应用NCCLS EP10-A2文件对五种半胱氨酸蛋白酶抑制剂C试剂进行初步评价

Preliminary function evaluation on five kinds of cystatin C reagent kits according to NCCLS EP10-A2 document

目的对五个厂家的半胱氨酸蛋白酶抑制剂C(胱抑素C)试剂检测性能进行初步评价。方法按照美国临床实验室标准化委员会(NCCLS)EP10-A2文件,使用五种试剂分别对胱抑素C低值、中值、高值标本进行检测,计算偏倚、总不精密度及其截距、斜率、携带污染、非线性、漂移性,并判断其临床可接受性。结果五个厂家的试剂总不精密度均在允许范围内,截距、非线性、漂移性均差异无统计学意义;利德曼试剂测定值偏倚大于允许偏倚,其余四个厂家试剂偏倚在允许范围内;科华、景源、迈克、美康的试剂存在携带污染。结论科华、景源、迈克、美康胱抑素C试剂盒准确度和精密度良好,试剂稳定,性能指标基本符合临床要求,但携带污染还有待进一步改进。

Objective To preliminarily evaluate the performance of five kinds of cystatin（Cys C） reagent kits.Methods According to the protocol EP10-A2 provided by National Committee for Clinical laboratory Standards（NCCLS）,samples with low,middle or high level of Cys C were detected by five kinds of reagent kits.The bias,total imprecision,intercepts,slope rates,nonlinearities,carry-over rate and drifts were calculated and compared with the range of set value to assess clinical acceptability.Results Total imprecision of the five kinds of reagent kits were all within allowed range.No significant difference was showed in intercepts,nonlinearities and drifts.Bias of LEADMAN reagent exceeded permissive ranges,and bias of the others four kinds of reagents were within allowed range.Carry-over could be demonstrated in reagent kits of KEHUA,JINGYUAN,MAKER and MEIKANG.Conclusion Cys C reagent kits of KEHUA,MAKER,MEIKANG and JINGYUAN might be with fine accuracy,precision and stability,and consistent with clinical application requirements,but more attention should be paid for carry-over.