Validation of the clinical applicability of the published standard reference interval of routine clinical chemistry（WS/T 404.1-2012,WS/T 404.1-2012): A retrospective study based on health examination results

Objective To validate the clinical applicability of the published standard reference interval of routine clinical chemistry（WS/T 404.1-2012,WS/T 404.1-2012) based on the results of health examination. Methods This was a retrospective study. The results of serum TP（Biuret）, ALB（BCG）, ALT（Rate without 5′-pyridoxal phosphate）, AST（Rate without 5′-pyridoxal phosphate）, ALP（Rate,AMP）, GGT（Rate） from healthy examination individuals (from January to July, 2013) were collected to calculate the 2.5% and 97.5% percentiles, excluding the significant abnormal results according to the Medical Deciding Level 2 recommended by Staland. The number of the cases after excluding were 19 708（M 12 044，F 7 664）、19 728（M 12 069，F 7 659）、45 569（M 26 299，F 19 270）、45 877（M 26 739，F 19 138）、5 965（M 4 208，F 1 757）、4 726（M 3 164，F 1 562），respectively. The proportions of all the examined results (with and without the excluded results) that fell in the published standard reference interval were also calculated. Results The test of normality revealed that the frequency distributions of all verified items were skewed distributions after excluded the abnormal results. The 2.5%-97.5% percentiles of TP, ALB, ALT(M), ALT(F), AST(M), AST(F), ALP(F20-49), ALP(F50-79), GGT(M) and GGT(F) were 64-79 g/L, 40-59 g/L,9-52 U/L,7-39 U/L, 13-41 U/L, 12-33 U/L, 42-116 U/L, 36-98 U/L, 44-130 U/L, 11-72 U/L and 7-50 U/L respectively. More than 90% results of TP, ALB, ALT(M), ALT(F), AST(M), AST(F), ALP(F20-49), ALP(F50-79), GGT(M) and GGT(F) (with and without the excluded results) fell in the reference intervals of national standards, GGT(M) was 80% and 91%. Conclusions The published standard reference interval of routine clinical chemistry（WS/T 404.1-2012,WS/T 404.1-2012) are applicable to our laboratory.（Chin J Lab Med,2014,37:951-953） Key words: Reference values; Reference Standards; Diagnostic tests, routine; Physical examination