The Siemens Healthineers CliniTest Rapid COVID Antigen Self-test has received FDA authorization (EUA) for unsupervised self-testing by individuals age 14 and older. The test is also authorized for adult-collected pediatric samples for children ages 2-13.
The Siemens Healthineers CliniTest is an easy-to-use nasal swab test provides visually read test results in just 15 minutes, offering nationwide access to a new at-home, over-the-counter self-test.
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 Siemens Healthineers CliniTest 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.”