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Evaluation Study of RDTs Detecting Antibodies Against HCV

NCT04033887 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1710

Last updated 2019-07-29

No results posted yet for this study

Summary

The study aims to evaluate 13 different HCV RDTs (10 on-market, 3 under development) for their diagnostic performance and operational characteristics in archived EDTA plasma samples, originating from patients from different geographical regions (Nigeria, Georgia, Cambodia, Belgium) and with or without HIV co-infection.

Conditions

  • Hepatitis C

Interventions

DIAGNOSTIC_TEST

13 Rapid Diagnostic Tests and reference tests

Rapid diagnostic tests: 1. HCV antibody test (under development); bioLytical Laboratories 2. DPP® HCV (under development); Chembio Diagnostic Systems 3. HCV-Ab Rapid Test; Beijing Wantai Biological Pharmacy Enterprise 4. Rapid Anti-HCV Test; InTec 5. First Response HCV Card Test; Premire Medical Corporation 6. Signal HCV Ver 3.0; Arkray healthcare 7. TRI DOT HCV; J. Mitra \& Co 8. Triplex HIV, HCV, HBsAg; Biosynex SA 9. Standard Q HCV Ab; SD Biosensor 10. HCV Hepatitis Virus Antibody Test; Artron Laboratories 11. SD Bioline HCV; Abbott Diagnostics 12. OraQuick HCV; OraSure 13. Care Start HCV Rapid Test (under development); Access Bio Reference tests: Enzyme Immunoassays (EIAs): Murex Anti-HCV EIA version 4.0; Fujirebio Innotest HCV Ab IV Line Immunoassay (LIA): MP Diagnostics HCV blot 3.0

Sponsors & Collaborators

  • Institute of Tropical Medicine, Belgium

    collaborator OTHER

  • Nigerian Institute of Medical Research

    collaborator OTHER_GOV

  • Richard Lugar Centre for Public Health Research, Georgia

    collaborator UNKNOWN

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Ranga Sampath, PhD · Foundation for Innovative New Diagnostics, Geneva, Switzerland

  • Rosemary Audu, PhD · Nigerian Institute of Medical Research, Lagos, Nigeria

  • Katrien Fransen, PhD · Institute of Tropical Medicine, Antwerp, Belgium

  • Maia Alkhazashvili, Masters · NCDC Lugar Centre, Tbilisi, Georgia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2019-03-15
Completion
2019-03-15

Countries

  • Belgium
  • Georgia
  • Nigeria

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 NCT04033887 on ClinicalTrials.gov