Part 2: Grant Funds Pathologists’ COVID Research

This is the second part of a two-part series covering the impact of the John H. Rippey Grant for Expedited Research on pathologists and their research. Read part one to learn how the grant was repositioned to address COVID-19 and how it provided unique opportunities for pathology residents.

In the spring of 2020, medical laboratories across the US were overwhelmed as they tried to implement reliable and effective solutions to meet the demand for COVID-19 testing. The CAP Foundation helped fund research for pathologists to conduct key research that would ultimately lead to better results for patients. Highlighted below are two pathologist grant recipients and their research initiatives.

Variability Specifications for Rapid COVID Tests

As diagnostic companies rushed to manufacture and distribute much needed tests for COVID-19, pathologists and other researchers needed to investigate the reliability, variability, and accuracy of these new tests. Brad S. Karon, MD, PhD, FCAP, of the Mayo Clinic, had the background to lead an innovation group to evaluate rapid and point-of-care tests for the novel coronavirus.

Brad S. Karon, MD, PhD, FCAP

“I have extensive expertise evaluating new point of care diagnostic tests but began to interact with many new diagnostic companies that were making rapid or point of care molecular tests for COVID-19 as their first diagnostic test available in US,” Dr. Karon explained.

Dr. Karon and his laboratory team noticed high variability among different cards and reagents for tests, which is usually a major source of error, he explained. To help address the issue, researchers wanted to combine user feedback on test performance with raw data from users—as opposed to internal testing in a controlled environment—which could aid vendors who were still working to develop and improve tests.

As the team examined the data, they recorded a very high rate of invalid results at 44% reportedly due to issues with the design of the test card, instrument, and software algorithm. Dr. Karon explained that eventually the company redesigned the card port for better sample flow, the fluidics in the card to promote filling of sample wells, the software algorithm to reduce false positives due to wells not filling, and the instrument design to avoid dust build-up on instrument optics.

Thanks in part to funding from the CAP Foundation, Dr. Karon and his team at Mayo Clinic were able to not only improve test performance but also provide a framework for other researchers.

He said, “We hope the study will serve as a template for how point of care programs and laboratories can interact with test developers to improve new diagnostic tests during pandemics and in other situations …”

Informatics Analysis of COVID Serology and Severity

Wade L. Schulz, MD, PhD, FCAP, received a Rippey Grant from the CAP Foundation in 2020 as he recognized research potential during the COVID-19 pandemic that could help determine the performance of testing assays.

Wade L. Schulz, MD, PhD, FCAP

“Most recently, my research has focused on the use of real-world data to identify appropriate patient cohorts to be used in outcomes research,” Dr. Schulz said. “This proposal allowed us to integrate real-world data along with protocol-driven research to assess the performance of SARS-CoV-2 serology in a longitudinal population.”

The project eventually provided Dr. Schulz and his colleagues at Yale School of Medicine with insights that informed their decision to select the right single platform for COVID-19 serologic testing while also validating a series of other assays and their performance—they ultimately decided on the Roche assay but confirmed the two others under review from Disaorin and Euroimmun both achieved good performance.

Dr. Schulz said their proposal provides several takeaways for pathologists and other laboratory professionals. It serves as a reminder that using an informatics-based approach to identify clinical specimens is an effective method for the rapid validation of clinical assays.

He added, “Real-world performance can provide valuable insights into assessing the ongoing performance of these assays but has limitations in terms of inter-assay performance once a laboratory begins to standardize on a single platform.”

Dr. Schulz’ methods may require further refinement like natural language processing and refined cohort definitions, but the study’s outcomes continue to be valuable in their laboratories.

He said, “We have continued to use our informatics-based approach for identifying appropriate individuals to validate multiple clinical assays based on the insights gained from this project.”

Learn more about the other awards and grants funded by the CAP Foundation, and find out how you can support these initiatives.