[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637081":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":24,"collaborators":10,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":10,"eligibilityCriteria":32,"healthyVolunteers":28,"sex":33,"minAge":10,"maxAge":10,"enrollmentInfo":34,"targetDuration":10,"studyType":37,"phases":10,"briefSummary":38,"conditions":39,"keywords":10,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":10},{"fullName":5,"class":6},"Foundation for Innovative New Diagnostics, Switzerland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Positive samples",null,"50 confirmed MPXV-positive samples",[13],"Diagnostic Test: MPOX IVD test",{"label":15,"type":10,"description":16,"interventionNames":17},"Negative samples","30 confirmed MPXV-negative samples",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","MPOX IVD test","Each (negative and positive) sample will be tested on the standard of reference and the investigational IVD",[15,9],{"type":25,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100637081","performance-evaluation-of-mpox-molecular-poc-diagnostics-100637081",false,"NCT07620600","Performance Evaluation of Mpox Molecular POC Diagnostics","Clinical Performance Evaluation of Novel Rapid Molecular Point-of-care (POC) Diagnostics for Mpox Virus","Inclusion Criteria:\n\n* Lesion swabs stored in VTM\u002FUTM (non-inactivating)\n* 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)\n* Available PCR result for specimen selection (i.e. confirmed MPXV positive or negative)\n* Samples collected from 2020 onwards.\n\nExclusion Criteria:\n\n* Unknown date of collection\n* \\>3 freeze-thaw cycles of sample.\n* Samples collected with expired swab collection devices or UTM\u002FVTM","ALL",{"count":35,"type":36},80,"ESTIMATED","OBSERVATIONAL","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\u002FOPX-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",[40],"Monkey Pox","NOT_YET_RECRUITING","2026-05-27",{"date":44,"type":45},"2026-06-02","ACTUAL",{"date":47,"type":36},"2026-06-15",{"date":49,"type":36},"2026-09-15",{"name":5,"class":6}]