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

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].

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Device: INSTI HCV Self Test

Detailed Description

The intent of this study was to collect data regarding the result interpretation of contrived results of INSTI HCV ST. The contrived test devices refers to mock test devices pre-made by bioLytical Laboratories Inc. Each contrived/mock test device was assigned to an ID number to be randomly provided to the participants.

Primary Objectives were to document and record the following:

•Successful interpretation of contrived test results using mock test devices (strong positive, weak positive, negative and a range of invalid results).

Depending on the device being evaluated participants received a contrived INSTI® HCV Antibody Self Test membrane unit.

Participants were asked to interpret "mock" results [read contrived device results using the reference chart in the Instructions for Use (IFU)].

Participants were recruited from the Ezintsha Research Site which was a low-prevalence area and the Yeoville Harm Reduction Site which was a high-prevalence area in the city of Johannesburg in the Republic of South Africa. For the purposes of this assessment, the participant population was the general population. The participants did not have any experience in conducting any rapid diagnostic self-test using standard test kits, nor were they familiar with the prospective HCVST devices prior to entering into this mock result interpretation assessment.

• Study Type: Observational
• Enrollment (Actual): 405

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Richmond, British Columbia, Canada, V6V 2A2
      • bioLytical Laboratories Inc.

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Participants were recruited and enrolled from high and low HCV-prevalence areas to participate in mock result interpretation of INSTI HCV Selt Tests.

Description

Inclusion Criteria:

• Understands and sign the written informed Consent form
• Able to complete the required testing on the allocated testing day[s]
• Able to speak/read English
• ≥18 years of age
• Provide a level of education (minimum grade 7)

Exclusion Criteria:

• Does not meet the inclusion criteria
• A practicing medical healthcare professional [doctor, nurse or counsellor that performs testing with Rapid Tests]
• Has used blood-based RDT for self-testing previously, either HIV or HCV
• Any condition which, in the opinion of the facilitator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the mock result interpretation assessment, consent form and questionnaire etc. or bias the outcome

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mock Result Interpretation; Testing with non-functional devices (Mock-ups) that are modified to display contrived results to assess the ability of previously untrained users to correctly interpret one of the possible results as defined by each device manufacturer (e.g., Negative/Non-Reactive, Positive/Reactive, Invalid etc.)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Successful Interpretation of contrived devices	3 Months

Collaborators and Investigators

• Sponsor: bioLytical Laboratories

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Actual): December 17, 2023
• Study Completion (Actual): December 17, 2023

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hepatitis C Self Test; Hepatitis C Rapid Test; HCV antibody; INSTI HCV Self Test
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: CLS-017A; HSTAR010 (Other Identifier: HSTAR Programme); EZIMOM012 (Other Identifier: Ezintsha)

Drug and device information, study documents

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