A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Go… (NCT07569900) | Clinical Trial Compass
RecruitingNot Applicable
A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test
South Africa650 participantsStarted 2025-11-26
Plain-language 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.
Who can participate
Age range16 Years
SexFEMALE
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Inclusion Criteria
* 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 can complete the required testing on the allocated testing day
* Subject can speak, read, and write English
* Subject's demographic information, risk factors, and symptoms are available and can be recorded on case report forms
* Subject agrees to comply with study procedures and sample collection for both the investigational device and the reference method
* Subject is willing to participate in the study site's standard-of-care Gonorrhea counselling and testing program and receive standard-of-care test results, as required and applicable
* Subject is indicated for sexually transmitted infection testing for one or more of the following reasons:
* At risk of Gonorrhea, such as recent unprotected intercourse, multiple or new partners within \< 60 days, known exposure to an infected partner, or prior STI history
* Having signs and/or symptoms suggestive of Gonorrhea (e.g., urethral, vaginal, rectal, or pharyngeal discharge; dysuria; pelvic or lower-abdominal pain; sore throat; or rectal discomfort)
* Undergoing routine or opportunistic STI screening, including family-planning, antenatal, or sexual-health clinic visits
* Undergoing re-testing (test-of-cure) \> 7 days after completion of Gonorr…