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iXensor Gets CE-IVD Mark for Point-of-Care SARS-CoV-2 Antigen Test

NEW YORK — iXensor said on Wednesday that it has received CE-IVD marking for its PixoTest POCT COVID-19 Antigen Test.

According to iXensor, the test is designed to detect SARS-CoV-2 antigens in nasopharyngeal specimens at the point of care. It runs on a palm-sized analyzer that provides results within 15 minutes, transmitting them to a companion smartphone app that stores vaccination certificates.

In clinical studies, the test has demonstrated sensitivity as high as 95 percent and specificity up to 100 percent, the Taiwanese company said.

In late 2019, iXensor received 510(k) clearance from the US Food and Drug Administration for the PixoTest POCT Analyzer and a companion test for the quantitative measurement of glycated hemoglobin.