OraSure test can now be used for children as young as 2 years

OraSure Technologies of Bethlehem has announced that its rapid COVID-19 test, InteliSwab, has 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. OraSure also confirmed that InteliSwab detects the Omicron variant, the Delta variant and other variants of concern. 

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 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. 

“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.”  

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. 

“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. “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.” 

Additionally, the company said it has launched a reporting app, InteliSwab Connect, which will allow people to easily report their test results to public health authorities, helping communities monitor for an increase in cases and employers track prevalence in the workplace.