title: Evaluation of the GeneXpert for Human Monkeypox Diagnosis.
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.
authors.affiliation: Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, National Center for Enteric and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Daniel
authors.initials: D
authors.lastname: Li
authors.affiliation: Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, National Center for Enteric and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Wilkins
authors.affiliation: Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, National Center for Enteric and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Andrea M
authors.initials: AM
authors.lastname: McCollum
authors.affiliation: Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, National Center for Enteric and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Lynda
authors.initials: L
authors.lastname: Osadebe
authors.affiliation: Centers for Disease Control and Prevention, Kinshasa, Democratic Republic of Congo.
authors.forename: Joelle
authors.initials: J
authors.lastname: Kabamba
authors.affiliation: Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo.
authors.forename: Beatrice
authors.initials: B
authors.lastname: Nguete
authors.affiliation: Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo.
authors.forename: Toutou
authors.initials: T
authors.lastname: Likafi
authors.affiliation: Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo.
authors.forename: Marcel Pie
authors.initials: MP
authors.lastname: Balilo
authors.affiliation: Ministry of Health, Kinshasa, Democratic Republic of Congo.
authors.forename: Robert Shongo
authors.initials: RS
authors.lastname: Lushima
authors.affiliation: University of Kinshasa, Kinshasa, Democratic Republic of Congo.
authors.forename: Jean
authors.initials: J
authors.lastname: Malekani
authors.affiliation: Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, National Center for Enteric and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Inger K
authors.initials: IK
authors.lastname: Damon
authors.affiliation: BioGX, Birmingham, Alabama.
authors.forename: Michael C L
authors.initials: MCL
authors.lastname: Vickery
authors.affiliation: Institut National de Recherche Biomédicale, Ministry of Health, Kinshasa, Democratic Republic of Congo.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Pukuta
authors.affiliation: Institut National de Recherche Biomédicale, Ministry of Health, Kinshasa, Democratic Republic of Congo.
authors.forename: Frida
authors.initials: F
authors.lastname: Nkawa
authors.affiliation: Institut National de Recherche Biomédicale, Ministry of Health, Kinshasa, Democratic Republic of Congo.
authors.forename: Stomy
authors.initials: S
authors.lastname: Karhemere
authors.affiliation: Institut National de Recherche Biomédicale, Ministry of Health, Kinshasa, Democratic Republic of Congo.
authors.forename: Jean-Jacques Muyembe
authors.initials: JM
authors.lastname: Tamfum
authors.affiliation: Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo.
authors.forename: Emile Wemakoy
authors.initials: EW
authors.lastname: Okitolonda
authors.affiliation: Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, National Center for Enteric and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Yu
authors.initials: Y
authors.lastname: Li
authors.affiliation: Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, National Center for Enteric and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Mary G
authors.initials: MG
authors.lastname: Reynolds
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D015023:Democratic Republic of the Congo / Q000453:epidemiology; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D045908:Mpox, Monkeypox / Q000175:diagnosis* / Q000453:epidemiology / Q000235:genetics*; D008993:Monkeypox virus / Q000235:genetics*; D019095:Point-of-Care Systems; D016133:Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D055815:Young Adult