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

30. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

650

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Sør-Afrika
    • Gauteng
      • Johannesburg, Gauteng, Sør-Afrika, 2193
        • Rekruttering
        • Epicentre Health Research (Johannesburg)
        • Ta kontakt med:
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, Sør-Afrika, 3650
        • Rekruttering
        • Epicentre Health Research
        • Ta kontakt med:
    • Western Cape
      • Cape Town, Western Cape, Sør-Afrika, 7925
        • Rekruttering
        • Epicentre Health Research (Cape Town)
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: iStatis Gonorrhea Test Performance (Operator-collected swabs)
Operator-collected vaginal swabs will be tested on the iStatis Gonorrhea Test
Enhet: iStatis Gonorrhea Antigen Test
Vaginal swabs are tested on the iStatis Gonorrhea Antigen Test
Eksperimentell: 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
Enhet: iStatis Gonorrhea Antigen Test
Vaginal swabs are tested on the iStatis Gonorrhea Antigen Test
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

bioLytical Laboratories

Samarbeidspartnere

Epicentre

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. november 2025

Primær fullføring (Antatt)

1. september 2026

Studiet fullført (Antatt)

1. januar 2027

Datoer for studieregistrering

Først innsendt

21. april 2026

Først innsendt som oppfylte QC-kriteriene

29. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juni 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • CLS-009A

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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