Top-tier lab scavenged supplies to test for COVID-19
When the first patients with potential symptoms of COVID-19 began showing up at the University of Virginia Medical Center in early March, doctors there had no way to quickly test for the novel coronavirus.
And as the epidemic unfolded, UVA’s clinical laboratory found that the things they’d counted on to work – developing their own test using U.S. government protocols and using commercially available tests to expand that capacity - failed in the early days, leaving the hospital to fight an uphill battle.
(SOUNDBITE) (English) UVA DOCTOR AMY MATHERS, SAYING:
“Having rapid tests available to in-patient settings is just central to how we’re going to manage some of the resources and the allocations that we need to protect healthcare workers and other patients within hospitals.”
Amy Mathers is an infectious diseases physician at UVA’s hospital and the associate director of its clinical laboratory.
(SOUNDBITE) (English) UVA DOCTOR AMY MATHERS, SAYING:
“Because if you suspect a patient who has symptoms consistent with having a COVID infection, you’re going to have to put them on isolation, up front, until you know that they don’t have that virus.”
UVA opted to use an early test protocol developed by the Centers for Disease Control and Prevention, approved by the Food and Drug Administration.
But things didn’t go according to plan.
Mathers says the CDC protocol was like a complex recipe.
And the ingredients included things the lab simply didn’t have on hand.
(SOUNDBITE) (English) UVA DOCTOR AMY MATHERS, SAYING:
“It is more of a recipe that the FDA signed off on. But that means you have to use the exact ingredients to make that. So, for example, if you were trying to make a nice pasta dinner, you had to get the spaghetti from a very particular supplier, and you had to get the tomato sauce from another supplier, and then you had to get the positive viral control from a different supplier. And the problem was is because this was the only FDA-cleared test, everyone was trying to get the exact same ingredients at the exact same time. So we were really, really hitting supply chain issues.”
And as Americans raced to supermarkets to stock up on necessities, a similar scramble was happening in the laboratory world.
(SOUNDBITE) (English) UVA DOCTOR AMY MATHERS, SAYING:
“The supplies available for diagnostic testing look a lot like the toilet paper shelves at Walmart. And you just cannot get the materials you need to run a test.”
The recipe also called for specific, highly technical instruments.
(SOUNDBITE) (English) UVA CLINICAL MICROBIOLOGIST MELINDA POULTER, SAYING:
“The instrumentation, we went out looking for who has this instrumentation.”
Melinda Poulter is a clinical microbiologist who heads the UVA lab, and said suppliers simply didn’t have enough stock to fill all the orders.
UVA began looking for substitute equipment, scrounging up whatever they could.
(SOUNDBITE) (English) UVA CLINICAL MICROBIOLOGIST MELINDA POULTER, SAYING:
“And nobody had the particular instrumentation that the FDA required, but they had a research version of it.”
And each tweak the lab wanted to make to the official recipe meant UVA had to go back to federal agencies for approval, which cost precious time as they tried to battle the epidemic.
(SOUNDBITE) (English) UVA CLINICAL MICROBIOLOGIST MELINDA POULTER, SAYING:
"So you’d have to validate this and write up some, you know, summary of what you had done to make these changes, and show it didn’t impact the performance of the test. And so, it was a lot of work.”
But their persistence paid off: Within about two weeks of seeing its first coronavirus patients, the hospital was able cobble together the parts needed to meet FDA and CDC standards and run their own in-house tests for the novel coronavirus.
(SOUNDBITE) (English) UVA DOCTOR AMY MATHERS, SAYING:
“Just to be clear, we didn’t write that recipe. We were trying to avoid writing the recipe. And so we didn’t really make our own test. We were just able to finally, through a lot of horse-trading, get the right ingredients, if you will.”
The lab now handles far more samples than some of the state labs that relied on tests supplied by the federal government.
The two agencies that oversaw testing, the Centers for Disease Control and Prevention and the Food and Drug Administration, have cast blame on the other for delays in testing.
The level of virus testing remains low in many states, and doctors and patients are left waiting days for results.
By late March, the UVA lab had more than enough testing capacity to meet its needs, so it began offering to test samples sent by other hospitals in the region.
Mathers says the fight is far from over.
(SOUNDBITE) (English) UVA DOCTOR AMY MATHERS, SAYING:
“I think we’re going to have a long road ahead of us. It is going to be a tough few months, if I’m honest about it. I think the testing, we will have more wide-spread testing capability over the next month you can sort of see it on the horizon as more commercial tests come online, and ramp up production, and so I think that will really help. But I think we’re going to have a lot of hospitalized patients. Different areas are going to crop up at different time points, and I think it’s going to be a really difficult, months ahead.”
