Siemens Healthineers announces that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the Clinitest Rapid Covid-19 Antigen Self-Test, providing nationwide access to a new at-home or over-the-counter self-test as Covid-19 testing needs continue to grow for individuals, families, and businesses. The easy-to-use nasal swab test is intended to aid in the rapid detection of SARS-CoV-2 (the virus that causes Covid-19) and provides visually read test results in just 15 minutes. It is authorized for self-testing use by individuals age 14 and older or adult-collected samples from individuals ages 2 to 13 years. The test is expected to be available starting in January. Siemens Healthineers has secured dedicated production capacity for U.S. bound product in the tens of millions per month.

“Undetected Covid-19 exposure is a major driver of community spread. With the Clinitest Rapid Covid-19 Antigen Self-Test, consumers will have access to a fast, reliable, and convenient test to provide additional safety,” said Christoph Pedain, PhD, Head of Point of Care Diagnostics, Siemens Healthineers.

The product comes in a specific configuration for the United States and has been evaluated in a study specifically designed for the U.S. market and fully conducted in the U.S. with laypersons, thereby covering currently circulating variants of SARS-CoV-2. Meeting the high threshold of the US FDA, the product is highly accurate, with sensitivity of 86.5% (95% CI: 79.6 to 91.3%) and a specificity of 99.3% (95% CI: 95.9 to 100.0%) compared to the nucleic acid (PCR) detection method. Sensitivity defines the test’s ability to produce a positive result in those infected with SARS-CoV-2 per the PCR reference method, and specificity defines the ability to produce a negative result in those not currently infected with SARS-CoV-2.