Abstract
BackgroundReference intervals of Liver function tests are very important for the screening, diagnosis, treatment, and monitoring of liver diseases. We aim to establish common reference intervals of liver function tests specifically for the Chinese adult population.MethodsA total of 3210 individuals (20–79 years) were enrolled in six representative geographical regions in China. Analytes of ALT, AST, GGT, ALP, total protein, albumin and total bilirubin were measured using three analytical systems mainly used in China. The newly established reference intervals were based on the results of traceability or multiple systems, and then validated in 21 large hospitals located nationwide qualified by the National External Quality Assessment (EQA) of China.ResultsWe had been established reference intervals of the seven liver function tests for the Chinese adult population and found there were apparent variances of reference values for the variables for partitioning analysis such as gender(ALT, GGT, total bilirubin), age(ALP, albumin) and region(total protein). More than 86% of the 21 laboratories passed the validation in all subgroup of reference intervals and overall about 95.3% to 98.8% of the 1220 validation results fell within the range of the new reference interval for all liver function tests. In comparison with the currently recommended reference intervals in China, the single side observed proportions of out of range of reference values from our study for most of the tests deviated significantly from the nominal 2.5% such as total bilirubin (15.2%), ALP (0.2%), albumin (0.0%). Most of reference intervals in our study were obviously different from that of other races.ConclusionThese used reference intervals are no longer applicable for the current Chinese population. We have established common reference intervals of liver function tests that are defined specifically for Chinese population and can be universally used among EQA-approved laboratories located all over China.
Highlights
Liver function tests, including assays for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), c-glutamyltansferase (GGT), total protein, albumin, and total bilirubin, are generally used to assess hepatocellular injury, cholestasis, infiltrative disease, biliary obstruction, or synthetic function of the liver
Individuals with common diseases that affect levels of liver function tests were excluded by specific screening procedure such as metabolic syndrome and fatty liver disease
The number of people with metabolic syndrome (MS) has increased rapidly, and the studies of Marchesini et al and Kim et al found that ALT, AST and GGT values are significantly enhanced in an MS group as compared with a control group [19,20]
Summary
Liver function tests, including assays for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), c-glutamyltansferase (GGT), total protein, albumin, and total bilirubin, are generally used to assess hepatocellular injury, cholestasis, infiltrative disease, biliary obstruction, or synthetic function of the liver. Part of the reference intervals are from the user instructions and reagent application manuals provided by manufacturers. In most cases these values are based on more than a decade old studies in European and American populations. Reference intervals in use are self-established by testing local healthy volunteers [3]. As a consequence, they vary from each other significantly among routine diagnostic laboratories across China. Reference intervals of Liver function tests are very important for the screening, diagnosis, treatment, and monitoring of liver diseases. We aim to establish common reference intervals of liver function tests for the Chinese adult population
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