Hepatitis CNCT04236973
Truenat™ HCV RNA Assay Evaluation
A study testing Molbio Truenat™ HCV assay (the investigational product) and Abbott RealTime HCV assay in people with Hepatitis C, run by Foundation for Innovative New Diagnostics, Switzerland at 5 sites in 5 countries.
Trial summary
Molbio Diagnostics Ltd. (India) has developed the Truelab™ Real Time quantitative PCR system that is widely used in India for diagnostics of tuberculosis (TB). The system consists of two portable machines and two microfluidic cartridges and can be used in point-of-care settings. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Molbio Truenat™ HCV assay (the investigational product) and Abbott RealTime HCV assay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,330 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 12 Jan 2020to 20 Jul 2021
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals reached the age of an adult as defined in the country that are able to understand the scope of the study and provide informed consent will be invited to take part in the study. In order to meet the study objectives, four different population groups will be considered:
- HCV SEROPOS: Individuals at risk of having HCV infection based on positive HCV serology test results, without history of HCV treatment
- Documented positive result of HCV serology test
- HCV RISK: Individuals with unknown serology status at risk of HCV infection based on past and/or current exposure to risk factors
- Past and/or current exposure to one of the high risk factors as defined by WHO and CDC guidelines (Appendix 1)
- HCV TREAT: 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)
- Initiated on DAA treatment (regardless of type of DAA regimen) within 12 months prior to the enrolment to the study
- BLOOD DONORS: Healthy blood donors free of HBV, HCV and HIV infections, as determined by standard blood bank protocols
Who cannot join
- Previously enrolled in the study
- Unwilling or unable to provide required volume of fingerstick blood
- Unwilling or unable to provide required volume of venous whole blood
- Positive results in HBV, HCV and HIV tests routinely used in the blood bank to assess blood products safety
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Ukraine1 site
International Charitable Foundation Alliance for Public Health
Kyiv, 03150
About this study
Official title: Multicentre Clinical Performance Evaluation of the Molbio Diagnostics Truenat™ HCV RNA Assay
Molbio Diagnostics Ltd. (India) has developed the Truelab™ Real Time quantitative PCR system that is widely used in India for diagnostics of tuberculosis (TB). The system consists of two portable machines and two microfluidic cartridges and can be used in point-of-care settings. The manufacturer has recently developed a new assay that detects HCV RNA, the Truenat™ HCV RNA assay. It is a simple two-step assay for RNA extraction and amplification with a total turnaround time of 60 min, using whole blood, plasma and serum as sample types. Most importantly, the assay can be performed from a drop of capillary blood eliminating the need for venous access and blood draw and increasing its usability in the settings where phlebotomy service are not available. To date, validation of the assay was performed using archived plasma specimens and contrived whole blood specimens. FIND aims to conduct a multicentre evaluation to assess the assay's sensitivity, specificity and quantitative accuracy in freshly collected whole blood, plasma and serum specimens from target populations. The evaluation aims to gather performance data in line with the requirements set forth in the Common Technical Specifications 2009/886/EC (CTS) of the CE In Vitro Diagnostics Medical Devices Directive 98/79/CE (CE-IVDD), as well as the World Health Organization (WHO) Technical Specification Series 10 (draft) (TSS-10) for In vitro diagnostic (IVDs) medical devices used for the qualitative and quantitative detection of HCV RNA.
Read the detailed description
Even though hepatitis C virus (HCV) infection can now be cured, globally, fewer than 20% of the 71 million living with HCV are aware of their status; diagnosis remains a major challenge. While serology screening tests that detect the presence of antibodies against HCV, can be performed in decentralized settings, these tests cannot distinguish between resolved (about 25% of seropositive cases) and active infection. Therefore, positive serology test results require further confirmation by laboratory-based methods that detects the viral particle. The two-step testing process results in high drop-off in confirmatory testing among HCV seropositive individuals, especially in low- and middle-income countries (LMIC) where laboratory infrastructure is lacking. Providing access to confirmatory testing in decentralized settings has a high potential to increase the coverage of HCV testing services in LMIC.
