Diagnosis and Monitoring of Hepatic Injury. I. Performance Characteristics of Laboratory Tests

Abstract

Purpose: To review information on performance characteristics for tests that are commonly used to identify acute and chronic hepatic injury. Data Sources and Study Selection: A MEDLINE search was performed for key words related to hepatic tests, including quality specifications, aminotransferases, alkaline phosphatase, γ-glutamyltransferase, bilirubin, albumin, ammonia, and viral markers. Abstracts were reviewed, and articles discussing performance of laboratory tests were selected for review. Additional articles were selected from the references. Guideline Preparation and Review: Drafts of the guidelines were posted on the Internet, presented at the AACC Annual Meeting in 1999, and reviewed by experts. Areas requiring further amplification or literature review were identified for further analysis. Specific recommendations were made based on analysis of published data and evaluated for strength of evidence and clinical impact. The drafts were also reviewed by the Practice Guidelines Committee of the American Association for the Study of Liver Diseases and approved by the committee and the Association’s Council. Recommendations: Although many specific recommendations are made in the guidelines, some summary recommendations are discussed here. Alanine aminotransferase is the most important test for recognition of acute and chronic hepatic injury. Performance goals should aim for total error of <10% at the upper reference limit to meet clinical needs in monitoring patients with chronic hepatic injury. Laboratories should have age-adjusted reference limits for enzymes in children, and gender-adjusted reference limits for aminotransferases, γ-glutamyltransferase, and total bilirubin in adults. The international normalized ratio should not be the sole method for reporting results of prothrombin time in liver disease; additional research is needed to determine the reporting mechanism that best correlates with functional impairment. Harmonization is needed for alanine aminotransferase activity, and improved standardization for hepatitis C viral RNA measurements.

Healthy range for serum ALT and the clinical significance of “unhealthy” normal ALT levels in the Korean population

“…[25][26][27][28] However, there is another possible explanation: the population in the present study was older (48 Ϯ 12 years) than that in the previous study (30 Ϯ 10 years). 8 Because serum ALT levels increase with age from the first to the fourth decade of life and decrease thereafter, 29 this difference in the age distribution might lead to a rightward shift of the ALT distribution. This agerelated change in serum ALT levels was also observed in the present study (Table 3).…”

Clinical, biochemical, immunological and virological profiles of, and differential diagnosis between, patients with acute hepatitis B and chronic hepatitis B with acute flare

“…A retrospective investigation (from January 2003 to March 2005) and a prospective study (from April 2005 to June 2006) were put into practice in patients with their first attack of HBV-related acute hepatitis whose status of prior HBV infection had been unknown. HBV-related acute hepatitis was defined according to: (i) biochemical parameters: levels of serum alanine aminotransferase (ALT) >10-fold the upper reference limit (URL), or total serum bilirubin (TBil) >5 ¥ URL, and serum alkaline phosphatase (ALP) <3 ¥ URL; 11 and (ii) HBV markers: positive for serum hepatitis B surface antigen (HBsAg), or serum antibodies to HBsAg, hepatitis B e antigen (HBeAg), and hepatitis B core antigen (HBcAg). Hepatitis A, C, D and E, and non-viral causes, such as drugs, alcohol, pregnancy, ischemia, etc.…”

A single non‐invasive model to diagnose non‐alcoholic fatty liver disease (NAFLD) and non‐alcoholic steatohepatitis (NASH)

“…GGT has also been shown to have relatively poor specificity. [7][8][9] Additionally, FLI cannot distinguish between NASH and other subtypes of NAFLD, a distinction of prognostic importance. Finally, FLI has been shown to have relatively poor performance in very obese patients with NAFLD.…”