OraSure Technologies’ InteliSwab COVID-19 rapid tests have been authorized by the U.S. Food and Drug Administration (FDA) for use in children ages 2 to 14.
As part of its submission to the FDA for this label expansion, OraSure conducted studies to evaluate the performance of the test in a pediatric population, as well as studies to evaluate usability and tolerability by children. The rapid tests were previously authorized for use in adults and in children 15 to 17 when administered by an adult.
From a combined performance perspective, InteliSwab was shown to have 85% positive percent agreement (PPA) for individuals ages 2 and up and 98% negative percent agreement (NPA). The overall accuracy of the InteliSwab test including a pediatric population is 93%, demonstrating similar accuracy when compared to the company’s clinical studies in adults. OraSure also evaluated the usability and acceptability of the test in children. In the usability study, parents were able to use the test on children error free 96% of the time, demonstrating the exceptional ease of use of the test. The test was also well accepted by children across a broad age range.
“Helping our children stay in school and get back to normal is crucial to their wellbeing and continued development,” says Stephen Tang, PhD, OraSure president and CEO. “Fast, frequent testing is a key component to making this happen and we are delighted that our InteliSwab test can now be used for children. The test is accurate and easy to use, so caregivers can feel confident when they choose to use this test on a child.”
The company also announced today the launch of a new reporting app, InteliSwab Connect, which will allow people to easily report their test results to public health authorities, helping communities with COVID-19 prevalence surveillance efforts. It can also help employers track prevalence in the workplace.
Featured image: The COVID rapid tests were previously authorized for use in adults and in children 15 to 17 when administered by an adult. Photo: OraSure
