By Kathleen Berger, Executive Producer for Science and Technology

Two years into the pandemic, there are many options for COVID-19 testing both at home and in health care settings. There are swab samples, saliva samples, rapid tests and lab tests. Many people needing to get tested may ask which one is best.

“Actually to even get FDA approval, you have to have an 80% reliability, meaning that the gold standard and the test in the hands of the patient have to match at least 80% of the time for a positive result,” explained Stacey House, MD, PhD, director of research in emergency medicine at Washington University School of Medicine in St. Louis. “So all of those that are approved are at least that accurate. But you have to pay attention to the details (instructions).”

Dr. House would know. She is principal investigator for the clinical trials of 25 different COVID-19 tests and growing. The tests are different types in different categories of testing, with more than 6,500 emergency room patients admitted to Barnes-Jewish Hospital participating.

“For the vast majority of the studies, we were the highest enrolling site in the country which is part of why we kept being asked to do so many of these studies,” explained House.

House, her team, and all participating patients in St. Louis helped bring COVID-19 tests to market.

“I think I’m most proud of the volume of patients that we were able to enroll and the rapidity with which we were able to do these studies. So typically, when you do a clinical study like this you find out that it’s going to happen. You go through a whole startup process. It takes months. You do the study over the course of months, two years, and then you don’t see the test that you were studying approved for another year or two,” she said. “I had situations where we would get a brand-new protocol. We would do everything and be ready to go and enrolling patients in a week. I’ve never seen anything like that before. Some of them, we were doing the entire study over the course of two weeks to a month. And then a month or two later they have FDA approval. That’s shocking to me.”

The historical research effort is funded by the National Institutes of Health. The goal was for the FDA to quickly approve effective tests. For tests to gain approval, results would be compared to the gold standard of COVID-19 tests, at the time, which would change as testing began to improve.

“When the pandemic started, there wasn’t really a true gold standard test. Then we started getting more of those PCR-based tests that got approved, and then they became the gold standard. So some of the tests that we had done studies with early on in the pandemic, once they received FDA approval, they then became the gold standard test for the remaining studies that we did. So it’s been a moving target over the last two years, which is very unusual for doing these types of studies.”

Not only Washington University School of Medicine play a key role in investigating the accuracy of 25 COVID-19 tests, the researcher team helped to perfect testing systems now on the market. This is important for the approval of over-the-counter tests. To model the conditions of testing at home, patients tested themselves while a clinical researcher observed, making notes on the process. Researchers could not help the patient in any way.

To be in the studies, they might be getting up to three different swabs, the ones for the standard of care and then a couple for our study,” House explained. “I just want to make sure I say thank you to all those people who participated because I know they didn’t feel good, and they were in the emergency department. That was hard. But a lot of people gave their time to get to these results, which now means that we have more testing available.”

More emergency room patients will be asked to participate as House and her team are continuing trials of new tests including a combination COVID-19 and Flu test.