When to Reopen: What We Know About Coronavirus Tests, Treatment and Vaccines

How the U.S. is faring in the public-health race to safely reopen schools, businesses and daily life

Leading medical experts say the U.S. needs levels of testing that are roughly four times what exist now.

Photo: michael reynolds/Shutterstock/european pressphoto agency

28365365体育投注Completed tests for the new coronavirus now number in the millions in the U.S. as the nation builds its capacity to contend with the threat and experts race to develop treatments and vaccines.

But there are signs the country needs to build far more testing capacity before it is safe for governors to loosen state lockdowns. Meanwhile, hospitals are developing blood tests that could give more health-care workers enough sense of safety that they can return to the job because they have been exposed to the virus and have sufficient antibodies to protect them from becoming infected by patients.

28365365体育投注At the same time, some researchers believe that as many as one in three infected people get inaccurate results on current tests, raising the chance they might inadvertently infect others.

Yet some states that lack a robust testing program nevertheless are going to reopen soon, with Georgia now a test case for whether infections in a few weeks begin to rise.

28365365体育投注We are updating this guide regularly with what we learn about testing and treatments across the U.S.

How much testing would it take for the country to safely lift restrictions?

28365365体育投注• Prominent public-health doctors say far more testing is needed—and that simple things like an insufficient supply of swabs, testing chemicals and temporary sites to conduct tests are the limiting factors. “It’s insane that we have the country shut down because of swabs,” said Ashish Jha, a physician and director of the Harvard Global Health Institute. “It’s swabs, it’s reagents [test chemicals], it’s all of it. The president could use the Defense Production Act, and he could use the Army Corps of Engineers to build testing facilities.”

28365365体育投注• He and other leading medical experts say the U.S. needs levels of testing that are roughly four times what exist now. Also called for, they said, is a greatly enhanced ability to do what is known as contact tracing, or finding people who had contact with an infected person. Those people, plus many contacts of contacts, would need to be tested and perhaps quarantined for the rest of Americans to go about their lives safely.

• That widespread testing would need to show declining cases for at least 14 days, and ideally “very, very low numbers,” to safely ease up current social-distancing rules, said Dr. Jha and others. Dr. Mark Rupp, chief of infectious diseases at the University of Nebraska Medical Center, called easing restrictions a complex decision that needs to be made locality by locality.

• Another benchmark, from the World Health Organization, is that the number of positive cases should be no more than 10% of total testing. Dr. Jha recommends even lower than 10%. The U.S. overall at the moment is about 19%. Georgia Gov. Brian Kemp said businesses like gyms and tattoo parlors can reopen on Friday. His state’s cases are at 23% of testing.

28365365体育投注• Even after the pandemic subsides, the U.S. should have a long-term ability to do at least 750,000 tests weekly, former Food and Drug Administration commissioners Mark McClellan and Scott Gottlieb wrote with colleagues on April 7. And each U.S. region, they wrote, should continue to have beefed up ability to watch for and respond to outbreaks.

Can anyone who wants a test get one?

28365365体育投注• As more tests are being distributed, the Centers for Disease Control and Prevention says doctors and health departments may decide whether a patient should be tested.

• Whether diagnostic tests are available depends on factors including where you live and the policies of local governments and your health-care provider. There still appears to be a mismatch between the number of people who need tests based on symptoms and those who actually get them. A possible boon to more testing: LabCorp on April 21 won FDA clearance for a nasal-swab test that can be done at home and mailed in.

• The CDC recommends calling your state or local health department or a medical provider.

Where in the country are tests being done?

• Ninety-five public health labs around the U.S. are using Covid-19 diagnostic tests, . The labs are in all 50 states, plus Washington, D.C., Puerto Rico, Guam and the U.S. Virgin Islands.

28365365体育投注• Academic hospitals across the country have developed their own distinct methods, through methodology that they have developed and that the Food and Drug Administration has generally accepted. The result is a small number of communities where testing is often widely available, such as Roseville, Calif., near the University of California, Davis.

CVS Health Corp. and other big drugstore chains have begun setting up drive-through sites outside stores. Walgreens offers tests to health-care workers and first responders at a Chicago-area site. Rite Aid plans testing at a Philadelphia site. The locations are run by health officials and aren’t open to the general public. People getting tested need to stay in their cars.

• Some companies are seeking to get their own test kits for staff. Amazon.com Inc. has started building a testing capacity to diagnose all employees, including those who display no symptoms. “We have begun assembling the equipment we need to build our first lab and hope to start testing small numbers of our front-line employees soon,” Chief Executive Jeff Bezos said Thursday.

