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:
ANRS, Emerging Infectious Diseases
Collaborator:
EPISTEM
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases
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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 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 |
Resource links provided by the National Library of Medicine

Drug Information available for:
Ribonucleic acid
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 |
Primary Outcome Measures :
- 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 :
- 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.
- 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.
- Assess the inter-examiner reproducibility of the PoC assay. [ Time Frame: Pre-treatment ]
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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:
-
No Contacts or Locations Provided
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | ANRS, Emerging Infectious Diseases |
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 ANRS, Emerging Infectious Diseases:
HCV Genedrive Point of Care |
Additional relevant MeSH terms:
Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Blood-Borne Infections Communicable Diseases |
Infections Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections |