Can labs that test animals run tests on humans? And, if so, what role are they playing in the national pandemic, and how much is it helping?
This article was published on Wednesday, August 5, 2020 in Kaiser Health News.
Adm. Brett Giroir, assistant secretary for health at the U.S. Department of Health and Human Services, during an appearance on CNN's "State of the Union" with Jake Tapper, July 26, 2020
In a heated exchange late last month on CNN's State of the Union, host Jake Tapper pressed Adm. Brett Giroir, the Health and Human Services assistant secretary who oversees COVID testing efforts for the Trump administration, on why the government isn't requiring commercial labs to increase testing capacity in order to speed turnaround time.
Giroir's response described a series of steps — some unusual — being taken by the federal government. One focus was on the role veterinary labs, including those with special certification, could play in helping to build capacity. "Five veterinary labs have their CLIA certification to officially test human patients," he said. "There are a lot of labs who are doing surveillance testing that don't need the CLIA certification."
He was referring to certification under the Clinical Laboratory Improvement Amendments of 1988, a federal law that sets the standard for labs that test human specimens.
So that got us wondering: Can labs that test cattle, chickens or your pet Fido run tests on humans? And, if so, what role are they playing in the national pandemic, and how much is it helping?
After all, the issue of expanding lab capacity will likely come up repeatedly as demand for testing increases with mounting case counts. Turnaround times at some labs have grown, with results now taking days to more than a week in some areas, frustrating consumers and public health officials. Delays for test results mean delays for contact tracing and quarantining. The administration's pandemic response, including testing issues, is also proving to be a hot topic on the campaign trail.
We reached out to HHS for more information about Giroir's statement.
An HHS spokesperson emailed a list of nine veterinary labs that have received the required certification to do patient-specific human testing, saying Giroir had been mistakenly briefed before the interview that there were only five. A U.S. Department of Agriculture spokesperson said there are 15 National Animal Health Laboratory Network facilities nationwide that have CLIA certification to test human samples. Clearly, there are vet labs in the U.S. with the necessary credentials, but the exact number is a matter of confusion.
As for the surveillance efforts, the HHS spokesperson did not provide specific examples of veterinary labs doing such work but provided a Centers for Medicare & Medicaid Services FAQ saying labs that don't have CLIA certification can do some types of surveillance if results are not given to specific patients.
Similar Science, Same Machines
Our experts all quickly noted that veterinary labs — especially those that focus on food animals, including cows, pigs and chickens, have long tested for diseases, including many kinds of coronaviruses.
They're on the lookout for microbes that can affect food safety, such as salmonella or E. coli, or diseases that can devastate the animals themselves, including avian influenza, hoof and mouth disease or African swine fever.
Hence, a lot of testing goes on in the 63 food-animal testing labs in 33 states and four Canadian provinces accredited by the American Association of Veterinary Laboratory Diagnosticians, said its executive director, David Zeman.
"In some states, we have more capacity in the vet labs than in the public health labs," he added.
Those vet labs, often affiliated with universities or government agencies, use highly sophisticated equipment, including polymerase chain reaction (PCR) techniques, as do labs focusing on human testing. Many of the COVID tests being done are PCR, which can detect the virus's genetic material.
"It's the same machines, the same science," said Zeman.
However, these are large, full-service labs that deal mainly with farm animals, different from the smaller labs generally found at your neighborhood vet. So, sorry, Fido.
A Different Regulatory Chain of Command
Earlier this year, researchers at Iowa State University found that the testing process for the new coronavirus is similar to that used to test pigs for porcine epidemic diarrhea (PED) virus, a disease that killed thousands of piglets in 2013. Because a lot of labs had updated their equipment and processes so they could check for PED, they were in a good position to help with COVID-19 testing.
Except, of course, it's never that simple.
While the science and technology are the same, the administrative requirements are not.
Veterinary labs must meet standards for accreditation by such groups as the American Association of Veterinary Laboratory Diagnosticians and are overseen by federal and state agricultural agencies.
Human labs also must meet strict standards, including CLIA, and fall under the auspices of other agencies, including the Centers for Medicare & Medicaid Services, the Food and Drug Administration and the Centers for Disease Control and Prevention.
One requirement is that the CLIA lab must have a director who is a medical doctor with specialized experience. Most animal labs are run by, not surprisingly, veterinarians, often ones with Ph.D.s. Some vet labs have formed partnerships with CLIA-certified labs to clear this hurdle. Still, it's a process that can take weeks, so it's not an overnight fix, said Zeman.
