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

NCT07569900 | Recruiting

• 1 other identifier: CLS-009A
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Gonorrhea Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Performance Evaluation

  The performance between iStatis Gonorrhea Test and the reference test result for vaginal swabs (operator-collected and self-collected) will be calculated for all sites combined. Diagnostic sensitivity and specificity values and 95% CIs will be calculated for all subjects combined. The percentage of invalids (tests that fail to produce a control dot with accurate use) will be identified and reported.

  3 months

Secondary Outcomes (2)

• iStatis Gonorrhea Test usability evaluation

  3 months

• iStatis Gonorrhea Test contrived result interpretation evaluation

  3 months

Study Arms (3)

iStatis Gonorrhea Test Performance (Operator-collected swabs)

EXPERIMENTAL

Operator-collected vaginal swabs will be tested on the iStatis Gonorrhea Test

Device: iStatis Gonorrhea Antigen Test

iStatis Gonorrhea Test Performance (Self-collected swabs)

EXPERIMENTAL

Self-collected vaginal swabs will be tested on the iStatis Gonorrhea Test. Participants assigned to the self-collection arm of the study will complete the self-collection Usability Questionnaire

Device: iStatis Gonorrhea Antigen Test

Reference Test to evaluate iStatis Performance

NO INTERVENTION

Vaginal swabs collected for reference testing will be tested using the Cobas CT/NG reference assay to determine the gonorrhea infection status of participants.

Interventions

iStatis Gonorrhea Antigen Test DEVICE

Vaginal swabs are tested on the iStatis Gonorrhea Antigen Test

iStatis Gonorrhea Test Performance (Operator-collected swabs); iStatis Gonorrhea Test Performance (Self-collected swabs)

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• bioLytical Laboratories: lead
• Epicentre: collaborator

Study Sites (3)

Epicentre Health Research (Johannesburg)

Johannesburg, Gauteng, 2193, South Africa

RECRUITING

Epicentre Health Research

Durban, KwaZulu-Natal, 3650, South Africa

RECRUITING

Epicentre Health Research (Cape Town)

Cape Town, Western Cape, 7925, South Africa

RECRUITING

Central Study Contacts

Ana Subramanian

CONTACT

16042046784; asubramanian@biolytical.com

Patrick Diaz

CONTACT

16042046784; pdiaz@biolytical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 6, 2026
• Study Start: November 26, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

ZA (3)