OraSure’s InteliSwab COVID-19 Tests Authorized for Pediatric Use

February 3, 2022

OraSure Technologies’ InteliSwab COVID-19 rapid tests have received Emergency Use Authorization (EUA) from the FDA for children age two to 14.

The Bethlehem, Pa.-based company supported the expanded EUA with data from pediatric studies that demonstrated 85 percent accuracy for identifying positive cases and 98 percent accuracy for negative samples.

The InteliSwab test was previously authorized for use in adults and children age 15 to 17, when administered by an adult.

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