Molbio Diagnostics Ltd. (India) has developed the Truelab™ Real Time quantitative PCR system that is widely used in India for diagnostics of tuberculosis (TB). The system consists of two portable machines and two microfluidic cartridges and can be used in point-of-care settings. The manufacturer has recently developed a new assay that detects HCV RNA, the Truenat™ HCV RNA assay. It is a simple two-step assay for RNA extraction and amplification with a total turnaround time of 60 min, using whole blood, plasma and serum as sample types. Most importantly, the assay can be performed from a drop of capillary blood eliminating the need for venous access and blood draw and increasing its usability in the settings where phlebotomy service are not available. To date, validation of the assay was performed using archived plasma specimens and contrived whole blood specimens. FIND aims to conduct a multicentre evaluation to assess the assay's sensitivity, specificity and quantitative accuracy in freshly collected whole blood, plasma and serum specimens from target populations. The evaluation aims to gather performance data in line with the requirements set forth in the Common Technical Specifications 2009/886/EC (CTS) of the CE In Vitro Diagnostics Medical Devices Directive 98/79/CE (CE-IVDD), as well as the World Health Organization (WHO) Technical Specification Series 10 (draft) (TSS-10) for In vitro diagnostic (IVDs) medical devices used for the qualitative and quantitative detection of HCV RNA. The data will be published as a peer-reviewed report and made available to the test manufacturer to support regulatory submissions.
- Conditions
- Hepatitis C
- Being tested
- Molbio Truenat™ HCV assay (the investigational product), Abbott RealTime HCV 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.
Molbio Truenat™ HCV assay (the investigational product)Device
The Molbio Truenat™ HCV assay (the investigational product) is a quantitative chip-based Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR) tests for the detection of HCV genomic RNA from human whole blood, EDTA plasma and serum. The Truenat™ HCV assay runs on the Truelab™ Uno, Truelab™ Duo or Truelab™ Quadro Dx. Results of testing by Truenat™ HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
Abbott RealTime HCV assayOther
Plasma specimens will be also tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities. Only the results of Abbott RealTime HCV assay may be used to make clinical decisions.
| Study group | Role | What they receive |
|---|---|---|
| clinical performance of the Truenat™ HCV assay | Experimental | The study will be conducted in different geographical regions and populations and is designed to meet requirements of the Common Technical Specifications 2009/886/EC (CTS) of the CE-IVDD and WHO TSS-10 (draft) for IVDs medical devices used for the qualitative and quantitative detection of Hepatitis C RNA. Receives: Device: Molbio Truenat™ HCV assay (the investigational product) |
| comparison CE-IVD 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: Other: Abbott RealTime HCV assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point estimates of clinical sensitivity and specificity
Point estimates (with 95% confidence intervals) of clinical sensitivity and clinical specificity of the Truenat™ HCV assay in fingerstick blood and plasma measured against Abbott RealTime HCV assay in plasma. Sensitivity and specificity of the Truenat™ HCV assay will be obtained for each sample type separately, using Abbott RealTime HCV assay as a reference method.
Measured: From day 1 (enrolment) up to day 30 (completion of the reference testing)
Accuracy of quantification of HCV viral load level in fingerstick blood and plasma by the Truenat™ HCV assay
To evaluate the quantitative performance of the Truenat™ HCV assay in fingerstick blood and plasma specimens, assay results for each specimen type within the linear range will be compared with the results of Abbott RealTime HCV assay performed from a paired plasma specimen. The data will be visualized with the use of scatter plots, and analyzed using Deming regression. The resulting slope of the regression fir will be reported, with 95% confidence intervals.
In addition to the linear regression analysis, a Bland-Altman plot will also be generated.
The percentage of samples with results >0.5 Log IU/mL apart in quantitation between the test and the reference method will be reported.
Measured: From day 1 (enrolment) up to day 30 (completion of the reference testing)
Secondary outcomes (3)
Level of agreement between result outputs of the Truenat™ HCV assay performed from different specimens.
Percentage of agreement between result outputs of the Truenat™ HCV assay performed from different specimen types will be calculated, with 95% confidence intervals based on Wilson's score method, as the percentage of the number of samples with identical results over the total number of samples tested. In addition, the Cohen's k coefficient of agreement will also be calculated as a measure of agreement between different sample types.
Measured: From day 1 (enrolment) up to day 30 (completion of the reference testing)
Accuracy of quantification of HCV viral load levels in serum and venous whole blood specimens by the Truenat™ HCV assay
Evaluation of the correlation of HCV viral load levels determined by the Truenat™ HCV assay in different specimen types, Truenat™ HCV assay results for each specimen type within the linear range will be compared with the results of the same assay in another specimen type. The data will be visualized with the use of scatter plots, and analyzed using Deming regression.
