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PoC-HCV Genedrive Viral Detection Assay Validation Study

NCT ID: NCT02992184

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

417 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C

Keywords

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HCV Genedrive Point of Care

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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HCV patients

228 HCV patients

HCV RNA detection with Genedrive assay

Intervention Type DEVICE

HCV RNA detection with RealTime HCV

Intervention Type DEVICE

control

189 controls

HCV RNA detection with Genedrive assay

Intervention Type DEVICE

HCV RNA detection with RealTime HCV

Intervention Type DEVICE

Interventions

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HCV RNA detection with Genedrive assay

Intervention Type DEVICE

HCV RNA detection with RealTime HCV

Intervention Type DEVICE

Other Intervention Names

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HCV RNA detection with Point of Care assay HCV RNA detection with RT-PCR assay

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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EPISTEM

UNKNOWN

Sponsor Role collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Llibre A, Shimakawa Y, Mottez E, Ainsworth S, Buivan TP, Firth R, Harrison E, Rosenberg AR, Meritet JF, Fontanet A, Castan P, Madejon A, Laverick M, Glass A, Viana R, Pol S, McClure CP, Irving WL, Miele G, Albert ML, Duffy D. Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus. Gut. 2018 Nov;67(11):2017-2024. doi: 10.1136/gutjnl-2017-315783. Epub 2018 Apr 3.

Reference Type DERIVED
PMID: 29615488 (View on PubMed)

Other Identifiers

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ANRS HC POC VIRAL DETECTION

Identifier Type: -

Identifier Source: org_study_id