国产某品牌谷胱甘肽还原酶试剂盒多中心横向联合性能评价

A multi-center evaluation of a domestic glutathione reductase determination kit

目的采用多中心横向联合评价方法对国产某品牌谷胱甘肽还原酶(GR)试剂盒的检测性能进行评价。方法在全国范围内选择9家三级甲等综合性医院实验室,按照统一的方案对国产某品牌GR检测试剂盒的重复性、室内精密度、偏移评估、批间差、线性范围和最大稀释倍数进行评价,并进行试剂间比较和仪器间比较。结果9家实验室的重复性精密度和实验室内精密度均满足要求[分别小于室间质量评价(EQA)标准的1/4(5%)和1/3(6.67%)]。除1家实验室低浓度样品和另1家实验室中浓度样品批间差>8%(厂家声明)外,其余7家实验室所有样品检测结果批间差均符合要求。在厂家声明的线性范围内,9家实验室验证结果均为线性,最大稀释倍数(5倍)验证回收率为92.6%~106.3%。使用40份血清样品与进口试剂进行偏移评估,相关系数(r)为0.997~1.000,偏移均小于EQA标准的1/2(10%)。国产试剂组和进口试剂组组内9家实验室之间的检测结果均具有显著相关性(P<0.01);国产试剂组和进口试剂组检测结果一致性良好(r=1.000,P<0.01),配对t检验结果显示差异无统计学意义。国产试剂组和进口试剂组组内平均变异系数(CV)分别为6.48%、6.68%。A、B、C仪器组检测结果两两配对t检验结果显示,国产试剂B仪器组和C仪器组检测结果差异有统计学意义(P<0.01),进口试剂C仪器组与A、B仪器组的检测结果差异均有统计学意义(P<0.01)。结论该品牌GR试剂盒检测性能良好,能满足临床的检测需求。

Objective To investigate the performance of a domestic glutathione reductase(GR)determination kit through a multi-center evaluation.Methods Totally,9 clinical laboratories of tertiary hospitals located in different geographic regions of China formed a multi-center evaluation group.According to the same evaluation scheme,the repeatability,within-laboratory precision,between-run variations,linearities,the maximum dilution ratio and estimation of bias of a domestic GR determination kit were investigated,which were classified and compared.Results The repeatability and within-laboratory precision of the 9 laboratories met the requirements[less than 1/4 standard of external quality assessment(EQA)(5%)and 1/3 standard of EQA(6.67%),respectively].Except a low-level sample of one laboratory and a middle-level sample of another laboratory(>8%),the betweenrun variations of all the other laboratories met the manufacturer's stated requirements.All the laboratories demonstrated the linear range claimed by the manufacturer.The recovery rates at maximum dilution ratio(5 times)of the 9 laboratories were 92.6%-106.3%.In the estimation of bias by using 40 patient samples compared with imported reagent,the correlation coefficients(r)were 0.997-1.000,the biases were less than 1/2 standard of EQA(10%).There was a significant correlation among the results of the 9 laboratories in the imported group and the domestic group respectively(P<0.01).The consistency of imported reagent and domestic reagent was good,and the difference of paired t-test was not significant statistically(P>0.05),and the correlation coefficients(r)were 1.000(P<0.01).The average coefficient of variation(CV)of imported reagent and domestic reagent was 6.48%and 6.68%,respectively.Pairwise paired t-test was performed on the results of instrument group A,B and C.There was statistical significance between group B and C for domestic reagent(P<0.01).There was statistical significance between group A and C,B and C for imported reagent(P<0.01).Conclusions The results of the multi-center evaluation show that the performance of the domestic GR reagent is good,and it can meet the clinical determination needs.