酶联免疫双抗原夹心法检测HCV抗体的应用与分析  

Application and Analysis of ELISA Double Antigen Sandwich Method for Detection of HCV Antibody

作　　者：孙鹏 嵇俊 SUN Peng;JI Jun(Clinical Laboratory,Center Blood Station of Huaian,Huaian Jiangsu 223001,China)

机构地区：[1]淮安市中心血站检验科,江苏淮安223001

出　　处：《中国卫生标准管理》2023年第3期26-29,共4页China Health Standard Management

摘　　要：目的通过对第四代双抗原夹心法HCV抗体检测试剂进行系列验证以及与第三代间接法HCV抗体检测试剂的平行比对,分析双抗原夹心试剂的检测性能。方法于2020年10月13日—2021年12月31日在淮安市中心血站用第四代试剂检测室内质控品、参考血清盘等样本,分析其重复性、批内和批间精密度以及敏感性和特异性等;运用第三代和第四代HCV抗体检测试剂平行检测同期无偿献血者标本等,比较其检测特异性和灵敏度。结果第四代试剂阴、阳性对照检测符合率100%;批内检测精密度4.36%,批间检测精密度6.88%;在确证试验结论为阳性的11例标本检测中,第四代试剂检测出9例,第三代试剂检测出3例,差异有统计学意义(χ^(2)=3.342,P<0.05);在确证试验结论为阴性的83237例标本中,第四代试剂检测假阳性12例,第三代试剂检测假阳性95例,差异有统计学意义(χ^(2)=32.238,P<0.05)。结论第四代双抗原夹心法HCV抗体检测试剂的重复性、灵敏度和特异性均明显高于第三代间接法HCV抗体检测试剂。Objective To analyze the detection performance of the double antigen sandwich reagent by serial verification of the fourth generation of double antigen sandwich HCV antibody detection reagent and parallel comparison with the third generation of indirect HCV antibody detection reagent.Methods From October 13,2020 to December 31,2021,the fourth generation reagent was used to detect indoor quality control products,reference serum discs and other samples in Center Blood Station of Huaian,and analyzed their repeatability,intra batch and inter batch precision,sensitivity and specificity.The third and fourth generation HCV antibody detection reagents were used to detect the samples of unpaid blood donors in parallel,and their specificity and sensitivity were compared.Results The coincidence rate of negative and positive control test of the fourth generation reagent was 100%.The precision of intrabatch detection was 4.36%and that of inter-batch detection was 6.88%.Among the 11 positive specimens,9 were detected by the fourth generation reagent and 3 were detected by the third generation reagent,the difference was statistically significant(χ^(2)=3.342,P<0.05).Among the 83237 confirmed negative specimens,12 cases were false positive with the fourth generation reagent and 95 cases with the third generation reagent,the difference was statistically significant(χ^(2)=32.238,P<0.05).Conclusion The reproducibility,sensitivity,and specificity of the fourth generation double antigen sandwich HCV antibody detection reagent is significantly better than the third generation indirect HCV antibody detection reagent.

关 键 词：抗-HCV 双抗原夹心法 间接法 第四代 重复性 灵敏度 

分 类 号：R446[医药卫生—诊断学]