PoC-HCV Genedrive Viral Detection Assay Validation Study
December 13, 2016 updated by: ANRS, Emerging Infectious Diseases
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
417
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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
Description
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:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
HCV patients
228 HCV patients
|
Other Names:
Other Names:
|
|
control
189 controls
|
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
pre-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Pre-treatment
|
|
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.
|
Pre-treatment
|
|
Assess the inter-examiner reproducibility of the PoC assay.
Time Frame: Pre-treatment
|
Pre-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
December 12, 2016
First Submitted That Met QC Criteria
December 13, 2016
First Posted (Estimate)
December 14, 2016
Study Record Updates
Last Update Posted (Estimate)
December 14, 2016
Last Update Submitted That Met QC Criteria
December 13, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANRS HC POC VIRAL DETECTION
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