DGKC手工法评价3种血清胆碱酯酶试剂盒的检测性能
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摘要
目的采用德国临床化学协会(DGKC)推荐的血清胆碱酯酶(CHE)手工检测方法(简称DGKC手工法)评价3种相同原理的CHE商品化试剂盒的检测性能。方法采用DGKC手工法评价3种CHE试剂的不精密度、线性范围及与DGKC手工法的相关性和可比性。结果 3种试剂与DGKC手工法均有良好的相关性(r2值均为0.999)和可比性[3种试剂CHE参考区间上、下限检测结果与DGKC手工法检测结果的相对偏移均<1/2允许总误差(TEa)(7.5%)]。3种试剂和DGKC手工法的重复精密度均<1%、实验室内精密度均≤1.5%。以相对偏移<7.5%为判断标准,DGKC手工法及3种试剂的线性范围分别为417～26 363、1 605～17 609、788～30853、839～25 767 U/L。3种试剂的线性范围下限均未达到DGKC手工法的线性范围下限,线性范围上限均已超出厂家声明的线性范围上限。结论 3种常用的血清CHE试剂检测性能良好,无明显基质效应,均能满足临床检测的需要。
Objective To evaluate the performance of 3 kinds of commercial serum cholinesterase(CHE)determination kits by manual method recommended by German Clinical Chemical Association(Deutsche Gesellschaft für Klimische Chemie,DGKC). Methods Through manual DGKC method,the performance of the 3 kinds of serum CHE determination kits,including the correlation with manual DGKC method,comparability,imprecision and linear range,was evaluated. Results There was a good correlation of the 3 determination kits with manual DGKC method(r2=0.999),and the relative deviation between the upper and lower limits of CHE reference intervals of the 3 determination kits and manual DGKC method was <1/2 allowable total error(TEa)(7.5%). The repeatabilities were all <1%,and within-laboratory precisions were all ≤1.5%. Using relative bias <7.5% as standard,the linear ranges of manual DGKC method and the 3 determination kits were417-26 363,1 605-17 609,788-30 853 and 839-25 767 U/L,respectively. The lower limit of the 3 determination kits were higher than that of manual DGKC method. The upper limit of linear range had exceeded the upper limit of linear range declared by the manufacturer. Conclusions The 3 kinds of serum CHE determination kits have good determination performance without matrix effect,which may meet the needs of clinical determination.
Objective To evaluate the performance of 3 kinds of commercial serum cholinesterase(CHE)determination kits by manual method recommended by German Clinical Chemical Association(Deutsche Gesellschaft für Klimische Chemie,DGKC). Methods Through manual DGKC method,the performance of the 3 kinds of serum CHE determination kits,including the correlation with manual DGKC method,comparability,imprecision and linear range,was evaluated. Results There was a good correlation of the 3 determination kits with manual DGKC method(r2=0.999),and the relative deviation between the upper and lower limits of CHE reference intervals of the 3 determination kits and manual DGKC method was <1/2 allowable total error(TEa)(7.5%). The repeatabilities were all <1%,and within-laboratory precisions were all ≤1.5%. Using relative bias <7.5% as standard,the linear ranges of manual DGKC method and the 3 determination kits were417-26 363,1 605-17 609,788-30 853 and 839-25 767 U/L,respectively. The lower limit of the 3 determination kits were higher than that of manual DGKC method. The upper limit of linear range had exceeded the upper limit of linear range declared by the manufacturer. Conclusions The 3 kinds of serum CHE determination kits have good determination performance without matrix effect,which may meet the needs of clinical determination.
引文
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[2]陈平,胡正强,岳新爱,等.血清胆碱酯酶水平与慢性心功能不全患者临床预后的相关性研究[J].检验医学与临床,2016,13(5):676-677.
[3]欧元祝,唐立萍,虞啸炫,等.上海地区血清胆碱酯酶检测情况调查[J].检验医学,2017,32(9):757-759.
[4]SCHMIDT E,HENKEL E,KLAUKE R,et al.Proposal of standard method for the determination of enzyme catalytic concentration in serum and plasma at 37 degrees C[J].Eur JClin Chem Clin Biochem,1992,30(3):805-808.
[5]王治国.临床检验方法确认与性能验证[M].北京:人民卫生出版社,2014:153-159.
[6]MASSOULIéJ,PERRIER N,NOUREDDINE H,et al.Old and new questions about cholinesterases[J].Chem Biol Interact,2008,175(1-3):30-44.