全国肿瘤标志物检测项目参考区间现状调查与分析

Investigation and analysis of reference intervals of tumor markers testing in China

目的：描述全国临床实验室肿瘤标志物参考区间上下限及其来源现状，比较各检测系统之间的差异。方法向参加实验室发放肿瘤标志物参考区间调查表，通过室间质量评价软件调查甲胎蛋白、癌胚抗原、总前列腺特异性抗原（ PSA）、CA 125、CA 153、CA 199、铁蛋白和游离PSA共8个项目的参考区间上下限、参考区间的来源、是否验证和检测系统。根据检测系统对所有参加者进行分组，使用Microsoft Excel 2007计算各项目各分组的均值、中位数、最大值和最小值，使用Kruskal－Wallis检验比较各检测系统所用参考区间上下限之间的差异。结果各项目的参考区间主要来源为系统厂家说明书（8个项目该来源比例的平均值为83．1％），接下来依次为试剂厂家说明书（平均值为8．4％）、全国临床检验操作规程（平均值为4．6％）、实验室自己确定（平均值为2．0％）和其他（平均值为1．9％）。共有48．0％（1906／3967）个项目进行了参考区间的验证。除游离PSA的参考区间上限以外，其他项目各系统之间的参考区间Kruskal－Wallis检验P值均＜0．05，存在统计学差异。结论目前临床实验室多以系统厂家说明书作为肿瘤标志物参考区间的来源，但是各检测系统之间的参考区间存在明显差异。（中华检验医学杂志，2015，38：349－352）

Objective To describe the reference intervals and their sources of tumor markers in clinical laboratories all over China.And make a comparison of difference between different testing systems.Methods The questionnaires about reference intervals of tumor markers testing were distributed to participants.The information was collected by external quality assessment software system based on website, which including upper and lower limits, sources, validation information and testing systems.The analytes were AFP, CEA, total-PSA, CA125, CA153, CA199, ferritin and free-PSA. The participants were classified according to the testing systems they used.The mean, median, maximum and minimum of each group were calculated using Microsoft Excel 2007.The difference of reference intervals between different testing systems were compared by Kruskal-Wallis test.Results The main source of reference intervals was instructions of testing system manufactures （ 83.1% for mean of 8 ratios ） .The next in sequence were instructions of reagent manufactures（8.4% for mean）, National Guide to Clinical Laboratory Procedures （4.6%for mean）, determined by their own laboratory（2.0% for mean） and the rest （1.9% for mean）. There were 48.0% （ 1 906/3 967 ） of analytes whose reference intervals had been validated.Difference of reference intervals which was with P value of Kruskal-Wallis test with ＆lt;0.05 was found between different testing system groups except the upper limit of free prostate specific antigen （ PSA ） .Conclusions Most clinical laboratories establish the reference intervals of tumor markers on the basis of instructions of testing system manufactures.The reference intervals among different testing systems have statistically significance.