This test has not been cleared or approved by FDA. This test has been authorized by FDA under an EUA for use by laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics).
The OraQuick® Ebola Rapid Antigen Test utilizes the OraQuick technology platform which is the same proven technology used in the Company's rapid HIV and HCV antibody test kits. This authorization allows the use of the OraQuick® Ebola Rapid Antigen Test for the duration of the U.S. Secretary of the Department of Health and Human Services' (HHS) August 5, 2014 declaration that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of Ebola virus, unless the EUA is terminated or revoked sooner.
The OraQuick® Ebola Rapid Antigen Test is designed to detect viral antigens in fingerstick and venous whole blood from patients presenting with signs and symptoms of Ebola infection in conjunction with epidemiological risk factors. The test is authorized only for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014). Positive (reactive) results may be read as soon as they appear and have been observed as early as 4 minutes. Negative (non-reactive) results have to be read at 30 minutes. The test can be used at ambient temperatures (up to 40°C / 104°F), is easy to use with only two operational steps, a simple visual read, and does not require instrumentation. Additionally, the test is shelf stable in a wide range of storage conditions.
"The OraQuick® Rapid Ebola Antigen Test is an easy to use, rapid test, that we believe will be a critical tool in containing and controlling current outbreaks of the Ebola virus," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "We are grateful to the FDA for working closely with us throughout the EUA process to expedite deployment of our test."
This project has been funded in whole or in part with Federal funds from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201500009C. OraSure has been awarded a contract for $1.8 million, with the potential of $10.4 million in total funding if all options are exercised from BARDA to advance clinical development of its rapid Ebola test. The Company continues to focus its efforts on securing sustainable product purchase commitments from both government and non-government sources.
Critical reagents in the OraQuick® Ebola Rapid Antigen Test are being supplied by the Viral Hemorrhagic Fever Consortium (VHFC; www.vhfc.org) and the Biological Defense Research Directorate at the United States Navy Medical Research Center (NMRC). The VHFC reagents were developed with the support of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health ("NIH/NIAID"). VHFC members, Autoimmune Technologies LLC, and Zalgen Labs LLC manufacture the critical reagents.