Performance Evaluation of Mpox Molecular POC Diagnostics
Starting soon
Conditions studied: Monkey Pox
In brief
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
Key facts
- Study ID
- NCT07620600
- Run by
- Foundation for Innovative New Diagnostics, Switzerland
- People needed
- 80
- Starts
- 2026-06-15
- Expected to finish
- 2026-09-15
- Last updated by the study team
- 2026-06-02
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.