Health officials are considering tapping into farm-animal testing labs to help process backlogs of coronavirus test samples, which recently were coming in at a rate of 700,000 per day, Julie Appleby reports for Kaiser Health News.
US officials seek solutions to coronavirus testing backlog
Labs around throughout the United States have faced backlogs of coronavirus tests as new cases of the virus surged and demand for the tests increased. In some cases, turnaround times for test results recently were taking longer than a week, resulting in delays for contact tracing and isolation after a positive test result.
When asked about increasing testing capacity at commercial labs to shorten the turnaround time, HHS Assistant Secretary Brett Giroir recently said that Trump Administration was considering using an unusual resource to boost testing capacity: veterinary labs. However, Giroir said the labs would have to be certified under the Clinical Laboratory Improvement Amendment (CLIA) of 1988, which specifies standards for testing human specimens.
According to a spokesperson for HHS, nine veterinary labs have received CLIA certification to do patient-specific human testing. And a spokesperson for the Department of Agriculture said 15 National Animal Health Laboratory Network facilities in the country have CLIA certification to test human samples.
Giroir also said, "There are a lot of labs who are doing surveillance testing that don't need the CLIA certification." According to HHS, CMS permits some labs that do not have the CLIA certification to conduct certain types of surveillance so long as results aren't given to specific patients.
Why using animal testing labs could work
According to Appleby, experts said the plan could very well work, noting that most veterinary labs that specialize in "food animals" such as pigs, chickens, and cows have a history of testing for coronaviruses and other diseases that can affect animals—including hoof and mouth disease—or microbes that can make food unsafe, including E. coli.
David Zeman, executive director of the American Association of Veterinary Laboratory Diagnosticians, said such tests are routinely conducted at the 63 food animal testing labs in the United States and Canadian provinces. "In some states, we have more capacity in the vet labs than in the public health labs," Zeman said.
And researchers at Iowa State University this year found that the testing process for the new coronavirus is similar to the process used to screen pigs for the porcine epidemic diarrhea (PED) virus, which killed thousands of pigs in 2013. As a result, a lot of the labs are "in a good position to help with Covid-19 testing," Appleby reports.
Moreover, these full-service labs use similar equipment as labs focused on human testing, including polymerase chain reaction (PCR) techniques, which is currently being used for coronavirus testing. "It's the same machines, the same science," Zeman said.
In fact, an article published by the American Veterinary Medicine Association in June said that the CLIA-certified vet labs—which numbered only seven at the time—could process 12,000 PCR samples within 24 hours. Separately, Zeman said survey responses from 63 members in July revealed that each lab, if CLIA-certified, had the capacity to process an average of 500 to 1,000 coronavirus testing samples per day.
But Appleby reports that, when it comes to human testing, things are "never that simple."
While some animal labs have the technology to analyze human samples, a lot of labs don't meet the standards for accreditation by federal and state agencies and groups like the American Association of Veterinary Laboratory Diagnosticians. In addition, human labs are required to meet standards set by CMS, FDA, and CDC.
"One requirement is that the CLIA lab must have a director who is a medical doctor with specialized experience," Appleby reports. However, most animal labs are run by veterinarians with PhDs—and while some vet labs have partnered with other CLIA-certified labs to qualify, the process can, according to Zeman, take weeks.
Are animal labs our last hope?
Gigi Gronvall, a senior scholar at Johns Hopkins Center for Health Security, concluded that soliciting vet labs to process samples "could ease the burden on [commercial] labs, but it doesn't sound like a game changer in terms of wait times."
Appleby reports that even if all 63 of the food-animal labs were CLIA-certified and processed human coronavirus tests, it likely would increase capacity by between just 31,500 to 63,000 samples per day, which "[w]hile helpful … would still be only a small portion of the more than 700,000 daily tests being conducted," Appleby writes.
That said, Michelle Forman, media manager for the Association of Public Health Laboratories, said some vet labs are already partnering with human health labs to help "test a specific segment of the population (university students, routine screening of government workers, etc.)," which Forman said is "not so much taking existing burden off of the public health labs and commercial labs but it is preventing additional burden from being put on them."
And Mark Ackermann—director of the Oregon Veterinary Diagnostic Laboratory which has CLIA certification—said some labs might be helping by manufacturing the liquid that holds the patients' nasal swabs in vials.
Overall, however, according to Appleby, there's "little evidence" that many labs without CLIA certification are currently participating in other research efforts, such as surveillance (Appleby, Kaiser Health News, 8/5).