OraQuick® HCV Rapid Antibody Test
OraQuick® HCV Rapid Antibody Test



The OraQuick® Ebola Rapid Antigen Test has been granted an Emergency Use Authorization (EUA) by the U.S. Department of Health and Human Services for the following two uses:

A. For presumptive detection of Ebola Zaire virus in whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors (including geographical location with high prevalence of Ebola infection)

B. For detection of Ebola Zaire virus in cadaveric oral fluid specimens to aid in diagnosing Ebola Zaire virus as the cause of death in order to make informed decisions on safe and dignified burial procedures to prevent transmission of the Ebola Zaire virus in the community.



The Emergency Use Authorization granted by the U.S. Department of Health and Human Services requires that you or any of your consignees will abide by the following conditions:

  1. A. Laboratories and facilities adequately equipped, trained and capable of testing for Ebola infection (including treatment centers and public health clinics) will include with reports of the results of the OraQuick® Ebola Rapid Antigen Test the authorized Fact Sheet for Health Care Providers and the authorized Fact Sheet for Patients.

    B. Laboratories, facilities, and public health authorities overseeing personnel adequately equipped, trained, and capable of testing for Ebola infection, and stakeholders working with such public health authorities, will provide the authorized Fact Sheet for Response Teams to personnel performing the cadaveric oral fluid testing, and will include with reports of the OraQuick® Ebola Rapid Antigen Test results the authorized Fact Sheet for Relatives and Caregivers.

    Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media.

    Note: Each 25 count or 100 count kit contains Patient Fact Sheets and Relative and Caregiver Fact Sheets for distribution to patients and relatives/caregivers of individuals who have been tested by the OraQuick® Ebola Rapid Antigen Test. The Health Care Provider Fact Sheet, Patient Fact Sheet, Relative and Caregiver Fact Sheet and Response Team Fact Sheet can be found below or from the FDA.

  2. Laboratories and facilities adequately equipped, trained and capable of testing for Ebola infection (including treatment centers, public health clinics and field surveillance and response teams directed by public health authorities) will have a process in place for reporting test results to health care professionals and relevant public health authorities, as appropriate.

  3. Laboratories and facilities adequately equipped, trained and capable of testing for Ebola infection (including treatment centers, public health clinics and field surveillance and response teams directed by public health authorities) will collect information on the performance of the assay, and report to OraSure Technologies, Inc. and any authorized distributor(s) any suspected occurrence of false positive or false negative results of which they became aware. Note: To report false positives or false negatives, call (800) ORASURE (800-672-7873) within the United States or +(001) 610-882-1820 for outside the United States. You can also go to http://www.orasure.com/contact/contact-customer-service.asp.

  4. All personnel from laboratories and facilities adequately equipped, trained and capable of testing for Ebola infection (including treatment centers, public health clinics and field surveillance and response teams directed by public health authorities) using the assay will be appropriately trained on the OraQuick® Ebola Rapid Antigen Test and use appropriate laboratory and personnel equipment when handling this kit.

    As a laboratory or facility planning to use the OraQuick® Ebola Rapid Antigen Test, you are required to use the OraQuick® Ebola Kit Controls and the OraQuick® Ebola Visual Reference Panel. All new operators must be able to correctly interpret all devices provided within the OraQuick® Ebola Visual Reference Panel prior to using the OraQuick® Ebola Rapid Antigen Test. Refer to the package insert for the OraQuick® Ebola Rapid Antigen Test for warnings, precautions, information on how the test works, how to use the device, interpretation of the results, and limitations of the test or for circumstances in which the OraQuick® Ebola Kit Controls should be run.

    If you have any questions, please call (800) ORASURE (800-672-7873) within the United States or +(001) 610-882-1820 for outside the United States. You can also go to www.OraSure.com.

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Page last updated: January 21, 2013