两种乙型肝炎表面抗原磁微粒化学发光法检测试剂盒性能比较  

Comparison of the performance between the 2 magnetic particle chemiluminescence kits for detection of hepatitis B virus surface antigen

作　　者：孙继云[1] 马小艳[1] 刘欢[1] 王雅杰 SUN Ji-yun;MA Xiao-yan;LIU Huan;WANG Ya-jie(Department of Laboratory,Beijing Ditan Hospital,Capital Medical University,Beijing 100015,China)

机构地区：[1]首都医科大学附属北京地坛医院检验科,100015

出　　处：《肝脏》2022年第4期418-420,共3页Chinese Hepatology

摘　　要：目的比较两种乙型肝炎表面抗原(HBsAg)磁微粒化学发光法检测试剂盒的性能,为乙型肝炎的诊断提供依据。方法使用郑州安图生物工程股份有限公司生产的HBsAg确认试剂盒(考核试剂)与已批准上市的同类产品Abbott Ireland Diagnostics Division生产的HBsAg确认试剂盒(对比试剂)同时检测血清及血浆样本380例,分析并比较两种试剂盒检测的性能。结果考核配套试剂检测结果的阳性符合率、阴性符合率、总符合率均为100%,2种配套试剂具有一致性(Kappa>0.75);考核试剂确认阳性符合率为100%,未确认阳性符合率为0、总符合率为91.58%,2种确认试剂具有一致性(Kappa>0.75)。考核试剂灵敏度为99.43%,特异度为100%,准确度为100%,对比试剂的灵敏度、特异度及准确度均为100%,2种试剂盒诊断效能差异无统计学意义(P>0.05),具有一致性(Kappa>0.75)。结论两种检测试剂盒性能相当,郑州安图生物工程股份有限公司生产的HBsAg确认试剂盒同样具有较高的敏感度、特异度,可满足临床检测的需要。Objective To investigate the performance of two kinds of magnetic particle chemiluminescence kits for detection of hepatitis B virus surface antigen(HBsAg)and to provide evidence for the diagnosis of hepatitis B.Methods A total of 380 serum and plasma samples were detected for HBsAg confirmation kits produced by Zhengzhou Antu Bioengineering Corporation(test reagent)and Abbott Ireland diagnostics division(control reagent).The performance of 2 kits was analyzed and compared.Results The positive coincidence rate,negative coincidence rate and total coincidence rate of 2 kinds of matching reagents were all 100.00%,which showed the good consistency between the 2 matching reagents(Kappa>0.75).The positive coincidence rate,the unconfirmed positive coincidence rate and the total coincidence rate of test reagent were 100.00%,0.00%and 91.58%,respectively.The two confirmation reagents were consistent(Kappa>0.75);The sensitivity,specificity and accuracy of the test kit were 99.43%,100%and 100%,respectively.The sensitivity,specificity and accuracy of the control kit were all 100%.There was no significant difference in the diagnostic efficiency between the two kits(P>0.05),and consistency was good(Kappa>0.75).Conclusion There was no statistically significant difference in the performance between the 2 kits.The HBsAg confirmation kit produced by Zhengzhou Antu Bioengineering Corporation also has high sensitivity and specificity,which can meet clinical detection needs.

关 键 词：乙型肝炎 乙型肝炎病毒表面抗原 磁微粒化学发光法 确认试剂盒 性能 

分 类 号：R44[医药卫生—诊断学]