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The Health 202: Here's one big reason U.S. coronavirus tests are lagging: test kits made by private companies

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with Paulina Firozi

President Trump and governors are pointing fingers at each other over the nation’s tardiness in ramping up essential testing for the novel coronavirus.

But the private-sector makers of these tests — and their proprietary interests — are central to the complex problem of why experts say the United States is falling far short of the testing capacity needed to safely lift widespread social distancing guidelines.

Labs around the United States, both public and private, have increased their testing capacity over the past six weeks. But private labs, which process about two-thirds of all tests, are limited by this problem: The companies selling the testing machines typically also make the chemicals, or “reagents,” needed to process their tests.

These reagents are often only compatible with the testing instrument made by their respective manufacturer. 

So if a lab has a backlog of tests to process, it has to get the reagent that is compatible with a particular piece of equipment. If the manufacturer doesn’t have enough supply, the testing machine can’t be used, even if a company has a backlog of samples to process.

New York Gov. Andrew Cuomo (D) described this problem yesterday as part of an extensive explanation of testing holdups. (New York has tested more people than any other state — more than 3 percent of its population — but Cuomo said he’s aiming for greater testing capacity if the supply problems can be solved.)

“[Labs] buy these machines from these national companies … each one requires that you go back to that manufacturer to get a test kit,” Cuomo said. “It gets complicated very quickly.”

Consider the tests used by Quest Diagnostics, one of the country’s two biggest commercial labs. Quest uses, among others, a test from manufacturer Hologic.

Hologic told me it manufactures its own reagents in its own facility. While the company has increased production dramatically, its supplies of the cartridges containing the reagents are still limited, according to Kevin Thornal, division president of diagnostic solutions at Hologic.

Quest said it also uses a coronavirus test produced by Roche Pharmaceuticals. In this case, too, the test only works when the lab buys a test kit containing the reagent from Roche. The same is true of testing machines produced by Qiagen, a top supplier of diagnostic supplies to labs.

All this is just one obstacle in the mad rush around the country to ramp up coronavirus testing.

Governors and the Trump administration are eyeing plans to let some Americans return to work and relax an economic shutdown that has resulted in massive, unprecedented waves of unemployment. About 140,000 tests are being performed daily around the country, but experts say that needs to multiply several times over to be able to identify and isolate cases. 

Expanded testing is a key component of virtually every plan put forward. Yet the effort is highly disorganized as governors scramble for supplies, even buying them directly from other countries, as Maryland Gov. Larry Hogan (R) did this week with help from his South Korean wife.

“We have the capability. It’s the supply chain issue that every state is facing” Michigan Gov. Gretchen Whitmer told CNN. “We have the capacity to process the tests. We don’t have the swabs and the reagents.”

Andy Slavitt, former head of the Centers for Medicare and Medicaid Services, noted the complexity of increasing testing in the U.S.:

Some progress is being made. 

The Food and Drug Administration has authorized the first coronavirus test letting people collect a sample at home using nasal swabs. 

The test, sold by LabCorp, will enable patients to collect nasal samples at home using the kit’s swabs and saline. The kits will then be mailed to the North Carolina-based company for testing, my colleague Laurie McGinley reports. 

Health-care workers and first responders on the front lines who may have been exposed or who are showing symptoms will be the first to have access to the newly authorized test.

“Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site,” FDA Commissioner Stephen Hahn said in a statement. “With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”

“The company said the test will cost $119. Consumers will have to pay out of pocket for the test, a company spokesman said, and ask their insurer for reimbursement,” the New York Times’s Katie Thomas and Natasha Singer report. “The Trump administration has repeatedly said that diagnostic tests for the coronavirus will be covered so that consumers don’t have to foot the bill.”

Former FDA commissioner Scott Gottlieb:

Yet Democrats and the Trump administration are butting heads over who is responsible for ensuring labs have enough tests. House Speaker Nancy Pelosi (D-Calif.) and Senate Minority Leader Chuck Schumer (D-N.Y.) want a national strategy, while the president says it’s up to the states. Leaders of his coronavirus task force, who had promised way more tests would be completed by now, have been giving less-than-direct answers to queries about the delays.

Brett Giroir, Trump’s testing czar, referred in Monday’s news briefing to an “end-to-end issue” the administration has been dealing with but didn’t detail exactly what he was referring to.

In truth, as Cuomo said yesterday, there’s a role for both the states and the federal government.

The governor said it’s his job to ensure that the labs his state regulates have sufficient testing capacity. 

“Hold me responsible,” Cuomo said.

But Cuomo also outlined an area where the administration could help: by stepping in and helping to secure supplies from other countries, so governors such as Hogan don’t have to compete with other states for them. The whole effort to expand testing should be a partnership between the states and the federal government, he said.

“Let the federal government figure out South Korea and China and international supply issues rather than have 50 states now figure out how to be like Governor Hogan,” Cuomo said.

The absence of a national strategy to increase testing illustrates the heightened challenges states face.

