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Evaluation Study of HCV RDTs in Fresh Samples

NCT04139941 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1540

Last updated 2020-07-07

No results posted yet for this study

Summary

This study evaluates the sensitivity and specificity performance of three Hepatitis C Virus (HCV) rapid diagnostic tests (RDTs) in freshly collected fingerstick whole blood, as well as serum and plasma (Premier Medical Corporation First Response HCV RDT; Beijing Wantai HCV RDT; AccessBio Care Start HCV under development). Performance is compared to the SD Bioline HCV RDT, as well as a composite reference standard, consisting of two enzyme Immunoassay and a line immunoassay.

Conditions

  • Hepatitis C Virus Infection

Interventions

DIAGNOSTIC_TEST

Test for HCV antibodies with an RDT

Fingerstick whole blood, plasma and serum of each participant is tested with three investigational HCV RDTs and one reference HCV RDT. Plasma is also used for testing with the composite reference standard, HCV viral load and genotyping. All participants are also tested for HIV with an HIV RDT.

Sponsors & Collaborators

  • Institute of Tropical Medicine, Belgium

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2019-12-31
Completion
2020-03-31

Countries

  • Cambodia
  • Georgia

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 NCT04139941 on ClinicalTrials.gov