Enhanced liver fibrosis test for the non-invasive diagnosis of fibrosis in patients with NAFLD: A systematic review and meta-analysisNovartis Pharma AG, Basel, Switzerland.
Department of Pathology, Academic Medical Center, Amsterdam, The Netherlands.
Internal Medicine Research Unit, Pfizer Inc, Cambridge, MA, USA.
Sanofi R&D, Translational Sciences Unit, Chilly Mazarin, France.
The Newcastle Liver Research Group, Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK; Newcastle NIHR Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, The Netherlands.
Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, The Netherlands.
Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, UK; Translational Gastroenterology Unit, University of Oxford, UK; Oxford NIHR Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust and the University of Oxford, Oxford, UK.
Translational Gastroenterology Unit, University of Oxford, UK.
Eli Lilly and Company Ltd (LLY), USA.
Pfizer Worldwide Research and Development (PFE), 1 Portland Square, Cambridge, USA.
SomaLogic, Inc. USA.
University Paris-Diderot, Pathology, Hôpital Beaujon, APHP (APHP), Paris, France.
Nordic Bioscience (NB), Denmark.
Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.
Genfit SA, France.
OWL/metabolomics, One Way Liver S.L, Spain.
University Medical Center Mainz (UMCM), Germany.
Takeda Development Center Europe, London, UK.
Eli Lilly and Company Ltd (LLY), USA.
Perspectum Diagnostics Ltd., Oxford, UK.
Novo Nordisk, Bagsværd, Denmark.
Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, The Netherlands.
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2020 (English)In: Journal of Hepatology, ISSN 0168-8278, E-ISSN 1600-0641, Vol. 73, no 2, p. 252-262Article, review/survey (Refereed) Published
Abstract [en]
BACKGROUND AND AIMS: The Enhanced Liver Fibrosis (ELF) test is a non-invasive biomarker, suggested as an appropriate test for advanced liver fibrosis in non-alcoholic fatty liver disease (NAFLD). This systematic review aimed to provide summary estimates of the accuracy of this test against biopsy.
METHODS: In this systematic review, we searched MEDLINE, Embase, Web of Science and the Cochrane Library, for studies included NAFLD patients and undertook both liver biopsy as the reference standard and the ELF test. Two authors independently screened the references, extracted the data and assessed the quality of included studies. Due to the variation in reported thresholds, we used a multiple thresholds random effects model for meta-analysis (diagmeta R-package).
RESULTS: The meta-analysis of 11 studies reporting advanced fibrosis and five studies reporting significant fibrosis showed sensitivity of >0.90 of the ELF test for excluding fibrosis at threshold of 7.7. However, as a diagnostic test at high thresholds, the test showed specificity and positive predictive value >0.80, only in very high-prevalence settings (>50%). Desiring specificity of 0.90 for advanced and significant fibrosis resulted in thresholds of 10.18 (sensitivity: 0.57) and 9.86 (sensitivity: 0.55), respectively.
CONCLUSION: The ELF test showed high sensitivity but limited specificity to exclude advanced and significant fibrosis at low cutoffs. The diagnostic performance of the test at higher thresholds was found to be more limited in low prevalence settings. We conclude that clinicians should carefully consider the likely disease prevalence in their practice setting and adopt suitable test thresholds to achieve the desired test performance.
Place, publisher, year, edition, pages
Elsevier, 2020. Vol. 73, no 2, p. 252-262
Keywords [en]
Enhanced Liver Fibrosis Test, Fibrosis, Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
National Category
Biomedical Laboratory Science/Technology
Identifiers
URN: urn:nbn:se:oru:diva-81116DOI: 10.1016/j.jhep.2020.03.036ISI: 000548853900016PubMedID: 32275982Scopus ID: 2-s2.0-85087029228OAI: oai:DiVA.org:oru-81116DiVA, id: diva2:1423005
2020-04-122020-04-122023-05-23Bibliographically approved