免疫比浊法测定的胱抑素C试剂盒性能验证和评价

摘要

目的 对使用免疫比浊法测定的胱抑素C(Cys-C)试剂盒进行实验室验证和评价,以确定该试剂盒分析性能的可靠性,评价其是否符合临床应用需要.方法 根据美国临床实验室标准协会颁布的《临床化学设备操作精密度评价核准指南》、《定量分析方法的线性核准指南》、《临床化学干扰试验核准指南》要求,分别对使用免疫比浊法Cys-C试剂盒的准确度、精密度、线性范围、抗干扰物质进行试验.结果 准确度测量:高水平质量控制偏差为2.76,低水平质量控制偏差为0.42,偏差<10%.精密度测量标准差为0.32,变异系数为0.45%,偏差<5%.线性范围:在理论水平0~200范围内,相关系数Y=0.9917 X+0.4681, r2=1呈线性关系.干扰物质血红蛋白测量值最高105.5 mg/L,最低102.5 mg/L;胆红素测量值最高104.0 mg/L,最低41.0 mg/L;抗坏血酸测量值最高104.0 mg/L,最低86.0 mg/L;未对试验产生干扰.结论 该试验使用的Cys-C检测试剂盒在准确度、精密度、线性范围、抗干扰物质试验等方面分析性能可靠,能满足临床应用需要和保证课题数据准确性的要求.%Objective To conduct the laboratory validation and evaluation on cystatin C(Cys-C)reagent kit by using the immu-noturbidimetry assay to determine the reliability of this reagent kit analytical performance and to evaluate whether,guaranteeing the project data accuracy.Methods The accuracy,precision,linearity and anti-interference materials of the Cys-C reagent kit(immuno-turbidimetry)were detected according to the standard requirements of EP 5-A,EP6-A and EP7-A promulgated by CLSI.Results The high level of quality control deviation in the accuracy measurement was 2.76 and which of the low level was 0.42,deviation<10%;the precision measurement standard deviation was 0.32,the variation coefficient was 0.45%,deviation<5%;the linear range was within the theoretical range of 0-200,the correlation coefficient Y=0.991 7X+0.4681,r2=1 showing a linear relationship;the highest detection value of interfering substance hemoglobin was 105.5 mg/L,the lowest detection value was 102.5 mg/L;the highest detection value of bilirubin was 82.0 mg/L,the lowest detection value was 41.0 mg/L;the highest detection value of ascor-bic acid was 104.0 mg/L,the lowest detection value was 86.0 mg/L,which generated no interference on the test.Conclusion The Cys-C reagent kit produced by Beijing Jiuqiang Company is reliable in the aspects of accuracy,precision,linearity and anti-interfer-ence material test,can meet the needs of clinical application and guarantee the requirements of project data accuracy.