NEW YORK – While clinical laboratories and the diagnostics industry continue to struggle to meet demand for SARS-CoV-2 testing, discussion has also begun around how to better prepare for coming pandemics.
During a virtual session at this week's American Association of Clinical Chemistry annual meeting on the role of clinical and public health labs in addressing COVID-19, panelists recounted the struggles they had faced in ramping up testing this spring and presented ideas for how the country could avoid similar issues in the future.
They also addressed potential new challenges around influenza testing that could arise as we move deeper into winter, with Kirsten St. George, director of virology and chief of the laboratory of viral diseases at the Wadsworth Center, the public health lab for the New York State Department of Health, noting that despite efforts begun months in advance to plan for the coming flu season, she and her colleagues were still struggling to scale testing to sufficient levels.
The arrival of flu season on top of the coronavirus pandemic "was a major concern, and we had a lot of plans and preparations in place and multiple tests and platforms that we were developing and gearing up to validate," she said.
But delays on the part of manufacturers in either bringing their tests to the US Food and Drug Administration for approval or clearance or getting their tests through the FDA EUA process have, to an extent, stymied these efforts, St. George said.
"We're still waiting for a number of [approvals] to come through for some of our platforms," she said. "It's been a struggle."
Reagent shortages have also undercut the center's flu planning, she said, noting that in particular supplies of probes the lab needs to run a pair of tests it has developed in house have been lacking.
"All of the big oligo manufacturers have been held up for months," she said. "That has been extremely problematic."
These shortages have prevented New York's public health system from meeting a state mandate to test all patients and deceased persons with respiratory symptoms for both COVID-19 and flu, St. George said. "It's just not possible for us to do that, and all of our labs are in the same situation."
She said that the issue has been mitigated by the fact that the country has seen relatively little flu thus far, something her fellow panelist, Morgan Pence, director of clinical and molecular microbiology at Cook Children's Health Care System in Fort Worth, Texas, likewise noted.
"It was definitely a concern early own for our physicians, what happens when we get to flu season and we want to test everyone for flu or COVID," Pence said. "But luckily flu hasn't really panned out to be much yet."
Nonetheless, the difficulties St. George cited highlight the fact that nearly a year into the pandemic, many of the challenges that have hamstrung SARS-CoV-2 testing remain.
"What is the solution, if there is a solution, to preparing ourselves better in the future?" asked Matthew Binnicker, director of clinical virology at the Mayo Clinic, who served as the moderator of the discussion. "Is it centered around working with select industry partners? Is it stockpiling supplies? Is it building out more resources to rapidly produce more tips and reagents and equipment?"
He suggested that regarding the supply chain issues, some sort of high-level government support would likely be required if industry were to maintain the ability to quickly ramp up production of tests, equipment, and reagents in the event of future pandemics.
St. George likewise noted that given the irregular and infrequent nature of pandemics, she "struggle[s] with how you get everybody, including industry, to buy into this concept of having massive ability and all the resources available and at the ready for an indiscernible period of time."
The panelists agreed that future gains in readiness could be made by streamlining the regulatory process.
Binnicker noted that "navigating the complexities" of the FDA's EUA process "was not something that we and probably most clinical laboratories in the United States has extensive experience with."
He added that "while the FDA was an excellent partner throughout the process and worked with us to get the tests authorized in what I thought was a timely fashion," the process was "definitely time-consuming" and that "many clinical laboratories would not have the resources to complete an EUA during a global pandemic."
He suggested that in the future a precertification process in which labs could apply to become certified pandemic testing sites could allow the country to ramp up testing much more quickly than happened in the case of COVID-19.
Such a program might "require the laboratory to have the necessary equipment on site," he said. "They would likely need to participate in a pre-inspection and demonstrate that they are able to follow a CDC testing protocol. They could undergo an annual or biannual recertification process."
This, he suggested, could allow these labs to begin testing in the event of a pandemic with a more streamlined and minimal validation process.
St. George also highlighted the need for more rapid access to clinical samples for test development and, when such samples are not available, the ability to use synthetic samples for such work.
Such samples aren't ideal, she noted, "but it's better than waiting weeks to get real specimens and delaying testing and letting the case count in the community rise rapidly, and then the horse is just outside the gate and gone."
She cautioned, however, against overly relaxing the regulatory process, noting that her experience at Wadsworth demonstrated its value. In March, in response to a lack of testing, the FDA gave the New York State Department of Health permission to authorize New York laboratories to launch their own SARS-CoV-2 tests.
St. George said that the Wadsworth Center, which handled these authorizations, had a simpler approval process compared to the FDA's EUA but that it received a number of applications for testing with significant problems.
"Our requirements for [SARS-CoV-2] LDTs are dramatically reduced below what normally is required for an LDT," she said. "But even with that, we have seen, as FDA saw with many of their submissions, that there were some serious issues with the submissions"
"It's clear that laboratories developing tests still needed some considerable guidance," she said. "So, to not have some crosscheck on them is a very uncomfortable place to be."