SERIES: Meeting the Needs of a Rural Community During the COVID-19 Pandemic: The Ups and Downs of Starting a University Based Clinical Lab for COVID-19 Testing, From Idea to Final Completion

By Karyn Fay - December 07, 2022

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At the beginning of the COVID-19 pandemic, Michigan Technological University in Houghton, Michigan, was tasked by the State of Michigan to develop a clinical laboratory capable of providing RT-PCR testing for the Western Upper Peninsula of Michigan. Using the resources and expertise available, the clinical laboratory was developed, and over the course of 20 months was able to meet the ever-changing demands associated with the pandemic. The following narrative describes the evolution of the testing lab from inception to closure. Read Part I , Part 2, Part 3, Part 4, and Part 5

Part VI: A New Rise in Cases and Testing Numbers 

In August, with the start of the next school year, the University had gone back to Level 2 Status, meaning masks were required indoors on campus. On-demand testing was being offered and it was decided the lab would stay open all Fall Semester. There would be no surveillance testing. With the current staff, the lab could run 300 samples per week if necessary.  

It was also learned at this time that the CDC was withdrawing the EUA on the Qiagen test systems on December 31, which was the backup system for the KingFisher. 

The Delta variant was beginning to rear its ugly head. Forty-nine counties in Michigan had detected Delta, including 6 cases in Houghton County and 2 in nearby Gogebic County. Of the variants reported in the State of Michigan, 98.9% were Delta (information per an online meeting with State Health Lab, 8/16/21). As the next few weeks progressed, Delta was increasing at a high rate. 

The first day of classes was August 30, and on-demand testing numbers were high, primarily with the student population. 

Our KingFisher was being recertified and the new OSHA standards were being monitored carefully. 

As the fall semester progressed, our positivity rate hovered around 8% with an increase of on demand testing at the University. This started to slowly rise in mid to late October. At that time the community samples had gone down to zero, as local facilities could handle their own patient volumes. The Western UP Health Department was also online with COVID-19 testing for the community overflow. It should be noted our General Supervisor was now employed at the Western UP Health Department and had been replaced with a new General Supervisor for the MTU-COVID-19-Lab. 

The next round of proficiency samples arrived with 100% success, and the lab was still in communication with COLA for an on-site visit.  There were still a lot of University samples being submitted, most of them from the student athletes who needed to be tested often. It was necessary to bring on more employees for logging and reporting, RNA extraction, and analytical PCR testing. 

Thanksgiving break would soon be upon us, so planning for that was a factor.  

By the end of October, the positivity rate was at 10%. The on-demand testing was becoming an issue, as employees with no symptoms were coming in regularly for swabbing and testing. Our staffing was tight, so this issue was addressed at the University level. 

Lab Closure 

By mid-November the positivity rate in the state was up to 14%, primarily Delta. The MTU lab saw a 12% positivity rate. It was decided at this time that with the new testing capacity in the region, the MTU COVID-19 lab had served its purpose and it was time to decommission the lab at the end of the semester. December 17, 2021, was the date the lab would be done. It would be an abrupt end, not just a tapering off. The lab space was in demand and the COVID-19 Lab had to be out by the start of Spring Semester, January 2022. During this last month, loose ends needed to be addressed. COLA had never been able to schedule an onsite visit, so it was necessary to find out the protocol. It was a disappointment to not have the site visit, to see exactly how we stood after starting a lab from scratch, in a three-week time span, completing over 40,000 tests over a period of 21 months. MTU would continue to swab students and employees, but the samples were being turned over to the Western UP Health Department for testing. 

The instrumentation and infrastructure items, such as safety cabinets, refrigerators, freezers, etc. would be returned to the entities that shared with the COVID-19 Lab or given away to those that had use of them. Employees would return to their “real” jobs at the University. On December 16, 2021, the last run of COVID-19 samples was completed. From conception of the idea to the completion of the final run, 40,000 samples were completed. (Figure 6) 

And the lights went out. 

   

Figure 6: The numbers, from inception to conclusion. (A) The positivity rate through time of the tests performed by the MTU COVID-19 Testing lab. (B) The test volume through time performed by the MTU COVID-19 Testing lab. 

 

In Summary 

Michigan Tech University answered an emergency call to start a clinical laboratory to process and test samples from the Western Upper Peninsula of Michigan. This was a major learning experience, but no one said, “We can’t do this.” Rather, everyone said, “Let’s do it!”  The lab was fortunate to have qualified Medical Laboratory Scientists, virology expertise, and PCR instrumentation with qualified people to analyze samples. A laboratory director was found, who volunteered his time, and the necessary CLIA, COLA, and proficiency testing certifications identified and approved. Personnel from across campus jumped in and volunteered their time.  This included everything from billing, specimen drop off, researchers, legal experts, laboratory experts, and everything else in between. It was a cohesive team. Between March 2020 when the call first was raised, to December of 2021, the MTU COVID-19 testing lab housed in the Great Lakes Research Center, was able to analyze more than 40,000 samples. This effort impacted not only MTU, but also the communities of the Western Upper Peninsula of Michigan, during these unprecedented times. 

 

This venture would not have been possible without the extraordinary help from the following departments at Michigan Technological University: 

Biological Science, Biomedical Engineering, Chemical Engineering, Chemical Stores, College of Forest Resources and Environmental Engineering, Facilities Management, Financial Services and Operations, General Counsel, Information Technology, Medical Laboratory Science, University Marketing and Communications, Vice President for Government Communications, Vice President for Research, and the many graduate and undergraduate students across campus who shared their expertise and professionalism. 

 

 

Karyn Fay

Former Laboratory Liaison, MTU COVID-19 Lab

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