FDA has granted an emergency use authorization (EUA) to OraSure Technologies Inc, Bethlehem, Penn, for the company’s OraQuick ebola rapid antigen test, for use with fingerstick and venous whole blood.
Douglas A. Michels, OraSure.
In August 2014, the US Department of Health and Human Services declared that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of ebola virus. FDA’s authorization permits the OraQuick ebola rapid antigen test to be used for the duration of the emergency, unless the EUA is terminated or revoked sooner.
The OraQuick ebola test utilizes the company’s OraQuick technology platform, which is the same technology used in OraSure’s rapid antibody tests for human immunodeficiency virus and hepatitis C. The ebola 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 detection of the ebola Zaire virus detected in the West African outbreak of 2014.
The OraQuick ebola test is easy to use, and does not require instrumentation. Performing the test requires only two operational steps and a simple visual read. Positive (reactive) results may be read as soon as they appear and have been observed as early as 4 minutes. Negative (non-reactive) results must be read at 30 minutes. The test is shelf-stable under a wide range of storage conditions, and can be used at ambient temperatures up to 40°C (104°F).
The agency’s authorization permits the OraQuick ebola test to be used by laboratories and facilities adequately equipped, trained, and capable of testing for ebola infection (including treatment centers and public health clinics). The test has not been cleared or approved by FDA.
“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,” says Douglas A. Michels, OraSure president and CEO. “We are grateful to FDA for working closely with us throughout the EUA process to expedite deployment of our test.”
OraSure’s project was funded in part by the HHS Biomedical Advanced Research and Development Authority (BARDA). To advance clinical development of the rapid ebola test, the company has been awarded a contract for $1.8 million, with the potential of $10.4 million in total funding if all BARDA options are exercised. OraSure also continues to focus efforts on securing sustainable product purchase commitments from both government and non-government sources.
For more information, visit OraSure Technologies.
