分析批长度Westgard西格玛规则在临床生化检测项目分析质量评价中的应用

The application of Westgard sigma rule with length of analytical run in the evaluation of analytical quality for clinical biochemical test items

目的运用分析批长度Westgard西格玛规则对临床生化项目的质控策略进行分析。方法收集实验室2019年室内质量控制数据,计算变异系数(CV);以室间质评(EQA)的结果计算偏倚(Bias);以美国临床实验室最新修正案(CLIA′2019)的允许总误差(TEA)及行业标准WS/T403-2012的TEA分别计算各生化检测项目的σ。根据分析批长度Westgard西格玛规则选择相应的质控数目、质控规则、质控次数以及分析批长度。结果2个σ都大于6的检测项目有尿酸(UA)、肌酐(CREA)、清蛋白(ALB)、总胆红素(TBIL)、丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、乳酸脱氢酶(LDH),表明其达到了世界级质量水平;σ都在优秀水平(5≤σ<6)的项目为碱性磷酸酶(ALP);σ都在良好(4≤σ<5)水平的项目有镁(Mg)、三酰甘油(TG)、磷(P)。钾(K)、钙(Ca)、总蛋白(TP)、总胆固醇(TC)、γ-谷氨酰转移酶(γ-GGT)的两个σ则相差较大,所选择相应的质控数目、质控规则、质控次数以及分析批长度也不相同。结论分析批长度Westgard西格玛规则是一种新的以患者风险为基础的统计质量控制(SQC)工具,可用于为高通量、连续工作的分析仪选定质控策略,但当σ<4时,其在实验室的实用性还需进一步探讨。

Objective To analyze the quality control strategy by using Westgard sigma rule with length of analytical run for clinical biochemical test items.Methods The external quality assessment(EQA)data of the laboratory in 2019 were collected and the coefficient of variation(CV)was calculated;Bias was calculated according to the results of EQA;The total allowable error(TEA)of the latest version of Clinical Laboratory Improvement Amendments(CLIA′2019)and industry standard WS/t403-2012 were used to calculate theσvalues of each biochemical test item.According to the Westgard sigma rule with length of analytical run,the corresponding quality control number,quality control rule,quality control times and length of analytical run were determined.Results Test items UA,CREA,ALB,TBIL,ALT,AST and LDH were with bothσvalues greater than 6,which showed that they reached the world-class quality level.Test item ALP was with bothσvalues at the excellent level(5≤σ<6).Test items Mg,TG,P were with bothσvalues at the good level(4≤σ<5).The twoσvalues of test items such as K,Ca,TP,TC,andγ-GGT were quite different,and the determined quality control number,quality control rules,quality control times and length of analytical run were also different.Conclusion The Westgard sigma rule with length of analytical run is a new statistical quality control(SQC)tool based on patient risk.It can be used to select a quality control strategy for a high-throughput,continuous working analyzer,but whenσ<4,its practicality in the laboratory needs to be further explored.