Abstract

Monkeypox virus (MPXV), a zoonotic orthopoxvirus (OPX), is endemic in the Democratic Republic of Congo (DRC). Currently, diagnostic assays for human monkeypox (MPX) focus on real-time quantitative polymerase chain reaction (PCR) assays, which are typically performed in sophisticated laboratory settings. Herein, we evaluated the accuracy and utility of a multiplex MPX assay using the GeneXpert platform, a portable rapid diagnostic device that may serve as a point-of-care test to diagnose infections in endemic areas. The multiplex MPX/OPX assay includes a MPX-specific PCR test, OPX-generic PCR test, and an internal control PCR test. In total, 164 diagnostic specimens (50 crusts and 114 vesicular swabs) were collected from suspected MPX cases in Tshuapa Province, DRC, under national surveillance guidelines. The specimens were tested with the GeneXpert MPX/OPX assay and an OPX PCR assay at the Institut National de Recherche Biomedicale (INRB) in Kinshasa. Aliquots of each specimen were tested in parallel with a MPX-specific PCR assay at the Centers for Disease Control and Prevention. The results of the MPX PCR were used as the gold standard for all analyses. The GeneXpert MPX/OPX assay performed at INRB had a sensitivity of 98.8% and specificity of 100%. The GeneXpert assay performed well with both crust and vesicle samples. The GeneXpert MPX/OPX test incorporates a simple methodology that performs well in both laboratory and field conditions, suggesting its viability as a diagnostic platform that may expand and expedite current MPX detection capabilities.

Highlights

  • Monkeypox virus (MPXV) is a zoonotic orthopoxvirus (OPX) endemic to west and central Africa

  • Majority of human monkeypox (MPX) infections are reported from the Congo Basin in the Democratic Republic of Congo (DRC).[1,2]

  • Contact with wildlife, which often occurs in rural communities in DRC that are dependent on bushmeat as a protein source, is thought to increase risk for human infection with MPXV.[13]

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Summary

Introduction

Monkeypox virus (MPXV) is a zoonotic orthopoxvirus (OPX) endemic to west and central Africa. Serologic evidence of OPX infection in Sierra Leone suggests human exposure to wild-type zoonotic OPXs in west Africa.[6] smallpox vaccination with Vaccinia virus provides protection against human MPXV infection,[7] lack of routine vaccination after smallpox eradication in 1980 has been hypothesized to have contributed to an increase in human MPX incidence.[8,9]. MPXV is transmitted to humans from a primary zoonotic source, and the virus is capable of human-to-human transmission.[10] The animal reservoir of MPXV remains unknown; several genera of African rodents (Cricetomys, Graphiurus, Funiscirurus) have been identified as potential reservoirs responsible for transmission and maintenance of the virus.[11,12] Contact with wildlife, which often occurs in rural communities in DRC that are dependent on bushmeat as a protein source, is thought to increase risk for human infection with MPXV.[13]

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