Roche has expanded its Covid-19 test portfolio with the introduction of Elecsys Anti-SARS-CoV-2 S antibody test in the CE mark accepting markets.
The company has filed an application to secure emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the test.
The Elecsys Anti-SARS-CoV-2 serology test is suitable for the quantitative measurement of antibodies in people who were exposed to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Roche’s immunoassay will help determine antibodies to SARS-CoV-2 in human serum and plasma
The immunoassay, which will help determine antibodies to SARS-CoV-2 in human serum and plasma, has the capacity to measure the quantity of antibodies to the spike protein of the coronavirus.
Roche’s antibody test is said to play a significant role in characterising a vaccine-induced immune response.
The test will target antibodies that are directed against the specific region of the viral spike protein that helps bind to the host cell receptor, which is crucial for the virus to enter the host cell.
Both Elecsys Anti-SARS-CoV-2 S and Elecsys Anti-SARS-CoV-2 tests will facilitate to know how much percentage of a given population has developed antibodies against SARS-COV-2 specifically in low to moderate seroprevalence settings.
The Elecsys Anti-SARS-CoV-2 is an immunoassay that will facilitate the qualitative in vitro detection of antibodies, including IgG, to SARS-CoV-2.
Roche Diagnostics CEO Thomas Schinecker said: “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.
“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.”
Recently, Roche has secured EUA from the FDA for its cobas SARS-CoV-2 & Influenza A/B Test for use on the the cobas 6800/8800 systems.
