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The OraQuick Ebola Rapid Antigen Test is an in vitro diagnostic single-use immunoassay for the qualitative detection of antigens 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: - individuals with epidemiological risk factors with signs and symptoms of EVD or - . 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. The OraQuick Ebola Rapid Antigen Test is intended for use with cadaveric oral fluid collected from recently deceased individuals with epidemiological risk factors who are suspected to have died of EVD. Cadaveric oral fluid should be collected directly with the device or collected with oral swabs in viral transport media. The OraQuick Ebola Rapid Antigen Test is intended as an aid in the determination of EVD as the cause of death to inform decisions on safe handling of cadavers to prevent disease transmission. The OraQuick Ebola Rapid Antigen 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. Negative results were observed in individuals with low levels of circulating virus, therefore negative results do not preclude infection with viruses within the Ebolavirus genus. The level of Ebolavirus antigens that would be present in EVD clinical specimens from individuals with early systemic infection is unknown. Test performance of the OraQuick Ebola Rapid Antigen Test is associated with the level of Ebolavirus antigens in the patient; therefore, the test is not intended for use in an asymptomatic population for massscreening purposes (e.g., as the sole means of EVD control at airports or bordercrossings) or for testing of individuals at risk of exposure without observable signs of infection. The OraQuick Ebola Rapid Antigen 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. The test is intended for use by laboratory professionals or healthcare workers who have demonstrated availability of biosafety equipment, access to patient containment facilities, and established procedures (e.g., SOP) for coordinating testing, results and patient management with public health authorities consistent with state, local and federal recommendations and guidelines.

The OraQuick Ebola Rapid Antigen Test is a manually performed, visually read immunoassay for the qualitative detection of Ebola virus in human venipuncture whole blood, fingerstick whole blood and cadaveric oral fluid. The OraQuick Ebola Rapid Antigen Test is comprised of both a single-use test device and a vial containing a pre-measured amount of a buffered developer solution. The single-use test devices consist of a plastic housing that protects the assay test strip with the reagents. The assay strip can be viewed through the test device result window. The test result window has indicated zones for the Ebolavirus specific Test Line and the Control Line of the test. The test consists of a sealed pouch with two separate compartments for each of the following two components: - 1. OraQuick Ebola Rapid Antigen Test - 2. Developer Vial The OraQuick Ebola Rapid Antigen Test further contains the following materials for the sample processing: - 1. Test Stand - 2. Micropipettes capable of pipetting 20ul of sample The OraQuick Ebola Rapid Antigen Test kit must be used with the OraQuick Ebola Rapid Antigen Test Kit Controls and a Visual Reference Panel (available separately). The OraQuick Ebola Rapid Antigen Test Kit Controls contain: - 1. One Ebola positive control vial (orange capped) - 2. One Ebola negative control vial (white capped) The positive control contains 0.25mL of Ebola recombinant VP40 equivalent to a moderate positive result and is diluted in a defibrinated pool of normal human plasma negative for Ebolavirus. The negative control contains 0.25 mL of defibrinated pool of normal human plasma negative for Ebolavirus. The controls do not contain infectious Ebolavirus material. The OraQuick Ebola Visual Reference Panel (VRP) is intended to assist new operators in becoming proficient at reading specimens with antigen levels near the limit of detection of the device. The devices in the VRP do not contain any infectious material. The VRP contains three Quick Ebola Rapid Antigen Test devices that have been designed to represent reading intensities representative of - 1. A test result near the limit of detection (LoD) - 2. A low positive test result - 3. A negative test result Additional materials required but not provided include 1. Timer