乙型肝炎病毒表面抗原确认试剂的临床研究  

Clinical research on confirmation reagent of hepatitis B virus surface antigen

作　　者：王新明 吴文娟 赵兵杰 许东勤 王洁 WANG Xinming;WU Wenjuan;ZHAO Bingjie;XU Dongqin;WANG Jie(Zhengzhou Auto Bioengineering Co.,Ltd.,Zhengzhou,Henan 450016,China)

机构地区：[1]郑州安图生物工程股份有限公司,河南郑州450016

出　　处：《中国医学工程》2022年第12期100-103,共4页China Medical Engineering

摘　　要：目的对郑州安图生物工程股份有限公司研制生产的乙型肝炎病毒表面抗原(HBsAg)确认试剂盒(中和实验法)进行初步临床研究,评价其应用价值。方法以Abbott Ireland Diagnostics Division(雅培)生产的乙型肝炎病毒表面抗原确认试剂盒(化学发光微粒子免疫检测法)为对照,完成1186例临床血清样本的平行测定及统计分析,1087例可重复样本的确认试验及215例血清血浆样本的对比试验。结果1186例临床样本检测结果显示,阳性样本1086例,阴性样本100例,考核配套试剂与对比配套试剂阳性符合率为99.91%(95%CI:99.48%~99.98%),阴性符合率为99.00%(95%CI:94.55%~99.82%),总符合率为99.83%(95%CI:99.39%~99.95%);对检测结果进行Kappa检验,Kappa值为0.989,结果基本一致。考核试剂与对比试剂1087例确认试验显示,其确认阳性符合率为99.82%(95%CI:99.33%~99.95%),总符合率为99.72%(95%CI:99.19%~99.91%)。210例血清血浆对比试验显示,考核试剂血清血浆对比结果确认阳性符合率为100.00%(95%CI:98.20%~100.00%),无未确认阳性结果,结果完全一致。结论郑州安图生物工程股份有限公司生产的HBsAg确认试剂盒可以对HBsAg检测结果呈可重复阳性的样本进行确认,适用于临床检验。【Objective】A preliminary clinical study was conducted on the hepatitis B virus surface antibody(HBsAg)confirmation kit(neutralization assay)developed and produced by Zhengzhou Antu Bioengineering Co.,Ltd.to evaluate its application value.【Methods】Using the hepatitis B virus surface antigen confirmation kit(chemiluminescent microparticle immunoassay)produced by Abbott Ireland Diagnostics Division(Abbott)as a control,parallel determination and statistical analysis of 1186 clinical serum samples were completed,and 1087 repeatable samples were analyzed.Confirmation test and comparative test of 215 serum plasma samples were conducted.【Results】The test results of 1186 clinical samples showed that there were 1086 positive samples and 100 negative samples.The positive coincidence rate of the assessment supporting reagents and the comparison supporting reagents was 99.91%(95%CI:99.48%-99.98%),and the negative coincidence rate was 99.00%(95%CI:94.55%-99.82%),the total coincidence rate was 99.83%(95%CI:99.39%-99.95%);Kappa test was performed on the test results,the Kappa value was 0.989,and the results were basically the same.The confirmation test of 1087 cases of assessment reagents and comparison reagents showed that the positive coincidence rate was 99.82%(95%CI:99.33%-99.95%),and the total coincidence rate was 99.72%(95%CI:99.19%-99.91%).The serum plasma comparison test of 210 cases showed that the positive coincidence rate of the serum plasma comparison results of the assessment reagent was 100.00%(95%CI:98.20%-100.00%),and there were no unconfirmed positive results,and the results were completely consistent.【Conclusion】The HBsAg confirmation kit produced by Zhengzhou Antu Bioengineering Co.,Ltd.can confirm the reproducible positive samples of HBsAg test results and is suitable for clinical testing.

关 键 词：乙型肝炎病毒 表面抗原 确认试验 

分 类 号：R373.21[医药卫生—病原生物学]