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Truenat™ HCV RNA Assay Evaluation

NCT04236973 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1330

Last updated 2021-07-26

No results posted yet for this study

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.

Conditions

  • Hepatitis C

Interventions

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Elena Ivanova, MD, PhD · Foundation for Innovative New Diagnostics

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-12
Primary Completion
2021-07-20
Completion
2021-07-20

Countries

  • Denmark
  • Ethiopia
  • Georgia
  • Thailand
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04236973 on ClinicalTrials.gov