- Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions
- Antigen test accurately screens individuals with known exposure to infected SARS-CoV-2 patients, providing fast answers regarding their infection status
- Affordable and small, instrument-free testing kit enables convenient use for healthcare professionals at different point of care locations, or in resource-limited settings
- Point of care testing increases access to high quality diagnostics solutions for the detection of a current SARS-CoV-2 infection, regardless of laboratory testing infrastructure or patient mobility
Roche announced last month that it will launch a SARS-CoV-2 Rapid Antigen Test for markets accepting the CE Mark. The test arrived in Malta this week and is available from Vivian.
The SARS-CoV-2 Rapid Antigen Test is for use in point of care settings for both symptomatic and asymptomatic people. This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results typically ready in 15 minutes.1 In addition, it serves as a valuable initial screening test for individuals that have been exposed to SARS-CoV-2 infected patients or a high risk environment. The test has a sensitivity of 96.52% and a specificity of 99.68%, based on 426 samples from two independent study centres.* At launch, there will be 40 million SARS-CoV-2 Rapid Tests available, per month.
The launch is a partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement.
The test is the tenth addition to the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions which help diagnose and manage COVID-19 during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.
The SARS-CoV-2 Rapid Antigen Test may be performed by healthcare professionals in a number of different settings close to the patient. This is highly beneficial where timely decisions are needed or laboratory testing is inaccessible. The test will help to quickly identify people who are infected and allows better patient management as well as more effective use of healthcare resources.
Reuben Fava, Sales Manager at Vivian responsible for Roche commented that testing continues to be an important focus for many countries and with the upcoming flu season, it is very important to know if a person has COVID-19 or the flu for him to be able to start the right treatment. The test from Roche will provide doctors and patients with a quick answer regarding their infection and this will help reduce the spread.
Roche’s SARS-CoV-2 Rapid Antigen Test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx. This test is performed by healthcare professionals using a nasopharyngeal swab collected from a patient.1 The results are intended to aid in the early diagnosis of SARS-CoV-2 infection in patients showing clinical symptoms of SARS-CoV-2 and assist in the initial screening of patients. The test has a sensitivity of 96.52% and a specificity of 99.68%, based on 426 samples from two independent study centers. Results are ready in only 15 minutes.1 This test is another important addition to the testing options for SARS-CoV-2 at the point of care, following the launch of the SARS-CoV-2 Rapid Antibody Test, in July 2020, that is helping healthcare professionals identify patients that have developed antibodies against SARS-CoV-2, indicating prior infection.
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 CHF61.5 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 www.roche.com.
Founded by local pharmacist Wilfred Gatt in 1952, today, the company remains a family-run business based on solid values set out by the founder. Vivian is a leading distributing and marketing organisation specialised in Healthcare.
Vivian distribute and market pharmaceuticals and diagnostics from world-leading innovative and research-based companies. Whilst providing pharma, biotech and diagnostics Vivian offers the patient, healthcare professional and the payer alike, a holistic and sustainable approach not only to diagnose a condition but also to treat with the right medication at the right time. Website: www.viviancorp.com
 Roche Diagnostics Ltd. (2020). SARS-CoV-2 Rapid Antigen Test package insert
 European Centre for Disease Prevention and Control. Diagnostic testing and screening for SARS-CoV-2. 2020. https://www.ecdc.europa.eu/en/covid-19/latest-evidence/diagnostic-testing. Accessed July 2020.
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