January 31, 2022 – OraSure Technologies, Inc., announced today that its InteliSwab® COVID-19 rapid tests have been authorized by the FDA for use in children ages 2 to 14. InteliSwab® was previously authorized for use in adults and in children 15 to 17 when administered by an adult.
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. From a combined performance perspective, InteliSwab® was shown to have 85 percent positive percent agreement (PPA) for individuals ages 2 and up and 98 percent negative percent agreement (NPA). The overall accuracy of the InteliSwab® test including a pediatric population is 93 percent, demonstrating similar accuracy when compared to the 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 percent 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,” said OraSure President and CEO Stephen Tang, Ph.D. “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.”
In addition, OraSure also announced 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. The app will be available on the Apple App Store and via Google Play.