Running the Numbers
Sources
CNN's "State of the Union With Jake Tapper" transcript of interview with Adm. Brett Giroir, U.S. assistant secretary for Health and Human Services, July 26
Telephone interview with Mark Ackermann, director of the Oregon Veterinary Diagnostic Laboratory, July 28, 2020
Email correspondence with Michelle Forman, manager, Media Association of Public Health Laboratories, July 28, 2020
Email correspondence with Mia Heck, spokesperson for Department of Health and Human Services, July 28 and 29, 2020
Telephone interview with Gigi Gronvall, a senior scholar at Johns Hopkins Center for Health Security, July 28, 2020
Telephone interview with David Zeman, executive director of the American Association of Veterinary Laboratory Diagnosticians, July 28, 2020
Telephone interview with Thomas Sparkman, senior vice president, government affairs and policy, American Clinical Laboratory Association, July 28, 2020
Email correspondence with Lyndsay Cole, assistant director for public affairs, USDA Animal and Plant Health Inspection Service, July 30, 2020
American Veterinary Medical Association, "Veterinary Labs Continue to Support COVID-19 Testing," July 1, 2020
The Washington Post, "This Veterinary Lab Is the Linchpin in One State's Coronavirus Testing Approach," May 12, 2020
American Association of Veterinary Laboratory Diagnosticians, "Requirements for an Accredited Veterinary Medical Diagnostic Laboratory," accessed July 29, 2020
Neoteryx, "How Veterinary Diagnostic Labs are Supporting Human COVID-19 Testing," July 13, 2020
Centers for Disease Control and Prevention, "Clinical Laboratory Improvement Amendments," Aug. 6, 2018
Johns Hopkins University Coronavirus Resource Center, accessed July 29, 2020
The Atlantic, "US Historical Data," The COVID Tracking Project, accessed July 29, 2020
Centers for Medicare & Medicaid Services, "Frequently Asked Questions: SARS-CoV-2 Surveillance Testing," June 19, 2020
But can these labs really make a difference in the testing backlog?
A June article on the American Veterinary Medicine Association website quoted an official in May saying that the then-seven CLIA-certified vet labs had the capacity to process 12,000 PCR samples with a 24-hour turnaround.
Zeman said he sent out a survey in July to his 63 members in response to an HHS inquiry and found that, on average, each lab — if CLIA-certified — could process 500 to 1,000 COVID samples a day on top of what it needs to do to monitor animals.
"Multiply that by 60 some labs and you have a rough idea of what they could do," he said. The math adds up to at least 31,500 tests a day.
Currently, more than 700,000 samples are taken daily and sent to all types of labs — mainly large commercial and hospital-based facilities, according to tracking by Johns Hopkins University. The Atlantic's COVID Tracking Project notes similar testing numbers at the end of July.
More vet labs participating "could ease the burden on these labs, but it doesn't sound like a game changer in terms of wait times," said Gigi Gronvall, a senior scholar at Johns Hopkins Center for Health Security.
Some vet labs are working with public health labs to "test a specific segment of the population (university students, routine screening of government workers, etc.)," said Michelle Forman, media manager for the Association of Public Health Laboratories in an email. "So it's 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."
Giroir said "lots" of labs that are non-CLIA certified labs are helping by doing research or surveillance, but Zeman was not aware of such efforts by such labs in his organization.
Perhaps Giroir was talking about "pooled testing," in which a number of specimens are tested in a batch, speculated Mark Ackermann, director of the Oregon Veterinary Diagnostic Laboratory in Corvallis, Oregon. Under that method, if any batch tests positive, individual specimens from the batch are then each tested to see who is positive.
Ackermann, whose lab has CLIA certification, pointed to another way vet labs might be helping: Many are making the liquid needed for the vials that hold the swabs taken from patients' nasal passages.
Our Ruling
Giroir was correct in saying there are some veterinary labs helping out with COVID testing.
But even if all 63 accredited food-animal vet labs in the U.S. and Canada were pressed into processing human COVID tests, an industry survey estimates it would increase capacity by between 31,500 to 63,000 samples per day. While helpful, that would still be only a small portion of the more than 700,000 daily tests being conducted, which some experts say falls short of what is needed.
Additionally, while vet labs are helping in some ways, Giroir provided little evidence to back up his assertion that "lots" of labs that lack CLIA certification are assisting in surveillance efforts.
We rate this statement Mostly True.
Julie Appleby: jappleby@kff.org, @Julie_Appleby
“Five veterinary labs have their CLIA certification to officially test human patients. There are a lot of labs who are doing surveillance testing that don't need the CLIA certification.”
Adm. Brett Giroir, Assistant Secretary, HHS
KFF Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
KEY TAKEAWAYS
Adm. Brett Giroir, HHS assistant secretary who oversees COVID testing efforts for the Trump administration, said one focus was on the role veterinary labs, including those with special certification, that could play in helping to build capacity.
He was referring to certification under the Clinical Laboratory Improvement Amendments of 1988, a federal law that sets the standard for labs that test human specimens.
HHS says nine veterinary labs have received the certification to do patient-specific human testing, and that Giroir had been mistakenly told there were only five.