Research article

Diagnostic value of biochemical markers (NashTest) for the prediction of non alcoholo steato hepatitis in patients with non-alcoholic fatty liver disease

Thierry Poynard¹ , Vlad Ratziu¹ , Frederic Charlotte² , Djamila Messous³ , Mona Munteanu⁴ , Françoise Imbert-Bismut³ , Julien Massard¹ , Luninita Bonyhay¹ , Mohamed Tahiri¹ , Dominique Thabut¹ , Jean François Cadranel⁵ , Brigitte Le Bail⁶ , Victor de Ledinghen⁷ and the LIDO Study Group and the CYTOL study group

¹  Hepato-Gastroenterology, AP-HP Groupe Hospitalier Pitié-Salpêtrière, Paris, France

²  Pathology, AP-HP Groupe Hospitalier Pitié-Salpêtrière, Paris, France

³  Biochemistry AP-HP Groupe Hospitalier Pitié-Salpêtrière, Paris, France

⁴  Biopredictive, Paris, France

⁵  Hepato-Gastroenterology, Hôpital Creil, Creil, France

⁶  Pathology, Hôpital Haut Lévèque, Bordeaux, France

⁷  Hepato-Gastroenterology, Hôpital Haut Lévèque, Bordeaux, France

author email corresponding author email

BMC Gastroenterology 2006, 6:34doi:10.1186/1471-230X-6-34

Published:	10 November 2006

Abstract

Background

Liver biopsy is considered the gold standard for assessing histologic lesions of non-alcoholic fatty liver disease (NAFLD). The aim was to develop and validate a new biomarker of non alcoholic steato hepatitis (NASH) the NashTest (NT) in patients with NAFLD.

Methods

160 patients with NAFLD were prospectively included in a training group, 97 were included in a multicenter validation group and 383 controls. Histological diagnoses used Kleiner et al's scoring system, with 3 classes for NASH: "Not NASH", "Borderline", "NASH"). The area under the ROC curves (AUROC), sensitivity (Se), specificity (Sp), and positive and negative predictive values (PPV, NPV) were assessed.

Results

NT was developed using patented algorithms combining 13 parameters: age, sex, height, weight, and serum levels of triglycerides, cholesterol, alpha2macroglobulin, apolipoprotein A1, haptoglobin, gamma-glutamyl-transpeptidase, transaminases ALT, AST, and total bilirubin. AUROCs of NT for the diagnosis of NASH in the training and validation groups were, respectively, 0.79 (95%CI 0.69–0.86) and 0.79 (95%CI 0.67–0.87; P = 0.94); for the diagnosis of borderline NASH they were: 0.69 (95%CI 0.60–0.77) and 0.69 (95%CI 0.57–0.78; P = 0.98) and for the diagnosis of no NASH, 0.77 (95%CI 0.68–0.84) and 0.83 (95%CI 0.67–0.90; P = 0.34). When the two groups were pooled together the NashTest Sp for NASH = 94% (PPV = 66%), and Se = 33% (NPV = 81%); for borderline NASH or NASH Sp = 50% (PPV = 74%) and Se = 88% (NPV = 72%).

Conclusion

In patients with non-alcoholic fatty liver disease, NashTest, a simple and non-invasive biomarker reliably predicts the presence or absence of NASH.