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

肝脏 ›› 2022, Vol. 27 ›› Issue (4): 418-420.

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

孙继云, 马小艳, 刘欢, 王雅杰

100015 首都医科大学附属北京地坛医院检验科

收稿日期:2021-07-09 出版日期:2022-04-30 发布日期:2022-06-02
通讯作者: 王雅杰

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

SUN Ji-yun, MA Xiao-yan, LIU Huan, WANG Ya-jie

Department of Laboratory, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China

Received:2021-07-09 Online:2022-04-30 Published:2022-06-02
Contact: WANG Ya-jie

摘要/Abstract

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。

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

Abstract: 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.

Key words: Hepatitis B, Hepatitis B virus surface antigen, Magnetic particle chemiluminescence method, Confirmation Kit, Performance

孙继云, 马小艳, 刘欢, 王雅杰. 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[J]. 肝脏, 2022, 27(4): 418-420.

SUN Ji-yun, MA Xiao-yan, LIU Huan, WANG Ya-jie. Comparison of the performance between the 2 magnetic particle chemiluminescence kits for detection of hepatitis B virus surface antigen[J]. Chinese Hepatolgy, 2022, 27(4): 418-420.

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