Recent research shows that a new rapid test more accurately identifies COVID-19 patients who will deteriorate, thus helping these patients to get life-saving treatment. Findings on this method, as well as a novel study on the performance of coronavirus tests in children, were presented at the 2021 AACC Annual Scientific Meeting & Clinical Lab Expo in Atlanta.
Improving Prediction of COVID-19 Severity
In about a third of all COVID-19 cases, there is still uncertainty about whether a patient will develop the severe form of the illness. As a result, about 8% of patients are not admitted to the hospital when they need to be, while another 20% of patients are admitted unnecessarily.
In an effort to solve this problem, a team of researchers from MeMed, Haifa, Israel, led by Niv Mastboim, MD, and Eran Eden, PhD, has developed a test that predicts COVID-19 outcomes with high accuracy. In 15 minutes, the test measures blood levels of TRAIL and IP-10 — two proteins that the immune system produces in response to viral infections — and CRP, a general marker of infection severity. The test then uses these values to calculate a COVID-19 severity score on a scale of 0 to 100, with 100 indicating the highest likelihood of severe outcome.
To develop this test, the team first used a rapid point-of-care instrument that MeMed previously built to measure TRAIL, IP-10, and CRP in a group of 518 COVID-19 patients, 113 of whom had a severe outcome. The researchers analyzed the data from this group with a machine learning algorithm to create the model that serves as the basis for the COVID-19 severity score. Through statistical analysis, the researchers then determined that the COVID-19 severity score has an area under the curve (AUC) of 0.86. According to the team, this means that it outperforms other COVID-19 severity stratification tests in terms of accuracy, including the commonly used biomarker IL-6, which only has an AUC of 0.77.
“There are three elements that are novel about this test,” Eden says. “First, we’re using the body’s immune response to tell us what is going on with the patient. Second, instead of using just one biomarker, we’re combining three complementary markers to get a more holistic picture. And third, we’re using a novel platform that is able to measure these specific proteins from blood within 15 minutes, making this test clinically applicable to the workflow in today’s emergency departments.”
Ensuring Testing Accuracy in Children
Another lesser-known challenge with COVID-19 care is the fact that the majority of FDA-authorized coronavirus tests were validated primarily using data from adults, meaning that these tests might not be as accurate in pediatric patients.
A team of researchers led by Mary Kathryn Bohn, a PhD candidate at the University of Toronto, therefore set out to investigate the accuracy of coronavirus antigen and antibody tests in a pediatric population. The researchers tested 140 asymptomatic children and adolescents (ages 5 to 18) with a coronavirus antigen test and an antibody test. The team found that the tests’ performance in pediatric individuals was on par with the tests’ performance in adults. All of the antigen test results were negative, which was in keeping with the fact that all study participants were asymptomatic. Furthermore, all of the study participants (3%) who had positive antibody test results had also previously tested positive for the coronavirus.
“A lot of the literature focuses on adults right now, and our study has been one of the few to go into the community and see the performance of these tests in asymptomatic school children and adolescents,” Bohn says. “These types of studies will be really important, especially as the school year starts.”