Corgenix Ebola Rapid Diagnostic Test Highly Accurate in Independent Study

Tuesday, June 30, 2015

DENVER--(BUSINESS WIRE)-- The Ebola rapid diagnostic test (RDT) from Corgenix Medical Corporation has proven to be highly accurate in an independent study published in the British medical journal Lancet. Results confirmed the value of the assay as a simple, point-of-care test for rapid detection of the Ebola virus in the field. It is the first study to show that a point-of-care Ebola test is faster than, and just as sensitive as, a conventional laboratory-based testing method.

The study, titled “ReEBOVTM Antigen Rapid Test kit for point-of-care and laboratory-based testing for Ebola virus disease: a field validation study,” was conducted in Sierra Leone by the independent, non-governmental organization Partners In Health.

Working in a designated “red zone” in Sierra Leone – a restricted area where suspected Ebola patients are managed and treated by health workers wearing personal protective equipment – researchers conducted point-of-care testing on 106 individuals. All 28 patients who tested positive for Ebola virus by clinical laboratory RT-PCR molecular assay were also positive by finger-stick rapid diagnostic test (100 percent sensitivity); 71 of 77 patients who tested negative by RT-PCR were also negative by the rapid diagnostic test (92.2 percent specificity). Researchers noted that the RT-PCR benchmark test itself had imperfect sensitivity.

“This study, conducted under difficult, real-life conditions, shows us that the ReEBOV test is the best available product for use in the field, until full laboratory confirmatory testing can be conducted,” said Corgenix President James Widergren.

As of June 2015, the WHO had reported more than 27,000 confirmed, probable and suspected Ebola virus cases and more than 11,000 deaths in West Africa in the worst outbreak of the disease ever recorded. The ReEBOV test enables the rapid and accurate detection of Ebola, which can help government and health officials better identify, contain and treat future outbreaks.

According to Dr. Robert Garry, professor of Microbiology and Immunology at Tulane and Principal Investigator of the Viral Hemorrhagic Fever Consortium (VHFC), the rapid diagnostic tests are designed for use on fresh blood coming directly from a person's fingertip, not from old, stored blood that reduces the accuracy of the RDT compared to clinical laboratory testing.

“Previous comparisons also used insensitive PCR assays, which have since been found to show negative readings on samples in which Ebola is actually present,” explained Garry. “In this independent study, the ReEBOV RDT worked exactly as designed. The best and proper use of the Corgenix Ebola RDT is in villages or neighborhoods, as well as in medical triage units so that Ebola cases can be appropriately segregated while waiting for secondary testing by PCR.”

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.

In February 2015, the Corgenix ReEBOV Antigen Rapid Test for the Ebola virus was listed as eligible for procurement by the World Health Organization and also received Emergency Use Authorization from the U.S. Food and Drug Administration. Unlike PCR molecular testing that in West Africa can take days to return results from central testing laboratories, the Corgenix point-of-care test can be used in any clinical facility or field laboratory adequately equipped and with trained personnel capable of such testing. Diagnosis can be made in 15-25 minutes.

Fio Corporation is currently adapting its Deki™ Reader to work with the Corgenix Ebola RDT to provide suspected Ebola patients in the most remote, resource-poor settings, access to automated test results through cloud-based data uplink technology.

The Corgenix Ebola rapid test was the first 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 when use of an authorized Ebola nucleic acid (molecular) test is not available, such as rapid case triage (point of contact) or bedside testing (point of care); or in poor resource environments such as austere clinical laboratories or remote field testing. The authorized ReEBOV Antigen Rapid Test is not intended for use for general Ebola virus infection screening such as airport screening or contact tracing of subjects not presenting with febrile symptoms and epidemiological risk factors. For the full intended use and FDA approved performance characteristics as authorized by the FDA for EUA use, please refer to the full Package Insert listed on www.corgenixonline.com.

The below restrictions apply to the Corgenix Ebola rapid test:

  • This test has not been FDA cleared or approved;
  • This test has been authorized by FDA under an Emergency Use Authorization for use by laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics);
  • This test has been authorized only for the detection of Ebola viruses (including Ebola Zaire virus detected in the West Africa outbreak in 2014);
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About Corgenix Medical Corporation

Corgenix, an ORGENTEC company, 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. The company merged with ORGENTEC Diagnostika in 2015 to offer more than 350 diagnostic products to clinical laboratories throughout the world. 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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