A major success has just been recorded in the fight against Ebola Virus Disease in West Africa through the development, production and deployment of the first Ebola Rapid diagnostic Test Kit (ReEBOV™ Antigen Rapid Test), which is a result of a collaboration between the Redeemer’s University, its strategic partners in the Viral Hemorrhagic Fever Consortium (VHFC) and Corgenix Medical Corporation (CMC) in Colorado State, USA.The new Ebola Rapid diagnostic test (RDT) has received a global endorsement as the United States Food and Drug Administration (FDA) and World Health Organisation (WHO) approved and authorised for listing the usage to health care community worldwide.The test kit is to be used for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in individuals with signs and symptoms of Ebola virus infection in conjunction and with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection.)The Ebola RDT is the first immunoassay authorised for emergency use by the FDA for the presumptive detection of Ebola virus. The EUA allows the use of the ReEBOV™ Antigen Rapid Test in circumstances when use of a rapid Ebola test is determined to be more appropriate than use of an authorized Ebola nucleic acid (molecular) test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus.The authorised ReEBOV™ Antigen Rapid Test is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing.Unlike molecular testing, which in West Africa can still take days to return results from central testing laboratories, the newly developed RDT is a point-of-care test that can be used in any clinical facility adequately equipped, trained and capable of such testing, or in any field laboratory with trained personnel capable of such testing, to diagnose suspected Ebola cases in 15-25 minutes.“The FDA and WHO have been working closely with us throughout this process to get this new test in the hands of those battling on the front lines of the Ebola outbreak as quickly as possible,” said Douglass Simpson, Corgenix President and CEO.“Completing this product development in less than a year demonstrates how governmental agencies, regulatory bodies, industry, non-profits and others can work together to find solutions to catastrophic events such as the Ebola virus outbreak.“This collaboration has enabled us to quickly deliver this critically important point-of-care test and potential breakthrough in the fight against Ebola in the current outbreak in West Africa.”Ebola is indigenous to Africa and is one of the deadliest viruses in the world, with mortality rates of between 30 and 90 per cent. Ebola and other viral hemorrhagic fevers are difficult to discriminate because many of the early signs and symptoms are nonspecific and common to other infectious diseases such as Dengue fever, Lassa fever, typhoid and malaria.The ReEBOV™ Antigen Rapid Test was developed by Corgenix in cooperation with additional members of the VHFC, a collaboration of academic and industry members headed by Tulane University, including Autoimmune Technologies LLC, Zalgen Labs LLC, The Scripps Research Institute and the University of Texas Medical Branch at Galveston, as well as Redeemer’s University in Nigeria.Mr Simpson noted, “We are pleased to be part of the VHFC. This is a remarkable group of scientists who have been in the forefront of research in Ebola, Lassa fever and other dangerous viral diseases in Africa for many years.“This has the potential to be a game-changer in stopping the spread of the epidemic,” said Dr. Robert Garry, Professor of Microbiology and Immunology at Tulane, and Principal Investigator of the VHFC. “Instead of taking days for lab results, the Ebola RDT uses a drop of blood from a finger prick to deliver a diagnosis in as little as 15 – 25 minutes, potentially allowing trained public health workers to isolate and treat patients immediately. Medical personnel will be able to quickly identify hotspots and may prevent resurgence of cases in the current outbreak.”“Our ability to develop and deploy the Ebola Rapid diagnostics test within a very short window, is a clear demonstration of our capability to translate knowledge of viral genomics into tools that significantly change healthcare in Africa,” said Dr. Christian Happi, Professor of Molecular Biology and Genomics, and Director of the World bank-funded African center of Excellence for Genomics of infectious Diseases (ACEGID) at Redeemer’s University. “We will continue to use the genomics platform that we have established at ACEGID, for the development of tools for the control and elimination of neglected infectious diseases in Africa,” Dr. Happi further stated.  The FDA’s emergency use authorization of the ReEBOV™ Antigen Rapid Test is for the presumptive detection of Ebola viruses (including Ebola Zaire virus detected in the West Africa outbreak in 2014) in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors, including geographic location with high prevalence of Ebola infection. The test was also evaluated under WHO’s Emergency Use Assessment and Listing procedure, which provides independent technical information on safety, quality and performance of in vitro diagnostics, principally to other United Nations (UN) agencies but also to WHO Member States and other interested organizations in the context of the Ebola emergency.Mr. Simpson stated that the VHFC will remain actively engaged in efforts to advance additional diagnostic products, some already under development for viral and parasitic diseases, and to expand collaborations with global health care partners, including providers in West Africa. The consortium has already developed a suite of additional laboratory assays to complement its RDTs. These additional assays are being developed to permit confirmation of point-of-care test results and augment much needed serosurveillance capabilities via ongoing and future seroprevalence studies on both Ebola and Lassa fever.



http://tribune.com.ng/business/money-market/item/31691-redeemer-s-university-cmc-vhfc-develop-ebola-rapid-diagnostic-test-as-kit-receives-usfda-who-s-approval-for-public-usage

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