Hepatitis C Virus InfectionNCT04139941
Evaluation Study of HCV RDTs in Fresh Samples
An observational study of Hepatitis C Virus Infection, run by Foundation for Innovative New Diagnostics, Switzerland at 2 sites in 2 countries.
Trial summary
This study evaluates the sensitivity and specificity performance of three Hepatitis C Virus (HCV) rapid diagnostic tests (RDTs) in freshly collected fingerstick whole blood, as well as serum and plasma (Premier Medical Corporation First Response HCV RDT; Beijing Wantai HCV RDT; AccessBio Care Start HCV under… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- Test for HCV antibodies with an RDT
- How many people
- 1,540 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 Jul 2019to 31 Mar 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: * General population * HCV high-risk individuals
Who may be able to join
- ≥ 18 years of age
- Known or unknown HCV serology
- No history of past or present HCV treatment
- Willing to undergo the information and consenting procedure and subsequently have enough time to participate in the study
- Willing to provide 13 ml venepuncture blood sample and a minimum of four whole blood fingerstick samples
- Willing to perform an HIV test
- Individuals can already be registered at the local site or register for the first time when enrolling in the study
Who cannot join
- Participants not able to consent themselves (incapable)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Georgia1 site
National Center for Disease Control & Public Health/Lugar Center
Tbilisi, 0198
About this study
Official title: Prospective Diagnostic Accuracy Study of Rapid Diagnostic Tests (RDTs) Detecting Antibodies Against Hepatitis C Virus (HCV) in Freshly Collected Whole Blood, Plasma and Serum
This study evaluates the sensitivity and specificity performance of three Hepatitis C Virus (HCV) rapid diagnostic tests (RDTs) in freshly collected fingerstick whole blood, as well as serum and plasma (Premier Medical Corporation First Response HCV RDT; Beijing Wantai HCV RDT; AccessBio Care Start HCV under development). Performance is compared to the SD Bioline HCV RDT, as well as a composite reference standard, consisting of two enzyme Immunoassay and a line immunoassay.
Read the detailed description
Hepatitis C virus (HCV) infection is a major public health burden, with an estimated 71 million patients being infected globally. If undiagnosed, HCV infection can lead to severe liver damage, including hepatocellular carcinoma (HCC). The World Health Organization (WHO) recently set a target to eliminate HCV by 2030. The first critical step in reaching this target is to accurately identify people infected with HCV. Globally, significant gaps remain in diagnosis of HCV, with four out of five people infected still unaware of their status, largely due to lack of access to testing services.
In resource-limited settings (RLS), laboratory-based testing remains a mainstay for HCV screening and confirmatory testing. Such laboratory-based assays rely on transportation of temperature-sensitive samples from clinic sites to centralized laboratories, high-tech equipment and highly skilled laboratory technicians, limiting the scope of access to testing and resulting in long turn-around times for results. In recent years, new technologies have been developed to decentralize HCV screening and confirmatory testing using point-of-care (POC) assays to overcome these barriers and improve patient outcomes.
Rapid diagnostic tests (RDT) for screening for HCV are affordable, accurate, easy to use by healthcare workers, and robust in field settings. Although a number of HCV RDTs are on the market, currently only two have received WHO pre-qualification (PQ) status, demonstrating their accuracy and reliability for use in the field in RLS. Data on a number of other RDTs indicate their suitability for use. More data is needed, however, in field settings for these HCV RDTs, to demonstrate their accuracy and quality in end-user studies and to provide evidence for WHO PQ approval.
Based on the results of a recent FIND laboratory evaluation assessing the performance of 13 HCV RDTs using archived plasma samples, we have selected three candidate HCV RDTs ("study RDTs") for further evaluation in field settings (e.g. primary healthcare facilities). The performance of these RDTs measured in frozen plasma specimens indicated that they have a high potential to meet WHO PQ performance criteria in freshly collected samples. In addition, the manufacturers each demonstrate evidence of engagement to pursue both CE-mark status and the WHO PQ process, showing commitment to delivering quality-assured tests to the market.
The data generated during this study will be used to inform national and international stakeholders on HCV RDT performance in field settings and shared with manufacturers to support the evidence package for WHO PQ and/or CE-marking.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- Test for HCV antibodies with an RDT
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test for HCV antibodies with an RDTDiagnostic test
Fingerstick whole blood, plasma and serum of each participant is tested with three investigational HCV RDTs and one reference HCV RDT. Plasma is also used for testing with the composite reference standard, HCV viral load and genotyping. All participants are also tested for HIV with an HIV RDT.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with known or unknown HCV status | Not described Receives: Diagnostic Test: Test for HCV antibodies with an RDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of HCV RDTs compared to a composite reference standard
1.1 Point estimates of sensitivity, specificity, positive and negative predicative values (with 95% confidence intervals) and Cohen's Kappa Coefficient (κ) of inter-rater agreement for each RDT, using a combination of two EIAs (Enzyme Immunoassay) and an LIA (Line immunoassay) as a composite reference standard for the detection of anti-HCV antibodies in fingerstick whole blood, EDTA plasma and serum.
