The FDA has raised objections, but the error rates could be significant

Apr 2, 2020 12:55 AM ET

During a meeting of the White House Coronavirus Task Force in the Situation Room on Tuesday, Vice President Pence and other officials discussed redirecting new tests to areas where there are relatively few cases, two people familiar with the matter, on condition of Anonymity spoke to describe internal considerations.

They said the administration “needs to find out the spread in places where we don’t currently fully understand it,” said one of the people present. The final consensus seemed to be, “Let’s send it south and to sparsely populated areas.”

The delay in the delivery of test results is burdensome for communities across the country, depriving them of workers who can respond to medical emergencies, and sowing uncertainty among hospital officials who decide what precautions to take. The competition for machinery is so intense that governors and mayors have started calling Abbott’s executives personally to negotiate orders.

In the troubled Detroit, which now has one of the highest infection rates in the country and one of the fastest rising fatalities, Mayor Mike Duggan said on Wednesday that he had secured the cell phone number from Miles White – the chairman and outgoing director of Abbott Labs. – and woke him up on Sunday morning to beg for the test because he knew the whole country would call. He said the fact that he had a contract for five machines and 5,000 kits was a “game changer” that would allow firefighters, police officers, and nurses to get back to work and quarantine.

The “#DETROITSTRONG” message burns day and night at the shuttered Greektown Hotel in the city’s casino district, where some policemen stay overnight this week to avoid risking their own families being infected.

According to spokeswoman Sgt., Five hundred and twenty-five officers have been quarantined in Detroit’s more than 2,500-strong police force. Nicole Kirkwood. 85 members are expected to return to work later this week and 91 have tested positive.

MP Debbie Dingell (D-Mich.), Whose district includes the neighboring town of Dearborn, said in a telephone interview on Tuesday that some of her voters are waiting up to two weeks to receive results from tests outside the state and outside the country State have been shipped to private companies.

“You need to know if someone is safe to go out, and we have to protect them,” said Dingell, adding that local police and fire chiefs are having difficulty dealing with staff who isolate themselves while testing results waiting .

“We cannot afford to wait another week,” wrote one.

Abbott spokesman John Koval, whose company started delivering 50,000 tests a day on Wednesday, said, “We are working with the government to deploy them where they have the most impact.” He would not go into further detail, but said that states across the country had already started to receive and use them.

Maryland Governor Larry Hogan (R) said in an interview that his state needs at least 100,000 more tests than it currently does.

“We spoke to Abbott. They are due to bring a small number of test machines to the United States shortly. No governor in America has yet received one,” said Hogan. “You said they are available. They are not yet available. They say, “Call, governors can get all of these things.” I just spoke to all the governors on the phone, no governors have these things. “

Public health experts say that tests are needed everywhere – up to several hundred thousand a day. “Hot zones are the most urgent need,” said Harlan Krumholz, cardiologist at Yale Medical School and director of Yale New Haven Hospital Center for Outcome Research and Assessment, “but everyone needs them.”

Joshua Sharfstein, a former health commissioner from Maryland and now a professor at the Bloomberg School of Public Health at Johns Hopkins University, said that any decision to send them south “instead of going to such hotspots must be part of a scientific plan, justified. And me haven’t seen any yet. “

In Kentucky, governor Andy Beshear (D) delayed the launch of mobile test sites, also because he doesn’t yet have enough tests and personal protective equipment. However, in a press conference on Tuesday, he noted that processing time is also important for tests as officials try to ensure that they have access to a non-state laboratory that “can turn it over in time, where it can be helpful.” . We. ” I want reports back in 48 hours. “

That is not the case now.

California is lagging behind in achieving test results. As of March 30, approximately 86,100 tests were performed, approximately 28,704 results were delivered and another 57,400 were still pending. Figures include data that California has received from commercial, private, and academic laboratories, including Quest Diagnostics, LabCorp, Kaiser, the University of California, Stanford University, and 22 state and regional health laboratories.

