Here’s why the U.S. can’t get its coronavirus testing act together

Want to massively ramp up coronavirus testing? No problem. It’s not as though the U.S. health-care system is complicated or anything.

The nation’s web of public and private labs straining to increase testing are up against unprecedented demand and a hugely complex supply chain that doesn’t just turn on a dime. They’re not equipped to process tens or hundreds of thousands of tests a day. They’re competing with one another — and with states — to get the specific supplies needed for their testing instruments. And they’re dependent on medical workers and public health officials to collect samples in the first place.

“Coordinating among 50 states and all the territories, all the hospital labs, the commercial labs, the manufacturers, et cetera, is really incredibly challenging,” Scott Becker, chief executive of the Association of Public Health Laboratories, told reporters yesterday.

A host of people and things need to be in the right places doing the right things to achieve widespread testing. The United States isn’t there yet.

It’s not that there hasn’t been progress. The country’s per capita testing rate is now secondonly to that of Italy. Yet for roughly 2½ weeks, tests administered daily around the nation have stalled at about 130,000 to 150,000 (although the last two days have shown higher counts). Epidemiologists say daily testing needs to be four or five times that to safely reopen the country.

Earlier promises by the Trump administration of tens of millions of tests by this point have fallen by the wayside. Governors are outbidding one another to purchase testing supplies. Some are buying them from other countries. The stakes are enormous, as millions of Americans remain locked down in their homes without the ability to earn income or send their children to school or day care.

It’s all turned into a mad scramble that isn’t producing quick results. Here are the most pernicious hang-ups:

It takes a lot longer to process molecular tests than chemical or toxicity tests.

Diagnosing a coronavirus infection involves a molecular test, in which a sample taken from the back of a patient’s throat is checked for the virus’s genetic material. Molecular tests are more complex and take longer than, say, blood chemistry tests (like a typical wellness panel), which simply count cells.

Labs don’t normally run tens of thousands of molecular tests, which is what they’re being asked to do now. The largest molecular analyzers can typically run about 3,000 samples a day; smaller ones, about 1,000. Even if a lab can get all the supplies needed for carrying out a test, it’s limited by the capacity of its analyzers.

“The molecular testing world has never seen this kind of volume,” Bill Miller, chief executive of Virginia-based lab Genetworx, told me. “It’s been a big ramp-up period for everybody.”

Manufacturers are aiming to provide supplies for 25 million tests by the end of April and increase that “significantly” by the end of May, said Scott Whitaker, president of AdvaMed, an international association of medical technology makers. 

That’s an ambitious goal. As of Thursday, about 4.6 million tests had been performed in the United States. Whitaker said the estimate is grounded in reports from his members based on how much they’re scaling up operations. 

But Becker gave a much more cautious take, saying public health labs are seeing “minor improvements” weekly and are looking for “that true ramp up coming very soon.” And Eric Blank, also with the public lab association, said he’s “not convinced the supply chain will ever keep up with demand.”

“We’ve been told over the course of this response the supply chain would open up, and it hasn’t been opening up,” Blank said.

Manufacturers of testing products create monopoly-like situations.

We wrote about this issue in Wednesday’s The Health 202: The companies selling testing machines typically also make the chemical reagents needed to actually carry out a test. So labs are often limited by brand. If the maker of their machine is out of the reagent, they have nowhere else to turn.

The Rockefeller Foundation’s Jonathan Quick compares testing machines to printers.

“You buy an HP printer, you gotta get the HP cartridges,” Quick said. “Once a lab is locked into a particular brand, it’s basically a monopoly.”

This is a problem with so-called “closed” testing systems, which rely on end-to-end products from one manufacturer and are used by large commercial labs, requiring fewer steps by technicians to process samples. Roche, a major producer of these testing systems, requires its own reagent to be used. 

But some labs avoid being tied to a particular brand of reagent by using so-called “open” testing systems. They’re having less difficulty ramping up coronavirus testing.

These open systems are compatible with a variety of reagents, but also require more steps by technicians to extract DNA before it goes into the analyzer.

Miller told me his lab uses an open testing system called IntelliQube, which is manufactured by the British company LGC. Because he’s been able to get enough reagent, Genetworx can now test between 5,000 and 7,000 samples daily for the coronavirus. The lab is aiming to double that capacity in the next few weeks by buying more analyzer machines and adding more employees to its 130-person team.

There’s a shortage of the supplies needed to process tests. But it’s unclear exactly where the chain is breaking down.

State governors, manufacturers and labs have all identified this as a central problem. The many products needed to process a test — reagents, swabs, cartridges, pipettes — are in high demand not just in the United States, but also around the world.

New York Gov. Andrew Cuomo (D) made precisely this point at his Tuesday news conference.

“Where it gets hard is when the labs that I regulate say the manufacturers are the problem,” he said. “And then I call the manufacturers and the manufacturers say, ‘I can’t do it because it’s an international problem.’ That’s where we are now.”

Whitaker said “the demand is nearly infinite,” adding the supply chain for tests is “incredibly complex.” Indeed, a complex web of manufacturers process the variety of testing components and machines.

