Virginia Tech’s In-House Development of New SARS-CoV-2 Test Shows the Power of University Labs

At the start of the pandemic, scientists at Virginia Tech created a COVID-19 testing lab and a new test for the virus from scratch.

They not only developed an in-house test that avoided reagent shortages that hampered nationwide testing efforts, but also used 3D designed supplies and stable storage media, allowing samples to be transported to rural locations in Virginia without the need for constant refrigeration.

This new protocol to turn a research lab into a testing operation capable of processing more than 130,000 tests for the communities of the Commonwealth of Virginia and Virginia Tech since April 2020, was described in a new article published on July 20 in Nature Communication.

Carla Finkielstein, Associate Professor at the Fralin Biomedical Research Institute at VTC and Scientific Director of the Virginia Tech Molecular Diagnostics Laboratory at the Fralin Biomedical Research Institute, is the corresponding author of the article.

Since testing began, the Molecular Diagnostics Lab has analyzed samples from eight health districts in Southwest Virginia and more than 650 businesses, retirement homes, medical and dental practices, construction sites, and schools.

This publication in Nature Communication provides insight into the tremendous dedication of people, including Dr. Finkielstein and his colleagues, and the successful business they have put into serving not only Virginia Tech, but the entire community. The partnership of faculty, staff, students and academic leaders at Virginia Tech working closely with the leaders of our healthcare services to meet the scientific, regulatory, legal, financial and infrastructural needs necessary for the implementation This program’s artwork represents the Virginia Tech spirit of Ut Prosim at its best. “

Michael Friedlander, executive director of the Fralin Biomedical Research Institute, vice president of health science and technology at Virginia Tech and author of the article

At Virginia Tech, Finkielstein, who is also an associate professor of biological sciences at the College of Science, helped scientists at the university develop a new test. Award-winning cancer researcher, Finkielstein has turned her attention away from her lab and enlisted “a small army of volunteers” at the Fralin Biomedical Research Institute to work around the clock to develop a reliable RT-qPCR-based test that could be validated and submitted to the Food and Drug Administration (FDA) for emergency use authorization review, while avoiding faulty test kits and potential reagent supply chain challenges to the horizon for the nation, Friedlander said.

The Virginia Tech COVID-19 Lab was launched on April 20, 2020, after submitting its emergency use clearance request from the FDA and receiving approval to begin testing. The initiative has helped expand the testing capacity of public health laboratories in southwest Virginia – a critical step in monitoring the spread of the virus in the Commonwealth and slowing the pandemic.

The Virginia Tech Visitors Council has since awarded Finkielstein its highest honor for faculty – the Ut Prosim Scholar Award – for his service to humanity and his work to improve the effectiveness and efficiency of COVID testing. 19 in support of Virginia Tech and the Department of Virginia. of health.

“Dozens of dedicated and caring people have contributed – it’s always more than just an individual effort,” said Finkielstein, who is also affiliated with the Fralin Life Sciences Institute. “I am grateful to work with people who cared about their well-being and came forward when needed. It is an honor to see teamwork making a contribution to people’s lives. “

Virginia Tech is located on the edge of southwestern Virginia, a rural part of the state that includes some counties facing economic challenges. The region’s population is older and lags behind the rest of Virginia in terms of income and access to health care, according to U.S. Census data, making it particularly vulnerable to COVID-19.

Paige Bordwine, Southwest Virginia Regional Epidemiologist in the Virginia Department of Health Office of Epidemiology, and Noelle Bissell, Director of the New River Health District, who worked closely with the Virginia Tech team to validate and implement the tests, are co-authors of the paper.

The Virginia Tech team has developed a test assay that in many cases is more sensitive and specific to SARS-CoV-2 than other molecular tests available. While most other tests target one or two regions of the same gene to identify the virus, the Virginia Tech test targets three, making it more precise and enhancing its ability to detect viral variants. The test can analyze a variety of types of clinical samples, including nasopharyngeal, nasal and throat swabs, and saliva.

To guard against errors, the molecular diagnostic laboratory, located in the new research building of the Fralin Biomedical Research Institute in Roanoke, was designed with physically separate processing stations, controls to report sources of contamination, monitors human error and strict criteria for reporting a sample. as positive.

Because the test was developed in-house, scientists can adapt it quickly to detect new mutations in the virus genome and virus variants and implement it within hours, allowing for faster assessment and better public health response to viral mutations. The laboratory has the capacity to process 7,500 tests per week.

Deborah Birx, former White House coronavirus response coordinator, praised Virginia Tech’s work to develop its own coronavirus testing site and open its campuses amid the global pandemic. In September, she told university officials that only a handful of universities nationwide were performing their own COVID-19 tests.

On November 10, 2020, state officials announced that Virginia Tech’s COVID-19 lab had been selected as one of three exclusive Tier 2 labs in the OneLab network to expand virus testing capability across the Virginia. The laboratory is called upon to receive samples from any health district in the state, based on the most important needs.

The first authors of the article are Alessandro Cela, an analyst in the molecular diagnostic laboratory of the Fralin Biomedical Research Institute; and Carmen Muñoz-Ballester, postdoctoral associate in the laboratory of Stefanie Robel, assistant professor at the Fralin Biomedical Research Institute.

Other authors include Friedlander; Allison Tegge, assistant research professor in statistics at the Virginia Tech College of Science; F. Marc Michel, associate professor of geosciences at the Virginia Tech College of Sciences; Harald Sontheimer, former professor at the Fralin Biomedical Research Institute; Robyn Umans, former postdoctoral associate in Sontheimer’s laboratory at the Fralin Biomedical Research Institute; Dipankumar Patel, former researcher at the Fralin Biomedical Research Institute; Tewari, former assistant research professor at the Fralin Biomedical Research Institute; Oscar Alcoreza, former graduate research assistant in Sontheimer’s laboratory at the Fralin Biomedical Research Institute; and Thomas Maynard, associate research professor in the laboratory of Anthony-Samuel LaMantia, professor at the Fralin Biomedical Research Institute; and Daniel Martinez-Martinez, postdoctoral researcher at the MRC London Institute of Medical Sciences.

The document serves as a model that could help research institutes act quickly to speed up viral testing protocols, navigate regulatory requirements and support testing in rural communities – in the event of another global pandemic.

“By openly sharing our experience in the development and implementation of a diagnostic test born out of the need of our community, we hope to inspire other university labs to overcome obstacles and provide assistance to their communities if they arise. Infectious disease problems arise in the future, ”said Finkielstein. .