Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US

Inclusion Criteria:

• a. Adults aged above 18 years old who have at least one indication for TE examinationdetermined by the physicians;
• b. Patients who have test results for platelet count, ALT, AST, globulin, HBA1c, andtotal bilirubin (TBIL) levels within 60 days;
• c. Patients who are willing to participate in the clinical study and can sign ICF.

Exclusion Criteria:

• a. Excessive drinking history within 90 days: For women-140 grams of alcohol per weekor more; For men-210 grams of alcohol per week or more;
• b. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase AST >100U/ml (or 2.5 × upper limit of normal (ULN) and/or total bilirubin (TBIL) > 1.8 mg/d (or >1.5 × ULN =1.2 mg/d);
• c. Patients with a history or current evidence of decompensated liver cirrhosis;
• d. Patients with various space-occupying tumors and cysts in the right liver;
• e. Patients with other serious systemically diseases or a history of malignant tumors;
• f. Patients with ascites;
• g. Patients with a non-healing wound on the right upper abdomen at this moment;
• h. Patients with intracavitary implantation of instruments;
• i. Pregnant women (urine pregnancy test should be performed for all women withchild-bearing potential during screening);
• j. Any history of organ transplantation and existing functional grafts (except cornealor hair transplantation);
• k. Lack of or limited legal capacity.