title: Validation of AshTest as a Non-Invasive Alternative to Transjugular Liver Biopsy in Patients with Suspected Severe Acute Alcoholic Hepatitis.
abstract: OBJECTIVE
  According to guidelines, the histological diagnosis of severe alcoholic steatohepatitis (ASH) can require liver biopsy if a specific treatment is needed. The blood test AshTest (BioPredictive, Paris, France) has been initially validated for the non-invasive diagnosis of ASH in a large population of heavy drinkers. The aim was to validate the AshTest accuracy in the specific context of use of patients with suspected severe ASH, in order to reduce the need for transjugular biopsy before deciding treatment.
  
  
  METHODS
  The reference was liver biopsy, performed using the transjugular route, classified according to its histological severity as none, minimal, moderate or severe. Biopsies were assessed by the same experienced pathologist, blinded to simultaneous AshTest results.
  
  
  RESULTS
  A total of 123 patients with severe clinical ASH (recent jaundice and Maddrey function greater or equal to 32) were included, all had cirrhosis and 80% had EASL histological definition of ASH. 95% of patients received prednisolone; and the 2-year mortality was 63%. The high AshTest performance was confirmed both for the binary outcome [AUROC = 0.803 (95%CI 0.684-0.881)] significantly higher than the AST/ALT AUROC [0.603 (0.462-0.714); P<0.001], and for the severity of ASH-score system by the Obuchowski measures for [mean (SE) 0.902 (0.017) vs. AST/ALT 0.833 (0.023); P = 0.01], as well as for the diagnosis and severity of ballooning, PMN and Mallory bodies. According to attributability of discordances, AshTest had a 2-7% risk of 2 grades misclassification.
  
  
  CONCLUSIONS
  These results confirmed the diagnostic performance of AshTest in cirrhotic patients with severe clinical ASH, in the specific context of use of corticosteroid treatment. AshTest is an appropriate non-invasive alternative to transjugular liver biopsy.
authors.affiliation: Assistance Publique Hôpitaux de Paris, University Pierre et Marie Curie, Paris, France.
authors.forename: Marika
authors.initials: M
authors.lastname: Rudler
authors.affiliation: Assistance Publique Hôpitaux de Paris, University Pierre et Marie Curie, Paris, France.
authors.forename: Sarah
authors.initials: S
authors.lastname: Mouri
authors.affiliation: Assistance Publique Hôpitaux de Paris, University Pierre et Marie Curie, Paris, France.
authors.forename: Frederic
authors.initials: F
authors.lastname: Charlotte
authors.affiliation: Assistance Publique Hôpitaux de Paris, University Pierre et Marie Curie, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Cluzel
authors.affiliation: BioPredictive, Paris France.
authors.forename: Yen
authors.initials: Y
authors.lastname: Ngo
authors.affiliation: BioPredictive, Paris France.
authors.forename: Mona
authors.initials: M
authors.lastname: Munteanu
authors.affiliation: Assistance Publique Hôpitaux de Paris, University Pierre et Marie Curie, Paris, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Lebray
authors.affiliation: Assistance Publique Hôpitaux de Paris, University Pierre et Marie Curie, Paris, France.
authors.forename: Vlad
authors.initials: V
authors.lastname: Ratziu
authors.affiliation: Assistance Publique Hôpitaux de Paris, University Pierre et Marie Curie, Paris, France; INSERM UMRS 938, Paris, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Thabut
authors.affiliation: Assistance Publique Hôpitaux de Paris, University Pierre et Marie Curie, Paris, France; INSERM UMRS 938, Paris, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Poynard
mesh_terms: D000208:Acute Disease; D001706:Biopsy; D005260:Female; D006519:Hepatitis, Alcoholic / Q000175:diagnosis* / Q000473:pathology*; D006801:Humans; D008099:Liver / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012372:ROC Curve; D015203:Reproducibility of Results