The process involves rigorous training to ensure safety and deliver accurate results.
When the coronavirus emerged in late December, it wasn't immediately on most people's radars. In China, it was a distant concern, if it was a concern at all.
In the months since, the disease has spread, coming nearer and nearer. It's now actively circulating in communities, threatening friends and neighbors.
The good news is, even though COVID-19 is in our community, so is a dedicated group of friends and neighbors who are helping to fight the disease. While many people are doing what they can to react appropriately to the threat – staying home, social distancing and washing hands – this particular group is taking a more proactive approach, actually helping to test for the disease.
Answering the call
On Feb. 28, Texas Tech University's Biological Threat Research Laboratory (BTRL), part of The Institute of Environmental and Human Health (TIEHH), alerted the Centers for Disease Control and Prevention (CDC) and the Texas Department of State Health Services that it was ready to receive and test samples from across its 67-country coverage area. The BTRL's five-person team could test 84 samples a day.
After the lab's first positive result on March 17, it became apparent that case numbers could increase quickly, and it needed to be able to test more samples each day. With coordination through the Texas Tech Office of Research & Innovation, a collaborative partnership between Texas Tech and the Texas Tech University Health Sciences Center (TTUHSC) was established to increase the capacity of the BTRL to test for coronavirus. In late March, the call went out for volunteers to join the Texas Tech/TTUHSC COVID-19 Testing Team.
The response has been phenomenal.
"More than 60 individuals from a wide array of educational and experiential backgrounds have answered the call," said Steve Presley, director of TIEHH and the BTRL.
Volunteers include undergraduate and graduate students from Texas Tech and TTUHSC, faculty members from both campuses, four laboratory technicians from the Texas Department of Public Safety and several from local hospitals and private clinics.
"On any given day," Presley said, "there are 12 to 16 volunteers and essential full-time faculty, staff, students and non-Texas Tech/TTUHSC personnel directly working at TIEHH executing the COVID-19 testing operations, supported by seven full-time administrative staff personnel on site and dozens of other Texas Tech and TTUHSC administrative staff working off site to keep the COVID-19 testing operations going."
Thanks to their efforts, the BTRL now boasts a guaranteed 24-hour turnaround for testing and an improved capacity of 350 to 400 samples each day.
"TIEHH staff were the first to communicate that the scope of this coronavirus crisis could totally overwhelm our capacity for testing under normal circumstances," said Joseph A. Heppert, vice president for research and innovation. "I am so glad they articulated this concern and then established an approved testing training program that embraces capable individuals from Texas Tech and TTUHSC who have the skills to meet this important regional need."
Jobs to be done
Volunteers can be involved in numerous ways, depending on their previous experience. Those on the accessioning team receive the packages of swab samples that arrive from regional hospitals, clinics and health departments and record information about the submitting facility and patient. Those on the laboratory support team help by cleaning the facilities, restocking shelves and maintaining the supplies necessary to conduct testing.
On the testing side are the individuals who perform the hands-on testing as well as the support personnel who are crucial in maintaining the operation's biosafety level (BSL).
As a BSL-2 pathogen, SARS-CoV-2 – the virus that causes COVID-19 – must be tested within a restricted-access laboratory with self-closing doors, a sink and eyewash. Testing personnel must wear appropriate personal protective equipment and procedures must be performed within a biological safety cabinet.
Because of this, the volunteers chosen to conduct testing must have experience working in a BSL-2 laboratory inside a biological safety cabinet. Since the testing requires extracting nucleic acids specific to SARS-CoV-2, processing them and analyzing the DNA using polymerase chain reaction (PCR) assays, potential testers must demonstrate their ability to perform these tasks.
While many of the volunteers came in with prior laboratory skills, all have received significant training.
"More than 30 individuals who volunteered to assist in the COVID-19 testing initiative have received required initial classroom training addressing regulatory biosafety and biosecurity and also have completed six online training courses," Presley said. "Once engaged and working as a Texas Tech/TTUHSC COVID-19 Testing Team member, individuals receive more advanced training relevant to the specific tasks they will be performing.
"Particularly for the volunteers who are working inside the lab testing samples, they each receive more advanced training on the specific CDC protocols that are being used for testing as well as hands-on training to adequately prepare them to pass a competency assessment."
Cynthia Reinoso Webb, TIEHH's biological threat coordinator, has been key in training the volunteers for their specific tasks both in and out of the lab. In her role as technical supervisor, Reinoso Webb also helps to ensure all testing follows the requirements laid out in the Clinical Laboratory Improvement Amendments of 1988 (CLIA), a set of federal regulatory standards that applies to clinical laboratory testing in the United States.
"Initially, we do an assessment of the educational background, technical skills and experience to determine the role that best fits an individual," she said. "After identifying a role, the training is very specific to the job they will perform. If someone is testing for COVID-19, we follow the training and competency requirements for testing personnel by CLIA."
Once a volunteer's role is determined, that person shadows someone who is already performing that job before they are allowed to work individually. Understandably so, the training requirements are more stringent for those who will perform hands-on testing.
"Testing personnel receive the most training to ensure they are following the testing and biosafety protocols to deliver accurate results," Reinoso Webb said. "A competency exam must be completed by testing personnel. After several times shadowing the testing process, volunteers who will be testing personnel receive blinded spiked samples that need to be tested and reported as patient samples. Results are verified by me and the CLIA High Complexity Testing Lab Director before they are able to test real patient samples."
Even then, the volunteers aren't completely on their own. Every shift has a leader and, usually, a laboratory leader to oversee the different areas from accessioning to testing to reporting.
It's a rigorous process but also a highly valuable one – not only to society at large, which benefits from accurate testing numbers, but also to the graduate students getting hands-on experience in their future field. Of the six Texas Tech and four TTUHSC graduate students directly involved in the testing team's day-to-day operations, three have passed the competency exam and certified to be shift leaders and work in the biological safety cabinet.
'They are committed to what we do'
For Reinoso Webb, who's witnessed the growth and development of such students alongside the BTRL's transition from a team of five to a team of five dozen, it's been a little bit surreal.
"I have been overwhelmed by the response of different people and their willingness to volunteer their time and expertise in this effort," she said. "We have a group of committed individuals who want to do their part in fighting COVID-19, and their team-focused attitude has helped our diagnostic team be successful and deliver fast and accurate results.
"Our lab before COVID-19 was a family, and that has extended to the COVID-19 testing operation, which helps it all work. Our team has amazing, selfless people doing their part because they care about each one of those patients they test. I have seen each one of our leads take on so much responsibility so quickly and give it their all because they are committed to what we do for this region."
To Presley, it's a perfect example of what this region does so well: neighbors helping neighbors.
"Once the call went out for volunteers to work in the lab and support the array of activities involved in sample testing, dozens of people immediately responded from the Texas Tech, TTUHSC and Lubbock community," Presley said. "The true West Texas spirit of our community coming together to aid each other in addressing any challenge has been, and continues to be, clearly evident in the fight against COVID-19."