RecruitingNot ApplicableNCT07569900
A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test
A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test by Trained Personnel at Near-Patient or Point-of-Care Settings
Sponsor
bioLytical Laboratories
Enrollment
650 participants
Start Date
Nov 26, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Sex: FEMALEMin Age: 16 Years
Inclusion Criteria15
- 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
Exclusion Criteria15
- 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
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Interventions
DEVICEiStatis Gonorrhea Antigen Test
Vaginal swabs are tested on the iStatis Gonorrhea Antigen Test
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT07569900