Trial reportGut2018
Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus.
Trial report in Gut, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02992184 (PoC-HCV Genedrive Viral Detection Assay Validation Study), which is not on this map. Cited by 24 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
PoC-HCV Genedrive Viral Detection Assay Validation Study
Who cites it
24 citing papers in PubMed, 71 citations in OpenAlex.
- Advances in Virus Biorecognition and Detection Techniques for the Surveillance and Prevention of Infectious Diseases.Biosensors · 2025Review
- Current advances in Hepatitis C diagnostics.Journal of biological engineering · 2024Review
- Molecular Point-of-Care Testing for Hepatitis C: Available Technologies, Pipeline, and Promising Future Directions.The Journal of infectious diseases · 2024Review
- Point-of-Care Testing for Hepatitis Viruses: A Growing Need.Life (Basel, Switzerland) · 2023Review
- Development of simple, rapid, and sensitive methods for detection of hepatitis C virus RNA from whole blood using reverse transcription loop-mediated isothermal amplification.Journal of clinical microbiology · 2023Article
- A simplified point-of-service model for hepatitis C in people who inject drugs in South Africa.Harm reduction journal · 2023Article
- A Point-of-Care Device for Fully Automated, Fast and Sensitive Protein Quantification via qPCR.Biosensors · 2022Article
- Determining the lower limit of detection required for HCV viral load assay for test of cure following direct-acting antiviral-based treatment regimens: Evidence from a global data set.Journal of viral hepatitis · 2022Article
- Diagnostic Accuracy of Point-of-Care HCV Viral Load Assays for HCV Diagnosis: A Systematic Review and Meta-Analysis.Diagnostics (Basel, Switzerland) · 2022Review
- Article
- Uncovering Resistance to Hepatitis C Virus Infection: Scientific Contributions and Unanswered Questions in the Irish Anti-D Cohort.Pathogens (Basel, Switzerland) · 2022Review
- Simultaneous determination of HCV genotype and NS5B resistance associated substitutions using dried serum spots from São Paulo state, Brazil.Access microbiology · 2022Article
- Article
- Role of hepatitis c virus in hepatocellular carcinoma and neurological disorders: an overview.Frontiers in oncology · 2022Review
- Paper microfluidic implementation of loop mediated isothermal amplification for early diagnosis of hepatitis C virus.Nature communications · 2021Article
- Diagnostic Performance and Usability of the GenedriveDiagnostics (Basel, Switzerland) · 2021Article
- Article
- Achieving a high cure rate with direct-acting antivirals for chronic Hepatitis C virus infection in Cameroon: a multi-clinic demonstration project.Tropical medicine & international health : TM & IH · 2020Article
- Article
- In-field evaluation of Xpert® HCV viral load Fingerstick assay in people who inject drugs in Tanzania.Liver international : official journal of the International Association for the Study of the Liver · 2020Article
Corrections and comments
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Authors and funding
21 authors at 8 institutions in 4 countries.
Funding
Abstract
objectiveRecently approved direct acting antivirals provide transformative therapies for chronic hepatitis C virus (HCV) infection. The major clinical challenge remains to identify the undiagnosed patients worldwide, many of whom live in low-income and middle-income countries, where access to nucleic acid testing remains limited. The aim of this study was to develop and validate a point-of-care (PoC) assay for the qualitative detection of HCV RNA.
designWe developed a PoC assay for the qualitative detection of HCV RNA on the PCR Genedrive instrument. We validated the Genedrive HCV assay through a case-control study comparing results with those obtained with the Abbott RealTi
resultsThe PoC assay identified all major HCV genotypes, with a limit of detection of 2362 IU/mL (95% CI 1966 to 2788). Using 422 patients chronically infected with HCV and 503 controls negative for anti-HCV and HCV RNA, the Genedrive HCV assay showed 98.6% sensitivity (95% CI 96.9% to 99.5%) and 100% specificity (95% CI 99.3% to 100%) to detect HCV. In addition, melting peak ratiometric analysis demonstrated proof-of-principle for semiquantification of HCV. The test was further validated in a real clinical setting in a resource-limited country.
conclusionWe report a rapid, simple, portable and accurate PoC molecular test for HCV, with sensitivity and specificity that fulfils the recent FIND/WHO Target Product Profile for HCV decentralised testing in low-income and middle-income countries. This Genedrive HCV assay may positively impact the continuum of HCV care from screening to cure by supporting real-time treatment decisions. TRIAL REGISTRATION NUMBER: NCT02992184 .
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.