Background and aim:Fibrosis prediction is an essential part of the assessment and management of pts with chronic liver disease. The ELF Test consists of an algorithm of three fibrosis markers: hyaluronic acid, amino-terminal propeptide-of-type-III-collagen and inhibitor of matrix-metalloproteinase-1. Aim of our study was to evaluate a serological marker method-ELF Test in the assessment of liver fibrosis, comparing with liver biopsy. Material and methods:We included 31 pts (14 M – 45%, 17 F – 55%; mean ±SD ages 52±11 yrs) with chronic C hepatitis (n=12/31 – 39%), chronic B hepatitis (n=10/31 – 32%) and non-alcoholic steatohepatitis (n=9/31-29%). A percutaneous liver biopsy specimen was obtained from all pts. Liver fibrosis stages were evaluated according to the Metavir scoring-system (F0–F4). Serum samples were analysed using the proprietary assays developed for ELF Test by Siemens Healthcare Diagnostics Inc. Results were entered into the established algorithm and expressed as discriminant scores for a comparison to Metavir histological staging. Liver fibrosis was classified in mild (ELF score <7.7), moderate (ELF score 7.7–9.8) and severe fibrosis (ELF score≥9.8). Statistical analysis was performed by evaluating area-under-the ROC-curves (AUROC), sensitivity (Se), specificity (Sp), positive- (PPV) and negative-predictive-values (NPV). Results:We found the following distribution by Metavir: F1=7, F2=11, F3=4, F4=9. The ELF Test diagnosed mild fibrosis in 7 pts, moderate fibrosis in 17 pts and severe fibrosis in 7 pts. The accuracy according to AUROC for the diagnosis of significant fibrosis (F ≥2; ELF score≥7.7) was 0.869 (95% CI 0.69–0.96; cut-off=8.49; p=0.0001), Se=0.87 and Sp=0.56, PPV=0.87 and NPV=0.57. The accuracy for the diagnosis of cirrhosis (F=4; ELF score≥9.8) was 0.995 (95% CI 0.81–0.99; cut-off=9.03; p=0.0001), Se=0.66 and Sp=0.95, PPV=0.85 and NPV=0.87. Conclusions:The ELF Test showed better efficacy in highlighting the presence of cirrhosis than in discriminating intermediate stages of liver fibrosis. Liver biopsy is still the gold standard in staging fibrosis. The ELF Test could be employed for a preliminary selection of patients eligible for biopsy and could be used during their follow-up.

ENHANCED LIVER FIBROSIS (ELF) TEST: A PROSPECTIVE STUDY OF NON-INVASIVE DIAGNOSTIC METHOD OF LIVER FIBROSIS

R. Catanzaro;MILAZZO, MICHELE;N. Bellavia;
2013

Abstract

Background and aim:Fibrosis prediction is an essential part of the assessment and management of pts with chronic liver disease. The ELF Test consists of an algorithm of three fibrosis markers: hyaluronic acid, amino-terminal propeptide-of-type-III-collagen and inhibitor of matrix-metalloproteinase-1. Aim of our study was to evaluate a serological marker method-ELF Test in the assessment of liver fibrosis, comparing with liver biopsy. Material and methods:We included 31 pts (14 M – 45%, 17 F – 55%; mean ±SD ages 52±11 yrs) with chronic C hepatitis (n=12/31 – 39%), chronic B hepatitis (n=10/31 – 32%) and non-alcoholic steatohepatitis (n=9/31-29%). A percutaneous liver biopsy specimen was obtained from all pts. Liver fibrosis stages were evaluated according to the Metavir scoring-system (F0–F4). Serum samples were analysed using the proprietary assays developed for ELF Test by Siemens Healthcare Diagnostics Inc. Results were entered into the established algorithm and expressed as discriminant scores for a comparison to Metavir histological staging. Liver fibrosis was classified in mild (ELF score <7.7), moderate (ELF score 7.7–9.8) and severe fibrosis (ELF score≥9.8). Statistical analysis was performed by evaluating area-under-the ROC-curves (AUROC), sensitivity (Se), specificity (Sp), positive- (PPV) and negative-predictive-values (NPV). Results:We found the following distribution by Metavir: F1=7, F2=11, F3=4, F4=9. The ELF Test diagnosed mild fibrosis in 7 pts, moderate fibrosis in 17 pts and severe fibrosis in 7 pts. The accuracy according to AUROC for the diagnosis of significant fibrosis (F ≥2; ELF score≥7.7) was 0.869 (95% CI 0.69–0.96; cut-off=8.49; p=0.0001), Se=0.87 and Sp=0.56, PPV=0.87 and NPV=0.57. The accuracy for the diagnosis of cirrhosis (F=4; ELF score≥9.8) was 0.995 (95% CI 0.81–0.99; cut-off=9.03; p=0.0001), Se=0.66 and Sp=0.95, PPV=0.85 and NPV=0.87. Conclusions:The ELF Test showed better efficacy in highlighting the presence of cirrhosis than in discriminating intermediate stages of liver fibrosis. Liver biopsy is still the gold standard in staging fibrosis. The ELF Test could be employed for a preliminary selection of patients eligible for biopsy and could be used during their follow-up.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/20.500.11769/363623
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