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.
Corgenix president James Widergren said: "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."
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.