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June 2, 2020

Siemens Healthineers receives EUA for Covid-19 total antibody test

Siemens Healthineers has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for a laboratory-based total antibody test for Covid-19.

Siemens Healthineers has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for a laboratory-based total antibody test for Covid-19.

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The Covid-19 test detects the presence of SARS-CoV-2 antibodies, including IgM and IgG in blood. It enables identification of recent or prior Covid-19 infection, based on the patient’s adaptive immune response to the virus.

Test data demonstrated 100% sensitivity and 99.8% specificity, the company noted.

The SARS-CoV-2 virus penetrates and infects human cells found in multiple organs and blood vessels, using a spike protein found on its surface.

The Siemens Healthineers total antibody COV2T assay is developed to detect antibodies to the spike protein. The antibodies are anticipated to prevent infection by neutralising the SARS-CoV-2 virus.

In addition, multiple potential vaccines, which are currently in development for Covid-19, mostly focus on spike protein.

Siemens Healthineers Laboratory Diagnostics president Deepak Nath said: “As a leader in laboratory diagnostics, Siemens Healthineers designed a high-quality, highly accurate antibody test with the capacity and reach necessary to help address a critical societal need.

“The test targets both IgM and IgG antibodies, which allows for early identification of individuals infected with the virus who have developed an immune response, even if they were asymptomatic or never diagnosed with the disease.”

The test uses Atellica IM immunoassay analysers, which can test approximately 440 samples an hour and deliver a result in ten minutes.

It is also available on the company’s expansive installed base of ADVIA Centaur XP and XPT analysers, which can run up to 240 samples an hour with the result provided in 18 minutes.

Siemens Healthineers has shipped over one million tests to health systems and laboratories to immediately begin testing. The company will scale up the production to deliver more than 50 million tests a month across its testing platforms.

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Navigate your business through the ‘new normal’

COVID-19 continues to dominate headlines the world over. It 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.  Faced with an explosion of conflicting information on how to plan and implement successful recovery strategies, decision-makers are in dire need of a single, reliable source of intelligence.   GlobalData’s COVID-19 Executive Briefing gives you access to unparalleled data and insights to successfully navigate the uncertain road to recovery across the world’s largest industries. Understand every aspect of this disruptive theme by delving into: 
  •  COVID-19 infection update, with statistics on the spread, testing by country, as well as the latest data on vaccines and therapeutic developments 
  • Economic impact overview, covering stock market indices, GDP, unemployment rates, policy responses & GlobalData’s economic recovery scorecards 
  • Sector developments, with access to sector insight summaries, cross-sector indices and the leaders and laggards in each industry vertical 
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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