Animal health laboratories aid testing for COVID-19 in people
Several partner with human health care, work under existing approvals
May 13, 2020
Veterinary diagnostic laboratories are helping overwhelmed public health laboratories identify COVID-19 in people.
The U.S. had conducted 17,717 tests through March 12, according to COVID Tracking Project estimates. By April 12, the total was up to 2.8 million. As of May 3, the project estimated the U.S. had run 7 million tests.
One veterinary laboratory—the Oklahoma Animal Disease Diagnostic Laboratory at Oklahoma State University—conducted polymerase chain reaction–based assays on more than 10,000 nasopharyngeal swabs in three weeks.
Dr. Jerry Ritchey, interim director of the Oklahoma State laboratory, said state public health authorities had trouble keeping up with the volume of incoming samples. The OADDL worked with the governor’s office, state public health department, and partners in the OSU Center for Health Sciences to become eligible to accept samples from humans.
“At our diagnostic laboratory, we had the equipment and expertise to perform high-volume testing because that’s what we do normally,” Dr. Ritchey said.
That typical work includes testing for animal disease outbreaks and conducting disease surveillance. But Dr. Ritchey and other laboratory directors said working in human health care involves additional procedures and standards for processing individual tests as well as meeting the documentation and privacy requirements for each patient.
Testing at OSU began at the end of March, and about 4% of the samples sent from human health facilities tested positive for SARS-CoV-2, Dr. Ritchey said.
The Centers for Medicare and Medicaid Services, a federal agency within the U.S. Department of Health and Human Services, regulates all diagnostic testing on humans in the United States—with exceptions for research—through the Clinical Laboratory Improvement Amendments program. The agency certifies about 260,000 laboratory entities through that program, according to CMS.
Veterinary diagnostic laboratories usually have no need for CLIA certification. The laboratory directors at OSU and veterinary diagnostic laboratories at Colorado State University and Oregon State University, instead, formed partnerships with human health care laboratories to work under their existing certifications.
Dr. Ritchey said Anil Kaul, MD, from the OSU Center for Health Sciences, was working as clinical director for the veterinary college’s COVID-19 diagnostic testing, meaning reports from the laboratory bore his name as the person responsible for those test results.
A CMS spokesperson said a veterinary degree meets the education requirements to direct a CLIA-approved laboratory conducting high-complexity testing, although a veterinarian also would need certification by one of the HHS-approved boards that evaluate the qualifications of individual laboratory directors.
Veterinary laboratories capable, if called
Though the U.S. Department of Agriculture coordinates animal disease responses, the veterinary laboratories decided on their own whether to help test human samples for the virus, without federal coordination, said Joelle R. Hayden, spokesperson for the USDA Animal and Plant Health Inspection Service. The agency runs the National Animal Health Laboratory Network, which was monitoring the laboratories’ capacities to test for animal diseases while they aided the COVID-19 response.
On April 15, World Organisation for Animal Health (OIE) authorities published guidance stating that veterinary laboratory personnel possess the skills and experience to help public health services meet the surge in demand for diagnostic testing for SARS-CoV-2 in humans.
“Testing of human specimens in veterinary laboratories should be part of a coordinated government-led Public Health response and laboratories performing COVID-19 diagnostics should ensure they comply with regulations regarding the laboratory testing of human specimens,” according to the guidance.
VDL officials also need to consider the impact of the added work on animal health and welfare, veterinary public health, trade, food safety, food security, and their own people and finances, according to the OIE guidance. Keeping laboratory staff members healthy is the priority, and laboratory managers should stagger employees’ schedules and evaluate their health daily.
Recommendations from an American Association of Veterinary Laboratory Diagnosticians task force state that member laboratories have limited resources to maintain their capacities for animal health work while they help peers in human health respond to the pandemic. The document focuses on testing for SARS-CoV-2 in animals, encouraging testing only on individual animals on the basis of health and COVID-19 exposure, rather than any blanket testing that could compete with public health laboratories for resources.
Dr. Deepanker Tewari, 2020 AAVLD president, said in an April newsletter to members that all veterinary diagnostic laboratories remained open to provide essential services. Many tested animals, aided human testing, or found other means of supporting public health.
“It is for every member to realize that our efforts and work are more important than ever,” he wrote.
Veterinary laboratories aid state, local efforts
The Louisiana State University School of Veterinary Medicine hosts the River Road Testing Lab, a facility set up during the pandemic to process COVID-19 virus tests in people. The laboratory is a collaboration with 18 local medical facilities, said Ginger Guttner, communications manager for the veterinary school.
Diagnosticians began work in the laboratory March 23 and processed about 2,500 samples in the first month. A physician at a nearby hospital helped the laboratory gain CLIA approval. The state had 25,739 total positive human cases and 1,540 COVID-19 related deaths as of April 23.
