Building the Plane While Flying It
July 13, 2020
UH system developed test, increased COVID-19 testing by nearly 20-fold in one month – and progress continues
UH Innovations COVID-19 Special Issue | Summer 2020
Christine Schmotzer, MDThe challenge of developing and ramping up COVID-19 testing during the pandemic has required healthcare professionals nationwide to innovate, collaborate and make almost continuous adjustments as conditions warrant. In Ohio, nowhere has this been more apparent than with the University Hospitals Department of Pathology laboratories.
“Upon the FDA’s release of the Emergency Use Authorization (FDA-EUA) for COVID-19 testing on Feb. 29, we begin planning development of testing for our patient population,” says Christine Schmotzer, MD, Division Chief of Clinical Pathology at UH Cleveland Medical Center, and Associate Professor of Pathology, Case Western Reserve University School of Medicine. “Our initial COVID-19 test relied on the expertise of our UH Translational Laboratory, which has the capability to implement complex, novel molecular and genetic tests stemming from their innovative experience in advanced cancer genomics. We brainstormed, we understood what was out there for us to build off of, and we chose to implement a method based on the CDC’s testing and had that method operational on March 13, just days after the first cases of COVID-19 were detected in Ohio.”
Testing capacity on day 1 was 30 samples per day. Within a week, under the leadership of Navid Sadri, MD, Division Chief of Genomic and Molecular Pathology, UH Cleveland Medical Center, capacity had increased more than five-fold to nearly 200 samples per day, with results returning in 12-36 hours. But still, the need for more and faster COVID-19 testing results continued unabated.
Dr. Schmotzer describes this work of developing and deploying sufficient testing to meet the challenge of the novel coronavirus as something akin to building a plane while flying it.
“To meet demand, UH Laboratories implemented two additional methods using relationships with IVD manufacturers whose products received FDA-EUA approval, completing validations rapidly yet safely to ensure accurate performance of each test method,” Dr. Schmotzer says. “The third method was implemented less than four weeks after the initial method and was deployed to the 11 acute care hospitals in our health system, providing results as fast as 30 minutes from sample collection in a time frame that is critical to supporting emergency department and inpatient clinical care, guiding PPE utilization, and impacting isolation decisions.”
To put this in perspective, within a month of the first cases of COVID-19 being detected in Ohio, UH Laboratories implemented three complex COVID-19 nucleic acid test methods, increased capacity by nearly 20-fold, and decreased time to result for critical patients from 30 hours to 30 minutes.
Dr. Schmotzer describes this work of developing and deploying sufficient testing to meet the challenge of the novel coronavirus as something akin to building a plane while flying it.
“Typically a method would be evaluated in clinical trials and be studied for more than a year, to make sure it can detect virus when it is present and that the presence or absence of virus correlates to the presence or absence of disease,” she says. “All of this is being assessed, evolved, vetted as our tests were being implemented.”
Since the initial ramp-up, UH Laboratories has also added several different COVID-19 testing modalities to build capacity and serve an ever-broader population of patients who should be tested for the virus, Dr. Schmotzer says. One method added, for example, expanded testing capacity by 1,000 tests per day. This has allowed UH to help support testing for other health systems regionally that lack it, as well as to expand its ability to support testing in congregate living facilities such as nursing homes and correctional facilities.
Adjusting to changing conditions has also been part of UH’s successful approach to testing for the virus, Dr. Schmotzer says.
"One of our key strategies has been to diversify across these platforms because there have been significant shortages of reagents,” she says. “As there were shortages, we would evaluate different types of swabs, different types of materials and keep slightly tweaking and modifying the test so that we could keep operating. Each vendor has limitations in supplies, so we needed to get creative in how we were still able to support our patient needs.”
As the standard work of running COVID-19 tests continues, Dr. Schmotzer and her colleagues in UH Laboratories are also working to understand which tests work best – and how they might be improved. In April, she and her colleagues published a paper in the Journal of Clinical Microbiology, comparing Abbott ID Now, Diasorin Simplexa, and CDC FDA EUA methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from individuals diagnosed with COVID-19.
“The other thing that we’ve done is that we have validated alternate sample types,” she adds. “We will continue to look at ways that can make the collection easier for patients. Early on, we did supervised self-collected nasal swabs. We have actually walked back from that based on feedback from the patients – they didn’t feel that they were getting the healthcare service they needed if they had to do it themselves. But the data looked very good for them to successfully do that. It can decrease the PPE needed by the healthcare providers in contact with them. We’re also looking at saliva, with minimally invasive and non-aerosolizing approaches to collection. There are some reports out there that that can be a successful sample and somebody can collect it and bring it to you without the aerosolization risk. We also have tested stool – there is some evidence that the virus is shed in the stool and this could provide an alternate sample.”
As the pandemic continues, Dr. Schmotzer says these constant refinements and adjustments to testing will be all the more necessary. She and her colleagues will keep up their work contributing to the science of COVID-19 testing.
“We’re both assessing and contributing to the literature,” she says. “That’s all in the vein of finding alternate ways to detect the virus, recognizing that we don’t know yet how and where it’s best detected.”
Christine Schmotzer can be reached at 216-553-1947.
UH COVID-19 Research Information