Many manufacturers are moving quickly to increase supply. Major supplier Qiagen, a Dutch company, is running three shifts a day, seven days a week at its facility in Germantown, Md.

It’s not entirely clear where the worst shortages are. Whitaker said he didn’t have specific information about where the supply chain is breaking down. Neither did Robin Patel, president of the American Society for Microbiology — although her group is working with President Trump’s coronavirus task force to identify specific supply chain issues.

“We’re struggling to solve these supply chain issues,” Patel told me.

Deborah Birx, a leader on the coronavirus task force and a familiar presence at the daily briefings, also called the issue “complicated.” 

She pointed to ASM’s work to identity problems lab by lab. And she stressed a need for more testing machines and more lab technicians to operate them.

“It’s lab by lab, state by state, and that’s the dialogue going on now to unlock the full potential of the United States,” Birx said.

The federal government is mostly staying out of it.

It’s up to states — not the federal government — to ensure labs can get sufficient supplies, experts agree. But there’s a crucial way the administration could help if it chose to: By procuring supplies in bulk from manufacturers so states don’t bid up the price of supplies in the process of competing with one another for them.

Quick, who was involved in President George W. Bush’s PEPFAR relief plan for AIDS, said the 2000s PEPFAR bulk procurement program could serve as a model for the coronavirus. 

“Basically, we had supply chain experts that mapped the end-to-end process,” Quick said. “We set up competitive procurement among qualified suppliers.”

Becker also said that not just public health labs — but all labs — would benefit from more involvement by the federal government to help secure supplies.

“The federal government has a really important role to play,” Becker said. “Sometimes it’s just a phone call, and sometimes it’s the federal government coming in and expending whatever is necessary.”

One way for the federal government to use its powers is by invoking the Defense Production Act to compel manufacturers to make more testing products. Trump has done this in limited ways, most recently directing a U.S. facility in Maine to produce 20 million additional swabs per month. 

Yet he has contradicted the pressing and widespread concerns about reagent shortages.

“We’re in great shape,” Trump said at Sunday’s briefing. “It’s so easy to get.”

Ahh, oof and ouch

AHH: The House overwhelmingly passed a fourth major bill responding to the pandemic.

The $484 billion spending package, approved 388-5, would restart a small-business loan program that was swamped by demand and allocate more money for health-care providers and virus testing, The Post’s Erica Werner reports. 

“The vote was historic, as many lawmakers wore masks on the House floor, some even speaking through face coverings as they delivered impassioned remarks,” she writes.

“Just hours earlier, the Labor Department announced that 4.4 million Americans sought unemployment benefits last week. More than 26 million people have filed jobless claims since the novel coronavirus knocked the U.S. economy off course last month, beginning an extraordinary economic tailspin.”

The legislation will now go to Trump’s desk. “Lawmakers from both parties are already talking about pursuing more large spending bills to try to contain the pandemic’s economic fallout, but the measure Thursday could be the last one for at least several weeks as divisions emerge between the parties about how much more to do,” Erica writes. “Congress is not scheduled to return to Washington until May 4 at the earliest.

OOF: One in five New Yorkers may have already had coronavirus infections.

Cuomo described preliminary results of a random study testing 3,000 people, where roughly 20 percent of the subjects tested positive for antibodies to the virus, the New York Times reports. That’s considerably more than the 4 to 5 percent of Los Angeles who tested positive in an antibody study announced earlier this week by authorities there.

“If the pattern holds, the results…raised the tantalizing prospect that many New Yorkers — as many as 2.7 million, the governor said — who never knew they had been infected had already encountered the virus, and survived,” J. David Goodman and Michael Rothfeld write. “Mr. Cuomo also said that such wide infection might mean that the death rate was far lower than believed.”

“While the reliability of some early antibody tests has been widely questioned, researchers in New York have worked in recent weeks to develop and validate their own antibody tests, with federal approval,” they write. “State officials believe that accurate antibody testing is seen as a critical tool to help determine when and how to begin restarting the economy, and sending people back to work.”

“The testing also can tell you the infection rate in the population — where it’s higher, where it’s lower — to inform you on a reopening strategy,” Cuomo said. “Then when you start reopening, you can watch that infection rate to see if it’s going up and if it’s going up, slow down.”

OUCH: Trump pondered whether disinfectants to clean surfaces could be used inside the human body to fight the coronavirus.

After a presentation on the disinfectants that can kill the virus on surfaces and in the air, the president suggested those chemicals could be used to fight the virus inside the human body. He also raised the possibility of using light to combat the viral infection and suggested consulting medical doctors with these questions, my colleagues Allyson Chiu and Katie Shepherd write.

“I see the disinfectant that knocks it out in a minute, one minute,” Trump said during Thursday’s coronavirus press briefing. “And is there a way we can do something like that by injection inside, or almost a cleaning? Because you see it gets inside the lungs and it does a tremendous number on the lungs, so it would be interesting to check that.”

“The question, which Trump offered unprompted, immediately spurred doctors to respond with incredulity and warnings against injecting or otherwise ingesting disinfectants, which are highly toxic,” Allyson and Katie write.

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