This high-quality test can help to reliably triage patients at the point of care and offer immediate reassurance of prior infection
A small blood sample, that can be easily collected from a minimally invasive finger prick by a healthcare professional, is sufficient to perform the test when venous blood draw is less accessible or suboptimal for the patient
Portable testing kit enables its convenient use at versatile point of care locations, or in resource-limited settings
Basel, 28 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the SARS-CoV-2 Rapid Antibody Test in markets accepting the CE Mark. The launch is a partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement. Our partner, SD Biosensor is actively working on an Emergency Use Authorisation (EUA)1 submission to the U.S. Food and Drug Administration (FDA).
This newly developed SARS-CoV-2 Rapid Antibody Test is for use in point of care settings and can help healthcare professionals identify patients that have developed antibodies against SARS-CoV-2, indicating prior infection. The test is part of the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19, which also includes molecular, serology and digital solutions.
The SARS-CoV-2 Rapid Antibody Test can be performed by healthcare professionals in a number of settings outside clinical labs and near to the patient. This is beneficial in situations where timely decisions are needed, laboratory SARS-CoV-2 testing is not available, or finger prick sampling is the better option over a venous blood draw.
Thomas Schinecker, CEO of Roche Diagnostics, stated that, “We have a global responsibility to help better manage the COVID-19 health crisis and provide reliable solutions to our patients when and where needed. We are proud to have a reliable and high quality antibody test for the point of care now included in our COVID-19 diagnostic portfolio.”
Roche’s SARS-CoV-2 Rapid Antibody Test is a rapid chromatographic immunoassay intended for qualitative detection of IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma or whole blood. When performed at least 14 days after symptom onset, the test has a sensitivity of 99.03%.2 Test specificity is 98.65%.2 This test can be performed using blood from a finger prick to produce high performance results within 10-15 minutes in a point of care setting.2 The results can help in assessing patients’ immune response to the virus. As more is understood about immunity to SARS-CoV-2, the test may help to assess who has built up possible immunity to the virus.
The human body develops antibodies in response to many illnesses. In the current situation of the COVID-19 pandemic, tests to detect antibody responses to SARS-CoV-2 will be critical to support vaccine development, add to our understanding about the rate and spread of infection among populations and, if scientific evidence shows, to determine whether a person might have gained immunity against the virus. As of 24 April 2020, no data from studies evaluating whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans have been published.3 Antibody tests need to be able to specifically detect antibodies against SARS-CoV-2 with no cross-reactivity to other infectious diseases, such as influenza, which could generate a false positive result. A false positive result occurs when a person (wrongly) receives a positive test result, when they should have received a negative result due to the absence of SARS-CoV-2 specific antibodies in their blood.
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE mark. On 3 May, Roche announced that its COVID-19 antibody test aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Also in June we received an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
We are actively involved in understanding the potential of our existing portfolio and are researching options for the future. On 19 March, we announced the initiation of COVACTA - a global Phase III randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous Actemra©/RoActemra© (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. Actemra©/RoActemra© is also being studied in combination with the investigational antiviral remdesivir in hospitalised patients with severe COVID-19 pneumonia in the REMDACTA trial in partnership with Gilead, announced 28 May and, separately, we are studying Actemra©/RoActemra© in the EMPACTA study, announced 1 May, in COVID-19 associated hospitalised pneumonia in patients that are often underrepresented in clinical trials. Actemra©/RoActemra© is not approved by any health authority for use in COVID-19 pneumonia. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
SD Biosensor is a global bio-diagnostic company that provides in vitro products engrafted with innovative technologies. Established in 2010, SD Biosensor has successfully launched diagnostics of blood glucose, glycated hemoglobin, and cholesterols globally, and with innovative products, are striving to become a leading global in vitro diagnostic company.
Roche is a global 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 personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases 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 medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted 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 in Chugai Pharmaceutical, Japan. For more information, please visit
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The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of medical countermeasures needed during public health emergencies
SD Biosensor. (2020). SARS-CoV-2 Rapid Antibody Test package insert