The new nasal swab test, which will help rapidly detect SARS-CoV-2, has the potential to deliver test results within 15 minutes
Siemens Healthineers’ CLINITEST rapid Covid-19 antigen self-test. (Credit: Business Wire)
Siemens Healthineers has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its CLINITEST rapid Covid-19 antigen self-test.
The new nasal swab test, which will help rapidly detect SARS-CoV-2, has the potential to deliver test results within 15 minutes.
The new at-home or over-the-counter self-test is authorised for self-testing use by individuals aged between 14 years and older, or adult-collected samples from individuals aged between two years and 13 years.
Siemens Healthineers point of care diagnostics head Dr Christoph Pedain said: “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.
“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 authorisation.”
Siemens Healthineers stated that it has secured production capacity for US bound product in the tens of millions per month.
Available in a specific configuration in the US, the test was assessed in a study specifically designed for the US market.
The study, which was fully carried out in the US, covered laypersons with currently circulating variants of SARS-CoV-2.
The test has a sensitivity of 86.5% and a specificity of 99.3% compared to the nucleic acid (PCR) detection method, said the company.
In August last year, Siemens Healthineers secured marketing authorisation from the FDA for its Enhanced Liver Fibrosis (ELF) Test.