Performance Evaluation of Mpox Molecular POC Diagnostics

Clinical Performance Evaluation of Novel Rapid Molecular Point-of-care (POC) Diagnostics for Mpox Virus

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

Study Overview

• Status: Not yet recruiting
• Conditions: Monkey Pox
• Intervention / Treatment: Diagnostic test: MPOX IVD test

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The study population consists of archived skin lesion swabs specimens. These were previously collected from individuals suspected of mpox infection - confirmed by PCR as MPXV positive or negative - under research studies and/or public health surveillance protocols during past and ongoing mpox outbreaks and available in the selected clinical sites.

Description

Inclusion Criteria:

• Lesion swabs stored in VTM/UTM (non-inactivating)
• Aliquot with sufficient volume to run the reference PCR and at least one index test (≥2600 μL per pair reference-index tests: ideally at least 1400 μL for 3 index tests and 1200 μL for reference PCR, including 1 possible repeat per test)
• Available PCR result for specimen selection (i.e. confirmed MPXV positive or negative)
• Samples collected from 2020 onwards.

Exclusion Criteria:

• Unknown date of collection
• >3 freeze-thaw cycles of sample.
• Samples collected with expired swab collection devices or UTM/VTM

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Positive samples; 50 confirmed MPXV-positive samples	Diagnostic test: MPOX IVD test; Each (negative and positive) sample will be tested on the standard of reference and the investigational IVD
Negative samples; 30 confirmed MPXV-negative samples	Diagnostic test: MPOX IVD test; Each (negative and positive) sample will be tested on the standard of reference and the investigational IVD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point estimates of sensitivity, specificity, positive and negative predictive value (PPV and NPV respectively) with 95% confidence intervals.	Point estimates of sensitivity, specificity, positive and negative predictive value (PPV and NPV respectively) with 95% confidence intervals.	July-August 2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point estimates of sensitivity/PPA stratified by Ct values of the reference PCR test.	Point estimates of sensitivity/PPA stratified by Ct values of the reference PCR test.	July-August 2026
Point estimates of sensitivity/PPA and specificity/NPA with 95% confidence intervals stratified by virus clade.	Point estimates of sensitivity/PPA and specificity/NPA with 95% confidence intervals stratified by virus clade.	July-August 2026

Collaborators and Investigators

• Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Virus Diseases; Poxviridae Infections; DNA Virus Infections; Animal Diseases; Primate Diseases; Rodent Diseases; Mpox, Monkeypox
• Other Study ID Numbers: PP016

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No