FEBRUARY 15, 2023

FDA Authorizes Xpert Mpox Test for Emergency Use

By IDSE News Staff

The FDA granted emergency use authorization (EUA) to the Xpert Mpox test (Cepheid) for the detection and/or diagnosis of infection with mpox in moderately complex settings, and is considered authorized for use in point of care on GeneXpert Xpress systems (Cepheid), according to a company release.

The test is authorized for use in settings that operate under a Clinical Laboratory Improvement Amendments Certificate of Waiver, Certificate of Registration, Certificate of