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Roche develops new serology test to detect COVID-19 antibodies

The detection of these antibodies could help indicate if a person has gained immunity against the virus and inform treatment decisions

16 Apr 2020
Diane Li
Assistant Editor

Industry news

Roche has announced the development and upcoming launch of its Elecsys® Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that causes the COVID-19 disease.

Antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms. Additionally, the test can support priority screening of high risk groups, such as healthcare workers, food supply workers who might already have developed a certain level of immunity and can continue serving and/or return to work. Once we understand more about the immunity of COVID-19, it could also help society return faster to normality.

Severin Schwan, CEO Roche Group: “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. Every reliable test on the market serves its purpose for healthcare systems to help us overcome this pandemic. Roche is collaborating closely with health authorities and ramping up production to ensure fast availability of the test globally.”

“Roche is deeply committed to supporting the global response to the COVID-19 pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. "Timely availability and fast access to reliable, high quality tests are essential for healthcare systems. 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.”

The Elecsys Anti-SARS-CoV-2 immunoassay is an in vitro test, using human serum and plasma drawn from a blood sample, to detect antibodies and determine the body’s immune reaction to SARS-CoV-2. The test may be used in epidemiological research to help better understand the spread of the disease and may also be used together with molecular tests to aid in the diagnosis of suspected COVID-19 patients. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available in laboratories around the world.

Roche aims to have the antibody test available by early May in countries accepting the CE mark and is actively working with the FDA for an Emergency Use Authorisation. Roche is planning on an accelerated ramp up of monthly production to high double-digit million tests by June and will further scale up production as fast as possible.

About SARS-CoV-2 (coronavirus)

Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans.

Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing, and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.

To control the spread of the infection, the World Health Organisation (WHO) recommends regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs and avoiding close contact with anyone showing symptoms of respiratory illness.

About Elecsys Anti-SARS-CoV-2 serology test

Elecsys® Anti-SARS-CoV-2 is an immunoassay for the in vitro detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma. Through a blood sample, the test can detect antibodies to the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. Hospitals and reference laboratories can run the test on Roche’s cobas e analyzers which are widely available around the world. These fully-automated systems can provide SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyzer.

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