Coronavirus antibody test: emergency authorisation
Roche has announced that the US Food and Drug Administration (FDA) has issued an Emergency Use Authorisation (EUA) for its new Elecsys Anti-SARS-CoV-2 antibody test, which is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2.
Roche has already started shipping the new antibody test to leading laboratories globally and will ramp up production capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark as well as in the USA.
Roche’s SARS-CoV2 antibody test, which has a specificity greater than 99.8% and 100% sensitivity (14-days post-polymerase chain reaction [PCR] confirmation), can help assess patients’ immune response to the virus. As more is understood about immunity to SARS-CoV-2, the test may help to assess who has built up immunity to the virus.
Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available around the world. These fully automated systems can provide SARS-CoV-2 test results in approximately 18 minutes for one single test, with a test throughput of up to 300 tests/hour, depending on the analyser.
“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 manage the COVID-19 health crisis,” said Severin Schwan (CEO Roche Group). ”I am pleased about the high specificity and sensitivity of our test, which is crucial to support healthcare systems around the world.”
“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,” said Thomas Schinecker (CEO, Roche Diagnostics). “Roche is committed to helping laboratories deliver fast, accurate and reliable results to healthcare professionals and their patients.”