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INSTI® HCV (Hepatitis C Virus) Antibody Self-Test Contrived Result Interpretation

NCT06357819 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 405

Last updated 2024-04-10

No results posted yet for this study

Summary

The purpose of this Interpretation Assessment was to document if "lay" people, non-professional and inexperienced in self-testing, were able to successfully perform the steps to use a Hepatitis C Virus (HCV) Self-Test (HCVST) device, without product familiarization \[demonstration\].

Conditions

  • Hepatitis C

Interventions

DEVICE

INSTI HCV Self Test

Each participant was provided with contrived INSTI membrane units by the study observer, in random order, and was asked to interpret the results using the INSTI HCV ST Instructions for Use.

Sponsors & Collaborators

  • bioLytical Laboratories

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-12
Primary Completion
2023-12-17
Completion
2023-12-17

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06357819 on ClinicalTrials.gov