Roche Receives FDA’s Emergency Use Authorization for its Elecsys to Detect COVID-19

Shots:

• Roche has received the US FDA’s EUA for its Elecsys anti-SARS-CoV-2 Ab test to detect patient’s immune response to the COVID-19 and run on its cobas e analysers, delivering results in ~18 minutes, up to 300 tests/hour
• Elecsys Anti-SARS-CoV-2 serology test, an immunoassay used an in-solution double-antigen sandwich format in 5272 patient blood samples with COVID-19 and patient developed Abs against COVID-19 to detect Abs with >99.8% specificity and 100% sensitivity in samples taken 14 days post-PCR confirmation
• Roche will ramp-up production capacity to high double-digit millions of tests/months in May for countries accepting the CE mark and in the US, under EUA

Click here ­to­ read full press release/ article | Ref: Roche | Image: Roche