Roche, a provider of diagnostic solutions, has developed a new serology test for the detection of COVID-19 antibodies.
The company has designed the Elecsys Anti-SARS-CoV-2 serology test to identify antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which is responsible for the COVID-19 disease.
Roche Group CEO Severin Schwan said: “Following the launch of our high-volume PCR test in mid-March to detect active infection of the disease, we are now going to launch a new antibody test in early May.”
Roche’s Elecsys Anti-SARS-CoV-2 immunoassay is an in vitro test, which uses human serum and plasma collected from a blood sample to identify antibodies and determine the immune reaction of the body to the novel coronavirus.
The in vitro test can be used along with molecular tests to diagnose suspected COVID-19 patients
The test is also suitable for use in epidemiological research to better understand the spread of the disease, as well as can be used along with molecular tests to diagnose suspected COVID-19 patients.
Roche’s cobas e analysers can be used by hospitals and reference laboratories to run the new serology test.
With a test throughput of about 300 tests per hour, the fully-automated systems can generate test results in around 18 minutes with the new SARS-CoV-2 test.
The company intends to supply the new test by early May in countries accepting the CE mark approval. It is also working with the US Food and Drug Administration (FDA) to secure an emergency use authorization for the test.
Roche Diagnostics CEO Thomas Schinecker said: “The antibody test is an important next step in the fight against COVID-19. Roche’s antibody test can be quickly scaled and made broadly available around the world as our instrument infrastructure is already in place.”
In March, Roche secured an emergency use authorisation from the FDA for its cobas SARS-CoV-2 test to detect patients with Covid-19 disease.
