免疫透射比浊法血清白蛋白检测试剂盒的性能验证和临床应用评价

目的对免疫透射比浊法血清白蛋白检测试剂盒进行性能验证和临床应用评价。方法根据美国临床实验室标准化委员会(CLSI)的标准要求,使用全自动日立生化分析仪7600-020,对该试剂盒的精密度、正确度、检出限、线性范围、干扰实验、参考区间、方法学比对进行验证,并将检测结果和厂家提供的的性能指标进行比较。结果该试剂检测血清白蛋白的批内精密度为1.1%、批间精密度为1.2%,均小于厂家提供的指标;正确度在允许偏倚范围内;检出限为0.152g/L;线性斜率为0.9755,相关系数的平方R2为0.9945,大于0.99符合要求;生物参考区间符合率100%;在厂家说明书标示的干扰物浓度范围内,对检测结果没有明显影响;与溴甲酚绿法做比对实验,相关性回归方程为Y=0.9894X-1.1033,R2为0.9794,在低值结果中两种方法学差异呈非线性分布,无法用校正系数调整。结论免疫透射比浊法血清白蛋白检测试剂盒在7600-020生化分析仪上主要分析性能符合厂家的声明,结果准确可靠,抗干扰能力强,可以开展用于临床检验分析。

The Performance Verification and Clinical Application Evaluation of an Immunoturbidimetric Serum Albumin Detection Kit

Objective To evaluate the performance and clinical application of an immunoturbidimetric serum albumin test kit.Methods According to the standard requirements of CLSI,the precision,accuracy,detection limit,linear range,interference experiment,reference range and methodology comparison of the kit were evaluated by using the automatic Hitachi biochemical analyzer 7600-020,and the test results were compared with the performance indexes provided by the manufacturer.Results The intra assay precision and inter assay precision of the reagent were 1.1%and 1.2%,respectively,which were less than the indexes provided by the manufacturer.The evaluation results of other parameters were as following:the accuracy was within the allowable bias range;the detection limit was 0.152g/L;the linear slope was 0.9755;the square R2 of the correlation coefficient was 0.9945,which was greater than 0.99 and met the requirements;the coincidence rate of the biological reference range was 100%.Within the range of the concentration of the interferents indicated in the manufacturer′s instructions,there was no obvious influence on the test results.Compared with bromocresol green method,the correlation regression equation was Y=0.9894X-1.1033,with R20.9794.The difference between the two methods was non-linear and could not be adjusted by the correction coefficient.Conclusion The main analytical performances of the immunoturbidimetric serum albumin test kit on 7600-020 biochemical analyzer meet the statement of the manufacturer,in which the results are accurate and reliable,with a strong anti-interference ability.The tested kit can be applied for the clinical analysis.