Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357819
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2024-04-05
Brief Title:
INSTI HCV Hepatitis C Virus Antibody Self-Test Contrived Result Interpretation
Sponsor:
bioLytical Laboratories
Organization:
bioLytical Laboratories
Study Overview
Official Title:
INSTI HCV Hepatitis C Virus Antibody Self-Test Contrived Result Interpretation
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 contrivedmock 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSTAR010 | OTHER | None | None |
| EZIMOM012 | OTHER | Ezintsha | None |