Nearly 2 million new U.S. crowns confirmed Why are tests still not enough?

We need more testing to safely restore order, but there are still many obstacles. After weeks of social alienation, restrictions and segregation, the federal government and some state governments are gradually issuing guidelines for reopening and restoring normal order. Virus detection is a key part of that, and most experts say the U.S. is not doing enough. In fact, it is not enough.

When President Donald Trump just signed the latest relief bill, which allocates $25 billion for virus testing, there are still many obstacles that are preventing the United States from deploying the massive testing programs it needs. Shortages and shortages of supplies, for example, are still in short supply until at least $25 billion is allocated. In addition, there is no comprehensive country programme to distribute kits where they are most needed. This lack of planning can be traced back to the early days of the epidemic. At that time, systemic failure greatly delayed the introduction of virus testing kits, leaving the United States significantly behind other countries in its detection capabilities. For these reasons, the number of tests performed in the United States is stable at about 150,000 a day. Experts say we need more than a few times the amount of testing.

“Not only do we need to significantly increase the amount of tests, but we also need to improve the execution of tests so that you don’t have a kit but you don’t have a kit that you can’t do because you don’t have a swabs or a proper reagent bottle,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told reporters in late April. We’ve made progress and I believe we can do it, but it’s not enough now. “

So what else is to do to increase detection to the level that allows the U.S. to begin to ease social distances? The situation is complex. The available kits are not as reliable as you might think, and the laboratory capabilities for handling tests need to be increased. Most importantly, the United States needs more public health personnel to test and manage laboratories. Then, without a doubt, it would cost a lot of money. These things are not impossible tasks, but they are not easy.

What’s the matter with the detection of the new corona virus?

There are two types of neo-coronavirus detection: molecular detection and serum detection. Molecular testing can detect the presence of viral genetic material, indicating the presence of active infections. These tests require swabs to be collected from the nose and throat (although – the good news is – the FDA recently authorized the collection of samples through the nostrils, followed by a new method of using saliva only). )

Serum testing is the search in the blood for antibodies against the virus, and the presence of antibodies indicates that there has been an infection in the past. Although molecular testing of the new coronavirus was already common in early February, serotesting was not approved until April 1. Many see the test as a way to prove immunity to the virus, allowing those who test positive to return to normal life and avoid reinfection. Some countries have even issued “immune passes” to citizens who have tested positive on the basis of serum test results. But there are also problems with serum testing: experts caution that we are not sure whether these antibodies will cause immunity or how long they will last.

Nearly 2 million new U.S. crowns confirmed Why are tests still not enough?

Molecular detection

Nearly 2 million new U.S. crowns confirmed Why are tests still not enough?

Serum testing

“We don’t know if the existence of protests is related to immunity,” said Gary Procop, director of clinical virology at Cleveland and director of the American Institute of Clinical Pathology’s Institute of Science, Technology and Public Policy. “

He added: “People want to make a leap of faith, but I can’t.” We do not conduct serum testing for influenza and other respiratory viruses. So why do we think that the new coronavirus can be tested with serum? “

New coronavirus testing has been granted emergency authorization due to the long-running approval process by the U.S. Food and Drug Administration (FDA). As of 24 April, 59 molecular and 4 serum tests had been authorized for emergency use. Then, nearly 100 tests have not yet been authorized, but the FDA has allowed them to be used to complete more virus tests more quickly. In addition, the FDA grants some state health departments the right to approve tests without waiting or REQUIRing FDA authorization.

While it is certainly a good thing that testing is available, there are significant questions about the accuracy of some tests due to the lack of strict FDA oversight and the actual testing that is often required by the normal approval process. On April 2nd media reported that doctors had found only 70 per cent sensitivity in certain molecular tests, meaning that 30 per cent of patients tested false lyno. Over time, these data will improve. None of the tests are perfect, but ABC News reports that similar molecules for influenza are 90 to 95 percent sensitive.

