Roche has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its new Elecsys Anti-SARS-CoV-2 antibody test.

Elecsys Anti-SARS-CoV-2 is an immunoassay for the in-vitro qualitative detection of antibodies to severe acute SARS-CoV-2 in human serum and plasma.

The test has been developed to determine a person whether he is exposed to the SARS-CoV-2 virus, as well as developed antibodies against SARS-CoV-2.

The company has already commenced distributing the new antibody test to major laboratories across the globe. It will also increase the production capacity to high double-digit millions per month to serve healthcare systems even in the countries accepting the CE mark.

Roche Group CEO Severin Schwan said: “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.”

Roche’s SARS-CoV2 antibody test has specificity greater than 99.8% and sensitivity of 100%

With a specificity of over 99.8% and 100% sensitivity, Roche’s SARS-CoV2 antibody test help to evaluate the immune response to the virus.

Roche’s cobas e analysers are used to run the test, which is widely available for hospitals and reference laboratories across the world.

The test, which is based on an in-solution double-antigen sandwich format, can identify antibodies to the new coronavirus causing COVID-19.

Elecsys Anti-SARS-CoV-2 assay has 99.81% specificity based on the measurement of a total of 5272 samples.

Elecsys Anti-SARS-CoV-2 helps to identify antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection.

Roche holds the capacity to deliver high double-digit millions of tests per month, with advanced global manufacturing capabilities.

Roche Diagnostics CEO Thomas Schinecker said: “Roche is committed to helping laboratories deliver fast, accurate, and reliable results to healthcare professionals and their patients.”

Recently, Roche has received the FDA approval for the cobas HPV test, used on its fully automated, high-throughput cobas 6800/8800 Systems.