Animal Disease Diagnostic Laboratory Receives CLIA Recertification

Friday, June 24, 2022

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We all remember the announcements that flooded our phones as the pandemic unfolded in 2020 – each new day seemed to bring with it new instructions about social distancing, mask wearing, disinfecting and limiting group meetings to smaller numbers due to the spread of the virus. As the pandemic made an ever-increasing global impact, these measures eventually affected schools and workplaces, and teachers and administrators were faced with the reality of needing to conduct lessons and meetings over virtual platforms. At the time, we had no idea how long these circumstances would last. Two years later, we can now reflect on how far we’ve come. A significant part of the pandemic response took place on university campuses and Purdue University soon emerged as a shining example of how to safely re-open for in-person instruction in part because of the pivotal role played by the College of Veterinary Medicine’s Animal Disease Diagnostic Laboratory.

As Purdue crafted its Protect Purdue plan, the need for efficient and accurate testing surfaced as a key priority, so that tests could be run on samples from thousands of students, faculty, and staff. Testing had to be available to anyone on campus experiencing symptoms, as well as people selected for surveillance testing. The ADDL responded to the need and has been an essential part of the success of the Protect Purdue plan since April 2020.

Erin processes a sample under the hood in the lab as Rebecca looks on from behind her
Laboratory Technician Erin Christian processes COVID-19 samples in the ADDL’s Molecular Lab as Dr. Rebecca Wilkes, head of the Molecular and Virology Sections looks on.

The ADDL’s journey into testing in support of Protect Purdue began when the lab, which routinely performs tests that identify animal diseases, pursued the necessary certification to be able to conduct high complexity testing on human samples. Laboratories are required to obtain Clinical Laboratory Improvement Amendments (CLIA) certification before performing diagnostic testing on human samples. Even though the ADDL routinely performs clinical diagnostic testing on thousands of animal samples, acquiring the CLIA certification was not something that was done by animal diagnostic labs prior to this pandemic. Yet, being part of a university known for persistence, resilience and dogged determination, sure enough, after filing the proper applications, following each small step in the certification process, and proving to the state officials that we had the proper training, the ADDL received its CLIA certification. The lab then began performing COVID-19 testing on thousands of samples in support of the Protect Purdue protocols and Big10 regulations, and even expanded its efforts to a local hospital and college. Furthermore, ADDL staff went the extra mile to arrange extra shifts to provide Purdue athletes with quick test results before game times.

The ADDL’s expertise also enabled the lab’s diagnosticians to not only detect COVID-19 but also to differentiate between variants of the virus by conducting sequencing, and then to share this information on state and national levels. And their work didn’t end there – the ADDL continues to perform PCR tests and sequencing today.

According to Dr. Kenitra Hendrix, director of the ADDL and clinical associate professor of veterinary diagnostic microbiology, the lab performed sequencing on more than 1,200 samples since August 2021. The total number of PCR tests conducted as part of the COVID-19 testing effort exceeded 212,300 as of this spring. “The ADDL is prepared for high volume testing during disease outbreaks,” said Dr. Hendrix. “We have the trained staff, proper equipment, necessary laboratory workflow, and established testing protocols in place. A rapid diagnostic response is critical to the authorities for decision making in times of crises. Disease mitigation and control depends on these test results. We were able to apply our capabilities related to high-consequence disease testing to the SARS-CoV-2 pandemic starting in April 2020.”

A Protect Purdue Summary Report published by the University found that, overall, the University was more efficient, effective, and responsive in helping to ensure the safety of its students, faculty, and staff throughout the pandemic with the benefit of the testing that the ADDL was able to perform, thanks to its CLIA certification. Perhaps the most exciting news since then is that, recently, the lab sailed through the CLIA recertification process. This success holds great significance because the lab is able to continue to run PCR testing on new COVID-19 cases and track the variants of the virus using sequencing technology even as the pandemic seems to subside.

The ADDL couldn’t have achieved such outstanding accomplishments without the vast expertise and dedication of its team members. Congratulations to the ADDL on receiving CLIA recertification, and thank you to each and every one of the faculty, staff, and students who have made it their mission to help Protect Purdue.

Writer(s): Madeline Brod, PVM Communications Intern |

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