iStatis gonorrhea antigen test — accuracy, ease of use, and result reading

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Trained personnel at three South African sites will perform the iStatis Gonorrhea Antigen Test on vaginal swab samples taken from eligible participants near the patient. Results will be compared to an established on-market NAAT reference assay (Cobas CT/NG) to calculate diagnostic sensitivity and specificity. Usability will be measured using a questionnaire and observed test performance with at least 15 intended users across a minimum of three sites. Intended users will also interpret contrived test outputs (strong positive, weak positive, negative, and invalid results) to document interpretation accuracy.

Why it matters

Who can join: the full rules

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

Exclusion Criteria

* 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's running

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

Study contacts

• Study coordinator: Ana Subramanian
• Email: asubramanian@biolytical.com
• Phone: 16042046784

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.