Method for NASH risk assessment

An in vitro method for diagnosing whether a nonalcoholic fatty liver disease (NAFLD) patient is at risk or not at risk of nonalcoholic steatohepatitis (NASH), of NASH progression or of severe fibrotic NASH, or an in vitro method for determining the progression of NASH, comprising the steps of:

• measuring the level of CHI3L1 in a blood, serum or plasma sample from said patient, said measuring comprising contacting said blood, serum or plasma sample with an antibody specific for CHI3L1 to measure CHI3L1 levels in said blood, serum or plasma samples;
• and
• comparing the level of CHI3L1 measured in the sample to reference levels;
• wherein a level of CHI3L1 in the sample from the patient compared to the reference levels is indicative of the risk of NASH, of NASH progression or of the fibrosis stage of NASH, or of the progression of NASH,
• wherein
• a measured CHI3L1 level lower than 26,727 pg/mL is indicative of a non-NASH patient;
• a measured CHI3L1 level from 26,727 to 31,211 pg/mL is indicative of a patient at risk of having NASH;
• a measured CHI3L1 level from 31,211 to 79,790 pg/mL is indicative of a patient with probable NASH;
• a measured CHI3L1 level from 79,790 to 91,399 pg/mL is indicative of a patient with probable NASH and significant fibrosis (F=2);
• a measured CHI3L1 level from 91,399 to 182,800 μg/mL is indicative of a patient with probable NASH and advanced fibrosis (F=3);
• a measured CHI3L1 level from 182,800 to 209,604 pg/mL is indicative of a patient with probable NASH and severe fibrosis (F=4);
• and
• a measured CHI3L1 level higher than 209,604 pg/mL is indicative of a patient experiencing NASH and severe fibrosis (F=4).