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PoC-HCV Genedrive Viral Detection Assay Validation Study

NCT02992184 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 417

Last updated 2016-12-14

No results posted yet for this study

Summary

The principal objective is to assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and non-infected controls.

Conditions

  • Hepatitis C

Interventions

DEVICE

HCV RNA detection with Genedrive assay

DEVICE

HCV RNA detection with RealTime HCV

Sponsors & Collaborators

  • EPISTEM

    collaborator UNKNOWN

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

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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 NCT02992184 on ClinicalTrials.gov