Hepatitis C Virus InfectionNCT04317729
DBS Evaluation of Fujirebio INNOTEST® HCV Ab IV
A study testing Fujirebio INNOTEST® HCV Ab IV assay in people with Hepatitis C Virus Infection, run by Foundation for Innovative New Diagnostics, Switzerland at 2 sites in Ukraine.
Trial summary
The goal of this trial is to evaluate the performance of the Fujirebio INNOTEST® HCV Ab IV using simpler collection methods such as fingerstick and venous whole blood collection on dried blood spots (DBS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- Fujirebio INNOTEST® HCV Ab IV assay
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUkraine
- Study dates
- 30 Jan 2020to 31 May 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥18 years
- Provision of written informed consent
- Routine RDT reactive or non-reactive and recruitment target not yet met
- No history of HCV treatment
Who cannot join
- Unwilling to provide required volume of fingerstick blood and venous whole blood
- Participants already enrolled in the trial
Trial locations and contacts
2 sites in 1 country.
Ukraine2 sites
Astar Medical Centre
Lviv, 79000
Lviv Regional Public Health Centre
Lviv, 79026
About this study
Official title: Evaluation of Hepatitis C Virus Antibody Detection From Dried Blood Spots With the Fujirebio INNOTEST® HCV Ab IV
The goal of this trial is to evaluate the performance of the Fujirebio INNOTEST® HCV Ab IV using simpler collection methods such as fingerstick and venous whole blood collection on dried blood spots (DBS). In order to assess performance in samples with high and low antibody titres, performance will be evaluated with undiluted samples of all trial participants and serial diluted samples for a subset of HCV antibody reactive samples. Serial dilution of reactive samples will provide further insights into the potential difference of sensitivity in samples collected on DBS versus plasma.
Results of this trial will also support the update of the regulatory claims to include DBS as an alternative sample type.
Read the detailed description
Access to Hepatitis C virus (HCV) screening in resource-limited settings should be enabled not only through the provision of point-of-care screening tests, but also through the possibility of collecting samples in decentralized settings One possible way of decentralizing sample collection is collecting dried blood spot (DBS) specimens, which can be easily transported to testing laboratories, not requiring any cold chain or complex sample transportation. DBS serology screening is complementary to established point-point-of care screening with rapid diagnostic tests, both methodologies being somewhat less cost-effective and less sensitive compared to lab-based methods but suitable for settings without sophisticated infrastructure.
To date, no HCV antibody serology test is formally evaluated for the use with DBS, however several studies on off-label use of DBS in serology screening assays, suggests that this sample type can serve as an alternative to plasma and serum. Fujirebio's enzyme immunoassay (EIA) INNOTEST® HCV Ab IV is CE marked and has received pre-qualification by the World Health Organization (WHO) for the use with venous plasma and serum, which require special equipment for sample collection, sample preparation and temperature controlled transportation.
Available data on the performance of HCV antibody detection from DBS samples are insufficient to introduce their use in clinical practice. Fujirebio is one of the few manufacturers who have an EIA test pre-qualified by the WHO for the use with plasma and serum to detect anti-HCV antibodies. A prospective diagnostic accuracy trial of the Fujirebio INNOTEST® HCV Ab IV assay in fWB and vWB collected on DBS, using EDTA plasma results obtained with the Fujirebio INNOTEST® HCV Ab IV assay as reference standard is needed to understand the relationship between results generated in plasma and WB samples collected on DBS. Furthermore, the data generated can be used by Fujirebio to update their regulatory claims and include DBS as an alternative sample type.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- Fujirebio INNOTEST® HCV Ab IV assay
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fujirebio INNOTEST® HCV Ab IV assayDevice
Enzyme Immunoassay
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic | Experimental | Collection of whole blood via fingerstick and venipuncture Receives: Device: Fujirebio INNOTEST® HCV Ab IV assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of fingerstick whole blood DBS
Point estimates of sensitivity and specificity (with 95% confidence intervals) of the Fujirebio INNOTEST® HCV Ab IV assay in fWB collected on DBS, using EDTA plasma results obtained with the Fujirebio INNOTEST® HCV Ab IV assay as reference standard
Measured: 4 months
Sensitivity and specificity of venous whole blood DBS
Point estimates of sensitivity and specificity (with 95% confidence intervals) of the Fujirebio INNOTEST® HCV Ab IV assay in vWB collected on DBS, using EDTA plasma results obtained with the Fujirebio INNOTEST® HCV Ab IV assay as reference standard
Measured: 4 months
Secondary outcomes (6)
Degree of agreement of undiluted samples fWB and vWB
Point estimates of Cohen's Kappa Coefficient (ĸ) and negative, positive and overall rate of agreement of all undiluted samples for the Fujirebio INNOTEST® HCV Ab IV assay between fWB and vWB collected on DBS.
Measured: 4 months
Degree of agreement of undiluted samples vWB and plasma
Point estimates of Cohen's Kappa Coefficient (ĸ) and negative, positive and overall rate of agreement of all undiluted samples for the Fujirebio INNOTEST® HCV Ab IV assay between vWB collected on DBS and plasma.
Measured: 4 months
Degree of agreement of undiluted samples fWB and plasma
Point estimates of Cohen's Kappa Coefficient (ĸ) and negative, positive and overall rate of agreement of all undiluted samples for the Fujirebio INNOTEST® HCV Ab IV assay between fWB collected on DBS and plasma.
Measured: 4 months
Degree of agreement of serial diluted samples fWB and vWB
Point estimates of Cohen's Kappa Coefficient (ĸ) and negative, positive and overall rate of agreement of serial-diluted HCV Ab positive samples for the Fujirebio INNOTEST® HCV Ab IV assay between fWB and vWB collected on DBS.
