Siemens Healthineers Gains EUA for CLINITEST Rapid COVID-19 Antigen Self-Test

By Sam Brusco, Associate Editor | 01.03.22

Unsupervised self-testing for SARS-CoV-2 by individuals age 14 and older.

Siemens Healthineers gained emergency use authorization (EUA) for its CLINITEST Rapid COVID-19 Antigen Self-Test, boosting access to at-home or OTC self-tests as testing needs grow. The nasal swab test visually provides results in 15 minutes.
 
It’s authorized for self-testing in people age 14 or older or adult-collected samples from individuals age 2 to 13. The company has secured production capacity for tens of millions of tests in the U.S. per month.
 
“Undetected COVID-19 exposure is a major driver of community spread,” Christoph Pedain, Ph.D., Head of Point of Care Diagnostics, Siemens Healthineers told the press. With the CLINITEST Rapid COVID-19 Antigen Self-Test, consumers will have access to a fast, reliable, and convenient test to provide additional safety. 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 was specifically configured for the U.S. and was evaluated in a study designed for the U.S. market. According to the study the test has a sensitivity of 86.5 percent and specificity of 99.3 percent. Clinical data was established under the company’s 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.”