四个生产来源血清β_(2)微球蛋白试剂的检测性能评价

Evaluation of the detection performance of serumβ_(2)-MG reagents of different manufacturers

目的:评价4个厂家4种血清β_(2)微球蛋白(β_(2)-MG)试剂的检测性能。方法:选取医院收治的肾病患者及同期健康体检者血清制备混合血清。依据北京市临床检验中心对β_(2)-MG项目的管理要求、美国临床和实验室标准协会(CLSI’88)关于β_(2)-MG项目的管理要求,对北京九强生物技术股份有限公司(简称A试剂)、北京莱帮生物技术有限公司(简称B试剂)、重庆中元生物技术有限公司(简称C试剂)及奥地利DIALAB有限公司(简称D试剂)4个厂家的4种血清β_(2)-MG试剂进行性能评价。结果:4种β_(2)-MG试剂测定高低值混合样本的批内精密度均小于国家卫生健康委临床检验中心(NCCL)1/4允许偏差(7.5%),总精密度均<1/3允许偏差(10%)。4种试剂测定不同批次的具有溯源性的校准品样本,A试剂、B试剂、C试剂和D试剂测定值与认证值的平均偏倚均<1/2允许偏差(±15%)。验证4种试剂的线性范围和参考区间,线性范围:A试剂(0.26~48.73 mg/L),B试剂(0.05~18.65 mg/L),C试剂(0.25~65.34 mg/L),D试剂(0.09~53.95 mg/L);参考区间:A试剂(0.8~1.8 mg/L),B试剂(0~3.0 mg/L),C试剂(0.8~2.8 mg/L),D试剂(0.8~2.8 mg/L)。干扰物质胆红素、血红蛋白及乳糜对4种试剂的影响均在可接受范围内。4种试剂的携带污染率均符合要求,其中A试剂、B试剂和C试剂3种试剂携带污染率均为0,D试剂为0.31%。结论:4个厂家的4种β_(2)-MG试剂的精密度、正确度、抗干扰能力和携带污染率均可满足临床使用要求,且差异不大。线性范围和参考区间也验证通过,B试剂线性范围较窄,C试剂线性上限较高。

Objective:To evaluate the detection performance of four kinds of serumβ_(2)-microglobulin(β_(2)-MG)reagents from 4 manufacturers.Methods:Mixed serum was prepared from patients with kidney disease admitted to hospital and from healthy people who underwent physical examination in the same period.According to the requirements of Beijing Center for Clinical Laboratory onβ_(2)-MG item and the management requirements of clinical and laboratory standards institute(CLSI'88)aboutβ_(2)-MG item,the performances of serumβ_(2)-MG reagents from Beijing Strong Biotechnologies,Inc.("A reagent"),Beijing Labo Biotech,CO.,LTD.("B reagent"),Chongqing Zhongyuan Biological Technology co.,LTD.("C reagent")and the Austrian DIALAB Co.,LTD.("D reagent")were evaluated,respectively.Results:The within-run precisions of high and low values of mixed samples of 4 kinds ofβ_(2)-MG reagents were less than 1/4 allowable deviation(7.5%)of National Center for Clinical Laboratories(NCCL)of National Health Commission,and the total precisions of them were less than 1/3 allowable deviation(10%).The results that 4 kinds of reagents determined calibration samples with traceability of different batches indicated that the average bias between the measured value of each reagent and authentication value was less than 1/2 allowable deviation(±15%).The verified results of linearity range and reference interval indicated that the linearity ranges of 4 kinds of reagents respectively were(0.26~48.73)mg/L(A reagent),(0.05~18.65)mg/L(B reagent),(0.25~65.34)mg/L(C reagent)and(0.09~53.95)mg/L(D reagent),and the reference intervals of them respectively were(0.8~1.8)mg/L(A reagent),(0~3.0)mg/L(B reagent),(0.8~2.8)mg/L(C reagent)and(0.8~2.8)mg/L(D reagent).The influences of interfering substances included bilirubin,hemoglobin and chylus were within tolerance interval on 4 kinds of reagents.The carryover rates of 4 kinds of reagents could meet the requirement,and those of A reagent,B reagent and C reagent were 0,and that of reagent D was 0.31%.Conclusion:The precisions,accuracies,anti-interference abilities and carryover rates of 4 kinds ofβ_(2)-MG reagents from 4 manufacturers can meet the requirements of clinical use,and the differences of them are small.The linear range and reference interval of them pass the verification,and the linear range of B reagent is narrower,and the upper limit of linear range of C reagent is higher.