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PoC-HCV Genedrive Viral Detection Assay Validation Study

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ClinicalTrials.gov Identifier: NCT02992184
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : December 14, 2016
Sponsor:
Collaborator:
EPISTEM
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Hepatitis C Device: HCV RNA detection with Genedrive assay Device: HCV RNA detection with RealTime HCV

Study Design
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Study Type : Observational
Actual Enrollment : 417 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Study Start Date : September 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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Groups and Cohorts
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Group/Cohort Intervention/treatment
HCV patients
228 HCV patients
 Device: HCV RNA detection with Genedrive assay
Other Name: HCV RNA detection with Point of Care assay

Device: HCV RNA detection with RealTime HCV
Other Name: HCV RNA detection with RT-PCR assay
control
189 controls
 Device: HCV RNA detection with Genedrive assay
Other Name: HCV RNA detection with Point of Care assay

Device: HCV RNA detection with RealTime HCV
Other Name: HCV RNA detection with RT-PCR assay


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of HCV RNA detection with PoC assay (Genedrive, Epistem) vs reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott). [ Time Frame: pre-treatment ]
    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 (with Genedrive channel acceptance set at 2 out of 3).


Secondary Outcome Measures :
  1. Diagnostic algorithm optimization [ Time Frame: Pre-treatment ]
    To optimize the diagnostic algorithm (i.e., 1, 2, or 3 out of 3 channels; repeat testing or not) that gives the optimal balance between sensitivity and specificity for detection of HCV RNA.

  2. Factors associated with false-positive of false-negative results [ Time Frame: Pre-treatment ]
    To identify factors associated with false-positive or false-negative results of the PoC assay.

  3. Assess the inter-examiner reproducibility of the PoC assay. [ Time Frame: Pre-treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pre-treatment cohort: 228 HCV patients samples

  • Age > 18 years old.
  • Patients with positive HCV RNA.
  • Heparinized plasma samples are available before the initiation of antiviral HCV therapy.
  • Patients have given a written consent that their blood samples will be further used for research.

Control samples : 189 controls

  • Age > 18 years old.
  • Participants were tested negative for anti-HCV antibody
  • Heparinized plasma samples are available
  • Participants have given a written consent that their blood samples will be further used for research
Criteria

Inclusion Criteria:

Criteria for case

  • Age > 18 years old.
  • Patients with positive HCV RNA.
  • Heparinized plasma samples are available before the initiation of antiviral HCV therapy.
  • Patients have given a written consent that their blood samples will be further used for research.

Criteria for control

  • Age > 18 years old.
  • Participants were tested negative for anti-HCV antibody
  • Heparinized plasma samples are available
  • Participants have given a written consent that their blood samples will be further used for research

Exclusion Criteria:

-

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT02992184    
Other Study ID Numbers: ANRS HC POC VIRAL DETECTION
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HCV
Genedrive
Point of Care
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections