On February 24, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the ReEBOV™ Antigen Rapid Test for the presumptive detection of Zaire Ebola virus (detected in the West Africa outbreak in 2014), Sudan Ebola virus, and Bundibugyo Ebola virus in fingerstick (capillary) whole blood, venous whole blood, and plasma from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection). The authorized ReEBOV™ Antigen Rapid Test is intended for circumstances when use of a rapid Ebola virus test is determined to be more appropriate than use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. The authorized ReEBOV™ Antigen Rapid Test is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing. The ReEBOV™ Antigen Rapid Test is authorized for use in laboratories or facilities adequately equipped, trained, and capable of such testing (including treatment centers and public health clinics). The ReEBOV™ Antigen Rapid Test does not distinguish between the different Ebola virus strains.
In response to Corgenix Inc.’s request to amend this EUA, on March 16, 2015 FDA reissued the February 24, 2015 EUA in its entirety with the Corgenix Inc. requested amendments incorporated. The amendments allow, in addition to Corgenix Inc., distributors that are authorized by Corgenix Inc. to distribute the ReEBOV™ Antigen Rapid Test with certain conditions applicable to such authorized distributor(s). The Instructions for Use have also been updated to incorporate these amendments.
In response to requests from Zalgen Labs, LLC and Corgenix Inc. to transfer ownership of the ReEBOV™ Antigen Rapid Test EUA from Corgenix Inc. to Zalgen Labs, LLC, on November 3, 2016, FDA amended and reissued the EUA. The amended EUA allows Zalgen Labs, LLC and its authorized distributors to distribute the ReEBOV™ Antigen Rapid Test manufactured by Corgenix Inc. and, upon subsequent concurrence by FDA, to distribute the ReEBOV™ Antigen Rapid Test manufactured by Zalgen Labs, LLC (or an authorized contract manufacturer), subject to the conditions of authorization set forth in the Authorization Letter. The authorized Fact Sheet for Health Care Providers, the authorized Fact Sheet for Patients, and the authorized Instructions for Use have been updated to incorporate the amendments.
- Letter of Authorization
- Fact Sheet for Healthcare Providers
- Fact Sheet for Patients
- Labeling