NCT04236973

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

1.5 years

First QC Date

January 15, 2020

Last Update Submit

July 23, 2021

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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.

    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

    From day 1 (enrolment) up to day 30 (completion of the reference testing)

  • Operational usability of the Truenat HCV assay

    From the enrolment of the first participant to the completion of all study procedures for the last enrolled participant and up to 12 months

Study Arms (2)

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.

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.

Other: Abbott RealTime HCV assay

Interventions

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.

clinical performance of the Truenat™ HCV assay
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.

comparison CE-IVD marked reference assay arm

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

St Paul's Hospital Millennium Medical College

Addis Ababa, Ethiopia

Location

National Centre for Diseases Control

Tbilisi, Georgia

Location

HIV-NAT Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Location

International Charitable Foundation Alliance for Public Health

Kyiv, 03150, Ukraine

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Elena Ivanova, MD, PhD

    Foundation for Innovative New Diagnostics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 22, 2020

Study Start

January 12, 2020

Primary Completion

July 20, 2021

Study Completion

July 20, 2021

Last Updated

July 26, 2021

Record last verified: 2021-07

Locations

DK(1)ET(1)TH(1)GE(1)UA(1)