Original from: Businesswire
Siemens Healthineers announces that the U.S. Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for the CLINITEST Rapid COVID-19 Antigen Self-Test,1, 2, 3 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. ¡°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 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.
All clinical data has been established under Siemens Healthineers participation in the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics¡¯ (RADx) Independent Test Assessment Program (ITAP).
¡°The CLINITEST Rapid COVID-19 Antigen Self-Test detects SARS-CoV-2 antigens in people who are actively infected with the virus, making important information more readily available,¡± added Dr. Pedain. ¡°We¡¯d like to thank the U.S. Government, specifically the National Institutes of Health Rapid Acceleration of Diagnostics¡¯ Independent Test Assessment Program, for their partnership in bringing much needed tests to the American people. We know this is a critical time in this pandemic, and we will do our part in providing support.¡±
Reliable results can help consumers make confident, informed decisions about their daily lives, with the simplicity of a nasal swab test at home. Consumers who receive a positive test result should follow guidance from the Centers for Disease Control and Prevention (CDC) to isolate and take steps to mitigate the spread of COVID-19.
