Performance Evaluation of Mpox Molecular POC Diagnostics

NCT07620600 | Not Yet Recruiting

• 1 other identifier: PP016
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Monkey Pox

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

  July-August 2026

Study Arms (2)

Positive samples

50 confirmed MPXV-positive samples

Diagnostic Test: MPOX IVD test

Negative samples

30 confirmed MPXV-negative samples

Diagnostic Test: MPOX IVD test

Interventions

MPOX IVD test DIAGNOSTIC_TEST

Each (negative and positive) sample will be tested on the standard of reference and the investigational IVD

Negative samples; Positive samples

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05