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NashTest validation
NashTest was developed and validated as a new biomarker of non alcoholic steato hepatitis (NASH) in patients with non-alcoholic fatty liver disease (NAFLD). NashTest is a simple and non-invasive biomarker to reliably predict the presence or absence of NASH.
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Diagnostic value of biochemical markers (NashTest) for the prediction of NASH in patients with non-alcoholic fatty liver disease.
Poynard T, Ratziu V, Charlotte F, Messous D, Munteanu M, Imbert Bismut F, Massard J, Bonyhay L, Tahiri M, Thabut D, Cadranel JF, Le Bail B, de Ledinghen V, Group Lido, Group Cytol.
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 als 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.
Result: 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.