Multicentre Clinical Trial to Assess the Performance of Centralized Assays for Hepatitis C Virus RNA Detection From Dried Blood Spot (DBS) Samples
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Enrollment
- 942
- Locations
- 5
- Primary Endpoint
- Evaluation of the correlation of HCV viral load level determined by each assay performed from DBS and/or PSC specimens with the HCV viral load level in plasma determined by Abbott RealTime HCV VL assay performed at the clinical site
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
FIND is preparing a study to evaluate the performance, as measured by sensitivity and specificity, of four centralized assays for the detection of HCV RNA using capillary blood collected on dried blood spots (DBS) and plasma separation card (PSC).
Detailed Description
Available data on the performance of HCV RNA assays from DBS samples are insufficient to introduce their use in clinical practice. Only a few studies have been performed on DBS stored at ambient temperature, while the majority had DBS samples refrigerated or frozen right after collection, which does not mimic real-life settings. Additionally, due to the lack of standardized procedures, DBS collection and elution protocols varied across different studies. A large multicentre diagnostic accuracy study using standardized DBS collection and elution protocols validated by test manufacturers is needed to inform national hepatitis programmes and international guideline development groups. Test manufacturers need clinical evaluation data to update their regulatory claims and include DBS as an alternative sample type. FIND is preparing a trial to evaluate the performance, as measured by sensitivity and specificity, of four laboratory-based assays for detection of HCV RNA assays using capillary blood collected on DBS/PSC. This will be provisional on the manufacturers agreeing to participate, as well as committing to applying to stringent regulatory approval for DBS/PSC.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Evaluation of the correlation of HCV viral load level determined by each assay performed from DBS and/or PSC specimens with the HCV viral load level in plasma determined by Abbott RealTime HCV VL assay performed at the clinical site
Time Frame: day 1 - day 30
Evaluation of the correlation of HCV viral load level determined by each assay performed
Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against Abbott RealTime HCV VL assay performed at the clinical site
Time Frame: day 1 - day 30
Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against Abbott RealTime HCV VL assay performed at the clinical site
Secondary Outcomes
- WHO technician's appraisal sheet completed by all operators performing investigational test(through study completion, an average of 1 year)
- evaluation of the correlation of HCV RNA levels in plasma determined by each assay with HCV RNA levels in plasma determined by Roche cobas® 6800 HCV VL assay(day 7 - day 30)
- Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against the performance of the same assay in plasma(day 1 - day 30)
- Evaluation of the correlation of HCV viral load level determined by each assay performed from DBS and/or PSC specimens with the HCV RNA level in plasma determined by the same assay(day 1 - day 30)
- point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection in plasma measured against the performance of Roche cobas® 6800 HCV VL assay(day 7 - day 30)