article · American Journal of Tropical Medicine and Hygiene
Monkeypox virus is an endemic zoonotic infection in the Democratic Republic of Congo. Standard diagnostic testing relies on quantitative polymerase chain reaction assays that require sophisticated laboratory infrastructure. To address this limitation, research evaluated a multiplex monkeypox assay adapted for the GeneXpert platform, a portable device designed for rapid point-of-care testing in endemic settings. The assay combines tests specific to monkeypox virus, generic orthopoxvirus tests, and an internal control. Researchers assessed 164 clinical specimens, consisting of 50 crusts and 114 vesicular swabs, collected from suspected cases in Tshuapa Province. Testing at the Institut National de Recherche Biomedicale achieved a diagnostic sensitivity of 98.8 percent and a specificity of 100 percent when compared against reference laboratory standards. The platform worked effectively across both crust and vesicle sample types. Its simple operational requirements and strong performance suggest it can expand and accelerate monkeypox detection.
Conventional diagnostic methods for monkeypox require advanced laboratory facilities that are often inaccessible in rural, endemic regions. Demonstrating that a portable testing platform delivers high sensitivity and specificity directly from patient swabs and crusts allows healthcare teams to detect infections much faster. This capability can support disease surveillance and help contain outbreaks in settings with limited clinical infrastructure.
This work demonstrates an applied and clinically tested diagnostic solution using the established GeneXpert platform. The assay could enable decentralised point-of-care testing by healthcare workers, public health agencies, and regional surveillance programmes in disease-endemic areas. Because the test has already been validated on clinical field samples against gold-standard laboratory methods, it appears close to broader operational deployment for rapid monkeypox screening.
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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.
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DOI: 10.4269/ajtmh.16-0567
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