
“Like other things, if those types of tests are going to be incorporated into real-world contexts, we want to think about smart systems and smart protocols about how to do it properly,” he says.
Michael Mina, MD, PhD, Assistant Professor, Departments of Epidemiology, Immunology and Infectious Diseases, Harvard T. H. Chan School of Public Health; Associate Medical Director in Clinical Microbiology, Department of Pathology, Brigham and Women’s Hospital, Boston, MA
Arthur Caplan, PhD, Director, Division of Medical Ethics, Langone Medical Center, NYU
Peter Lurie, MD, President, Center for Public Interest Science, Washington, D.C.
Isaac Bogoch, MD, clinical researcher, Toronto General Hospital Research Institute and University of Toronto, Toronto, Canada
Tedros Adhanom Ghebreyesus, Director-General, World Health Organization, Geneva, Switzerland
3M, Press Release, 14 July 2020
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