Ortho antigen test receives FDA EUA

Jan. 15, 2021

Ortho Clinical Diagnostics announced that its VITROS SARS-CoV-2 Antigen Test, designed to detect active infection, has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA), according to a press release from the company.

Ortho said the VITROS SARS-CoV-2 Antigen Test is the first high-throughput antigen test to receive an EUA from the FDA. It produces accurate, clinically reliable results on Ortho’s high-volume VITROS Systems. With utility for mass-scale testing and same-day results for labs, Ortho’s COVID-19 solution can run up to 130 tests per hour.

These analyzers normally run a broad menu of over 150 different tests from blood and body fluid samples, but they now are also able to run samples derived from swabs.

U.S. distribution of the test began in November 2020 after the company submitted an application for EUA from the FDA. Ortho said it is currently able to deliver 5 million of the antigen tests per month and can scale up to 15 million tests per month in February.

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