“Together, we are easing the burden on the other labs throughout the state,” Guttner said.
Dr. Kristy Pabilonia, interim director for the Colorado State University Veterinary Diagnostic Laboratories, said her laboratory accepted its first 60 nasopharyngeal swabs for testing in early April, following a few weeks of validation, resupply, and CLIA registration, which allows human health work pending an audit for full certification. The director of the CSU Health Network laboratory, Bruce Smith, MD, is serving as director of the VDL CLIA laboratory.
The laboratory was ready to handle more testing, Dr. Pabilonia said, and she expected to do more testing in the near future. But she noted that commercial laboratories are taking on increasing numbers of samples as well.
Dr. Pabilonia said that in exercises, her laboratory handled upward of 1,200 animal diagnostic samples in a day. With the different procedures for handling and documenting human samples, she expects the laboratory could handle 300-500 daily.
The Indiana Animal Disease Diagnostic Laboratory, located at Purdue University College of Veterinary Medicine, is working with the human hospital Parkview Health to start conducting COVID-19 tests for human patients. Testing began after the laboratory received CLIA certification to conduct human diagnostic testing, with Parkview agreeing to provide clinical oversight. The laboratory was certified days after Purdue leaders suggested using the ADDL to address the state’s limited testing capacity and need for resources, according to an April 17 university press release.
Dr. Mark R. Ackermann, director of the Oregon Veterinary Diagnostic Laboratory, said physicians and physician groups near the university asked for help processing samples at a time when he and others at the laboratory were looking for ways to contribute. The owners of nearby Willamette Valley Toxicology Laboratory wanted to contribute as well and had CLIA certification but lacked the equipment to perform the testing, he said.
By moving a PCR machine and staff to Willamette’s laboratory, employees of the institutions could work together under the existing approvals, he said.
As private laboratories began testing, state health authorities told Ackermann his animal disease laboratory’s capacity wasn’t needed, Dr. Ackermann said. But nearby physicians still wanted faster testing for their own patients, plus Oregon State University researchers needed a place to test 4,800 samples for an epidemiology study that could help measure community prevalence of the virus.
“We’ll still be handling all of our veterinary samples,” he said. “But we have the capacity to help out with the COVID testing. We want to do that to support the response.”
In April, his laboratory began taking in samples for the study and conducting testing for community members, including commercial fishing employees who will spend months away from shore.
Other laboratories contributed equipment. The Texas A&M University Veterinary Medical Diagnostic Laboratory, for example, sent 2,000 COVID-19 sampling kits to hospitals in cities with TAMU campuses, including Galveston, McAllen, and Fort Worth. Laboratory officials made the kits from their existing stocks of swabs, vials, and transport medium—materials that were back-ordered for months as the need for testing surged.
Later, the TVMDL laboratory in College Station began limited human testing on April 27 through a temporary partnership with a local health care provider, according to a university news release. Since March, Texas A&M System officials had been trying to get exempted from the CLIA certification requirement.
Texas had one of the nation’s lowest rates of COVID-19 testing per capita with 390,560 tests done as of May 4 in a state with a population of 29 million.
Cornell University College of Veterinary Medicine donated medical supplies useful in both clinical care and diagnostic testing, including swabs and transport medium needed by human health care providers.
Dr. Francois Elvinger, executive director of Cornell’s Animal Health Diagnostic Center, said his team contacted the New York State Department of Health with an offer to help conduct PCR assays for human patients, and he said the offer stands. But conducting the testing would involve clearing regulatory hurdles. He also noted that commercial laboratories were increasing testing as well, and they may be more efficient in that work.
Dr. Elvinger’s laboratory adopted staggered schedules so that only half his staff members worked in the laboratory at any time. They handled about 85% of their typical caseload as of mid-April, and he saw a decline in submissions starting in mid-March.
Dr. Pabilonia estimated her laboratory had received about 30% fewer submissions for animal care since the pandemic started, including a substantial drop in routine tests such as vaccine antibody titers.
“We’re still getting the normal amounts of livestock testing,” she said.
In April, the diagnostic laboratory’s site included a notice that laboratory employees continued accepting samples but performed triage to determine the order of testing, and results for routine sampling might take longer than usual.
Submissions to Oregon’s veterinary diagnostic laboratory declined during the pandemic, Dr. Ackermann said.
Dr. Ritchey saw steady numbers of samples during the pandemic. Some of that ongoing work comes from agriculture, where disease sampling continued, but he heard other regions had substantial declines in overall submission numbers.
“There might be a slight downtick, but it’s really not noticeable, to be honest with you,” Dr. Ritchey said.
When health departments catch up, he assumes his role will quietly shift back to solely working in animal health.
“It’s been tough,” he said. “It’s long hours many days—every day, actually. But, overall, it’s been rewarding.”