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.

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.

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