Hepatitis C, ChronicNCT03896087
Evaluation of Dried Blood Spot for HCV RNA Testing
A study testing Abbott RealTime HCV assay from DBS, HCV for use on the cobas® 6800/8800 Systems from PSC and DBS and Aptima® HCV Quant Dx Assay from DBS in people with Hepatitis C, Chronic, run by Foundation for Innovative New Diagnostics, Switzerland at 5 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Abbott RealTime HCV assay from DBS, HCV for use on the cobas® 6800/8800 Systems from PSC and DBS and Aptima® HCV Quant Dx Assay from DBS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 942 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Apr 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Aged 18 years or older
Show all 14Show fewer
- 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)
- 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
Who cannot join
- Previously enrolled in the trial
- Unwilling to provide required volume of fingerstick blood
- Unwilling to provide required volume of venous whole blood
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Australia1 site
St Vincent's Institute of Medical Research National Serology Reference Laboratory
Victoria Park, Fitzroy, 3065
Greece1 site
Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases
Athens, 11527
About this study
Official title: Multicentre Clinical Trial to Assess the Performance of Centralized Assays for Hepatitis C Virus RNA Detection From Dried Blood Spot (DBS) Samples
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).
Read the 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.
- Conditions
- Hepatitis C, Chronic
- Being tested
- 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
- Keywords
- dried blood spots, plasma separation card, HCV RNA test
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott RealTime HCV assay from DBSDiagnostic test
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.
HCV for use on the cobas® 6800/8800 Systems from PSC and DBSDiagnostic test
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.
Aptima® HCV Quant Dx Assay from DBSDiagnostic test
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.
HCV for use on the cobas® 4800Systems from PSC and DBSDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| clinical performance of the HCV DBS assay | Experimental | 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. Receives: Diagnostic Test: Abbott RealTime HCV assay from DBS; Diagnostic Test: HCV for use on the cobas® 6800/8800 Systems from PSC and DBS; Diagnostic Test: Aptima® HCV Quant Dx Assay from DBS; Diagnostic Test: HCV for use on the cobas® 4800Systems from PSC and DBS |
| comparison PQ marked reference assay arm | Active comparator | Plasma specimens from the participants will be tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities. Receives: Diagnostic Test: Abbott RealTime HCV assay from DBS; Diagnostic Test: HCV for use on the cobas® 6800/8800 Systems from PSC and DBS; Diagnostic Test: Aptima® HCV Quant Dx Assay from DBS; Diagnostic Test: HCV for use on the cobas® 4800Systems from PSC and DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 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
Measured: day 1 - day 30
Secondary outcomes (5)
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
Measured: 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
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
Measured: day 1 - day 30
WHO technician's appraisal sheet completed by all operators performing investigational test
WHO technician's appraisal sheet completed by all operators performing investigational test
Measured: through study completion, an average of 1 year
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
Measured: day 7 - day 30
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
Measured: day 7 - day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Apr 2019
- Primary completion30 Nov 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 942 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- UNITAID
- Responsible party
- Sponsor
- Investigators
- Elena Ivanova, Ph.D., Study director, Foundation for Innovative New Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896087
- Sponsor's protocol ID
- 8160-2/1
- Status last verified
- Dec 2020
- First submitted
- 14 Mar 2019
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Clinical Trial to Assess the Performance of Centralized Assays for Hepatitis C Virus RNA Detection From Dried Blood Spot (DBS) Samples
- ClinicalTrials.gov ID
- NCT03896087
- Acronym / sponsor ID
- 8160-2/1
- Conditions
- Hepatitis C, Chronic
- Keywords
- dried blood spots, plasma separation card, HCV RNA test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 942 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- UNITAID
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clinical performance of the HCV DBS assay | Experimental | Diagnostic Test: Abbott RealTime HCV assay from DBS, Diagnostic Test: HCV for use on the cobas® 6800/8800 Systems from PSC and DBS, Diagnostic Test: Aptima® HCV Quant Dx Assay from DBS, Diagnostic Test: HCV for use on the cobas® 4800Systems from PSC and DBSThe 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 | Active comparator | Diagnostic Test: Abbott RealTime HCV assay from DBS, Diagnostic Test: HCV for use on the cobas® 6800/8800 Systems from PSC and DBS, Diagnostic Test: Aptima® HCV Quant Dx Assay from DBS, Diagnostic Test: HCV for use on the cobas® 4800Systems from PSC and DBSPlasma specimens from the participants will be tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Individuals at risk of having HCV infection based on past and/or current exposure to risk factors
- 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)
- Aged 18 years or older
- Able to understand the scope of the trial
- Provided written informed consent
Key exclusion criteria (3 listed)
- Previously enrolled in the trial
- Unwilling to provide required volume of fingerstick blood
- Unwilling to provide required volume of venous whole blood
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbott RealTime HCV assay from DBSThe 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. | Diagnostic test | clinical performance of the HCV DBS assay, comparison PQ marked reference assay arm |
| HCV for use on the cobas® 6800/8800 Systems from PSC and DBSThe 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. | Diagnostic test | clinical performance of the HCV DBS assay, comparison PQ marked reference assay arm |
| Aptima® HCV Quant Dx Assay from DBSThe 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. | Diagnostic test | clinical performance of the HCV DBS assay, comparison PQ marked reference assay arm |
| HCV for use on the cobas® 4800Systems from PSC and DBSThe 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. | Diagnostic test | clinical performance of the HCV DBS assay, comparison PQ marked reference assay arm |
Primary outcome
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
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
5 secondary outcomes
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
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
WHO technician's appraisal sheet completed by all operators performing investigational test
Time frame: through study completion, an average of 1 year
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
Time frame: day 7 - day 30
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
Time frame: day 7 - day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Ivanova, Ph.D. study director
Foundation for Innovative New Diagnostics
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbott RealTime HCV assay from DBS, HCV for use on the cobas® 6800/8800 Systems from PSC and DBS and Aptima® HCV Quant Dx Assay from DBS in people with Hepatitis C, Chronic, run by Foundation for Innovative New Diagnostics, Switzerland at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, Cameroon, Georgia, Greece, Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.