NCT06357819

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 405 (actual)
• Sponsor: bioLytical Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 \[demonstration\].

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-12
• Primary completion: 2023-12-17
• Completion: 2023-12-17
• First posted: 2024-04-10
• Last updated: 2024-04-10

Locations

1 site across 1 country: Canada