应用功效函数图法评价常规生化室内质量控制方法

Evaluation for quality control procedures with power function graph in routine biochemistry

目的应用功效函数图法评价常规生化室内质量控制方法,获取适当的质量控制规则和质控测定个数的质控方案。方法确定临床允许分析总误差(TEa),实验室检测项目的实际不精密度,计算分析方法的临界系统误差(△SEc),利用功效函数图法,选择合适的质控规则和质控测定个数。结果分析项目性能不同,质控规则和控制测定个数有所不同。其中直接胆红素(DB)、丙氨酸氨基转移酶(ALT)、门冬氨酸氨基转移酶(AST)、总蛋白(TP)、白蛋白(ALB)、尿酸(UA)、甘油三酯 (TG)、胆固醇(CHOL)、碱性磷酸酶(ALP)、肌酸激酶(CK)、乳酸脱氢酶(LDH)、钠(Na)、钾(K)、氯 (CL)的质控规则为13s,质控测定个数N=2;总胆红素(TB)、糖(GLU)、磷(P)的质控规则13s或13s／ 22s／R4s／(41sW),质控测定个数N=2;尿素(Urea)、肌酐(Crea)、钙(Ca)、镁(Mg)的质控规则为12．5s 或13s／22s／R4s／(41sW),质控测定个数N=4或12．5s或13s／22s／R4s／(41sW),质控测定个数N=2。结论临床实验室要根据分析项目的性能选用不同的室内质控方法。利用功效函数图法计划制定质控规则,可满足临床质量要求,达到期望的误差检出率且控制假失控率,提高质控工作的有效性。

Objective Evaluation for quality control （QC） procedures in routine biochemistry with power function graph. Methods Define the quality required for the test in the form of an allowable total error and performance specifications of the method of analysis, then the critical systematic error was calculated, select and assess QC performance of candidate procedures with power function curves. Results For 21 of 14 tests, a 13s rule with N=2 was selected for direct bilirubin, sodium, potassium, chloride, uric acid, triglycerides, cholesterol, total protein, albumin, ALP, AS＇T, ALT, CK and LDH; a 135 rule or 13s/22s/R4s/（41s W） with N=2 was selected for total bilirubin, glucose and phos- phorus; a lzs, or 13s/22s/R4s/（41s W） with N=4 or a 12.5s or 13s/22s/R4s/（41s W） with N=2 was selected for urea nitrogen, creatinine and calcium. Clonclusion Different performance specifications of the methods of analysis meet clinical requirements, which involves specifying statistical control rules, number of control measurements.