health

U.S. has more COVID-19 testing than most. So why is it falling so short?

18 Comments
By Allison Martell and Ned Parker

The United States might have more COVID-19 testing capacity than any other country. So why have we seen laboratories overwhelmed and many patients again waiting a week or more for results?

At the heart of the crisis is a reliance by public and private labs on automated testing equipment that locks them in to using proprietary chemical kits and other tools made by a handful of manufacturers.

The result: as infection rates spike nationwide, many labs aren't running anywhere near capacity because of supply-chain bottlenecks, according to Reuters interviews with 16 hospital, state, commercial and academic labs and an analysis of state and city procurement plans.

A few companies – Cepheid, Hologic Inc, Roche and Abbott Laboratories – dominate this market. Their machines run on chemical kits and disposable plastic parts like sample plates and pipettes that only they sell, much like branded printer cartridges.

"The vendors are in an impossible situation right now where they can't say yes to everyone," said Geoffrey Baird, who runs the medical laboratory at the University of Washington.

U.S. labs now run about 800,000 diagnostic tests daily, according to the COVID Tracking Project. But the United States needs 6-10 million tests per day, by various estimates.

Congress has earmarked $11 billion to support this drive, and in May, states filed plans with the government describing the equipment and supplies they would buy.

But taken together, the plans show that public health officials are not addressing the core supply-chain problem, according to the Reuters analysis.

Many states planned to buy more of these automated machines from just two manufacturers, even though the same equipment was already running below capacity or idled in other states because of shortages of chemicals or parts.

Other countries, including China and Canada, have not been hamstrung to the same extent by supply shortages. Their use of less automated testing provided more flexibility in sourcing such materials.

NO SIMPLE SOLUTION

Early in the pandemic, testing looked similar globally. Lab workers would extract genetic material using one instrument, and then move to a second machine to identify it. But such multi-step tests are labor-intensive and require technical expertise.

Many U.S. labs now rely on the highly automated - or"sample-to-answer" - analyzers. But some experts say this has proved inadequate because of a lack of standardized chemicals and parts.

Gary Procop, who helps lead the Cleveland Clinic's labs, said the government could have used the Defense Production Act (DPA) to scale up multi-step tests, using existing instructions from the Centers for Disease Control and Prevention.

"That uses really standardized reagents," Procop said of the CDC test. "You could make that in a generic form, if you will, and take the companies out of it. And then you could actually mass-produce that type of a test. But nobody's done that."

The U.S. Department of Health and Human Services told Reuters the government had used the DPA to buy some testing supplies, but reagents used to run the CDC test are already available, so buying more would not help.

"As a result of working directly with companies to improve their supply chain, eliminate barriers, and investing through the DPA, we do expect supplies of each of these platforms to increase in the fall," spokeswoman Mia Heck said in a statement.

Health experts also caution there is no single, simple solution to testing in a once-in-a-century pandemic that has infected more than 16 million people and killed more than 640,000 worldwide.

In China, combining patients' samples to save supplies made it possible to test millions of Beijing residents in June, beating back a resurgent outbreak. But experts warn this method can increase false negative results and be ineffective when disease is prevalent.

Canada has built up a domestic supply chain for chemicals in multi-step tests, meaning most patients can be diagnosed within a few days. Yet this regime is more viable in a country with a fraction of the U.S. population.

"When you're asked to process more than 1,000 samples a day or more than 4,000 as we are now doing - you have to do some of it on sample-to-answer platforms," said Alex Greninger, assistant director of University of Washington Medicine Clinical Virology Laboratories.

By late April, Hologic, Cepheid, Roche and Abbott were all selling COVID-19 tests for their automated machines. Lab workers could load samples into the devices, sometimes hundreds at a time, and walk away.

Those companies became critical to the U.S. response. A May survey from the Association for Molecular Pathology (AMP) showed 47% of labs listed one of them as its primary COVID-19 testing system.

For states seeking to boost testing capacity, the most sought-after machine has been Hologic's Panther, which can process up to 1,000 tests in 24 hours, state filings show.

"The demand has been amazing. We feel very proud of the role we're playing," Hologic CEO Stephen MacMillan told an investor conference in June.

