摘要
目的探讨由生物学变异确定的允许总误差和允许不精密度质量规范在常规化学室间质评和室内质控中的应用，确定我国常规化学检验项目的质量规范。方法组织全国常规化学室间质评且同时要求各实验室上报当月室内质控变异系数，对钾、钠、氯、钙、磷、葡萄糖、尿素、尿酸、肌酐、白蛋白、总蛋白、胆固醇、三酰甘油、丙氨酸转氨酶、天冬氨酸转氨酶、总胆红素、碱性磷酸酶、淀粉酶、肌酸激酶、乳酸脱氢酶、铁、镁、铜、锌、γ-谷氨酰基转移酶25个检测项目进行评价，并用SPSS13．0软件对室内质控变异系数进行统计分析。结果室间质评结果显示，评价项目以基于生物学变异导出的允许总误差作为室间质评评价标准计算出及格率，除氯、钙、镁、铜、锌项目外，其余检测项目有80％的实验室能达到最低评价限，钾、磷、葡萄糖、尿素、尿酸、肌酐、总胆固醇、三酰甘油、丙氨酸转氨酶、天冬氨酸转氨酶、总胆红素、淀粉酶、肌酸激酶、乳酸脱氢酶、铁、γ-谷氨酰基转移酶有80％以上实验室能达到适当的评价限，尿素、尿酸、总胆固醇、三酰甘油、丙氨酸转氨酶、天冬氨酸转氨酶、总胆红素、肌酸激酶、γ-谷氨酰基转移酶有80％以上的实验室能达到最佳评价限。室内质控结果显示，计算不同检测项目满足允许不精密度要求的实验室百分比，钾、磷、血糖、尿素、尿酸、总胆固醇、三酰甘油、丙氨酸转氨酶、天冬氨酸转氨酶、总胆红素、淀粉酶、肌酸激酶、乳酸脱氢酶、直接胆红素、铁、γ-谷氨酰基转移酶检测项目有80％以上实验室能满足最低的质量规范要求，磷、尿素、尿酸、三酰甘油、丙氨酸转氨酶、天冬氨酸转氨酶、总胆红素、肌酸激酶、直接胆红素、铁、γ-谷氨酰基转移酶检测项目有80％以上的实验室能达到适当质量规�
Objective To discuss the application of allowable total error （TEa） and allowable imprecision derived from biological variation in routine chemistry external quality assessment （EQA） and internal quality control （IQC） and set up quality specifications of routine chemistry in our country. Methods Data of test items including K, Na, Cl, Ca, P, Glu, Urea, UA, Cre, Alb, TP, TC, TG, AST, ALT, TBil, ALP, AMY,CK,LDH,Fe,Mg, Cu, Zn and GGT was collected and evaluated by a nationwide EQA. At the same time the coefficients of variation （CVs） of these test items during the month were acquired from the IQC reports of each laboratory and then the results were analyzed. Results Percent of pass was different in these test items based on TEa derived from biological variation in EQA results. Except for items of CI, Mg, Cu and Zn, about 80% of participant laboratories could achieve the minimum performance of biological variation. About 80% of participant laboratories could achieve the desired performance of biological variation for K, P, Glu, Urea, UA, Cre, TC, TG, ALT, AST, TBil, AMY, CK, LDH, Fe and GGT. About 80% of participant laboratories could achieve the optimum performance of biological variation for Urea, UA,TC,TG, ALT, AST, TBil, CK, and GGT. And the IQC results showed that acceptable percents of different items based on three allowable imprecision were different. More than 80% of participant laboratories could achieve the minimum allowable imprecision for K, P, Glu, Urea, UA, TC, TG, ALT, AST, TBil, AMY, CK, LDH, DBil, Fe, GGT , the desirable imprecision for P, Urea, UA, TG, ALT, AST, TBil, CK, DBil, Fe, GGT and the optimum imprecision for TG, ALT, CK, DBil, Fe. Conclusions The quality specifications derived from biological variation can be as evaluation criteria for EQA and IQC in order to know the detection ability of each laboratory more completely and objectively, set up quality specifications derived from allowable total error and allowable imprecision in routine chemistry and to provide basis for mu
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2012年第6期531-537,共7页
Chinese Journal of Laboratory Medicine
关键词
临床化学试验
参考值
质量控制
Clinical chemistry tests
Reference values
Quality control
