Clinical Trial: Performance Evaluation of Mpox Molecular POC Diagnostics

U.S., June 3 -- ClinicalTrials.gov registry received information related to the study (NCT07620600) titled 'Performance Evaluation of Mpox Molecular POC Diagnostics' on May 27.

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 as...