The company "had virtually every governor in the U.S. just talk to us directly over the last few weeks, months, pleading their case for why they need more," he said.

Twenty nine states and cities planned to buy a total of at least 51 Panthers, which are also used to test for HIV and other infections. Officials in Washington and North Carolina told Reuters they were still waiting on delivery.

However Hologic is not making enough COVID-19 kits to run on its existing machines - about 1,100 across the country - at capacity. At full tilt, the machines could process about 33 million tests per month, but the company makes roughly 4.8 million.

Hologic said its manufacturing teams were working around the clock while it hires more people and invests in new equipment to increase production. The company said it had already made "a huge contribution" to testing, making it possible for labs to generate more results with less hands-on time.

The runner-up in states' plans was Cepheid, with 45 of its GeneXpert machines on wish-lists. The company, which has about 25,000 machines worldwide, is making about 2 million tests per month - enough to run two or three tests globally per machine each day.

Cepheid is focusing on customers that need rapid results, like hospitals, said Chief Medical Officer David Persing. It is working on millions of new cartridges but does not expect a dramatic supply boost until mid-2021.

This month, Arkansas congressional leaders warned in a letter to Vice President Mike Pence that their state's hospitals were testing at 10% of capacity. There are shortages of key supplies from Roche, Abbott, Cepheid and Hologic, said the state's medical director of infectious diseases Naveen Patil.

Roche told Reuters its automated equipment reduces errors, frees up staff and returns results more quickly. The company said it is increasing production capacity, and is "very intentional" about where it sends tests and instruments.

Abbott said it is expanding capacity, and closely managing supply to ensure tests get where they are needed.

Some labs have managed shortages by buying instruments from different vendors, so they can take advantage of whichever vendor's supplies are available. But that also means they run below capacity, according to the Reuters interviews. The AMP survey found 57% of labs were running tests on at least three companies' machines.

"It's pretty much like we went to the buffet and got one of everything," said University of Washington's Baird, whose lab runs most of the state's tests.

But as cases spiked in more than 30 states this month, some labs became overwhelmed as they struggled to get chemicals and disposable parts.

In the months ahead, separate antigen tests and gene-sequencing machines could boost capacity. The National Institutes of Health is working with companies to reach at least 6 million tests per day by December.

Some labs are also turning to suppliers of multi-step tests.

New Jersey's RUCDR Infinite Biologics can run 50,000 samples a day in two steps. Arizona's Sonora Quest recently announced a plan to run up to 60,000 tests a day using similar equipment.

Gary Kobinger, a Canadian researcher best known for his work on Ebola, argues that all diagnostics should be done on open platforms.

"At one point there will be a new pathogen, and the company that makes the cassette that is controlling everything is not going to be able to supply you," he said. "And this is where we are now, right?"

© Thomson Reuters 2020.

©2020 GPlusMedia Inc.

18 Comments
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One can go into great detail in trying to answer the question raised in the title, but the simple answer is that the disastrous response in the USA to the pandemic is due to what appears to be intentional incompetence at the top.

7 ( +9 / -2 )

Well, that's a pretty easy one to answer - you can do all the testing you want....

But if your nation's leader, the one in charge of the response to the virus says things like; "it's contained", "it's just one person from China", "It'll disappear like magic", and "inject disinfectant".....

It ain't going to go well...

5 ( +8 / -3 )

the disastrous response in the USA to the pandemic

The worst bit was NY Gov Cuomo sending coronovirus patients to nursing homes.

But if your nation's leader, the one in charge of the response to the virus says things like; "it's contained", "it's just one person from China", "It'll disappear like magic", and "inject disinfectant".....

You people never learn, do you? Trump never suggested that people inject disinfectant into themselves. I know you won't bother to watch this, but I'll post the link AGAIN anyway -

Trump said WHAT about disinfectant?!

https://www.youtube.com/watch?v=wXARy68kl1E

-6 ( +3 / -9 )

You people never learn, do you? Trump never suggested that people inject disinfectant into themselves. I know you won't bother to watch this, but I'll post the link AGAIN anyway -

Their overriding hatred of Trump short circuits any ability to accurately process information, so I'm afraid you can go on posting the link until the cows come home but it won't have much effect.

-6 ( +1 / -7 )

You people never learn, do you?

