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

29. april 2026 opdateret af: bioLytical Laboratories

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

650

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Sydafrika
    • Gauteng
      • Johannesburg, Gauteng, Sydafrika, 2193
        • Rekruttering
        • Epicentre Health Research (Johannesburg)
        • Kontakt:
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, Sydafrika, 3650
        • Rekruttering
        • Epicentre Health Research
        • Kontakt:
    • Western Cape
      • Cape Town, Western Cape, Sydafrika, 7925
        • Rekruttering
        • Epicentre Health Research (Cape Town)
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: iStatis Gonorrhea Test Performance (Operator-collected swabs)
Operator-collected vaginal swabs will be tested on the iStatis Gonorrhea Test
Enhed: iStatis Gonorrhea Antigen Test
Vaginal swabs are tested on the iStatis Gonorrhea Antigen Test
Eksperimentel: 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
Enhed: iStatis Gonorrhea Antigen Test
Vaginal swabs are tested on the iStatis Gonorrhea Antigen Test
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Performance Evaluation
Tidsramme: 3 months
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
iStatis Gonorrhea Test usability evaluation
Tidsramme: 3 months
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
Tidsramme: 3 months
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

bioLytical Laboratories

Samarbejdspartnere

Epicentre

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. november 2025

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. januar 2027

Datoer for studieregistrering

Først indsendt

21. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CLS-009A

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Gonorrhea Infection

Kliniske forsøg med iStatis Gonorrhea Antigen Test

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ghana

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner