The diagnostic value of biomarkers (SteatoTest) for the prediction of liver steatosis
1 Department of Hepato-Gastroenterology, Groupe Hospitalier Pitié-Salpêtrière, Paris, France
2 Department of Hepato-Gastroenterology, Hôpital Antoine Béclère, Clamart, France
3 Department of Pathology, Groupe Hospitalier Pitié-Salpêtrière, Paris, France
4 Department of Biochemistry, Groupe Hospitalier Pitié-Salpêtrière, Paris, France
5 Department of Pathology, Hôpital Antoine Béclère, Clamart, France
6 Department of Biochemistry, Hôpital Antoine Béclère, Clamart, France
7 Biopredictive, Paris, France
8 Tranfusion Unit, Groupe Hospitalier Pitié-Salpêtrière, Paris, France
9 Division of Gastroenterology and Hepatology, Medical School of Hannover, Hannover, Germany
10 Schering Plough Research Institute, Kenilworth NJ, USA
Comparative Hepatology 2005, 4:10 doi:10.1186/1476-5926-4-10Published: 23 December 2005
Biopsy is the usual gold standard for liver steatosis assessment. The aim of this study was to identify a panel of biomarkers (SteatoTest), with sufficient predictive values, for the non-invasive diagnosis of steatosis in patients with or without chronic liver disease. Biomarkers and panels were assessed in a training group of consecutive patients with chronic hepatitis C and B, alcoholic liver disease, and non-alcoholic fatty liver disease, and were validated in two independent groups including a prospective one. Steatosis was blindly assessed by using a previously validated scoring system.
310 patients were included in the training group; 434 in three validation groups; and 140 in a control group. SteatoTest was constructed using a combination of the 6 components of FibroTest-ActiTest plus body mass index, serum cholesterol, triglycerides, and glucose adjusted for age and gender. SteatoTest area under the ROC curves was 0.79 (SE = 0.03) in the training group; 0.80 (0.04) in validation group 1; 0.86 (0.03) in validation group 2; and 0.72 (0.05) in the validation group 3 – all significantly higher than the standard markers: γ-glutamyl-transpeptidase or alanine aminotransferase. The median SteatoTest value was 0.13 in fasting controls; 0.16 in non-fasting controls; 0.31 in patients without steatosis; 0.39 in grade 1 steatosis (0–5%); 0.58 in grade 2 (6–32%); and 0.74 in grade 3–4 (33–100%). For the diagnosis of grade 2–4 steatosis, the sensitivity of SteatoTest at the 0.30 cut-off was 0.91, 0.98, 1.00 and 0.85 and the specificity at the 0.70 cut-off was 0.89, 0.83, 0.92, 1.00, for the training and three validation groups, respectively.
SteatoTest is a simple and non-invasive quantitative estimate of liver steatosis and may reduce the need for liver biopsy, particularly in patients with metabolic risk factor.