On May 19, 2020, Swiss pharmaceutical company Roche announced its Elecsys® Anti-SARS-CoV-2 antibody test is now live at more than 20 commercial and hospital lab sites throughout the United States.
The Elecsys® antibody test has received Emergency Use Authorization (EUA) from the FDA, allowing doctors to utilize this serology test to “determine if a person has developed antibodies to COVID-19,” explained Matt Sause, President and CEO of Roche Diagnostics North America.
Roche Achieves Highly Accurate Serology Test
Unlike other COVID-19 antibody tests with uncertain reliability, Roche claims that its serology test is “highly accurate” and “uniquely designed” to identify mature coronavirus antibodies. By identifying the antibodies developed late in a patient’s COVID-19 immune response, this antibody test greatly reduces the likelihood of a false positive result.
According to Roche and the Public Health England (PHE) laboratories that conducted analysis on the antibody test, “It provides 99.8 percent specificity, which is greater than previously available antibody tests.” This specificity is paramount to determining if a person has been exposed to the coronavirus and has developed antibodies.
What Can We Learn From COVID-19 Antibodies?
The body naturally creates antibodies to fight infections. For instance, every winter, the human body develops antibodies to attempt to fight the flu. As soon as an antibody recognizes foreign substances, it blocks them from causing harm. This process of recognizing and eliminating foreign invaders makes antibodies key to health and longevity.
Despite the fact that antibodies have been doing their job for thousands of years, scientists and researchers are extremely interested in the unique property of antibodies when it comes to combating the coronavirus. When a new infectious disease develops, the antibodies developed by the human body to fight that new infection actually provide a roadmap for vaccines and treatments.
As explained by Timothy Tellinghuisen, PhD, Head of Virology Discovery of Roche Pharma Research and Early Development, “All the interest in COVID-19 [serology tests] is because antibodies are the fastest way to get a protective and therapeutic drug.” Furthermore, antibodies provide reliable diagnostic tools to determine who has been infected with a virus, and who has not.
2 Million Tests Per Week Expected by June
Many public health officials view antibody tests as one of the essential keys to preventing a second or third outbreak of the coronavirus as cities and states slowly reopen. However, until now, no antibody test offered the reliability necessary to sway public health decisions.
Now, thanks to its 99.8% accuracy rating, Roche’s antibody test will become widely available in the U.S, England, and other countries.
“Roche’s new antibody test allows LabCorp to provide more options and increase COVID-19 testing capacity as we support the country’s response to the health crisis,” stated Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics.
Overall, Roche is working to meet demand as LabCorp and other commercial labs plan to perform more than 2 million tests per week by June.