The new serology test, with more than 99.8% specificity and 100% sensitivity, will determine a person’s exposure to the virus and antibodies and in a patient
Roche Elecsys Anti-SARS-CoV-2 antibody test. (F. Hoffmann-La Roche Ltd.)
Roche has obtained the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for its new Elecsys Anti-SARS-CoV-2 antibody test.
The company said that its new test has been designed to determine whether a patient has been exposed to the SARS-CoV-2 virus and has developed antibodies against SARS-CoV-2.
Roche Group CEO Severin Schwan said: “Thanks to the enormous efforts of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the Covid-19 health crisis.
“I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the Covid-19 health crisis.”
SARS-CoV2 antibody test has more than 99.8% specificity and 100% sensitivity
Roche said that its new SARS-CoV2 antibody test has been designed to have more than 99.8% specificity and 100% sensitivity, 14 days after PCR confirmation.
The test is capable of measuring a patient’s immune response to the SARS-CoV-2, to help evaluate who has developed immunity to the virus.
Also, Hospitals and reference laboratories can run the new serological test on the company’s existing cobas e analysers.
Roche has already started shipping its new antibody test to laboratories around the world and intends to speed up the production to serve healthcare systems in the US and countries accepting the CE mark.
Roche Diagnostics CEO Thomas Schinecker said: “Our best scientists have worked 24/7 over the last few weeks and months to develop a highly reliable antibody test to help fight this pandemic. Roche is committed to helping laboratories deliver fast, accurate, and reliable results to healthcare professionals and their patients.”