WHO has assessed and today listed the ReEBOV Antigen Rapid Test Kit (Corgenix, USA) as eligible for procurement to Ebola affected countries. The test was evaluated under WHO’s Emergency Assessment and Use, a procedure established to provide minimum quality, safety and performance assurance for diagnostic products in the context of the Ebola emergency.
Ebola is currently being tested in laboratories largely through the detection of the virus’s nucleic acid (genetic material), using commercial or in-house tests. Nucleic acid tests (NATs) are more accurate but are complex to use and require well-established laboratories and fully trained personnel. In addition, turn-around time can vary between 12 and 24 hours.
The ReEBOV Antigen Rapid Test, which can provide results within 15 minutes, is based on detection of the Ebola protein rather than nucleic acid. When compared with the results of a NAT previously listed by WHO and currently being used in the field (RealStar® Filovirus Screen RT-PCR Kit 1.0, altona Diagnostics GmbH), ReEBOV Antigen Rapid Test is able to correctly identify about 92% of Ebola infected patients and 85% of those not infected with the virus.
While less accurate, the antigen test is rapid, easy to perform and does not require electricity – it can therefore be used at lower health care facilities or in mobile units for patients in remote settings. Where possible, results from ReEBOV antigen Rapid Test Kit should be confirmed by testing a new blood sample using an approved Ebola NAT.
Source: The World Health Organization
In view of the unprecedented outbreak of Ebola virus disease (EVD) in West and Central Africa, WHO has implemented an emergency mechanism to assess in vitro diagnostics (IVDs) that will be used to diagnose Ebola Virus Disease. This is considered necessary because most IVDs for EVD have not undergone an independent assessment of quality, safety or of the minimal performance data supporting the IVD.
The WHO Emergency Use Assessment and Listing (EUAL) procedure has three key components:
1. Review of technical documentation relating to safety and performance (e.g. analytical and clinical evidence, stability data); and
2. Review of the documentation relating to the manufacture of the product and the manufacturer’s quality management system (QMS);
3. An independent laboratory evaluation coordinated by WHO of the product’s performance and operational characteristics.
The results of the review of the EUAL procedure-related documentation, the safety and performance documentation, and the evaluation are then submitted to WHO for a decision on the product’s suitability for WHO procurement. Products that are reviewed favourably are then listed as eligible for WHO procurement.
List of submissions to the WHO Emergency Use Assessment and Listing (EUAL) Procedure for IVDs
This table provides an overview of the status of submissions to the WHO EUAL. The products listed have not undergone yet the full assessment and as such are not eligible for WHO procurement.
o List of submissions to the WHO Emergency Use Assessment and Listing (EUAL) procedure of diagnostics for Ebola virus disease
Public Reports: WHO list of IVDs for Ebola virus disease accepted for procurement through the EUAL Procedure for IVDs.
o Public report for Liferiver™ – Ebola Virus (EBOV) Real Time RT-PCR Kit (EA 0009-009-00)
o Public report for ReEBOV™ Antigen Rapid Test Kit (EA 0011-011-00)
o Public report for RealStar® Filovirus Screen RT-PCR Kit 1.0 (EA 0002-002-00)
EBOLA IVDs: Invitation to manufacturers (Extended)
o Invitation to manufacturers
o Ebola Diagnostics
Source: The World Health Organization
Germantown’s Zalgen Labs announces its technology, a key component of the VHFC’s ReEBOV RDT for Ebola, has received approval from the World Health Organization (WHO)and authorization for emergency use from the U.S. FDA. Zalgen’s platform enables POC detection of Ebola within 15 minutes while the only other approved tests take up to 72 hours for collection, transport andt PCR analysis at central labs. Zalgen Labs received funding from the BioMaryland Center and Montgomery County to validate this test in Sierra Leone last November.
Emergency use authorization allows the Ebola rapid test to be used worldwide
Corgenix Medical Corporation (CONX), a worldwide developer and marketer of diagnostic test kits, announced it has received U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) of its ReEBOV™ Antigen Rapid Test. The test 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 Corgenix Ebola rapid test is the first rapid diagnostic test (RDT) and the first immunoassay authorized 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 authorized 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 Corgenix 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 U.S. regulatory authorization follows last week’s World Health Organization (WHO) listing for procurement for the Corgenix Ebola RDT, making this test available to the health care community worldwide.
“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 percent. 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.
“Corgenix’s work is crucial to addressing the Ebola outbreak in West Africa,” said United States Senator from Colorado Michael Bennet. “This new test has the potential to help medical officials in the field diagnose Ebola virus disease quicker than before to help control the spread of this vicious disease. We’re extremely grateful that this Colorado-based company has invested its resources and completed this research to develop such a valuable tool.”
The ReEBOV™ Antigen Rapid Test was developed by Corgenix in cooperation with additional members of the Viral Hemorrhagic Fever Consortium (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 other collaborators in West Africa. 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. A key component of our success is a result of the commitment and participation of the Ministry of Sanitation and Public Health of the Republic of Sierra Leone and the dedicated medical personnel of the Kenema Government Hospital in Kenema, Sierra Leone, a number of whom have died fighting the current Ebola outbreak.”
“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.”
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.
Development of the Corgenix ReEBOV™ Antigen Rapid Test for Ebola was supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) (grants 1R43AI088843 and 2R44AI088843). Additional support has been provided by The Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation.
About Corgenix Medical Corporation
Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases (including the world’s only non-blood-based test for aspirin effect), bone and joint disorders and a line of unique detection products for viral hemorrhagic disease. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network. Additionally, Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2003 certified and compliant with FDA regulations. More information is available at www.corgenix.com (Corporate website) and www.corgenix.net(Contract Services website).
About the Viral Hemorrhagic Fever Consortium
The Viral Hemorrhagic Fever Consortium was established as a result of numerous multi-year grants and contracts awarded to Tulane University by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to support Tulane’s ongoing efforts to diagnose, treat and prevent Lassa fever. The VHFC expanded its work into Ebola in 2010. The goal of the Consortium is to understand mechanisms related to the human immune response to viral infection. Specifically, by understanding what parts of the virus are recognized by the immune system, scientists can better understand mechanisms of antibody-mediated protection or pathogenesis in humans with Lassa fever, Ebola, and similar diseases. Consortium efforts have focused on the development of new recombinant proteins for diagnostic products, which have shown to be extremely effective in clinical settings in Africa. This progress is allowing a transition of efforts towards instituting better treatment of affected individuals and ultimately prevention of Lassa fever, Ebola, and other diseases altogether. The Consortium is a collaboration between Tulane, The Scripps Research Institute, the Broad Institute, Harvard University, the University of California at San Diego, the University of Texas Medical Branch at Galveston, Autoimmune Technologies LLC, Corgenix Medical Corporation, Zalgen Labs LLC, the Kenema Government Hospital (Sierra Leone), the Irrua Specialist Teaching Hospital and the Redeemer’s University Hospital (Nigeria), and various other partners in West Africa. More information is available at www.vhfc.org.
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