America has the 3rd highest mortality rate per capita, that's because there is a far higher rate of positive tests that the actual rate of increased testing, why , because of a failed pandemic response, the math will always prove the deniers wrong

4 ( +6 / -2 )

Their overriding hatred of Trump short circuits any ability to accurately process information, so I'm afraid you can go on posting the link until the cows come home but it won't have much effect.

heres a link for you, all of Trumps words and it doesn't help his case, total failure;

https://www.youtube.com/watch?v=2uLJkpH__os

0 ( +2 / -2 )

wtfjapan

heres a link for you, all of Trumps words and it doesn't help his case, total failure;

https://www.youtube.com/watch?v=2uLJkpH__os

Old clips, from the time when the WTO said the virus has no human/human transmission, when Nancy Pelosi invited peiple to party in Chinatown to show solidarity and when Joe Biden called Trumps travel ban xenophobic.

What is your point showing selective old clips and judge them with current knowlege?

-2 ( +3 / -5 )

kyronstavic

their overriding hatred of Trump short circuits any ability to accurately process information, so I'm afraid you can go on posting the link until the cows come home but it won't have much effect.

Yeah I wonder why I waste my time here too. This really shows the power of the media, doesn-t it? The consumers of CNN, NYT, Guardian etc. have been whipped into such an emotional frenzy that rational thought has been completely shut off.

-2 ( +2 / -4 )

What is your point showing selective old clips and judge them with current knowlege?

what are you talking about , all show Trump downplaying there virus from when it first started, claiming victory once the curve went down, then once he told stated to reopen and it spiked again , he still downplayed it shifting blame right up to July 22. Trump has been constituant from Jan 22 to July 22

and that's why coronavirus is now the Trump virus, covid45,

thats the way it is. Donald Trump

1 ( +4 / -3 )

Yeah I wonder why I waste my time here too.

dont worry Trump will be gone soon then you can waste your time on another site.

2 ( +4 / -2 )

wtfjapan

dont worry Trump will be gone soon then you can waste your time on another site.

If he is replaced with the current suggestion for replacement, you better knock on wood we survive that insanity. You really want a guy with early stage dementia in control of China policy and the nuclear button? The mind boggles.

-4 ( +2 / -6 )

That's an easy question - Trump!

5 ( +6 / -1 )

 You really want a guy with early stage dementia in control of China policy and the nuclear button? The mind boggles.

You really want a guy you has beginning stages of Alzheimer's same thing that killed his father, a man whos overweight and unhealthy eating, Trumps a walking heart attack, stroke waiting to happen. Id be fine placing a bet that Biden will outlive Trump and have far more of his mental faculty intact. Trump is unwell both physically and mentally, his total failure for the last 3.5 yrs is proof of that

0 ( +2 / -2 )

The number of daily new cases in US is alarming considering the following,

The US Environmental Protection Agency reported the following products effective against the coronavirus, COVID-19,

https://www.healthline.com/health-news/lysol-disinfectant-approved-for-use-against-covid-19-heres-what-else-can-work

Also, status of Japanese drug Avigan,

https://en.wikipedia.org/wiki/Favipiravir

0 ( +0 / -0 )

https://www.healthline.com/health-news/lysol-disinfectant-approved-for-use-against-covid-19-heres-what-else-can-work

yes bleach is a good disinfect same with alcohol , but its most certainly not good to inject, as it will kill you

2 ( +3 / -1 )

I went to a restaurant two days ago to pick up an order I called in.

I walked in with my mask and was met with the place packed full of people, side by side at the bar, all tables full, a bar area packed shoulder to shoulder and not a single person wearing a mask. And bars are supposed to be closed and restaurants at 50% capacity.

Nobody cares.

No one was more than two feet away from each other and they looked at me like I was an idiot for wearing a mask.

It was like the Yamanote at 8:15.

And that is why the city has one of the highest positivity rates in the world (over 24%) and answers the question of "why."

2 ( +3 / -1 )

Trump lovers. Your dear leader declared himself a wartime president back in March. There are now over 150,000 deaths and still counting. The buck stops where?

2 ( +2 / -0 )

@ Peter Neil

You weren’t in Japan then, right?

0 ( +0 / -0 )

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