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Multicenter Study
. 2006 Nov 10:6:34.
doi: 10.1186/1471-230X-6-34.

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

Thierry Poynard  1 , Vlad Ratziu, Frederic Charlotte, Djamila Messous, Mona Munteanu, Françoise Imbert-Bismut, Julien Massard, Luninita Bonyhay, Mohamed Tahiri, Dominique Thabut, Jean François Cadranel, Brigitte Le Bail, Victor de Ledinghen; LIDO Study Group; CYTOL study group
Affiliations
Multicenter Study

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

Thierry Poynard et al. BMC Gastroenterol. .

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%C I 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.

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Figures

Figure 1
Figure 1
ROC curves of the NashTest for the diagnosis of No NASH in Training and in Validation Groups.
Figure 2
Figure 2
ROC curves of the NashTest for the diagnosis of Borderline NASH in Training and in Validation Groups.
Figure 3
Figure 3
ROC curves of the NashTest for the diagnosis of NASH in Training and in Validation Groups.
Figure 4
Figure 4
ROC curves of the NashTest for the diagnosis of NASH made by pathologist in Training and in Validation Groups. The diagonal line represents that achieved by chance alone (area under the curve 0.50); the ideal area under the curve is 1.00. Dotted curve is the Training Group, Solid curve is the Validation Group. There was no difference between the area under the ROC curves (AUROCs) for No NASH [AUROC = 0.77 (95%CI 0.68–0.84) versus 0.83 (95%CI 0.72–0.90; P = 0.34)], for Borderline NASH [AUROC = 0.69 (95%CI 0.60–0.77) versus 0.69 (95%CI 0.57–0.78; P = 0.98)] and for NASH [AUROC = 0.79 (95%CI 0.69–0.86) versus 0.79 (95%CI 0.67–0.78; P = 0.87)] in the Training and Validation Groups, respectively.
Figure 5
Figure 5
Value of the index No-NashTest designed for the diagnosis of No NASH.
Figure 6
Figure 6
Value of the index Borderline-NashTest designed for the diagnosis of No NASH.
Figure 7
Figure 7
Value of the index Nash-NashTest designed for the diagnosis of NASH.
Figure 8
Figure 8
Value of the index Nash-NashTest for the diagnostic of NASH as stated by the pathologist independent of NAS score. Each index is a specific logistic regression combining parameters weighted according to their diagnostic values. Notched box plots showing the relationship between NAS category (No NASH n = 98), borderline NASH n = 96 and NASH n = 63 and index of No-Nash (Figure 4), index of Borderline-Nash (Figure 5) and index of Nash (Figure 6) and between the pathologist conclusion and index of Nash (Figure 7). The horizontal line inside each box represents the median, and the width of each box the median ± 1.57 interquartile range/√ n (to assess the 95% level of significance between group medians). Failure of the shaded boxes to overlap signifies statistical significance (P < 0.05). The horizontal lines above and below each box encompass the inter-quartile range (from 25th to 75th percentile), and the vertical lines from the ends of the box encompass the adjacent values (upper: 75th percentile plus 1.5 times interquartile range, lower 25th percentile minus 1.5 times interquartile range).
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