Measured: From day 1 (enrolment) up to day 30 (completion of the reference testing)
Operational usability of the Truenat HCV assay
Assessment of operational characteristics including but not limited to rate of invalid results, total hands on time, description of operator experience with the assays through the appraisal sheet.
Measured: From the enrolment of the first participant to the completion of all study procedures for the last enrolled participant and up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start12 Jan 2020
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- 1,330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Ivanova, MD, PhD, Study director, Foundation for Innovative New Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236973
- Sponsor's protocol ID
- HC014
- Status last verified
- Jul 2021
- First submitted
- 15 Jan 2020
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Clinical Performance Evaluation of the Molbio Diagnostics Truenat™ HCV RNA Assay
- ClinicalTrials.gov ID
- NCT04236973
- Acronym / sponsor ID
- HC014
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,330 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 22 Jan 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.
Molbio Diagnostics Ltd. (India) has developed the Truelab™ Real Time quantitative PCR system that is widely used in India for diagnostics of tuberculosis (TB). The system consists of two portable machines and two microfluidic cartridges and can be used in point-of-care settings. The manufacturer has recently developed a new assay that detects HCV RNA, the Truenat™ HCV RNA assay. It is a simple two-step assay for RNA extraction and amplification with a total turnaround time of 60 min, using whole blood, plasma and serum as sample types. Most importantly, the assay can be performed from a drop of capillary blood eliminating the need for venous access and blood draw and increasing its usability in the settings where phlebotomy service are not available. To date, validation of the assay was performed using archived plasma specimens and contrived whole blood specimens. FIND aims to conduct a multicentre evaluation to assess the assay's sensitivity, specificity and quantitative accuracy in freshly collected whole blood, plasma and serum specimens from target populations. The evaluation aims to gather performance data in line with the requirements set forth in the Common Technical Specifications 2009/886/EC (CTS) of the CE In Vitro Diagnostics Medical Devices Directive 98/79/CE (CE-IVDD), as well as the World Health Organization (WHO) Technical Specification Series 10 (draft) (TSS-10) for In vitro diagnostic (IVDs) medical devices used for the qualitative and quantitative detection of HCV RNA.
Detailed description
Even though hepatitis C virus (HCV) infection can now be cured, globally, fewer than 20% of the 71 million living with HCV are aware of their status; diagnosis remains a major challenge. While serology screening tests that detect the presence of antibodies against HCV, can be performed in decentralized settings, these tests cannot distinguish between resolved (about 25% of seropositive cases) and active infection. Therefore, positive serology test results require further confirmation by laboratory-based methods that detects the viral particle. The two-step testing process results in high drop-off in confirmatory testing among HCV seropositive individuals, especially in low- and middle-income countries (LMIC) where laboratory infrastructure is lacking. Providing access to confirmatory testing in decentralized settings has a high potential to increase the coverage of HCV testing services in LMIC.
Molbio Diagnostics Ltd. (India) has developed the Truelab™ Real Time quantitative PCR system that is widely used in India for diagnostics of tuberculosis (TB). The system consists of two portable machines and two microfluidic cartridges and can be used in point-of-care settings. The manufacturer has recently developed a new assay that detects HCV RNA, the Truenat™ HCV RNA assay. It is a simple two-step assay for RNA extraction and amplification with a total turnaround time of 60 min, using whole blood, plasma and serum as sample types. Most importantly, the assay can be performed from a drop of capillary blood eliminating the need for venous access and blood draw and increasing its usability in the settings where phlebotomy service are not available. To date, validation of the assay was performed using archived plasma specimens and contrived whole blood specimens. FIND aims to conduct a multicentre evaluation to assess the assay's sensitivity, specificity and quantitative accuracy in freshly collected whole blood, plasma and serum specimens from target populations. The evaluation aims to gather performance data in line with the requirements set forth in the Common Technical Specifications 2009/886/EC (CTS) of the CE In Vitro Diagnostics Medical Devices Directive 98/79/CE (CE-IVDD), as well as the World Health Organization (WHO) Technical Specification Series 10 (draft) (TSS-10) for In vitro diagnostic (IVDs) medical devices used for the qualitative and quantitative detection of HCV RNA. The data will be published as a peer-reviewed report and made available to the test manufacturer to support regulatory submissions.
