Roche launched its Elecsys Anti-SARS-CoV-2 S antibody test for markets that accept the CE Mark. It has also filed with the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA).
The test can be used to measure the antibodies in people exposed to COVID-19. The company believes the test can play an important role in characterizing a vaccine-induced immune response, meaning that it can be used in clinical trials to evaluate the effectiveness of experimental COVID-19 vaccines in stimulating an immune response against the SARS-CoV-2 virus that causes COVID-19.
The test targets antibodies that are directed against the specific part of the viral spike (S) protein that the virus uses to bind to the host cell receptor and is needed to enter the host cell. Most vaccine candidates, as well as therapeutic antibodies, target the spike protein.
“As the possibility of an effective SARS-CoV-2 vaccine becomes a reality, quantitative measurement of antibodies will be crucial in the evaluation of any potential vaccine,” said Thomas Schinecker, chief executive officer of Roche Diagnostics. “The new quantitative Elecsys antibody test can play a pivotal role in vaccine clinical trials as well as helping clinicians assess patients’ immune response. This will be instrumental in protecting people most vulnerable to the virus, as well as in overcoming COVID-19 for society in general. This new test, the twelfth in the Roche SARS-CoV-2 testing portfolio, is another essential addition to support healthcare systems and patients as we jointly fight COVID-19.”
The test is a serology test. It can also be used to identify antibody levels in plasmapheresis donations. Roche notes that performing a combination of the Elecsys Anti-SARS-CoV-s S and Elecsys Anti-SARS-CoV-2 tests can help physicians and public health authorities to more effectively define what proportion of a given population has developed antibodies against the virus, particularly in settings with low to moderate seroprevalence. This can be used to help contain the spread of the virus and provide information on how to safely relax lockdown restrictions.
One type of therapy, convalescent antibody therapy, which has been granted EUA in the U.S. to treat COVID-19 patients, draws blood from patients who have recovered from the disease, and using plasmapheresis, removes the plasma from the blood. The plasma is then given to COVID-19 patients, with the theory that they will have antibodies against the virus to battle it in these sick patients. This new test allows for a higher level of testing of the antibodies, with a clinical specificity of 99.98% and sensitivity of 98.8%, 14 days or later after diagnosis of COVID-19 with a PCR assay.
The test has also been demonstrated to not be cross-reactive with other endemic human coronaviruses, infectious respiratory diseases, other infectious diseases, auto-immune and liver-related diseases.
The assay can be run on Roche’s cobas e analyzers, which are deployed around the world. The fully-automated systems are able to churn out SARS-COV-2 test results in about 18 minutes, with a test throughput of up to 300 tests per hour, depending on the analyzer.