Performance Evaluation of Mpox Molecular POC Diagnostics

Overview

PP016 is a FIND-sponsored retrospective clinical performance study evaluating rapid molecular point-of-care (mPOC) tests for the detection of Mpox virus (MPXV) using archived lesion swab specimens collected in Uganda. Conducted at the Central Public Health Laboratory (CPHL) in Kampala, the study compares up to three investigational assays-Genes2Me VZV-Q, KH Medical RADI-ONE Mpox, and SD Biosensor STANDARD M10 MPX/OPX-against the BioPerfectus laboratory PCR reference test. The primary objective is to determine the sensitivity and specificity of each assay for detecting MPXV in archived positive and negative samples, while secondary analyses assess performance by Ct value and viral clade. The study uses a blinded, non-interventional case-control design with de-identified specimens collected since 2020. Approximately 80 samples per device evaluation are included. PP016 was initiated in response to ongoing mpox outbreaks and the need for accurate decentralized diagnostics in low-resource settings. The study complies with ISO 20916, ICH-GCP principles where applicable, and Ugandan ethical and regulatory requirements, with findings expected to support future regulatory approvals and implementation of rapid mpox diagnostics in low- and middle-income countries

PP016 is a FIND-sponsored retrospective, non-interventional clinical performance evaluation study designed to assess the diagnostic accuracy and operational suitability of up to three rapid molecular point-of-care (mPOC) tests for the detection of Mpox virus (MPXV) using archived lesion swab specimens collected in Uganda. The study, titled "Clinical Performance Evaluation of Novel Rapid Molecular Point-of-Care Diagnostics for Mpox Virus," is being conducted at the Central Public Health Laboratory (CPHL) in Kampala, Uganda. The study was developed in response to the growing public health importance of mpox, particularly following the 2022 and 2024 WHO Public Health Emergencies of International Concern (PHEICs), and the ongoing outbreaks affecting several African countries including Uganda, where thousands of confirmed cases have been reported. Because conventional laboratory PCR testing remains centralized and difficult to access in many low-resource or decentralized settings, the study aims to determine whether rapid molecular POC assays can provide accurate and scalable diagnostic alternatives to improve outbreak response, surveillance, patient management, and contact tracing. The study evaluates three investigational molecular diagnostic platforms: the VZV-Q Real-Time PCR Kit for OnePCR (Genes2Me, India), the RADI-ONE Mpox Detection Kit (KH Medical, South Korea), and the STANDARD M10 MPX/OPX assay (SD Biosensor, South Korea). Their performance is compared against the laboratory-based BioPerfectus Monkeypox Virus Real Time PCR Kit, which serves as the reference standard and is currently listed under the African Medicines Regulatory Harmonisation Emergency Use Listing for mpox diagnosis. The study uses archived lesion swab samples stored in viral or universal transport medium from suspected mpox cases collected since 2020 under routine surveillance or prior research activities. Eligible samples must have known PCR status, adequate volume for both reference and index testing, and acceptable storage conditions. The primary objective is to determine the clinical sensitivity/positive percent agreement (PPA) and specificity/negative percent agreement (NPA) of each investigational assay relative to the reference PCR, while secondary objectives include assessing performance according to PCR cycle threshold (Ct) values as a proxy for viral load and evaluating potential differences in performance by circulating mpox virus clades if such information is available. Statistical analyses will use Wilson score confidence intervals, with subgroup analyses by age, sex, Ct value, and viral clade. The study follows a blinded case-control design in which specimens are de-identified, shuffled, relabeled with unique FIND study identifiers, and tested independently to minimize bias. Reference PCR testing is performed first to confirm specimen quality and classification before testing on the investigational devices. Invalid or inconclusive results are repeated once and documented according to predefined procedures. No patient recruitment or intervention occurs, and test results are not used for clinical management, making the study low risk from an ethical and safety perspective. Data are collected using OpenClinica Enterprise Edition, a validated electronic data capture system with audit trails and secure cloud hosting. FIND oversees monitoring, quality assurance, operator training, and regulatory compliance throughout the study. The study is funded by FIND with support from the Government of the Netherlands and is expected to generate independent evidence to support regulatory submissions, procurement decisions, WHO evaluation processes, and future implementation of rapid mpox diagnostics in low- and middle-income countries.