Some states with extensive health-care resources have made more progress in tracking the virus, while others are struggling to catch up, The Washington Post’s Juliet Eilperin and Chris Mooney report. Just look at Kentucky versus Rhode Island. Both states have done comparable numbers of diagnostic tests and lost similar numbers of residents to the disease. 

But there’s one key difference,” Juliet and Chris write. “Kentucky has more than four times Rhode Island’s population, meaning it has tested 0.7 percent of its residents, compared with Rhode Island’s 3.7 percent, the highest per capita testing level in the United States.”

“The difference suggests Rhode Island probably has a better sense of the virus’s spread throughout the state, making it better prepared to curb it,” they add.

Ahh, oof and ouch

AHH: The virus may have spread in the U.S. weeks earlier than thought.

Health officials in California say at least two people who died in early and mid-February had contracted the virus, The Post's Allyson Chiu and Teo Armus report. Tissue samples taken during autopsies of two individuals who died at home on Feb. 6 and Feb. 17 in Santa Clara County, Calif., tested positive for the virus, local health officials said in a statement.

Initially, the nation’s earliest coronavirus fatality was believed to have occurred on Feb. 29, in Kirkland, Wash. “The Santa Clara County fatalities push the earliest coronavirus-related fatality back by weeks, with the new findings potentially altering the timeline of the U.S. outbreak,” Allyson and Teo write.

OOF: The next wave of coronavirus could be far deadlier. 

That’s what the head of the Centers for Disease Control and Prevention told our Post colleague Lena H. Sun, warning that the second wave is also likely to coincide with the start of the flu season in the winter.

“There’s a possibility that the assault of the virus on our nation next winter will actually be even more difficult than the one we just went through,” CDC Director Robert Redfield told Lena. “And when I’ve said this to others, they kind of put their head back, they don’t understand what I mean.”

The possibility of two respiratory outbreaks at once could pummel the health-care system.

The first wave of the coronavirus has already overwhelmed hospitals and revealed testing gaps as well as shortages in critical equipment, including ventilators and protective equipment.

Redfield told The Post that federal and state officials need to use the coming months to prepare for that next wave. Redfield acknowledged a larger workforce is critical and he said the CDC is planning to hire more workers to assist with tracking the virus. “Redfield said the agency is talking with state officials about the possibility of using Census Bureau workers, Peace Corps and AmeriCorps volunteers to build ‘an alternative workforce,’ ” Lena writes. 

Redfield’s comments underline the greater need for workers to track the virus. 

“Before the pandemic, state and local health departments had fewer than 2,000 workers carrying out contact tracing — the detailed investigatory work to track and stop outbreaks of everything from syphilis to measles,” Politico’s Dan Goldberg and Alice Miranda Ollstein report. “The real number needed could be somewhere between 100,000 and 300,000 — an astronomical figure that seems near impossible to reach without a massive national program to build a highly trained public health workforce.”

OUCH: The true toll of the pandemic may be greater than official counts report. 

There have been at least 25,000 more deaths during the pandemic than official death reports, the New York Times’s Jin Wu and Allison McCann report, citing a review of mortality data in 11 countries.

“In the last month, far more people died in these countries than in previous years, the New York Times found. The totals include deaths from Covid-19 as well as those from other causes, likely including people who could not be treated as hospitals became overwhelmed,” they write. “These numbers undermine the notion that many people who have died from the virus may soon have died anyway. In Paris, more than twice the usual number of people have died each day, far more than the peak of a bad flu season. In New York City, the number is now four times the normal amount.”

“Today’s rise in all-cause mortality takes place under conditions of extraordinary measures, such as social distancing, lockdowns, closed borders and increased medical care, at least some which have positive impacts,” Vladimir Shkolnikov from the Max Planck Institute for Demographic Research told the Times. “It is likely that without these measures, the current death toll would be even higher.”

The pandemic’s impact on states

Some states are advancing plans to partly reopen.

Colorado Gov. Jared Polis (D) announced this week he will shift his stay-at-home order, which is expiring Sunday, to a “safer at home” phase. 

Polis said starting Monday, retailers can open with curbside pickup, and they can open with social distancing guidelines in place and limited numbers of in-store customers starting on May 1, the Denver Post’s Shelly Bradbury reports. 

“Companies likely can reopen offices with 50% of their workforces the following Monday, on May 4, the governor said, although he added that telecommuting should be maximized as much as possible, particularly with older employees,” Shelly adds. “Personal service providers and elective medical providers, including hair salons, dental offices and tattoo shops, will be able to reopen with some precautions on April 27, such as hair stylists wearing masks. One-on-one real estate showings — though not open houses — and child care can restart then, too, Polis said.” 

Colorado Public Radio has a helpful table comparing the stay-at-home and safer-at-home phases. 

In Georgia, Republican Gov. Brian Kemp’s move to ease restrictions and begin reopening the state “put his state at the center of a deepening national battle over whether Americans are ready to risk exacerbating the public health crisis to revive the shattered economy,” our Post colleague Isaac Stanley-Becker reports

“Epidemiologists say restrictions on economic activity and public assembly, combined with ramped-up testing and aggressive contact tracing to identify other potentially infected people, are necessary to contain the outbreak of the new coronavirus, which has killed more than 42,000 Americans,” Isaac writes. 

