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Roche announced Friday that it has launched its second CE-marked antibody test for COVID-19, the Elecsys Anti-SARS-CoV-2 S, which can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus.
"As the possibility of an effective SARS-CoV-2 vaccine becomes a reality, quantitative measurement of antibodies will be crucial in the evaluation of any potential vaccine," remarked CEO Thomas Schinecker. "The new quantitative Elecsys antibody test can play a pivotal role in vaccine clinical trials as well as helping clinicians assess patients' immune response," he added.
Vaccine-induced immune responses
According to Roche, Elecsys Anti-SARS-CoV-2 S can also help characterise a vaccine-induced immune response. The company explained that its test targets antibodies directed against the specific region of the viral spike protein responsible for binding to host cell receptors, noting that the spike protein "is the focus of vaccines in development and convalescent plasma therapy."
Roche added that the test can also be used to determine antibody levels in plasmapheresis donations. Further, the company said it can help to more effectively determine, alongside its earlier Elecsys Anti-SARS-CoV-2 test, what percentage of a given population has developed antibodies against the novel coronavirus, particularly in low-to-moderate seroprevalence settings
FDA emergency use filed
Roche has filed for FDA emergency-use authorisation (EUA) of the Elecsys Anti-SARS-CoV-2 S test, while its Elecsys Anti-SARS-CoV-2 test gained an EUA in May and is also available in markets accepting the CE mark.
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