BD launches portable, rapid point-of-care antigen test to detect SARS-CoV-2 in 15 minutes, targeting to expand access to COVID-19 testing in South Africa
BD (Becton, Dickinson and Company, NYSE: BDX), a leading global medical technology company, has started to introduce its rapid, point-of-care, SARS-CoV-2 diagnostic test in South Africa.
BD completed the authorisation process from the South African Department of Health through the National Health Laboratory Services, and is making the BD Veritor™ System for Rapid Detection of SARS-Cov-2 available to health care professionals.
The test delivers results in 15 minutes on an easy-to-use, portable instrument, which is a critical improvement in turnaround time for COVID-19 diagnostics, because it provides real-time results and enables decision-making while the patient is still onsite.
The BD Veritor™ System for Rapid Detection of SARS-Cov-2 uses a nasal swab collection method and the sample is read on an instrument that provides a clear positive or negative indicator on a digital screen.
Ian Wakefield, general manager of BD Africa said: “The BD Veritor™ System for Rapid Detection of SARS-Cov-2 incorporates an analyser which is slightly larger than a mobile phone, offers an easy-to-use workflow that makes it an ideal solution for point-of-care settings. Locations that may use the test include pharmacies, clinics, long-term care homes, airports, schools and various sites in rural communities. It also offers customers traceability and reporting capabilities through the optional BD Synapsys™ Informatics Solution.”
The World Health Organization supports the use of rapid antigen diagnostic technology in the WHO’s September 2020 guideline WHO Target Product Profiles for COVID-19 Diagnostics: “Many countries, especially low- and middle-income countries, rely on centralised testing facilities that rarely meet the needs of patients, caregivers, health workers and society as a whole. Therefore, a highly specific, rapid and easy-to-use test that could identify the majority of patients with early, acute SARS-CoV-2 infection, allowing for immediate implementation of isolation and other efforts to arrest transmission of the virus, would reduce the number of people with suspected infection requiring secondary testing.”1
The BD Veritor™ System for Rapid Detection of SARS-Cov-2 antigen test was granted Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) in July 2020 and since then, the company has leveraged its global manufacturing network to scale-up supply of the test. The BD Veritor™ System for Rapid Detection of SARS-Cov-2 antigen test received CE-marking approval in September 2020, ensuring access throughout the European Union. In addition, the test has been listed on the Global Fund list of SARS-CoV-2 diagnostic test kits and equipments eligible for procurement.2 The technology will become available across the globe as additional country-specific regulatory approvals are granted.
The company is working with governments and global health agencies to holistically advance the worldwide response to COVID-19. BD is expanding access to COVID-19 diagnostic testing, training health workers on infection control, supporting patient management in the ICU, accelerating immune response research and providing injection devices to countries around the world that are preparing for mass vaccination efforts.
BD has been operating in South Africa for more than 25 years through collaborations with stakeholders and local business partners to address challenges across the patient care continuum.
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to accurately detect disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
For more information on the BD Veritor™ System for Rapid Detection of SARS-Cov-2 please visit https://lp.bd.com/pocrapiddiagnostic.html#form or for more information on BD solutions please visit https://www.bd.com/en-za/our-products/microbiology-solutions/point-of-care-testing/bd-veritor-system-for-rapid-detection-of-sars-cov-2.
2 The Global Fund. List of SARS-CoV-2 Diagnostic test kits and equipments eligible for procurement according to Board Decision on Additional Support for Country Responses to COVID-19 (GF/B42/EDP11). https://www.theglobalfund.org/media/9629/covid19_diagnosticproducts_list_en.pdf. Accessed 11 November 2020