The Morning Jolt

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Everything You’ve Ever Wanted to Know about Coronavirus Testing

Dr. Roxana Sauer looks into a car as she prepares a test kit for a COVID-19 coronavirus test during a media event at a drive-in coronavirus check at the hospital of Gross-Gerau, Germany, March 9, 2020. (Kai Pfaffenbach/Reuters)

On the menu today: Everybody and their brother keeps emphasizing that this country needs a lot more testing for the coronavirus . . . but has anyone walked you through what the logistical hurdles and complications are? If you want something beyond someone pounding the table and repeating “we need more testing!” then read on.

The Technicalities of Large-Scale Testing

You’ve heard it over and over again — “The key to reopening our society safely is testing, testing, testing.”

The United States has had a nice jump in recent weeks, from about 140,000 tests per day to around 200,000 per day. But it’s still well below what most public-health experts think we need to really keep the outbreak under control in even a partially reopened society. Our economy is trying to function with as little human interaction as possible, and we see the results. Reopened businesses are going to get people in physical contact again, and even if everyone tries to follow social-distancing guidelines, we’re going to get more infections. To minimize the spread of SARS-CoV-2 in our workplaces, we need ubiquitous, fast testing.

President Trump declared yesterday that the United States will be able to conduct five million tests a day “very soon.” That would be a considerable feat, considering that the country has conducted just under 5.8 million tests since this crisis began. Public-health laboratories and the CDC have conducted about a half-million tests.

So just what is the holdup?

The first step in any medical testing process is developing the test, which has thankfully been pretty fast and easy, considering no one had heard of this virus before December. All medical testing operates on generally the same system: collecting some sample from the patient and seeing if it matches confirmed examples of infection. For coronavirus testing, a sample is collected by sticking a swab up the patient’s nose until it reaches the back of the nasal passage and collecting the body’s “secretions” — i.e., mucus. Then the swab gets sealed in liquid and sent off to a lab — although the waits are getting shorter (more on that later). The process of testing is called quantitative reverse transcription, which basically amounts to taking genetic material called RNA from the sample and making a lot of copies of it, and seeing if it matches confirmed examples of infection.

While we are seeing breakthroughs in testing techniques on an almost weekly basis, the general gist is that the simpler the test is to administer, the tougher it is produce; the easier it is to produce, the tougher it is to administer. “The first Covid-19 tests were simple to make but required specialized expertise. Many early tests take about four hours — two hours of hands-on work, two hours in the machines. Roche and Abbot instruments, available in some academic laboratories, can run 80 to 100 samples at a time. They’re partially automated but still require skilled technicians.”

You may have heard about Abbott Laboratories’ new rapid test, which can provide results for the patient within a matter of minutes, instead of hours or days — or for some patients in the past two months, more than a week. By April 25, Abbott had shipped one million tests to sites in all 50 states. The bad news is that some doctors are worried this is a less safe form of testing: “Running a test involves swabbing a potentially infected person’s nasal passage and swirling the specimen in an open container with liquid chemicals, raising the potential of releasing the highly contagious virus into the air.” And then there are concerns about accuracy: Researchers at the Cleveland Clinic tested 239 known positive samples using the Abbott rapid test, and the test came back positive . . . 85 percent of the time. Having 15 percent of those who are infected walk around thinking they don’t have the virus could cause considerable problems. (Back in 2018, the CDC concluded that the most commonly used rapid flu tests are only 50 to 70 percent accurate.) Clinicians have to calculate — is the ability to do a lot more tests a lot more quickly worth a 15 percent error rate?

Then companies have to manufacture the tests. As of this writing, the Food and Drug Administration has granted 50 companies “emergency use authorizations” to produce tests for for detection of the coronavirus. They range from big names the average consumer might have heard of, like Abbott Laboratories, Roche, LabCorp, and Quest Diagnostics, to smaller, more obscure companies.

How quickly a company can manufacture tests depends in part upon how quickly and easily they can obtain the supplies. Puritan Medical Products of Guilford, Maine says it is currently manufacturing “over 1 million swabs for COVID-19 testing a week.”

Puritan is “one of only two manufacturers in the world that produce nasal swabs recommended by the U.S. Centers for Disease Control and Prevention. The swabs are highly specialized because they have to be long and skinny enough to reach to the nasopharynx, or the upper part of the throat behind the nose. They also must be made of synthetic fiber and cannot have a wooden shaft, according to the CDC.”

Earlier this month, White House trade advisor Peter Navarro told CNN that the administration would invoke the Defense Production Act to get more swabs produced at Puritan. “With DPA support, Puritan will be able to increase its industrial capacity in machine tooling, people, and facilities with the broader goal of increasing nasal swab production from 3 million to more than 20 million within 30 days of the contract award.”