• At Partners HealthCare, which includes Massachusetts General Hospital, Chief Academic Officer Ravi Thadhani said staffers are working on blood tests for hospital employees and their families. The idea would be to identify workers who have been infected and developed antibodies against the coronavirus and are protected.

How do tests work?

• Current tests for live infections use nasal swabs to collect samples for testing. RNA is extracted, isolated and processed through a device called a thermocycler that amplifies the amount of genetic material to identify it.

What about antibody tests—how much can they help?

28365365体育投注• At Partners HealthCare, which includes Massachusetts General Hospital, Chief Academic Officer Ravi Thadhani said staffers are working on blood tests for hospital employees and their families. The idea would be to identify workers who have been infected and developed sufficient antibodies against the coronavirus to be protected.

28365365体育投注• Dr. Thadhani said there are more than 250 antibody tests on the U.S. market, and “we have no idea” how accurate they are. But it is vital that such tests be precise—that they show a person has developed antibodies against this current virus and not some earlier coronavirus, such as a cold.

• Even with accurate antibody tests, Dr. Thadhani said, researchers would need to show that a person’s antibody levels are high enough to confer immunity against getting the disease.

28365365体育投注• Dr. Jha, of Harvard Global Health Institute, said that unless it turns out roughly 40% or more of the U.S. population has already been infected and built up immunity—something most doctors don’t believe has occurred—“antibody testing is not a central feature of letting businesses get back to work.”

How do testing numbers match up with the number of actual infections in the U.S.?

•As of Wednesday morning there were 825,306 confirmed cases and 45,075 deaths in the U.S., according to data from Johns Hopkins University.

28365365体育投注• The number of confirmed cases is substantially lower than the number of infections, public-health officials say. Along with a shortage of tests, many people who get infected might not be sick enough to realize it or can’t get a test.

A growing number of hospitals are investigating antibody testing and blood plasma therapy as a way to combat the new coronavirus in sick patients. WSJ’s Daniela Hernandez explains. Photo illustration: Laura Kammermann

28365365体育投注• The number of tests done still is hampered by a lack of mundane supplies, plus a shortage of trained personnel and protective gear at many testing sites, say the nation’s nearly 400 academic medical centers. “We hear a constant cry to remedy the various shortages that leave individuals untested,” said David Skorton, president of the Association of American Medical Colleges, in an April 13 letter to the Trump administration’s coronavirus task force.

How long does it take to get test results?

• As with many medical tests, there can be a wait of as much as two to three weeks to get results, depending on where testing is done. Some processing, however, is as short as several hours or even minutes.

• LabCorp said it now can run about 40,000 tests and that based on current volume levels, it can provide results within two to four days to the health-care provider from the date of the specimen pickup. Abbott Laboratories has a test that can give results within minutes, but these generally are at hospitals that use Abbott analysis machines.

What snags has the U.S. hit in expanding testing?

• CDC officials botched an initial test kit28365365体育投注 developed in an agency lab, and retracted many tests. They resisted calls from state officials and medical providers to broaden testing, and health officials failed to coordinate with outside companies to ensure that needed test-kit supplies, such as nasal swabs and chemical reagents, would be available, according to suppliers and health officials.

• Early on, the CDC restricted testing to people with symptoms who had recently traveled to China, where the virus first emerged, or had been exposed to a known case. That narrow effort was “a failing,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

• The FDA relaxed testing regulations28365365体育投注 on Feb. 29. Under its policy now, testing companies and academic hospital labs with ability to perform complex tests can do so with only retroactive review by the FDA of data verifying accuracy.

• Medical professionals have limited supplies of the swabs and chemicals known as reagents needed to conduct the tests and personal protective equipment needed for those who treat patients.

Are tests accurate?

• Health experts say they now believe nearly one in three patients who are infected are nevertheless getting a negative test result. They caution that only limited data are available, and their estimates are based on their own experience in the absence of hard science.

• That picture is troubling, many doctors say, as it casts doubt on the reliability of a wave of new tests developed by manufacturers, lab companies and the CDC. Most of these are operating with minimal regulatory oversight and little time to do robust studies amid a desperate call for wider testing.

• The FDA said it has prioritized getting new tests out and that it is unable now to disclose the rate of test inaccuracies. Two members of Congress, Reps. Lloyd Doggett (D., Texas) and Rosa DeLauro (D., Conn.) wrote to FDA Commissioner Stephen Hahn on April 9 asking for labs’ data on the new tests’ precision.

How many Americans have been tested?

