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

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

This tests whether the iStatis point-of-care gonorrhea antigen test gives accurate results and is easy for trained staff to use in people older than 16 who need STI testing.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 650 (estimated)
• Ages: 16 Years and up
• Sex: Female
• Sponsor: bioLytical Laboratories (Industry-sponsored)
• Locations: 3 sites (Johannesburg, Gauteng and 2 other locations)
• Trial ID: NCT07569900 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Females older than 16 who are indicated for STI testing, can consent and communicate in English, and can provide multiple vaginal swabs and complete testing on the allocated day are ideal candidates.

Not a fit: People who are male, under 17, unable to provide vaginal swabs, or unable to consent or communicate in English are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the iStatis test could give trained clinic staff a faster point-of-care option for detecting gonorrhea and help people get treated sooner.

How similar studies have performed: NAAT-based assays like Cobas CT/NG are established gold standards, while antigen point-of-care tests have shown mixed sensitivity in prior work, so this approach is partly novel and requires direct comparison to NAAT.

Eligibility criteria

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 this trial is running

Johannesburg, Gauteng and 2 other locations

• 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

Conditions Gonorrhea Infection; Gonorrhea test; Point-of-care test; iStatis test