Public Health England has approved an antibody test, which may be used to identify how much of the UK population has been infected by COVID-19.
Elecsys® Anti-SARS-CoV-2 is an antibody test that has been manufactured by Swiss pharmaceutical company, Roche. 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.
The test, which was approved for use at the start of May by the EU and by the Food and Drug Administration in the USA, 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.
Following evaluation by Public Health England at Porton Down, experts declared that the test was ‘highly specific’ and described it as a ‘very positive development’.
‘Thanks to the enormous efforts of our dedicated colleagues,’ said Severin Schwan, CEO of Roche Group, ‘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.’
‘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.’
Roche has already started shipping the new antibody test to laboratories globally and will ramp up its production capacity to deliver high double-digit millions of tests per month. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available around the world.
For countries with specific regulatory requirements, local approval timelines apply. In addition there may be other country-specific regulations, such as import requirements, which will determine when the test becomes available locally.
‘Reliable antibody testing is the crucial next step in helping us to understand the spread of the virus,’ added Geoff Twist, managing director of Roche Diagnostics UK & Ireland, ‘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.’