Another problem is that not every lab can run all types of kits — in fact, the problem is serious. Therefore, even if the company has a spare kit, the lab that can run the kit may not have enough capacity, while other capable laboratories may not have the materials needed to run the kit. In the BBC’s words, it’s like expecting parts from a Chevrolet truck to be used on the Prius – how could it be!

In most cases, molecular testing must be performed in the laboratory. A simple description of the process is when a medical technician prepares a sample, runs it in a machine, and then manually reads and interprets the results. It takes hours for the machine to run the part alone. Coupled with the time it takes to send the kit to the lab, you may need one or two days to get the test results (which can be much less time if there is a lab on site). But if the lab has a large backlog of testing to do, the wait may be longer.

These factors make “Instant Detection” (POCT) particularly attractive. These operations can be done quickly in a matter of minutes at the place where the samples are collected – such as at the get-off test point or at the emergency center. Abbott Lab’s ID NOW machine can get positive results in five minutes, while Cepheid’s GeneXpert can get positive results in 45 minutes. Although these tests are also molecular tests, they are used in a different way than PCR tests performed in the laboratory. But the accuracy of instant detection is less accurate than the PCR test in the laboratory.

At a News Conference on March 29th, Mr. Trump introduced the ID NOW machine to the nation, showing the crowd the 6.6-pound machine. To apply the latest instant detection solutions to huge and complex global problems, the president called the test “a new game.” But the test also has some problems, such as accuracy and availability that are far below the government’s initial commitment.

Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said bluntly in a recent panel discussion on the Government Oversight Project: “These tests are doing terrible. “

In response, Abbott Labs told reporters that as of April 19, the company had distributed 600,000 kits, adding: “From the beginning, we knew what we could offer, and we made every promise.” “Currently, the company produces 50,000 kits a day, but the number of kits does not mean that tests can be run so many times. Since the machine can only do one test at a time, the immediate detection capability actually depends on the number of machines. (However, PCR testing in the lab, although long-running, can detect multiple samples at the same time.) There are currently 18,000 ID NOW machines in the United States, according to NPR. Cepheid says there are currently 23,000 GeneXpert machines worldwide. Therefore, it is simply not realistic to equip every workplace, school or airport entrance in the country with instant inspection machines, not to mention trained inspection staff in the necessary personal protective equipment.

Home testing may make things simple, but having untrained non-professionals collect samples and complete the testing process can create another set of problems. Many people can’t even wear masks properly. It’s a bit difficult to expect them to collect samples correctly, pack them, and send them back to the lab. For these reasons, the FDA has been slow to authorize any kit with home elements, and so far it has approved only one of those types. The test, called LabCorp COVID-19 RT-PCR, allows people to collect their own samples and send them back to the lab for processing.

“For all home testing, there will always be a problem with sample collection, ” Prokop said. ” …… It may be that some people collect only samples from the front of the nasal cavity, and this part of the virus is largely unviable, which may also reduce the sensitivity of the test. In most cases, however, that’s fine. “

Testing that can be done at home, without the need for trained clinicians or expensive laboratory equipment, sounds great. Some researchers believe they can achieve this goal. Technology Review at the Massachusetts Institute of Technology recently reported on the work researchers are doing to develop such tests. The virus is completely detected at home and has never been heard before. You can buy an HIV home test at a pharmacy, but the test can only detect antibodies and antigens. However, the formation of antibodies and antigens takes some time, so this test can miss early cases. And it’s been three decades since HIV was widely known to the FDA for approving the HIV home testing tool.

“I think we have a long way to go, ” Prokop said, referring to the possibility of a new coronavirus test entirely at home. “

Why is the Testing in the United States still not enough?

The widespread use of virus detection kits involves a very long process, and the development of virus diagnostic testing is only the first step in this process. After development, the kits will have to be manufactured, distributed and managed on a large scale as needed. Here are the implications of the delays we’ve seen and the lack of funding and guidance from the federal government.

Some of these problems are inevitable. For example, when the outbreak first broke out at the beginning of the year, the supply chain of kits to meet mass production was largely non-existent. As a result, many testing companies face shortages of materials ranging from swabs to reagents, the chemicals used in molecular testing to produce the reactions needed to detect viruses. The FDA is trying to help alleviate the material shortage by authorizing alternatives to other materials, but once again, there are few alternatives to samples collected, and the FDA can only remind you that its recommendations for alternative swabs are based only on limited available evidence.

