国内抗-HCV酶联免疫试剂批内和批间可信度的比较分析  

An analysis of intra-and inter-reliability of domestic anti-HCV kits

作　　者：杨振[1] 祁自柏[1] 于洋[1] 谷金莲[1] 周诚[1] 张华远[1] 李河民[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国病毒病杂志》2009年第6期415-417,共3页Chinese Journal of Viral Diseases

摘　　要：目的通过对不同生产厂家试剂盒的国家参考品检测结果,分析国产丙型肝炎抗体酶联免疫试剂(ELISA试剂)的批内可信度以及批间可信度对试剂质量的影响。方法以国家第三代第二批抗-HCV参考品40份阳性血清,40份阴性血清分别对不同试剂多批次不同批号试剂盒进行检定,利用检测数据进行统计分析,对设定"灰区"血清(CUTOFF×15%)范围内同一试剂不同批次所测得吸光度(A)值,计算其批间CV值、标准差和标准误。结果不同国产试剂对Core区,NS3区抗体谱血清漏检情况不同,存在抗体谱漏检错位现象。同一厂家不同批次检测弱阳性临界值血清CV值较高,"灰区"标本血清检测结果变化较大。结论建议试剂生产厂家应建立临界值对照血清,以控制"灰区"标本的检测结果,确保试剂的批间可信度。Objective To analyze the intra-and inter-reliability as well as its influence to the reagent quality of domestic anti-HCV ELISA kits by analyzing the test results of national reference materials detected by different kits of several manufacturers.Methods The second batch of the third generation national reference materials(including 40 positive sera and 40 negative sera)were used as controls to detect the intra-and inter-reliability of the tested kits.The inter-CV value,standard deviation and standard error were calculated according to the absorbance values of the sera in'gray zone'detected by the same reagent of different batches.Results The different domestic reagents had different missing detections of the antibodies to Core or NS3 regions.The CV values of weakly positive serum samples detected by reagents of different batches from the same manufacturer were relatively high.The test results of serum samples in'gray zone'changed greatly.Conclusion It is recommended that the reagent manufacturers should establish a threshold for the control serum to control the test results of specimens in the'gray zone',and to ensure the inter-reliability of the reagents.

关 键 词：肝炎病毒 酶联免疫 试剂 可信度 

分 类 号：R446.6[医药卫生—诊断学]