Measured: through study completion, on average 1 year
Secondary outcomes (3)
Sensitivity and specificity of HCV RDTs compared to an HCV RDT pre-qualified by WHO as reference standard
2.1 Point estimates of sensitivity, specificity, positive and negative predicative values (with 95% confidence intervals) and Cohen's Kappa Coefficient (κ) of inter-rater agreement for each RDT, using the WHO-PQ RDT as reference standard for the detection of anti-HCV antibodies in fingerstick whole blood, EDTA plasma and serum
Measured: through study completion, on average 1 year
Operational characteristics
2.2 Operational characteristics and usability of study RDTs:
- Rate of invalid test results /errors: Percentage of invalid test results/errors by RDT, site and error type
Measured: through study completion, on average 1 year
Operational characteristics
Operational characteristics and usability of study RDTs:
- Technical appraisal rating on kit instructions, labelling and test conduct, on a Likert scale
Measured: through study completion, on average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start31 Jul 2019
- Primary completion31 Dec 2019
- Study completion31 Mar 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139941
- Sponsor's protocol ID
- 8162-2/2
- Status last verified
- Jul 2020
- First submitted
- 7 Oct 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be shared with the manufacturers who's RDTs are being evaluated
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
- Prospective Diagnostic Accuracy Study of Rapid Diagnostic Tests (RDTs) Detecting Antibodies Against Hepatitis C Virus (HCV) in Freshly Collected Whole Blood, Plasma and Serum
- ClinicalTrials.gov ID
- NCT04139941
- Acronym / sponsor ID
- 8162-2/2
- Conditions
- Hepatitis C Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,540 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 25 Oct 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.
This study evaluates the sensitivity and specificity performance of three Hepatitis C Virus (HCV) rapid diagnostic tests (RDTs) in freshly collected fingerstick whole blood, as well as serum and plasma (Premier Medical Corporation First Response HCV RDT; Beijing Wantai HCV RDT; AccessBio Care Start HCV under development). Performance is compared to the SD Bioline HCV RDT, as well as a composite reference standard, consisting of two enzyme Immunoassay and a line immunoassay.
Detailed description
Hepatitis C virus (HCV) infection is a major public health burden, with an estimated 71 million patients being infected globally. If undiagnosed, HCV infection can lead to severe liver damage, including hepatocellular carcinoma (HCC). The World Health Organization (WHO) recently set a target to eliminate HCV by 2030. The first critical step in reaching this target is to accurately identify people infected with HCV. Globally, significant gaps remain in diagnosis of HCV, with four out of five people infected still unaware of their status, largely due to lack of access to testing services.
In resource-limited settings (RLS), laboratory-based testing remains a mainstay for HCV screening and confirmatory testing. Such laboratory-based assays rely on transportation of temperature-sensitive samples from clinic sites to centralized laboratories, high-tech equipment and highly skilled laboratory technicians, limiting the scope of access to testing and resulting in long turn-around times for results. In recent years, new technologies have been developed to decentralize HCV screening and confirmatory testing using point-of-care (POC) assays to overcome these barriers and improve patient outcomes.
Rapid diagnostic tests (RDT) for screening for HCV are affordable, accurate, easy to use by healthcare workers, and robust in field settings. Although a number of HCV RDTs are on the market, currently only two have received WHO pre-qualification (PQ) status, demonstrating their accuracy and reliability for use in the field in RLS. Data on a number of other RDTs indicate their suitability for use. More data is needed, however, in field settings for these HCV RDTs, to demonstrate their accuracy and quality in end-user studies and to provide evidence for WHO PQ approval.
Based on the results of a recent FIND laboratory evaluation assessing the performance of 13 HCV RDTs using archived plasma samples, we have selected three candidate HCV RDTs ("study RDTs") for further evaluation in field settings (e.g. primary healthcare facilities). The performance of these RDTs measured in frozen plasma specimens indicated that they have a high potential to meet WHO PQ performance criteria in freshly collected samples. In addition, the manufacturers each demonstrate evidence of engagement to pursue both CE-mark status and the WHO PQ process, showing commitment to delivering quality-assured tests to the market.
The data generated during this study will be used to inform national and international stakeholders on HCV RDT performance in field settings and shared with manufacturers to support the evidence package for WHO PQ and/or CE-marking.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with known or unknown HCV status | – | Diagnostic Test: Test for HCV antibodies with an RDT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * General population * HCV high-risk individuals
Key inclusion criteria (7 listed)
- ≥ 18 years of age
- Known or unknown HCV serology
- No history of past or present HCV treatment
- Willing to undergo the information and consenting procedure and subsequently have enough time to participate in the study
- Willing to provide 13 ml venepuncture blood sample and a minimum of four whole blood fingerstick samples
Key exclusion criteria (1 listed)
- Participants not able to consent themselves (incapable)
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 |
|---|---|---|
| Test for HCV antibodies with an RDTFingerstick whole blood, plasma and serum of each participant is tested with three investigational HCV RDTs and one reference HCV RDT. Plasma is also used for testing with the composite reference standard, HCV viral load and genotyping. All participants are also tested for HIV with an HIV RDT. | Diagnostic test | Individuals with known or unknown HCV status |
Primary outcome
Sensitivity and specificity of HCV RDTs compared to a composite reference standard
Time frame: through study completion, on average 1 year
1.1 Point estimates of sensitivity, specificity, positive and negative predicative values (with 95% confidence intervals) and Cohen's Kappa Coefficient (κ) of inter-rater agreement for each RDT, using a combination of two EIAs (Enzyme Immunoassay) and an LIA (Line immunoassay) as a composite reference standard for the detection of anti-HCV antibodies in fingerstick whole blood, EDTA plasma and serum.
3 secondary outcomes
Sensitivity and specificity of HCV RDTs compared to an HCV RDT pre-qualified by WHO as reference standard
Time frame: through study completion, on average 1 year
Operational characteristics
Time frame: through study completion, on average 1 year
Operational characteristics
Time frame: through study completion, on average 1 year
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: Yes. Anonymised data will be shared with the manufacturers who's RDTs are being evaluated
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus Infection, run by Foundation for Innovative New Diagnostics, Switzerland at 2 sites in 2 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 7 inclusion and 1 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 Cambodia, Georgia. 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 HCV RDTs compared to a composite reference standard (time frame: through study completion, on average 1 year). 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.