常规化学检测项目线性检验的实验室调查

The linearity survey of testing clinical chemical analytes

目的对常规化学检测项目的检测作线性检验，评价实验室对常规化学检测项目的检测能力，试图提高实验室对该检测项目的检测质量。方法按照Kroll对EP6-A补充的方法对检测数据作精确度检验；利用美国临床实验室标准化委员会（NCCLS）EP6-A线性判定指南推荐的多项式回归分析方法判断统计学标准的线性和非线性；利用Kroll对EP6-A补充的方法，对统计学标准的非线性作程度判断。结果测量数据的不精确度范围为0．17％～5．76％。在检测浓度范围内，实验室C、E、G、H、I和J通过了全部检测项目的线性检验；实验室A和F未通过葡萄糖检测项目的线性检验；实验室B和D分别未通过白蛋白和镁检测项目的线性检验。结论参加线性调查的10家实验室测量数据的不精确度低于设定值（9％），因此测量数据符合作线性检验的要求。10家实验室已具备了对常规化学检测项目的检测能力。

Objective To survey the linearity of testing clinical chemical analytes, in order to evaluate the performance of clinical laboratories and improve the quality of tests, Methods The precision of analytical data was analyzed according to Dr. Kroll＇ s EP6-A extended method; The statistical significance of linearity and non-linearity was judged according to polynomial regression analysis recommended by NCCLS EP6-A guideline. The extent of non-linearity was determined according to Dr. Kroll＇ s EP6-A extended method. Results The range of imprecision was from 0.17% to 5.76%. In reportable ranges, Lab C, E, G, H, I and J successfully passed the linearity surveys of all analysis ; Lab A and F did not pass the linearity surveys of glucose analysis ; Lab B and D did not pass the linearity surveys of albumin and magnesium analysis respectively. Conclusions The imprecision of analytical data did not exceed the limit on precision （9%）, therefore, all of the analytical data were precise enough for surveys of linearity. All laboratories attending in the linearity surveys have the ability to test the clinical chemical analytes.