Rapid Ebola virus disease test OraQuick®

for antigensviruswhole blood

The OraQuick® Ebola Rapid Antigen Test is an in vitro diagnostic single-use immunoassay for the qualitative detection of antigens from viruses within the Ebolavirus genus but does not differentiate between these viruses. Testing with the OraQuick Ebola Rapid Antigen Test must only be performed when public health authorities have determined the need for this test. Testing for Ebola Virus Disease (EVD) must be performed in accordance with current guidelines provided by the appropriate public health authorities that address appropriate biosafety conditions, interpretation of test results, and coordination of testing, results and patient management with public health authorities. The OraQuick Ebola Rapid Antigen Test is intended for use with specimens from: A. Individuals with epidemiological risk factors with signs and symptoms of EVD or B. Recently deceased individuals with epidemiological risk factors who are suspected to have died of EVD. EVD is a nationally notifiable condition and must be reported to public health authorities in accordance with local, state, and federal regulations. The OraQuick® Ebola Rapid Antigen Test is intended for use with venipuncture whole blood and fingerstick whole blood specimens as an aid in diagnosis of EVD in patients suspected of and with signs or symptoms consistent with EVD who have epidemiological risk factor(s) for Ebolavirus exposure (e.g., contact with a known or suspected case, travel to a geographic location at a time when Ebolavirus transmission was known or suspected to have occurred). Performance of the device with Ebolavirus positive fingerstick whole blood was established in a non-human primate model.