Performance of the XpertTM Mpox PCR assay with oropharyngeal, anorectal, and cutaneous lesion swab specimens

Human mpox is caused by the monkeypox virus (MPXV) and best recognized for its cutaneous manifestations. Mpox cases had been largely limited to endemic regions until the 2022 worldwide outbreak that primarily affected men who have sex with men (MSM) [1]. Both virologic and epidemiologic evidence from the 2022 outbreak have implicated anorectal and oropharyngeal exposures in the sexual transmission of MPXV in addition to close contact with cutaneous lesions [2], [3], [4], [5]. Data from the 2022 outbreak suggest that infectious virus can be found in specimens collected from mucosal sites in individuals with no overt signs of cutaneous mpox disease including individuals who are completely asymptomatic and individuals with mucosal symptoms only, such as pharyngitis or hematochezia [6], [7], [8], [9]. Evaluation of oropharyngeal and anorectal swab specimens may therefore be beneficial in diagnosis of mpox or in screening of asymptomatic, high-risk individuals should future outbreaks occur.

The Xpert® Mpox assay (Cepheid) has received emergency use authorization (EUA) from the United States (US) Food and Drug Administration (FDA) and is one of two assays with EUA for Clinical Laboratory Improvement Amendments (CLIA)-waived settings [10,11]. The Xpert® platform has previously been evaluated only with lesion swab specimens for the detection of MPXV DNA both before and during the 2022 outbreak [12,13]. In this work, we investigate the performance of the Xpert® Mpox assay in cutaneous, oropharyngeal and anorectal swab specimens collected from 20 male patients presenting for evaluation during the 2022 outbreak.

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