Nearly 2 million new U.S. crowns confirmed Why are tests still not enough?

Laboratory scientists handle testing

Nearly 2 million new U.S. crowns confirmed Why are tests still not enough?

Testing material supply chain

Expanding the scale of reagent production is more complicated. These compounds include DNA composition, enzymes, and salt solutions.

“Very complex biochemistry,” Prokop said, “and, obviously, companies have to make these reagents in a specific environment… They must manufacture this particularly complex reagent in a very controllable manner. “

There are signs that testing capabilities are beginning to improve. According to the COVID tracking project, 311,000 tests were conducted on April 22. It was also the highest single-day test to date, double the average daily test in April. At that time, the average daily detection volume of about 150,000. That is, on April 23rd, the daily test volume dropped to about 190,000. So whether the U.S. can maintain such a high detection capability remains a question.

Quest Diagnostics, one of the largest Laboratory companies in the United States, told reporters that the company currently runs 50,000 diagnostic tests for the new coronavirus every day and has cleared the backlog of tests that have previously led to delays in testing.

“The lab’s capabilities meet demand,” Quest said. Our current configuration can theoretically cope with growing demand, depending on real demand growth. If additional capabilities are required, we may introduce testing capabilities from other laboratories or try other methods. “

The current testing needs may not actually be as high as experts believe can reduce the need to maintain social distance. To reach that goal, some programs say 1 to 2 million tests a day are required, and one even requires 100 million tests per day. Scott Gottlieb, the former FDA director of the Trump administration, has drawn up a plan for the American Enterprise Institute (AEI) to resume work. He says the shortage of materials is not easy to solve because most of the materialcomes come from other countries — but those countries do test sits themselves and need them — and manufacturers have to spend time configuring new sources in the United States:

“It’s going to be very difficult to get 2 to 3 million tests a week. We’ve leveraged the platforms we can, and now we’re relying on creating new platforms and supply chains to provide resources for those platforms. Our standby capacity is close to the upper limit. The question is, how quickly can Abbott and other companies develop new detection platforms? And how quickly can LabCorp and Quest expand new labs that didn’t exist before? “

Next, finding enough trained personnel to run laboratories and testing equipment is also a problem.

“If we’re going to double or triple our testing capabilities, we need to retrain our employees for those tests,” said Louise Serio, a spokeswoman for the American Clinical Laboratories Association (ACLA), which represents american commercial laboratories. In addition to having a high-throughput platform ( devices that can run multiple samples at a time), people are key to significantly improving detection capabilities. “

A medical laboratory scientist and training specialist told ACLA that she has been busy training medical technicians working in the molecular testing department.

But even if we manage to solve all supply, equipment and personnel problems, and can conduct a lot of virus testing so that the country can relax its social-away policies without endangering the health and safety of more people, we also face a daunting task: distributing kits to those who need them, and those who need them.

How does the U.S. do against other countries?

Until recently, the United States lagged behind many other countries in testing. Although President Trump said in early March that “anyone who wants to do it can do it,” that’s not the case. Mr. Trump also boasted that companies such as Google, Wal-Mart, Target, Walgreens, LedEade and CVS would work with the government to make testing easier, but the reality was far less than expected.

As of April 23, the United States has completed about 4.6 million virus tests, the current average daily detection of about 150,000. But detection rates have stagnated rather than steadily rising to the level seisparbes that experts expect. This may suggest that U.S. testing capabilities have peaked and that many regions are still unable to test, or that testing is limited to people who meet certain criteria.

There is also a problem with the way viruses are detected in the United States. Currently, the U.S. test positive rate (the percentage of all tests tested positive) is 20 percent, 10 times higher than in South Korea. William Hanage, an epidemiologist at Harvard University, told NPR that a positive rate of 10 percent or less is a good benchmark for appropriate testing. A higher positive rate, such as a 20 percent positive rate in the U.S., could mean that we only test people suspected of being infected with the virus, which means that many more people are not tested.

