FDA grants EU authorization for Clinitest Rapid COVID-19 Antigen Self-Test

The Food and Drug Administration has granted Emergency Use Authorization to Siemens Healthineers for its Clinitest Rapid COVID-19 Antigen Self-Test, providing another option for consumers to purchase over-the-counter at-home tests.

The nasal swab test is intended to aid in the rapid detection of the SARS-CoV-2 virus and provides test results in 15 minutes. The Clinitest is authorized for self-testing use by individuals age 14 and older or samples from individuals ages 2 to 13 years collected by adults.

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.

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“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. “Siemens Healthineers is proud to bring this high-quality test, already used and trusted by families, medical professionals, businesses and governments in many parts of the world, to the United States under FDA Emergency Use Authorization.”

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. The product has a 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.