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

Recruiting now · Not applicable

Conditions studied: Gonorrhea Infection

In brief

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.

Key facts

Study ID: NCT07569900
Run by: bioLytical Laboratories
People needed: 650
Starts: 2025-11-26
Expected to finish: 2027-01-01
Last updated by the study team: 2026-07-02

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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 Gonorrhea treatment and clinically stable
Undergoing co-testing for other STIs where Gonorrhea testing is part of a broader diagnostic panel

You may not qualify if…

Subject 15 years of age or younger
Male gender
Female currently menstruating
Subject is unable or unwilling to provide informed consent
Subject is medically unstable or has psychiatric condition(s) that pose a risk or prevent study compliance
Subject is unable to provide paired samples for reference testing
Subject requires urgent antimicrobial treatment before specimen collection
Subject received systemic or topical antibiotics active against Gonorrhea within the previous 7 days
Subject used topical intravaginal or rectal antiseptics within 48 hours prior to study sampling
Previously enrolled for the same infection episode
Anatomical or clinical contraindication to study sampling (e.g., severe cervical pathology)
Recent urogenital procedure (e.g., cystoscopy, lavage) < 72 hours before study sampling
Subject belongs to a protected group excluded by local ethics (e.g., incarcerated persons), unless explicitly approved by the EC/IRB
Any condition that, in the opinion of trained personnel or study staff, would make the participant unsuitable or unsafe for enrolment, interfere with completion of assessments, consent, or questionnaires, or bias study outcomes
Subject is participating in another interventional clinical study within 30 days that could interfere with study results

Where it is running

Epicentre Health Research (Johannesburg) — Johannesburg, Gauteng, South Africa (enrolling)
Epicentre Health Research — Durban, KwaZulu-Natal, South Africa (enrolling)
Epicentre Health Research (Cape Town) — Cape Town, Western Cape, South Africa (enrolling)

Full record on ClinicalTrials.gov

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