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.
Age > 16 years
Subject (or legally authorized representative) is willing to provide written informed consent before any study procedures
Female gender
Subject is able and willing to provide vaginal swab specimen for study procedures (3-4 swabs)
Subject 15 years of age or younger
Male gender
Female currently menstruating
Subject is unable or unwilling to provide informed consent
bioLytical Laboratories
Lead sponsor
Epicentre
Collaborator