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


CONCLUSIONS
In patients with non-alcoholic fatty liver disease, NashTest, a simple and non-invasive biomarker reliably predicts the presence or absence of NASH.
Poynard
Thierry
T
Hepato-Gastroenterology, AP-HP Groupe Hospitalier Pitié-Salpêtrière, Paris, France. tpoynard@teasr.fr
Ratziu
Vlad
V
Charlotte
Frederic
F
Messous
Djamila
D
Munteanu
Mona
M
Imbert-Bismut
Françoise
F
Massard
Julien
J
Bonyhay
Luninita
L
Tahiri
Mohamed
M
Thabut
Dominique
D
Cadranel
Jean François
JF
Le Bail
Brigitte
B
de Ledinghen
Victor
V
D000465:Algorithms; D015415:Biomarkers / Q000097:blood*; D001706:Biopsy; D005234:Fatty Liver / Q000097:blood* / Q000150:complications*; D005260:Female; D006505:Hepatitis / Q000097:blood / Q000175:diagnosis* / Q000209:etiology* / Q000473:pathology; D006801:Humans; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D015415:Biomarkers; D011933:Reagent Kits, Diagnostic