“The high positive rate of the new coronavirus test shows that our testing capacity is still too low,” Gottlieb said. “

So, before the U.S. was a big surprise in its testing capabilities, it’s now catching up with some countries. At present, our per capita test number is already higher than South Korea, you know that once, the United States once fell far behind South Korea. The United States and South Korea were almost all confirmed on January 21st, the first case of the new coronavirus. The initial response was not very different. But as South Korea rapidly improves its testing capabilities and effectively controls the spread of the virus, the U.S. side is wasting time refusing testing protocols from the World Health Organization (WHO) and insisting on developing its own kits through the CDC. At the same time, the Trump administration and some health agencies have repeatedly underestimated the threat posed by the new corona virus to the American public.

But the kits released by the CDC are defective. Also, only those who meet the strict testing requirements can do the test, and only a few CDC-licensed laboratories can run the testing program. It wasn’t until late February that the FDA allowed commercial laboratories to use their kits for virus testing, greatly expanding the nation’s testing capabilities. By this time, however, the virus had spread everywhere. By the end of March, South Korea’s per capita detection rate was six times that of the United States. Although much better than it was at the start, the U.S. still lags behind many countries in terms of per capita detection rates, including Germany, Canada, Spain and Italy.

“We’re not ready for this, as in other countries, where everyone can easily get a virus test,” Dr. Fauci said at a March 12 hearing. But the truth is we can’t do it yet. “

South Korea and Germany, by contrast, are well prepared. South Korea actively learns from the country’s mistakes in dealing with the Middle East Respiratory Syndrome (MERS) in 2015 and already has a better response mechanism, including a virus-contact track system that the U.S. public will not accept because of its privacy risks. Before the virus hit the country, Germany had taken the first step and prepared the kits it needed. As of 24 April, there were only 150,000 confirmed cases and 5,500 deaths in Germany. Germany and South Korea also have their own effective systems to track people infected with viruses and centralize public health care systems. None of these Americas.

The Population of the United States is several times that of Germany and South Korea combined, which is clearly compounding the shortage of testing and supply. This is a reason, but not sufficient. South Korea may have extra kits because it is providing some of them to the United States. Maryland’s Republican governor, Larry Hogan, struggled to get kits from U.S. suppliers, and eventually turned to South Korea to get half a million test kits (and later thanked the federal government for “generously” providing laboratories for testing). In mid-April, the Federal Emergency Management Agency (FEMA) purchased another 750,000 kits from South Korea.

Given all these problems, the U.S. still has a lower mortality rate than most European countries, including britain, Belgium, Spain, France and Italy. However, the premise is that the number of confirmed cases and deaths tracked and published in these countries is accurate. Because of previous media reports, the actual number of new coronavirus deaths worldwide may be far higher than the number of published cases, and the lack of testing makes it impossible to know exactly how many confirmed cases there are.

But while the United States is not the only country to suffer dire consequences for not adequately preparing and responding to a pandemic, the number of confirmed cases and deaths here is indeed higher than in any other country in the world.

Large-scale virus detection challenges that labs can’t solve: money

How many virus tests do we need to do? As mentioned above, the data given by different experts are quite different. The extreme approach requires a virus test every three to four days for the entire population of the United States to isolate patients before the virus begins to spread.

Most of the scenarios, however, suggest that millions of tests are performed every day. Dr. Brett Giroir, the Trump administration’s director of virus testing, called for lower projections for these programs, saying he thinks the nation’s roughly 4.5 million tests a month is enough. Meanwhile, Ashish Jha, director of the Harvard Institute for Global Health, told reporters that at least 152 tests per 100,000 people a day (three times the current average). A recent report by Harvard University, the Pandemic Resilience Program, states that by early June, there should be 5 million daily tests (to “safely reopen social activities”), and then by mid-July, 20 million tests a day should be conducted (to “fully restore economic activity”). Even so, the report notes, the test may not be enough.

