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Evaluation of Dried Blood Spot for HCV RNA Testing

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Abbott RealTime HCV assay from DBS
HCV for use on the cobas® 6800/8800 Systems from PSC and DBS
Aptima® HCV Quant Dx Assay from DBS
HCV for use on the cobas® 4800Systems from PSC and DBS
Sponsored by
Foundation for Innovative New Diagnostics, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatitis C, Chronic focused on measuring dried blood spots, plasma separation card, HCV RNA test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Three different population groups will be considered:

  1. Individuals at risk of having HCV infection based on positive HCV serology test results

    Inclusion criteria:

    • Aged 18 years or older
    • Able to understand the scope of the trial
    • Provided written informed consent
    • Documented positive result of HCV serology test

  2. Individuals at risk of having HCV infection based on past and/or current exposure to risk factors

    Inclusion criteria:

    • Aged 18 years or older
    • Able to understand the scope of the trial
    • Provided written informed consent
    • Past and/or current exposure to one of the high risk factors as defined by WHO and CDC guidelines (Appendix I)
  3. Individuals diagnosed with chronic HCV infection who initiated or completed the anti-HCV treatment with direct acting antivirals (DAA) presenting at the clinical site for treatment monitoring or test of cure (i.e. sustained virological response)

Inclusion criteria:

  • Aged 18 years or older
  • Able to understand the scope of the trial
  • Provided written informed consent
  • Initiated on DAA treatment (regardless of type of DAA regimen) within 12 months prior to the enrolment to the trial

Exclusion criteria (for all trial populations):

  • Previously enrolled in the trial
  • Unwilling to provide required volume of fingerstick blood
  • Unwilling to provide required volume of venous whole blood

Sites / Locations

  • St Vincent's Institute of Medical Research National Serology Reference Laboratory
  • Centre Pasteur du Cameroun
  • National Centre for Disease Control
  • Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases
  • Rwanda Military Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

clinical performance of the HCV DBS assay

comparison PQ marked reference assay arm

Arm Description

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.

Plasma specimens from the participants will be tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities.

Outcomes

Primary Outcome Measures

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
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
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
Evaluation of the correlation of HCV viral load level determined by each assay performed

Secondary Outcome Measures

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
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
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
WHO technician's appraisal sheet completed by all operators performing investigational test
WHO technician's appraisal sheet completed by all operators performing investigational test
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
For Central Laboratory only
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
For Central Laboratory only

Full Information

First Posted
March 14, 2019
Last Updated
December 16, 2020
Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Collaborators
UNITAID
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1. Study Identification

Unique Protocol Identification Number
NCT03896087
Brief Title
Evaluation of Dried Blood Spot for HCV RNA Testing
Official Title
Multicentre Clinical Trial to Assess the Performance of Centralized Assays for Hepatitis C Virus RNA Detection From Dried Blood Spot (DBS) Samples
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Collaborators
UNITAID

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
dried blood spots, plasma separation card, HCV RNA test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
942 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clinical performance of the HCV DBS assay
Arm Type
Experimental
Arm Description
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.
Arm Title
comparison PQ marked reference assay arm
Arm Type
Active Comparator
Arm Description
Plasma specimens from the participants will be tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities.
Intervention Type
Diagnostic Test
Intervention Name(s)
Abbott RealTime HCV assay from DBS
Intervention Description
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
Intervention Type
Diagnostic Test
Intervention Name(s)
HCV for use on the cobas® 6800/8800 Systems from PSC and DBS
Intervention Description
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 6800/8800 Systems for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
Intervention Type
Diagnostic Test
Intervention Name(s)
Aptima® HCV Quant Dx Assay from DBS
Intervention Description
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays Aptima® HCV Quant Dx Assay from DBS for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
Intervention Type
Diagnostic Test
Intervention Name(s)
HCV for use on the cobas® 4800Systems from PSC and DBS
Intervention Description
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 4800 for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
Primary Outcome Measure Information:
Title
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
Description
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
Title
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
Description
Evaluation of the correlation of HCV viral load level determined by each assay performed
Time Frame
day 1 - day 30
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
day 1 - day 30
Title
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
Description
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
Time Frame
day 1 - day 30
Title
WHO technician's appraisal sheet completed by all operators performing investigational test
Description
WHO technician's appraisal sheet completed by all operators performing investigational test
Time Frame
through study completion, an average of 1 year
Title
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
Description
For Central Laboratory only
Time Frame
day 7 - day 30
Title
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
Description
For Central Laboratory only
Time Frame
day 7 - day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Three different population groups will be considered: Individuals at risk of having HCV infection based on positive HCV serology test results Inclusion criteria: Aged 18 years or older Able to understand the scope of the trial Provided written informed consent Documented positive result of HCV serology test Individuals at risk of having HCV infection based on past and/or current exposure to risk factors Inclusion criteria: Aged 18 years or older Able to understand the scope of the trial Provided written informed consent Past and/or current exposure to one of the high risk factors as defined by WHO and CDC guidelines (Appendix I) Individuals diagnosed with chronic HCV infection who initiated or completed the anti-HCV treatment with direct acting antivirals (DAA) presenting at the clinical site for treatment monitoring or test of cure (i.e. sustained virological response) Inclusion criteria: Aged 18 years or older Able to understand the scope of the trial Provided written informed consent Initiated on DAA treatment (regardless of type of DAA regimen) within 12 months prior to the enrolment to the trial Exclusion criteria (for all trial populations): Previously enrolled in the trial Unwilling to provide required volume of fingerstick blood Unwilling to provide required volume of venous whole blood
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Ivanova, Ph.D.
Organizational Affiliation
Foundation for Innovative New Diagnostics
Official's Role
Study Director
Facility Information:
Facility Name
St Vincent's Institute of Medical Research National Serology Reference Laboratory
City
Victoria Park
State/Province
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Centre Pasteur du Cameroun
City
Yaoundé
State/Province
Yaounde
Country
Cameroon
Facility Name
National Centre for Disease Control
City
Tbilisi
Country
Georgia
Facility Name
Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Rwanda Military Hospital
City
Kigali
State/Province
Kanombe
ZIP/Postal Code
0000
Country
Rwanda

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Dried Blood Spot for HCV RNA Testing

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