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 Truenat™ HCV assay | Experimental | Device: Molbio Truenat™ HCV assay (the investigational product)The study will be conducted in different geographical regions and populations and is designed to meet requirements of the Common Technical Specifications 2009/886/EC (CTS) of the CE-IVDD and WHO TSS-10 (draft) for IVDs medical devices used for the qualitative and quantitative detection of Hepatitis C RNA. |
| comparison CE-IVD marked reference assay arm | Active comparator | Other: Abbott RealTime HCV assayPlasma 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
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals reached the age of an adult as defined in the country that are able to understand the scope of the study and provide informed consent will be invited to take part in the study. In order to meet the study objectives, four different population groups will be considered:
- HCV SEROPOS: Individuals at risk of having HCV infection based on positive HCV serology test results, without history of HCV treatment
- HCV RISK: Individuals with unknown serology status at risk of HCV infection based on past and/or current exposure to risk factors
- HCV TREAT: 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)
- BLOOD DONORS: Healthy blood donors free of HBV, HCV and HIV infections, as determined by standard blood bank protocols
Key exclusion criteria (4 listed)
- Previously enrolled in the study
- Unwilling or unable to provide required volume of fingerstick blood
- Unwilling or unable to provide required volume of venous whole blood
- Positive results in HBV, HCV and HIV tests routinely used in the blood bank to assess blood products safety
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 |
|---|---|---|
| Molbio Truenat™ HCV assay (the investigational product)The Molbio Truenat™ HCV assay (the investigational product) is a quantitative chip-based Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR) tests for the detection of HCV genomic RNA from human whole blood, EDTA plasma and serum. The Truenat™ HCV assay runs on the Truelab™ Uno, Truelab™ Duo or Truelab™ Quadro Dx. Results of testing by Truenat™ HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants. | Device | clinical performance of the Truenat™ HCV assay |
| Abbott RealTime HCV assayPlasma specimens will be also tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities. Only the results of Abbott RealTime HCV assay may be used to make clinical decisions. | Other | comparison CE-IVD marked reference assay arm |
Primary outcome
Point estimates of clinical sensitivity and specificity
Time frame: From day 1 (enrolment) up to day 30 (completion of the reference testing)
Point estimates (with 95% confidence intervals) of clinical sensitivity and clinical specificity of the Truenat™ HCV assay in fingerstick blood and plasma measured against Abbott RealTime HCV assay in plasma. Sensitivity and specificity of the Truenat™ HCV assay will be obtained for each sample type separately, using Abbott RealTime HCV assay as a reference method.
Accuracy of quantification of HCV viral load level in fingerstick blood and plasma by the Truenat™ HCV assay
Time frame: From day 1 (enrolment) up to day 30 (completion of the reference testing)
To evaluate the quantitative performance of the Truenat™ HCV assay in fingerstick blood and plasma specimens, assay results for each specimen type within the linear range will be compared with the results of Abbott RealTime HCV assay performed from a paired plasma specimen. The data will be visualized with the use of scatter plots, and analyzed using Deming regression. The resulting slope of the regression fir will be reported, with 95% confidence intervals. In addition to the linear regression analysis, a Bland-Altman plot will also be generated. The percentage of samples with results >0.5 Log IU/mL apart in quantitation between the test and the reference method will be reported.
3 secondary outcomes
Level of agreement between result outputs of the Truenat™ HCV assay performed from different specimens.
Time frame: From day 1 (enrolment) up to day 30 (completion of the reference testing)
Accuracy of quantification of HCV viral load levels in serum and venous whole blood specimens by the Truenat™ HCV assay
Time frame: From day 1 (enrolment) up to day 30 (completion of the reference testing)
Operational usability of the Truenat HCV assay
Time frame: From the enrolment of the first participant to the completion of all study procedures for the last enrolled participant and up to 12 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 26 Jul 2021.
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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, MD, PhD 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 Molbio Truenat™ HCV assay (the investigational product) and Abbott RealTime HCV assay in people with Hepatitis C, 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 8 inclusion and 4 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 26 Jul 2021. 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 Denmark, Ethiopia, Georgia, Thailand, 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?
Point estimates of clinical sensitivity and specificity (time frame: From day 1 (enrolment) up to day 30 (completion of the reference testing)). 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 26 Jul 2021.