OraSure COVID-19 Rapid Tests Receive U.S. FDA Authorization for Pediatric Use

 

With less than one minute of “hands-on time,” the InteliSwab test is as simple as “Swab, Swirl, and See.”

Data Demonstrates InteliSwab® is Accurate, Easy to Use, and Well Accepted by Children

 OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that its 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. 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, the Company 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 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 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.

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