Roche’s antibody test for Covid-19 has been given the CE mark and has been issued Emergency Use Authorisation from the US Food and Drug Administration.
The company states that its Elecsys Anti-SARS-CoV-2 antibody test has a specificity greater than 99.8% and 100% sensitivity (14 Days post-PCR confirmation) and 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.
The test 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.
Thomas Schinecker, CEO of Roche Diagnostics, 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.”
Through a blood sample, the test, which is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing Covid-19, which could signal whether a person has already been infected and potentially developed immunity to the virus. Based on the measurement of a total of 5,272 samples, the Elecsys Anti-SARS-CoV-2 assay has 99.81% specificity and shows no cross-reactivity to the four human coronaviruses causing common cold. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual, but are specific for coronaviruses other than SARS-CoV-2. Elecsys Anti-SARS-CoV-2 detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection.
Severin Schwan, CEO of Roche Group, commented: “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.”
Geoff Twist, managing director of Roche Diagnostics UK and Ireland, added: “Reliable antibody testing is the crucial next step in helping us to understand the spread of the virus and to provide much-needed reassurance to our valued key workers, enabling them to continue providing their vital support.
“More than ever, it is critical that industry works in collaboration with the NHS to help alleviate pressures and provide a solution, and we are extremely proud to be able to deliver our high quality antibody test, which will lead to greater confidence as we move into the next phase.
“We will continue to work closely with the NHS, public health bodies and the UK government to enable the roll out of the test across the UK.”
The test is currently being evaluated by Public Health England at Porton Down with first results of this evaluation expected at the end of this week.
Roche diagnostics is currently in dialogue with the NHS and the UK government about a phased roll-out of the test from mid-May, with the company saying it will be able to provide hundreds of thousands tests per week - with results from tests expected to be provided within 18 minutes.