However, experts also agree that while testing for viruses, you should not relax tracking of contact tracks, and that people should continue to maintain good hygiene habits, maintain social distance, and consciously isolate them if they are unwell.

So how do we scale from 150,000 tests per day to millions of tests per day? Why can’t we do that now? At the end of the day, it’s the money problem – it’s not just funding so patients can test. We’ve seen the government out of this part of the money. But the nation’s health-care system also needs money to cover huge upfront costs, such as the purchase of machinery, equipment, materials and personnel training.

“Everyone knows that virus detection is critical to us out of trouble, but there is a disconnect between the government’s willingness to invest in large commercial laboratories that test most viruses,” said Serio of ACLA. “

One thing to keep in mind is that a lot of this material is not used after the outbreak, so it’s a bad investment for the lab. Even the largest laboratories are under financial pressure. While large commercial laboratories can afford the extra cost of more machines, smaller commercial laboratories can’t. Although the demand for new coronavirus esmotests remains high, overall testing is actually decreasing, as non-emergency surgery or routine blood tests for annual medical examinations are cancelled. Quest recently granted 4,000 employees temporary leave and announced a pay cut in light of the overall reduction in testing.

So who should pay for this? We may wish to use ventilators as an example to illustrate this problem more intuitively. There is a similar dilemma for ventilators: hospitals can’t afford such expensive equipment, and after the outbreak, they don’t have as many ventilators. The federal government eventually spent $3 billion to buy hundreds of thousands of ventilators in the name of strategic national reserves and deploy them across the country as needed.

The Trump administration has been reluctant to pay for testing programs, even if the need for testing is greater than the need for ventilators. Mr. Trump himself came out against the idea of the federal government’s involvement in the testing program, calling it “absurd” and tweeting that “states” should be “responsible for virus detection in their states”! Earlier this month, the federal government stopped funding testing sites, saying they would be managed by the states themselves.

On the other hand, states have asked the federal government to fund their efforts to advance virus testing programs, including an open letter to Congress sent by the Governors Association of America on April 21. Most states have a need to balance their budgets, making it difficult or impossible for them to invest heavily in testing systems immediately, while the state’s tax revenues are significantly lower than expected because of suspensions in business activity, job losses and significantly lower-than-expected state tax revenues. But the federal government has never been able to make ends meet. So the U.S. national debt sipped upward.

But the good news is that the Centers for Medicare and Medicaid has raised reimbursements for new coronavirus tests from $51 to $100, hoping to encourage labs to invest in more testing by increasing subsidies for each test. The first relief bill, signed in March, pays for testing for patients without health insurance. The $25 billion relief bill for new coronavirus detection also covers programs to increase detection capabilities. Once the money is in place, the federal and state governments must decide how to use and distribute the money. How much money will actually go to the lab remains a question.

“ACLA urges the Department of Health and Human Services (HHS) to take the time to provide funding details on how to help the affected and high-risk populations, while increasing efforts to increase high-throughput testing nationwide,” ACLA President Julie Khani said in a statement. “

However, the $25 billion grant was not the original version of the relief package, but was added after a week of negotiations , which Democrats demanded and Republicans opposed. This shows that, given the federal government’s eagerness to resume economic activity throughout the country, it is difficult to secure the necessary funds to do these things safely.

The crux lies at the top. President Trump has said he would rather leave patients on cruise ships (though it could infect other passengers) rather than let them into the United States, as it would increase the number of confirmed cases of coronavirus. It has also been reported that the president is more concerned with reducing the number of publicly diagnosed cases than finding ways to actually reduce the number of infections. If so, mass testing is clearly not in the president’s best interest, even if it is in the best interests of his country.

The situation is difficult. After all this problems are encountered in the new coronavirus detection system in the United States , developing new tests, solving supply chain problems, distributing kits to those who need them, allowing more laboratories to run tests, and expanding the ability of laboratories to run complex analytical tests. Finally, getting enough money to get this going well will require federal support. All of which means that the decision to step up testing in the United States may depend on President Trump’s brain. After all, when the man declared a national state of emergency during the outbreak, he said of the virus testing, “I am not ashamed to take any responsibility.” “