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What is required from HCV point-of-care tests to reduce the burden of hepatitis C infection? ‘Development and clinical validation of the genedrive point-of-care test for qualitative detection of hepatitis C virus
  1. Maud Lemoine1,
  2. Hans L Tillmann2,3
  1. 1 Department of Surgery and Cancer, Hepatology Section, St Mary’s Hospital, Imperial College, London, UK
  2. 2 Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, Brody School of Medicine, East Carolina University, Greenville, North Carolina, USA
  3. 3 Gastroenterology and Hepatology, Specialty Clinics, Greenville VA Health Care Center, Greenville, North Carolina, USA
  1. Correspondence to Dr Maud Lemoine, Department of Surgery and Cancer, Hepatology Section, St Mary’s Hospital, London W2 1NY, UK; m.lemoine{at}

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The major advances in hepatitis C virus (HCV) diagnosis and treatment now make hepatitis C infection a curable disease over a short period of time and thus, theoretically, an eliminable disease. In its viral hepatitis elimination plan, the WHO aims, by 2030, to scale-up HCV treatment coverage to 80% and reduce HCV incidence and related mortality by 90% and 65%, respectively.1 This plan is ambitious and requires new strategies for the identification of hepatitis C cases especially in resource-limited countries which bear the highest burden of disease. The WHO estimates that only 20% of the 71 million individuals infected with HCV globally have been diagnosed and <10% have been treated.2 These figures are even lower in resource-limited countries. This poor intervention coverage is not only related to limited access to direct antiviral agents at low cost but also to the high cost and complexity of the conventional HCV RNA tests required for the identification of patients with viraemia. As a result, inexpensive and simple alternatives to conventional HCV nucleic acid tests (NAT) are urgently needed not only for low-income and middle-income countries but also high-income countries where healthcare resources are not infinite and HCV mainly affects difficult to reach populations.

In Gut, Llibre et al report high diagnostic accuracy of a new point-of-care (POC) test for qualitative detection of HCV (Genedrive, Epistem, Manchester, UK). From a large case–control study including samples from HCV-infected -treatment naïve- and uninfected patients identified in 2 European (France and UK) and 10 African countries, the authors assessed the performance of the new test for the detection of HCV RNA using the Abbott real-time PCR assay as a reference. …

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  • Contributors ML and HT drafted and finalised the paper together.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests ML and HLT have no competing interests directly related to this manuscript; ML received research funding from Gilead US company and Viiv company. ML gave consultancies to MSD and Viiv. HLT’s wife is a full-time employee of AbbVie and holds stocks in AbbVie, Abbott and Gilead. HLT served as a DSMB chair to a Novartis.

  • Provenance and peer review Commissioned; internally peer reviewed.

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