"When we first started identifying people under investigation for COVID-19, the testing was sent to the state lab with turnaround time between 3 and 4 days. By running diagnostic tests now in-house, we've significantly reduced the turnaround time to 6–8 hours, and under 70 minutes for special populations. That's a huge gamechanger," says Dr. Paulina Rebolledo. (pictured center)
Paulina Rebolledo, MD, MSc, Assistant Professor, Emory University School of Medicine, Division of Infectious Diseases, Rollins School of Public Health, Hubert Department of Global Health and Georgia Clinical & Translational Science Alliance (Georgia CTSA) Master in Science in Clinical Research (MSCR) graduate, has worked with her team to scale up an in-house COVID-19 diagnostic test at Grady Memorial Hospital. Two commercial platforms are now being utilized for the testing at Grady. One platform can run a large number of tests with results in 6–8 hours. For rapid testing within 70 minutes, the second platform focuses on special populations where results may have important implications for triaging, such as the obstetrics population with implications in terms of separation between mother and child, or other populations that may need an emergent procedure.
"To set up these in-house diagnostic tests, I collaborated with my fellow infectious disease specialists and Dr. Wayne Wang, Director of Microbiology, Immunology, Molecular Diagnostics at Grady. We worked together to get the protocols in place to collect the specimen and the process of getting it to the lab. For the first two weeks, we concentrated on getting those tests to the health department. As we started to bring the testing platforms into Grady, we performed a validation process to run in-house those same samples that were sent to the state lab. By conducting a comparison of the results to validate the in-house testing, we were then able to go live with the two platforms at Grady and stop sending the tests to the state lab. We are prepped to scale it up to test hundreds of patients at a time if needed," explains Dr. Rebolledo.
One critical aspect, especially in the validation piece, is having good control of the collection process and the quality of those samples in the preanalytical phase to ensure the specimen is properly collected. Continuous communications between the infectious diseases team, the teams that are collecting the specimens, and the lab ensures samples are done in a timely fashion, appropriately labeled and collected, and adequately tested.
"The other piece that's really important is the performance of the test, the sensitivity, and the specificity. It is crucial with the disease presentation for SARS-CoV-2 because information is pouring in very rapidly and it's changing constantly. Beyond how a test performs, we review the timing of the test which relates to the clinical presentation of the disease process," adds Rebolledo. "When a person is tested early during the disease process and the test result is negative, it doesn't mean that person could not have infection with SARS-CoV-2. The test may not be able to pick up copies of the virus at lower quantities. Having a negative test does not exclude the disease if a person is presenting the clinical syndrome or signs that could be indicative of infection. This person could be retested at a different time point, or a different type of specimen could be collected where there may be a higher quantity of virus. For example, doing a nasopharyngeal swab versus doing a lower respiratory sample. As we review testing approaches and how algorithms should be used for different scenarios, we explore beyond how a test performs; we also consider how it clinically correlates with the disease process."
As Co-Director of Emory's Global Health Distinctions Program, Dr. Rebolledo has recently worked on a research study in Bolivia that looked at vaccine performance for the rotavirus vaccine. This study also required significant testing and had a very important preanalytical phase to ensure the biological samples were properly collected, processed and tested, and the results interpreted and correlated to the individual.
"My global health work also employs a collaboration process between the different entities involved. The research studies in Bolivia and this response to a critical clinical situation at Grady both use team science in a way where it’s a multidisciplinary approach. It's the labs working with infectious diseases, infection control, and the teams on the ground. These situations require a team approach and really collaborating together, which is what has been so important to see in this pandemic - that willingness of different entities to be very collaborative for the good of what we're trying to do. It's been very gratifying to see how everyone has come together."
When thinking about the skillset she received through Georgia CTSA’s MSCR program, Rebolledo says, "I learned more about critical thinking and understanding how the performance of different tests come into play. By taking that into consideration with the epidemiology and clinical characteristics, I discovered how to use an overall comprehensive approach. In addition to using team science, the MSCR program showed me the correlation with global health. It is very clear that cross-cultural collaboration and aspects that go beyond our borders very much play a role. The MSCR program helped me approach this disease by realizing we’re all in this together and it’s a global problem. Different aspects interplay, whether travel or different disparities, and that’s true no matter where you go. Thinking about the various aspects of overall epidemiology and population studies are more important than ever before."
The Emory Master of Science in Clinical Research (MSCR) degree program, in the Laney Graduate School at Emory University, provides innovative didactic and mentored research training to those interested in pursuing a career in clinical and/or translational research. The MSCR degree is designed for predoctoral, postdoctoral trainees, and junior faculty from Emory, Morehouse School of Medicine, Georgia Tech and UGA.
The Georgia CTSA is a statewide partnership between Emory, MSM, Georgia Tech, and UGA and is one of over 60 in a national consortium striving to improve the way biomedical research is conducted across the country. The consortium, funded through the National Center for Advancing Translational Sciences (NCATS) and the National Institutes of Health's Clinical and Translational Science Awards, shares a common vision to translate laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train the next generation of clinical investigators. For more information, visit GeorgiaCTSA.org.