As the new coronavirus spreads around the world, scientists are rushing to find ways to identify those who have been infected – including those who have recovered from COVID-19. In order to understand the true scope of the pandemic, antibody tests are being introduced as the next step in responding to the outbreak, as they can detect specific antibodies in people who have been exposed to the virus and if they have developed some immunity to it.
Since March 2020 Roche has been developing the Elecsys Anti-SARS-CoV-2 serology test, which uses human serum and plasma drawn from a blood sample, to detect antibodies and determine the body’s immune reaction to SARS-CoV-2. The test has a specificity greater than 99.8% and 100% sensitivity (14 Days post-PCR confirmation). It may be used in epidemiological research to help better understand the spread of the disease and may also be used together with molecular tests to aid in the diagnosis of suspected COVID-19 patients.
The Elecsys Anti-SARS-CoV-2 serology test is processed in laboratories using Roche analysers and the company says its fully automated systems can provide results in approximately 18 minutes for one single test, with a capability to do 300 tests an hour, depending on the analyser.
Following the launch of the test in early May, Roche started shipping the new antibody test to leading laboratories globally. It was approved at the start of May by the EU and by the Food and Drug Administration in the USA and just recently, by Public Health England, in order to roll out COVID-19 antibody testing programme in the UK. On that occasion, Dr Thomas Schinecker, CEO of Roche Diagnostics, stated the following in an interview for the Guardian.
“Roche is deeply committed to supporting the global response to the Covid-19 pandemic. Timely availability and fast access to reliable, high quality tests are essential for healthcare systems. The antibody test is an important next step in the fight against Covid-19 and Roche’s antibody test can be quickly scaled and made broadly available as more than 40,000 of our instruments are already in use in many laboratories around the world.”