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FDA Grants Emergency Use Authorization for Siemens Healthineers OTC COVID-19 Antigen Test

NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for Siemens Healthineers' over-the-counter Clinitest Rapid COVID-19 Antigen Self-Test.

The lateral flow chromatographic immunoassay is designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in self-collected anterior nasal swab specimens from symptomatic individuals aged 14 years and older, as well as in adult-collected samples from individuals aged two years and older. It is also intended for use in asymptomatic individuals when used for testing twice over three days with at least 24 hours, and no more than 48 hours, between tests, according to the FDA.

Siemens Healthineers said that the test is expected to be available beginning in January and that it has the capacity to produce tens of millions of tests per month.

The Erlangen, Germany-based company said that the test, which provides results within 15 minutes, has demonstrated 86.5 percent sensitivity and 99.3 percent specificity versus PCR-based detection.

The FDA said that it granted EUA for the test based on data gathered under its collaboration with the National Institutes of Health Independent Test Assessment Program (ITAP).

Earlier this week, the FDA granted EUA to SD Biosensor's COVID-19 At-Home Test, a non-prescription SARS-CoV-2 antigen test distributed by Roche, based on data evaluated through NIH ITAP.