The OraQuick® Ebola Rapid Antigen Test is an in-vitro diagnostic test designed for the detection of antigens from viruses within the Ebolavirus genus. The test is intended for use with venipuncture whole blood and fingerstick whole blood specimens as an aid in diagnosis of Ebola Virus Disease (EVD) in patients suspected of and with signs or symptoms consistent with EVD who have epidemiological risk factor(s) for Ebolavirus exposure. Performance of the device with Ebolavirus positive fingerstick whole blood was established in a non-human primate model. The test results are presumptive, definitive identification of EVD requires performing additional testing and confirmation procedures in consultation with public health and/or other authorities to whom reporting is required.

It is important to note that testing with the OraQuick Ebola Rapid Antigen Test must only be performed when public health authorities have determined the need for this test and that EVD is a nationally notifiable condition and must be reported to public health authorities in accordance with local, state, and federal regulations. The test is intended for use by experienced personnel who have documented device-specific training offered by OraSure Technologies Inc., training in the correct use of recommended personal protective equipment (PPE) and expertise in infectious disease diagnostic testing, including the safe handling of clinical specimens potentially containing Ebolavirus.

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