Clinical Trial

A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test

Recruiting
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Summary
The objective of this study is to evaluate the performance, usability, and contrived result interpretation of iStatis Gonorrhea Antigen Test (iStatis Gonorrhea Test) in the intended near-patient or point-of-care setting by trained personnel.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-29.
Trial Details
NCT Number NCT07569900
Lead Sponsor bioLytical Laboratories
Collaborators: Epicentre
Conditions Gonorrhea Infection
Enrollment 650 participants
Start Date 2025-11-26
Primary Completion 2026-09-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-02