Evaluation of Dried Blood Spot for HCV RNA Testing
- Conditions
- Hepatitis C, Chronic
- Interventions
- Diagnostic Test: Abbott RealTime HCV assay from DBSDiagnostic Test: HCV for use on the cobas® 6800/8800 Systems from PSC and DBSDiagnostic Test: Aptima® HCV Quant Dx Assay from DBSDiagnostic Test: HCV for use on the cobas® 4800Systems from PSC and DBS
- Registration Number
- NCT03896087
- Lead Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 942
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description clinical performance of the HCV DBS assay Abbott RealTime HCV assay from DBS The study will be conducted in different geographical regions and populations and is designed to meet requirements of the for assays (medical devices) used for the qualitative and quantitative detection of Hepatitis C RNA. clinical performance of the HCV DBS assay HCV for use on the cobas® 6800/8800 Systems from PSC and DBS The study will be conducted in different geographical regions and populations and is designed to meet requirements of the for assays (medical devices) used for the qualitative and quantitative detection of Hepatitis C RNA. clinical performance of the HCV DBS assay Aptima® HCV Quant Dx Assay from DBS The study will be conducted in different geographical regions and populations and is designed to meet requirements of the for assays (medical devices) used for the qualitative and quantitative detection of Hepatitis C RNA. comparison PQ marked reference assay arm Aptima® HCV Quant Dx Assay from DBS Plasma specimens from the participants will be tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities. comparison PQ marked reference assay arm Abbott RealTime HCV assay from DBS Plasma specimens from the participants will be tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities. comparison PQ marked reference assay arm HCV for use on the cobas® 6800/8800 Systems from PSC and DBS Plasma specimens from the participants will be tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities. clinical performance of the HCV DBS assay HCV for use on the cobas® 4800Systems from PSC and DBS The study will be conducted in different geographical regions and populations and is designed to meet requirements of the for assays (medical devices) used for the qualitative and quantitative detection of Hepatitis C RNA. comparison PQ marked reference assay arm HCV for use on the cobas® 4800Systems from PSC and DBS Plasma specimens from the participants will be tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities.
- Primary Outcome Measures
Name Time Method 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 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 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 Outcome Measures
Name Time Method WHO technician's appraisal sheet completed by all operators performing investigational test through study completion, an average of 1 year WHO technician's appraisal sheet completed by all operators performing investigational test
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 For Central Laboratory only
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 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
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 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
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 For Central Laboratory only
Trial Locations
- Locations (5)
Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases
🇬🇷Athens, Greece
Centre Pasteur du Cameroun
🇨🇲Yaoundé, Yaounde, Cameroon
National Centre for Disease Control
🇬🇪Tbilisi, Georgia
Rwanda Military Hospital
🇷🇼Kigali, Kanombe, Rwanda
St Vincent's Institute of Medical Research National Serology Reference Laboratory
🇦🇺Victoria Park, Fitzroy, Australia