The test will identify antibodies to determine if a person has ever been infected with the coronavirus. The presence of SARS-CoV-2 antibodies in human serum or plasma can also indicate an adaptive immune response.
Switzerland-based Roche has begun shipping the antibody test to laboratories globally and will continue to ramp up production capacity to high double-digit millions per month, according to the company. It plans to serve healthcare systems in countries accepting the CE mark and the U.S.
“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,” CEO Severin Schwan said in a news release. “I am particularly pleased about the high specificity and sensitivity of our test, which is crucial to support healthcare systems around the world with a reliable tool to better manage the COVID-19 health crisis.”
The company claims the antibody test has a specificity greater than 99.8% and 100% sensitivity. The test may also help determine who has built up immunity to the virus.
“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 in March secured FDA emergency use authorization for its Cobas SARS-CoV-2 diagnostic test to help with the coronavirus pandemic.