FDA gives limited approval for OraQuick Ebola Rapid Antigen Test- OraSure
OraSure Technologies has received an FDA Emergency Use Authorization (EUA) for its OraQuick Ebola Rapid Antigen Test for use with fingerstick and venous whole blood. This test has not been cleared or approved by the FDA. This test has been authorised under an EUA for use by laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centres and public health clinics).
The test is authorised 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, has 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.
Comment: In 2014, bioMérieux received FDA approval for emergency use of two of its rapid Ebola tests. In December 2014, Roche was given FDA approval for emergency use of its quick diagnostic for Ebola. In March 2015, Corgenix received the FDA's EUA for its 20-minute Ebola diagnostic.
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