Status:
COMPLETED
Evaluation Study of RDTs Detecting Antibodies Against HCV
Lead Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Collaborating Sponsors:
Institute of Tropical Medicine, Belgium
Nigerian Institute of Medical Research
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Brief Summary
The study aims to evaluate 13 different HCV RDTs (10 on-market, 3 under development) for their diagnostic performance and operational characteristics in archived EDTA plasma samples, originating from ...
Detailed Description
Background and rationale: Screening of past exposure to Hepatitis C Virus (HCV) infection is done by detection of HCV specific antibodies. In Low and Middle Income Countries (LMICs), where equipped l...
Eligibility Criteria
Inclusion
- Inclusion Criteria of archived samples:
- Non-hemolytic plasma samples with EDTA used as anticoagulant
- Sample were frozen at -20°C or lower on the day of processing and stored at -20°C or lower until they are used in this study
- Samples pre-characterized for, HCV, HIV serology status using assays routinely used at the sites and approved for diagnostic use by a local health authority. If available, samples should also be characterized for HBV status.
- Samples taken from subjects aged ≥18 years
- Availability of informed consent to use the sample in future research
- Exclusion Criteria:
- \- Samples not stored correctly
Exclusion
Key Trial Info
Start Date :
September 21 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2019
Estimated Enrollment :
1710 Patients enrolled
Trial Details
Trial ID
NCT04033887
Start Date
September 21 2018
End Date
March 15 2019
Last Update
July 29 2019
Active Locations (3)
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1
Institute of Tropical Medicine
Antwerp, Belgium, 2000
2
National Center for Disease Control & Public Health/Lugar Center
Tbilisi, Georgia, 0198
3
Nigerian Institute of Medical Research
Lagos, Nigeria