28365365体育投注• The CDC isn’t reporting how many people have been tested. The Covid Tracking Project, a volunteer effort to collect data from public-health authorities and other sources, reported more than 4.1 million completed tests in the U.S. as of Wednesday.

• The how many people have been tested. The , a volunteer effort to collect data from public health authorities and other sources, reported more than four million completed tests in the U.S. as of Tuesday.

• Dr. Gottlieb, the former FDA commissioner, estimates that the nation’s capacity now is roughly a million tests a week.

What treatments are in the works?

28365365体育投注• Possible treatments for Covid-19, the disease caused by the coronavirus, are all experimental or have only emergency-use approval, as opposed to full approval from the FDA.

• One is called remdesivir. It is a drug from Gilead Sciences that senior officials at the National Institutes of Health believe may have promise. It is in a clinical trial that could be as brief as two months, but promising drugs before have failed in clinical studies. You can learn more about the at the company’s website. Some leaked data from a portion of a remdesivir trial suggested positive results in 113 patients at the University of Chicago.

• Another possible treatment is “convalescent plasma,” which uses the colorless fluid in blood taken from recovered Covid-19 patients that contains antibodies to the virus. This approach worked in some respiratory viruses before, though the plasma from one patient can treat only one or two others. The approach was FDA-endorsed on an “emergency use” basis, meaning it can be used during the pandemic but not necessarily beyond. You can learn more about how to seek treatment and to donate plasma28365365体育投注 from the National Covid-19 , a collaboration of doctors and scientists in 17 states.

• On the horizon are possible novel treatments. Drugmakers including Vir Biotechnology Inc., AbCellera Biologics Inc. and Regeneron Pharmaceuticals Inc. are all pursuing therapies. Overall, more than 120 drug and vaccine research programs aimed at the coronavirus are under way. Ten agents are being studied in some 200 clinical trials, and hundreds more trials are planned, many spearheaded by universities and government research agencies.

• The NIH said it is forming a public-private partnership with drug companies, the FDA and the European Medicines Authority to prioritize which drugs and vaccines are most promising for further research.

What about hydroxychloroquine and chloroquine and other drugs touted by some politicians?

• These two are years-old drugs approved for malaria, with limited evidence of their effectiveness against Covid-19 from small studies in France and China, so the FDA is overseeing clinical trials. The agency also says the drugs are being distributed from the Strategic National Stockpile for doctors to prescribe when appropriate and a clinical trial isn’t available. Because the drugs are also needed for other conditions, including lupus, some states are limiting prescriptions or demanding proof of a Covid-19 diagnosis.

• Various studies are taking place of these drugs, including an effort by Intermountain Healthcare and the University of Utah in Salt Lake City. They said it would be the largest trial to evaluate hydroxychloroquine and chloroquine, and are seeking to enroll 2,300 patients. Also, an NIH-backed study of hydroxychloroquine in 500 patients with coronavirus has begun at Vanderbilt University Medical Center and other hospitals.

• A recent development in France, while short of a randomized study, illustrates why many medical experts caution against wide use28365365体育投注 of drugs unproven for coronavirus treatment. Government monitoring authorities there reported 54 cases of patients with Covid-19 who developed serious heart problems while taking hydroxychloroquine. Seven had cardiac arrest and four died.

28365365体育投注• Hydroxychloroquine didn’t help patients and was linked to increased deaths in a non-peer-reviewed study conducted of patients at Veterans Affairs medical centers. The study was a so-called retrospective analysis, meaning that researchers looked back at results in patient records. It isn’t the sort of gold-standard research called a prospective, randomized controlled trial, in which comparable patients are randomly assigned to different treatments. There were a total of 368 patients in the VA analysis, of whom 97 received hydroxychloroquine, 113 received the drug plus an antibiotic and 158 didn’t get hydroxychloroquine at all. Deaths were higher in the first group, researchers reported. The researchers wrote that their findings highlight the need for other, prospective studies “before widespread adoption of these drugs.”

• Another unproven drug is being touted, with limited evidence28365365体育投注, by Japan’s Prime Minister Shinzo Abe, who calls favipiravir a silver bullet and has discussed it with President Trump.

How far away is a vaccine?

• There is considerable hope that a vaccine may arise that could protect people, perhaps as soon as some time next year. One came from work at Moderna Inc., and the National Institute of Allergy and Infectious Diseases has already started human testing28365365体育投注, among 45 adults in the Seattle area.

• Other companies, including Johnson & Johnson, Sanofi SA and Inovio Pharmaceuticals Inc., are also seeking to develop Covid-19 vaccines, and J&J said recently that it could start human trials as soon as this fall.

Have you been tested? Tell us about it.

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