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

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.

Study Overview

• Status: Recruiting
• Conditions: Gonorrhea Infection
• Intervention / Treatment: Device: iStatis Gonorrhea Antigen Test

Detailed Description

The study is designed to evaluate iStatis Gonorrhea Test performance when used by trained personnel as follows:

1. A method comparison will be performed to determine the diagnostic sensitivity and specificity of the iStatis Gonorrhea Test compared to a reference test that is an approved, current on-market Gonorrhea/Chlamydia combo assay, Cobas CT/NG.
2. To evaluate the usability of iStatis Gonorrhea Test by means of assessing user experience via a questionnaire in combination with the success in performing the test. A minimum of 15 intended users to participate in the usability evaluation.
3. To evaluate and document whether intended users (trained personnel), a minimum of 15 intended users across a minimum of three (3) sites, can successfully interpret contrived iStatis Gonorrhea Test results that include - strong positive, weak positive, negative and a range of invalid results.

• Study Type: Interventional
• Enrollment (Estimated): 650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Subramanian; Phone Number: 16042046784; Email: asubramanian@biolytical.com
• Study Contact Backup: Name: Patrick Diaz; Phone Number: 16042046784; Email: pdiaz@biolytical.com

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Recruiting
      • Epicentre Health Research (Johannesburg)
      • Contact: Cherie Cawood; Phone Number: +42 082 065 2172; Email: cheriec@epicentre.org.za
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 3650
      • Recruiting
      • Epicentre Health Research
      • Contact: Cherie Cawood; Phone Number: +27 31 880 2150; Email: cheriec@epicentre.org.za
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7925
      • Recruiting
      • Epicentre Health Research (Cape Town)
      • Contact: Cherie Cawood; Phone Number: +27 21 201 1658; Email: cheriec@epicentre.org.za

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iStatis Gonorrhea Test Performance (Operator-collected swabs); Operator-collected vaginal swabs will be tested on the iStatis Gonorrhea Test	Device: iStatis Gonorrhea Antigen Test; Vaginal swabs are tested on the iStatis Gonorrhea Antigen Test
Experimental: iStatis Gonorrhea Test Performance (Self-collected swabs); 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; Vaginal swabs are tested on the iStatis Gonorrhea Antigen Test
No Intervention: Reference Test to evaluate iStatis Performance; Vaginal swabs collected for reference testing will be tested using the Cobas CT/NG reference assay to determine the gonorrhea infection status of participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
iStatis Gonorrhea Test usability evaluation	Overall test usability and self collection usability will be determined via a questionnaire completed by trained personnel who used the device during testing and study participants that performed sample self-collection respectively. The usability questionnaire will use a scale of one (1) to 5 (1 - very difficult/very unlikely to 5 - very easy/very likely), with a rating of 3 being satisfactory.	3 months
iStatis Gonorrhea Test contrived result interpretation evaluation	Trained operators will evaluate a panel of contrived (mock) iStatis devices. These devices are designed to represent a comprehensive range of test outcomes, including strong positives, weak positives, negatives and invalid results. Operators will interpret the results of the mock devices and record their interpretations which will be compared to the correct interpretation of the device.	3 months

Collaborators and Investigators

• Sponsor: bioLytical Laboratories
• Collaborators: Epicentre

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Point-of-care test; Gonorrhea test; iStatis test
• Other Study ID Numbers: CLS-009A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No