“Many governors, including some Republicans, have heeded that advice, holding out against protesters who have descended on state capitol buildings to decry the emergency orders. Others are charting a different course.”

The White House’s response to coronavirus

Most Americans give Trump negative marks for his handling of the outbreak, a new poll found. 

A Washington Post-University of Maryland poll found that 54 percent of Americans say the president’s overall response to the coronavirus outbreak has been not so good or poor. That’s compared with 72 percent of Americans who say governors’ overall response has been excellent or good. 

Most Americans are also expecting to stay home for at least a couple more months. A majority say it will be June or later before it will be safe to have larger gatherings of 10 or more people, our Post colleagues Scott Clement and Dan Balz report. 

A study found the drug Trump aggressively promoted was linked to higher death rates in Veterans Affairs patients. 

The use of anti-malarial drug hydroxychloroquine for Veterans Affairs coronavirus patients had no benefit and was linked to higher death rates, according to a study by VA and academic researchers. 

It's the latest development to spur questions about the safety and efficacy of the medicine, which has been widely used during the pandemic, our Post colleague Christopher Rowland reports

The study “analyzed outcomes of 368 male patients nationwide, with 97 receiving hydroxychloroquine, 113 receiving hydroxychloroquine in combination with the antibiotic azithromycin, and 158 not receiving any hydroxychloroquine,” he writes. “Rates of death in the groups treated with the drugs were worse than those who did not receive the drugs, the study found. Rates of patients on ventilators were roughly equal, with no benefit demonstrated by the drugs.” 

Trump has touted the drug as a treatment for the coronavirus in White House news conferences and on Twitter. 

A panel of National Institutes of Health experts is recommending against a drug combination Trump has promoted. 

The panel of experts convened by the National Institute of Allergy and Infectious Diseases, which is led by Anthony S. Fauci, is recommending against the combination of hydroxychloroquine and azithromycin for the treatment of patients with covid-19. The experts are warning about potential toxicities, NPR’s Joe Palca reports.

Trump has touted the combination in a tweet and in his task force briefings. 

“The recommendation against their combined use would seem to fly in the face of comments made by President Trump suggesting the combination might be helpful,” Joe writes. “… As for using the use of hydroxychloroquine or chloroquine alone, the panel said there was ‘insufficient clinical data to recommend either for or against.’ It reached the same conclusion about the drug remdesivir.”

Coronavirus latest

A few more developments to catch up on this morning: 

More relief on its way:
  • The Senate passed a $484 billion deal to boost funding for the small-business loan program overwhelmed by demand. The legislation, which Trump said he would sign, is also meant to provide additional funding for coronavirus testing and for hospitals, our Post colleagues Erica Werner and Seung Min Kim report.
  • House Democrats are pushing for a historic change: allowing lawmakers to vote in absentia for the first time in the chamber’s more than 230-year history. The short-term solution would allow them to vote without traveling across the country to return to Washington amid the pandemic, our Post colleague Paul Kane reports.
More cases emerge: 
  • At least seven residents in Milwaukee have tested positive for the coronavirus after standing in lines or working the polls during Wisconsin’s April 7 elections, our Post colleague Amy Gardner reports. “The drama in Wisconsin offered a preview of what could play out in upcoming primaries — and possibly in the November election — as the health crisis upends voting throughout the country,” she adds.
Returning to a new normal:
  • A new white paper from Harvard University calls for policymakers, technology providers and others to work together to develop digital health credentials or “immunity certificates” that will help people “prove their covid-19 status.”
The Trump administration’s efforts: 
  • Surgeon General Jerome Adams appears to have been sidelined from television appearances following his remarks last week on the impacts of covid-19 on minority communities, “silencing the White House's loudest voice on racial disparities even as concerns mount about risks to communities of color,” Politico’s Dan Diamond reports.
Ways to cope: 
  • Meditation apps such as Headspace, Calm and Ten Percent Happier are seeing a surge in use as people turn to their devices to find moments of calm, The Post’s Rachel Lerman reports.
Potential secondary consequences: 
  • Poison hotlines are seeing an uptick in calls related to accidental exposures to household cleaners and disinfectants, according to a new CDC study. “From January through March, poison centers received 45,550 exposure calls related to cleaners (28,158) and disinfectants (17,392), the report said, representing overall increases of 20.4 percent compared with the same period in 2019 and 16.4 percent more than 2018,” the New York Times’s David Waldstein reports.
In the states: 
  • Numerous states have sought to ban abortions as part of their coronavirus response, as they halt some medical procedures and nonessential businesses. “The coronavirus-linked restrictions have all followed the trend of recent years in which states in the South and upper Midwest have restricted or attempted to ban abortion, while states on the West and East Coasts have strengthened access to abortion,” The Post’s Dan Keating, Lauren Tierney and Tim Meko report.

Sugar rush

YouTuber Patrick Starrr is a beauty expert with over 9 million social media followers. Dave Jorgenson asked him for beauty tips for his office Zoom calls. (Video: The Washington Post)