Truenat™ HCV RNA Assay Evaluation

NCT ID: NCT04236973

Last Updated: 2021-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-12
• Study Completion Date: 2021-07-20

Brief 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. 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.

Conditions

Hepatitis C

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

clinical performance of the Truenat™ HCV assay

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.

Group Type: EXPERIMENTAL

Molbio Truenat™ HCV assay (the investigational product)

Intervention Type: 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.

comparison CE-IVD marked reference assay arm

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

Group Type: ACTIVE_COMPARATOR

Abbott RealTime HCV assay

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

Abbott RealTime HCV assay

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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:

1. HCV SEROPOS: Individuals at risk of having HCV infection based on positive HCV serology test results, without history of HCV treatment

Inclusion criterion:

• Documented positive result of HCV serology test

2. HCV RISK: Individuals with unknown serology status at risk of HCV infection based on past and/or current exposure to risk factors

Inclusion criterion:

• Past and/or current exposure to one of the high risk factors as defined by WHO and CDC guidelines (Appendix 1)

3. 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)

Inclusion criterion:

• Initiated on DAA treatment (regardless of type of DAA regimen) within 12 months prior to the enrolment to the study

4. BLOOD DONORS: Healthy blood donors free of HBV, HCV and HIV infections, as determined by standard blood bank protocols

Exclusion Criteria

• 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

Exclusion criterion for BLOOD DONORS:

• Positive results in HBV, HCV and HIV tests routinely used in the blood bank to assess blood products safety

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation for Innovative New Diagnostics, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena Ivanova, MD, PhD

Role: STUDY_DIRECTOR

Foundation for Innovative New Diagnostics

Locations

Aarhus University Hospital

Aarhus, , Denmark

St Paul's Hospital Millennium Medical College

Addis Ababa, , Ethiopia

National Centre for Diseases Control

Tbilisi, , Georgia

HIV-NAT Thai Red Cross AIDS Research Centre

Bangkok, , Thailand

International Charitable Foundation Alliance for Public Health

Kyiv, , Ukraine

Countries

Denmark; Ethiopia; Georgia; Thailand; Ukraine

Other Identifiers

HC014

Identifier Type: -

Identifier Source: org_study_id