NEW YORK — Biomerica said on Tuesday that it has received a CE mark for its COVID-19 Rapid Antigen Test for the detection of SARS-CoV-2 infection.
According to the company, the lateral flow test can be used at the point of care and provides results within 15 minutes without the need for additional equipment. It uses nasal swab samples and has demonstrated 94.7 percent sensitivity and 99.7 percent specificity as compared to lab-based molecular PCR tests.
Biomerica said it has received orders for the test and plans to begin shipping them in the coming weeks.
In May, Irvine, California-based Biomerica received CE marking for its COVID-19 IgG/IgM Rapid Test for detecting antibodies to the SARS-CoV-2 coronavirus.