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- The serological test has a specificity greater than 99.8% and a sensitivity of 100% (14 days after the confirmation of the PCR)
- The high specificity of the test is crucial to reliably determine whether a person has been exposed to the virus and whether the patient has developed antibodies.
- Roche will provide millions of double-digit tests in May for CE-accepting countries and the US. USA Under the authorization of emergency use, subsequently increasing the capacities
- The test is available on Roche’s cobas e analyzers, which are widely available worldwide.
Basel, May 3, 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (FDA) has issued an Emergency Use Authorization (USA)one for your new Elecsys® Anti-SARS-CoV-2 antibody test. The test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2. Roche has already begun shipping the new antibody test to the world’s leading laboratories and will increase production capacity to double-digit millions per month to serve health systems in countries that accept the CE mark.2 as well as the USA USA
“Thanks to the tremendous efforts of our dedicated colleagues, we are now able to offer high-quality antibody testing in large quantities, so we can support healthcare systems around the world with an important tool to better manage the health crisis of COVID-19 “. said Severin Schwan, CEO of Roche Group. “I am particularly pleased with the high specificity and sensitivity of our test, which is crucial in supporting healthcare systems around the world with a reliable tool to better manage the COVID-19 health crisis.”
“Our top scientists have worked 24/7 for the past few weeks and months to develop a highly reliable antibody test to help combat this pandemic,” said Thomas Schinecker, CEO of Roche Diagnostics. “Roche is committed to helping laboratories deliver fast, accurate, and reliable results for healthcare professionals and their patients.”
Roche SARS-CoV2 antibody test, which has a specificity of over 99.8% and a sensitivity of 100%3 (14 days after confirmation of PCR), it can help to assess the immune response of patients to the virus. As more immunity to SARS-CoV-2 is understood, the test may help assess who has developed immunity to the virus.
With extensive global manufacturing capabilities, Roche will be able to deliver millions of double-digit tests per month. Reference hospitals and laboratories can run the test on Roche’s cobas e analyzers, which are widely available worldwide.
For countries with specific regulatory requirements, local approval deadlines apply. Additionally, there may be other country-specific regulations, such as import requirements, that will determine when the test will be available locally. Roche will work closely with respective regional representatives to ensure that we adequately support local registration efforts.
About antibody tests
An antibody test, also called a serology test, is used to determine whether or not a person could have obtained immunity against a pathogen. The human body produces antibodies in response to many diseases. In the current situation of the COVID-19 pandemic, antibody tests must be able to specifically detect antibodies against SARS-CoV-2 without cross-reactivity with other similar coronaviruses, which could generate a false positive result and, therefore, Therefore, erroneously indicate potential immunity. A false positive result occurs when a person receives a positive test result, when they should have received a negative result. False positives are particularly critical when we don’t know how many people in a given population have had COVID-19. As of April 24, 2020, no study has evaluated whether the presence of antibodies against SARS-CoV-2 confers immunity to subsequent infection by this virus in humans.4 4.
About the Elecsys Anti-SARS-CoV-2 serology test
Elecsys® Anti-SARS-CoV-2 is an immunoassay for the qualitative in vitro detection of antibodies (including IgG) to coronavirus 2 of severe acute respiratory syndrome (SARS-CoV-2) in human serum and plasma. Based on a blood sample, the test, which is based on a double antigen sandwich format in solution, can detect antibodies against the new coronavirus that causes COVID-19, which could indicate whether a person has already been infected and potentially You have developed immunity to the virus. virus. Based on measurement of a total of 5272 samples, the Elecsys® Anti-SARS-CoV-2 Assay has a specificity of 99.81% and shows no cross-reactivity with the four human coronaviruses that cause the common cold. This means that it can reduce the possibility of false positives due to the detection of similar antibodies that may be present in an individual, but which are specific for coronaviruses other than SARS-CoV-2. Elecsys® Anti-SARS-CoV-2 detected antibodies with 100% sensitivity in samples taken 14 days after a confirmed PCR infection. The importance of the specificity and sensitivity of a particular test will depend on its purpose and the prevalence of the disease within a given population.
Reference hospitals and laboratories can run the test on Roche’s cobas e analyzers, which are widely available worldwide. These fully automated systems can provide SARS-CoV-2 test results in approximately 18 minutes for a single test, with a test throughput of up to 300 tests / hour, depending on the analyzer.
About Roche
Roche is a world pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare, a strategy that aims to tailor the right treatment for each patient in the best possible way.
Roche is the world’s largest biotechnology company, with truly differentiated medications in oncology, immunology, infectious diseases, ophthalmology, and central nervous system diseases. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a pioneer in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat disease and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty drugs developed by Roche are included in the World Health Organization Model Lists of Essential Drugs, including life-saving antibiotics, antimalarials and cancer drugs. In addition, for the eleventh consecutive year, Roche has been recognized as one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indexes (DJSI).
The Roche Group, based in Basel, Switzerland, operates in more than 100 countries and in 2019 employed approximately 98,000 people worldwide. In 2019 Roche invested CHF 11.7 billion in R&D and recorded sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder of Chugai Pharmaceutical, Japan. For more information please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] The Emergency Use Authorization (USA) authority enables the FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of necessary medical countermeasures during public health emergencies. https://www.fda.gov/home
[2] CE-IVD marking is granted by completing a comprehensive technical validation and self-declaration under the European Directive for In Vitro Diagnostic Medical Devices.
[3] In our diagnostics.roche website
[4] https://www.who.int/news-room/commentaries/detail/immunity-passports-in-the-context-of-covid-19
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