United States

The OraQuick® Ebola Rapid Antigen Test has been granted De Novo 510(k) clearance by the U.S. Department of Health and Human Services for the following intended use:

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.

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 mass-screening purposes (e.g., as the sole means of EVD control at airports or border-crossings) 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.

*OraSure provides information regarding reimbursement (including potentially applicable CPT and/or HCPCS codes) for background purposes only. It does not constitute legal advice or a recommendation regarding clinical practice. Information provided is gathered from third-party sources and is subject to change without notice. The provider has the responsibility to determine medical necessity and to submit appropriate codes and charges for care provided. Any decision regarding specific coding is at the discretion of the healthcare professional, and provision of this information does not guarantee or facilitate reimbursement. OraSure makes no guarantee that the use of this information will prevent differences of opinion or disputes with Medicare or other payers as to the correct form of billing or the amount that will be paid to providers of service. Please contact your Medicare contractor, insurance provider, other payers, reimbursement specialists and/or legal counsel for interpretation of coding, coverage and payment policies or specific billing questions or concerns. Nothing herein is intended to promote or facilitate the purchase or use of products outside of their approved or cleared indications, and appropriate use of products should be based on the healthcare professional’s medical judgment.

© OraSure Technologies Inc., 2024