Results are for the identification of MPX and OPX DNA. Positive results are indicative of the presence of MPX and OPX DNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude MPX infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. STANDARD M10 MPX/OPX test is intended to be performed by trained users in both laboratory and near patient testing settings.