Besides the swabs, those processing the tests need reagents, chemicals that react in the presence of the virus. For what it’s worth, Michael Bevan, director of supply chain services at ARUP Labs, told PolitiFact that he was “not aware of any of the components for the COVID testing platforms that are being manufactured in China.” Some of the chemicals used to produce the reagents do come from China, but there are also some smaller U.S. suppliers.

The supply chain for assembling a diagnostic test kit is complicated, and one delay at one producer can hold up the assembly and distribution further down the chain.

Once a company has all the component parts, swabs, and reagents, it can start assembling them and sending them out the door. All of the big testing companies have dramatically increased their capacity over the past two months. But reaching that several-million-per-day threshold, even collectively, is still a steep climb.

Marc Casper, president and CEO of Thermo Fisher Scientific, said at a White House event Monday that his company “met our original commitments of producing 5 million kits a week, and we’re up to scaling that to double that in the coming weeks in terms of supporting testing around the world.”

At that same event, Steve Rusckowski, president and CEO of Quest Diagnostics said that for his company, “by the end of May, we’ll be close to 250,000 a day, about 7,000 a month. So you put those two numbers together, and it’s about 10 million tests by the end of May that we’ll be doing at Quest Diagnostics.” Quest Diagnostics states that by mid April, they were “processing as many as 50,000 COVID-19 tests per day.”

LabCorp CEO Adam Schechter said, “just 45 days ago, we said we could do several thousand tests a day. We can now do 60,000 tests a day, and we’re continuing to expand that capacity every single day.” He added that regarding serology testing — which is the test for antibodies in a person’s system, indicating that they have already caught and fought off SARS CoV-2 — “we can currently do about 50,000 today, and we’ll be able to do several hundred thousand per day by the middle of May.”

Once the tests are assembled and shipped, someone who knows what they’re doing has to administer the test. The responsibility of the testing process is gradually shifting from U.S. public labs and hospitals to pharmacies across the country.

Larry Merlo with CVS Health said at the White House event that since last month, “we have opened large-scale testing facilities across five states in partnership with the administration and working with the governors of Rhode Island, Massachusetts, Connecticut, Georgia, and Michigan . . . These sites are enabling us to test approximately 1,000 individuals a day with real-time results. We now have a capacity to test about 35,000 individuals each week. And this afternoon, we announced plans to expand that capacity even further.”

Merlo added that beginning next month, CVS will install testing capabilities in up to 1,000 pharmacies in its stores. “We’ll be using our drive-throughs and our parking lots with swab testing. So again, you’ll see that coming online, you know, in May.” Richard Ashworth, president of Walgreens, added that his company would be expanding testing capabilities across all states, including Puerto Rico. “We’ll be able to triple the volume that we do now, in partnership with our lab partners.”

Walmart CEO Doug McMillon said Monday, “We’re now up to 20 sites across 11 states. By the end of next week, we’ll be to 45, and by the end of the May — end of May, we’ll be at 100.”

Heyward Donigan, the CEO of Rite Aid, said Monday, “we are currently operating 40 percent of the current test sites in 25 locations across eight states. We’re doing about 1,500 a day.”

The good news is that week by week, the pace of testing in the United States should increase considerably. The bad news is that despite the president’s pledge that the country would be completing five million tests per day “really soon,” that seems unrealistic considering the current capacity and even with the promised expansions.

It did not help that back on March 13, President Trump addressed the country in the Rose Garden and promised a “sweeping national campaign of screening, drive-through sample collection and lab testing,” — vastly overstating the expectations for a handful of small pilot projects.

That said, even if Trump had not oversold a small group of pilot programs, all of the logistical, supply, manufacturing, distribution, and processing issues described above would still exist. The president’s habit of making grandiose promises with little regard for how those promises will be kept is a problem, but not the problem. The problem is that the world’s medical equipment manufacturers cannot turn on a dime and increase their production capacity tenfold or a hundredfold overnight.

One final thought: We’ve seen separate bits of promising news on a potential vaccine from Oxford University and Pfizer Pharmaceuticals in the past two days. If they are correct that there is a real chance that we get the miracle of a working vaccine by autumn, our manufacturers need to start thinking now about what they would need to do to produce the vaccine on massive scale.

ADDENDUM: Kevin Williamson’s latest has me wondering about the argument of a Joe Biden presidential campaign. He more or less pitched himself as the “return to normalcy” candidate. If the vaccine does not come through, and we are living with this virus throughout 2020 and into 2021 and for the foreseeable future . . . and mind you, we are every bit at risk from some other future virus as we were to this one . . . what happens to a “return to normalcy” candidate when normalcy cannot return?

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