Ignite Creation Date:
2024-07-17 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-16
Brief Title:
Lay User Evaluation of the Panbio HCV Self Test in an EU Population
Sponsor:
Abbott Rapid Dx
Organization:
Abbott Rapid Dx
Study Overview
Official Title:
Lay User Evaluation of the Panbio HCV Self Test in an EU Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This study is part of the performance evaluation to support the conformity assessment procedure for the use of fingerstick whole blood samples with Abbotts Panbio HCV Self Test device as performed by lay users The study will be conducted in accordance with the Commission Implementing Regulation EU 20221107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation EU 2017746 of the European Parliament and of the Council and to provide data to demonstrate the product is safe and effective for its intended use
Detailed Description:
Hepatitis C is a liver disease caused by the hepatitis C virus HCV The virus can cause both acute and chronic disease ranging in severity from a mild illness lasting a few weeks to a serious lifelong illness Globally around 50 million people per year are living with HCV resulting in 244000 deaths The WHO estimates that only 36 of individuals chronically infected with HCV are diagnosed and the WHO HCV targets include increasing the diagnoses to 90 by 2030 WHO guidelines published in 2021 strongly recommend offering self-testing for HCV as an additional approach to HCV testing services
The Panbio HCV Self Test is a lateral flow test designed for the qualitative detection of antibodies specific to HCV in finger-stick whole blood The test is designed to be used by lay users and uses a sample volume of 10 µL The professional use version test Bioline HCV Test is commercially available and has previously been clinically validated by the manufacturer demonstrating a sensitivity of 993-100 and a specificity of 981-100
Evaluation of the test performance when used by professional users has been conducted and evaluation of lay user sensitivity and specificity based on lay user populations outside the EU is being conducted This study will demonstrate the test performance and usability of the test when used in a European lay user population The study will be conducted at one recruiting hospital in Spain
The Panbio HCV Self Test is a lateral flow test designed for the qualitative detection of antibodies specific to HCV in finger-stick whole blood The test is designed to be used by lay users and uses a sample volume of 10 µL The professional use version test Bioline HCV Test is commercially available and has previously been clinically validated by the manufacturer demonstrating a sensitivity of 993-100 and a specificity of 981-100
Evaluation of the test performance when used by professional users has been conducted and evaluation of lay user sensitivity and specificity based on lay user populations outside the EU is being conducted This study will demonstrate the test performance and usability of the test when used in a European lay user population The study will be conducted at one recruiting hospital in Spain
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