Measured: 4 months
Degree of agreement of serial diluted samples vWB and plasma
Point estimates of Cohen's Kappa Coefficient (ĸ) and negative, positive and overall rate of agreement of serial-diluted HCV Ab positive samples for the Fujirebio INNOTEST® HCV Ab IV assay between vWB collected on DBS and plasma.
Measured: 4 months
Degree of agreement of serial diluted samples fWB and plasma
Point estimates of Cohen's Kappa Coefficient (ĸ) and negative, positive and overall rate of agreement of serial-diluted HCV Ab positive samples for the Fujirebio INNOTEST® HCV Ab IV assay between fWB collected on DBS and plasma.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start30 Jan 2020
- Primary completion30 Apr 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Vasylyev, MD, Principal investigator, Medical Centre Astar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317729
- Sponsor's protocol ID
- HC016
- Status last verified
- Jul 2020
- First submitted
- 19 Dec 2019
- Last updated
- 7 Jul 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 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hepatitis C Virus Antibody Detection From Dried Blood Spots With the Fujirebio INNOTEST® HCV Ab IV
- ClinicalTrials.gov ID
- NCT04317729
- Acronym / sponsor ID
- HC016
- Conditions
- Hepatitis C Virus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 23 Mar 2020 (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.
The goal of this trial is to evaluate the performance of the Fujirebio INNOTEST® HCV Ab IV using simpler collection methods such as fingerstick and venous whole blood collection on dried blood spots (DBS). In order to assess performance in samples with high and low antibody titres, performance will be evaluated with undiluted samples of all trial participants and serial diluted samples for a subset of HCV antibody reactive samples. Serial dilution of reactive samples will provide further insights into the potential difference of sensitivity in samples collected on DBS versus plasma.
Results of this trial will also support the update of the regulatory claims to include DBS as an alternative sample type.
Detailed description
Access to Hepatitis C virus (HCV) screening in resource-limited settings should be enabled not only through the provision of point-of-care screening tests, but also through the possibility of collecting samples in decentralized settings One possible way of decentralizing sample collection is collecting dried blood spot (DBS) specimens, which can be easily transported to testing laboratories, not requiring any cold chain or complex sample transportation. DBS serology screening is complementary to established point-point-of care screening with rapid diagnostic tests, both methodologies being somewhat less cost-effective and less sensitive compared to lab-based methods but suitable for settings without sophisticated infrastructure.
To date, no HCV antibody serology test is formally evaluated for the use with DBS, however several studies on off-label use of DBS in serology screening assays, suggests that this sample type can serve as an alternative to plasma and serum. Fujirebio's enzyme immunoassay (EIA) INNOTEST® HCV Ab IV is CE marked and has received pre-qualification by the World Health Organization (WHO) for the use with venous plasma and serum, which require special equipment for sample collection, sample preparation and temperature controlled transportation.
Available data on the performance of HCV antibody detection from DBS samples are insufficient to introduce their use in clinical practice. Fujirebio is one of the few manufacturers who have an EIA test pre-qualified by the WHO for the use with plasma and serum to detect anti-HCV antibodies. A prospective diagnostic accuracy trial of the Fujirebio INNOTEST® HCV Ab IV assay in fWB and vWB collected on DBS, using EDTA plasma results obtained with the Fujirebio INNOTEST® HCV Ab IV assay as reference standard is needed to understand the relationship between results generated in plasma and WB samples collected on DBS. Furthermore, the data generated can be used by Fujirebio to update their regulatory claims and include DBS as an alternative sample type.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | Experimental | Device: Fujirebio INNOTEST® HCV Ab IV assayCollection of whole blood via fingerstick and venipuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥18 years
- Provision of written informed consent
- Routine RDT reactive or non-reactive and recruitment target not yet met
- No history of HCV treatment
Key exclusion criteria (2 listed)
- Unwilling to provide required volume of fingerstick blood and venous whole blood
- Participants already enrolled in the trial
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 |
|---|---|---|
| Fujirebio INNOTEST® HCV Ab IV assayEnzyme Immunoassay | Device | Diagnostic |
Primary outcome
Sensitivity and specificity of fingerstick whole blood DBS
Time frame: 4 months
Point estimates of sensitivity and specificity (with 95% confidence intervals) of the Fujirebio INNOTEST® HCV Ab IV assay in fWB collected on DBS, using EDTA plasma results obtained with the Fujirebio INNOTEST® HCV Ab IV assay as reference standard
Sensitivity and specificity of venous whole blood DBS
Time frame: 4 months
Point estimates of sensitivity and specificity (with 95% confidence intervals) of the Fujirebio INNOTEST® HCV Ab IV assay in vWB collected on DBS, using EDTA plasma results obtained with the Fujirebio INNOTEST® HCV Ab IV assay as reference standard
6 secondary outcomes
Degree of agreement of undiluted samples fWB and vWB
Time frame: 4 months
Degree of agreement of undiluted samples vWB and plasma
Time frame: 4 months
Degree of agreement of undiluted samples fWB and plasma
Time frame: 4 months
Degree of agreement of serial diluted samples fWB and vWB
Time frame: 4 months
Degree of agreement of serial diluted samples vWB and plasma
Time frame: 4 months
Degree of agreement of serial diluted samples fWB and plasma
Time frame: 4 months
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 7 Jul 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.
Marta Vasylyev, MD principal investigator
Medical Centre Astar
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fujirebio INNOTEST® HCV Ab IV assay in people with Hepatitis C Virus Infection, run by Foundation for Innovative New Diagnostics, Switzerland at 2 sites in Ukraine.
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 4 inclusion and 2 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 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ukraine. 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?
Sensitivity and specificity of fingerstick whole blood DBS (time frame: 4 months). 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 7 Jul 2020.