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December 30, 2021

Siemens Healthineers gets EUA from FDA for Covid-19 antigen self-test

CLINITEST Rapid COVID-19 Antigen Self-Test offers results in 15 minutes.

By Shalini Nair

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Siemens Healthineers for CLINITEST Rapid COVID-19 Antigen Self-Test.

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The receipt of EUA will enable Siemens Healthineers to make the at-home or over-the-counter self-test available countrywide from January.

Claimed to be easy to use, this nasal swab test helps in the quick detection of SARS-CoV-2 and offers test results in 15 minutes.

The CLINITEST Rapid COVID-19 Antigen Self-Test has been authorised for self-testing use by people from the age of 14 years and above or adult-collected samples from individuals between the age of two and 13 years.

Siemens Healthineers stated that it has secured the production capacity for the test kit in the tens of millions in a month.

Siemens Healthineers Point of Care Diagnostics head 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 Authorization.”

The test kit has been analysed in a study designed for the US market and completely conducted in the US with laypersons, and therefore covers the presently circulating variants of concern of SARS-CoV-2.

It has a sensitivity of 86.5% and a specificity of 99.3% as against the nucleic acid (PCR) detection method.

This clinical data has been established under the company’s participation in the National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics’ (RADx) Independent Test Assessment Programme (ITAP).

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Build resilience in the face of COVID-19 disruption

COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
by GlobalData
Enter your details here to receive your free Report.

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