Although widespread test analysis only takes four hours, the lack of large, expensive machines used for these analyzes has led to bottlenecks, so patients have to wait four or more days for the test results.

On March 18, as the pandemic worsened, the American Clinical Laboratory Association unsuccessfully appealed to congressional leaders to enact $ 5 billion in laws to help private laboratories meet the growing demand for testing and analysis. Some test providers feared Medicaid could reimburse a fraction of the cost. And laboratory companies are already suffering from a decline in other business areas. Quest announced in a U.S. securities regulator filed Tuesday that total volume had declined by 40 percent in the last two weeks of March, even after Covid 19 tests were included.

There are now more than a dozen main players in the test world. The disease control and prevention centers have their own laboratories, but on February 29, they asked hospitals and private companies for help. Since then, private companies have carried out up to 84,000 tests a day and carried out around three quarters of the 1,064,506 tests completed on April 1.

The largest companies that have dealt with Covid-19 tests include Roche, LabCorp and Quest, established names in laboratory analysis. They started up quickly, but not quickly enough. For example, LabCorp can run more than 20,000 coronavirus tests per day and has performed more than 250,000 tests in total since the company started testing for covid-19 on March 5. Quest announced on March 24 that its capacity will soon reach 30,000. However, both companies routinely need four to five days to share the test results with healthcare providers.

“This time frame can vary as needed, the time it takes for the sample to travel to the LabCorp test facilities, and the prioritization of patients (as determined by the health and coronavirus task force of the White House, HHS and other health authorities),” said Labcorp said in a statement referring to the Department of Health and Human Services.

Scott Becker, a spokesman for the Association of Public Health Laboratories, said in an email that delayed results are pervasive in private and public laboratories.

“These backlogs are system-wide problems that indicate supply shortages, equipment shortages, and skills shortages,” he said. “These tests are not simple blood tests, but are highly complex tests that require qualified scientific staff. ”

A state like New York could turn tests around faster because it is primarily about who should be tested, and because of the severity of the outbreak, it gets more supplies there, Becker added, but that means other states may get fewer supplies. “All laboratories, whether they are public health, hospitals, other clinical laboratories, or commercial laboratories, all need the same limited pool of resources.”

Some states like Oklahoma are making progress. The state could only process 300 tests in a 24- to 48-hour window and began sending tests to Dallas, resulting in a three to five day turnaround. Two weeks ago, the company partnered with the University of Oklahoma and Oklahoma State University to conduct tests, and ordered 10,000 from Thermo Fisher, which arrived last Thursday.

Now Oklahoma is being “dispatched a delivery of Abbott’s rapid genetic tests and we have been told they could arrive this week,” said Shelley Zumwalt, the state’s chief innovation officer, in an email.

The new Abbott test places a sample of a nasal swab into a 6.6-pound toaster-sized device, which returns the results in five to 13 minutes. The new test is only used in medical facilities. The company announces that it will provide 50,000 test kits per day and has distributed 18,000 of the analyzers.

Abbott’s technology is largely out of reach for general practitioners. Gary Bergman, a senior physician at Children’s Medical Associates in Northern Virginia, said in a phone interview on Wednesday that he and his partners had considered buying the company’s machine, but would cost between $ 12,000 and $ 15,000, and it couldn’t tell how many covid-19 tests they could deliver or what they would cost.

“It doesn’t pay off. It’s not practical,” said Bergman, who continues to see sick children and newborns, despite the fact that business has declined by two-thirds.

Dozens of companies around the world are working on tests that they hope will receive emergency approval from the Food and Drug Administration: Abbott’s new test is the second to receive such approval. Together, the number of Abbott test kits will reach 5 million a month.

With this latest test device, Abbott is working with other companies to develop new techniques, marking another small step towards eliminating bottlenecks and bottlenecks across the country. The new test is just one of many Covid-19 diagnoses that are currently under review or that have recently been approved by the FDA.

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