印度泰米尔纳德邦一家三级医院患者乙型肝炎表面抗原快速筛查试验与ELISA诊断的比较

P. Prabha, D. Saikeerthana, V. Vijayashree, M. Gogan
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引用次数: 1

摘要

乙型肝炎病毒感染是一个主要的公共卫生问题,也是全世界死亡的主要原因。世界卫生组织(世卫组织)估计,2015年约有2.57亿人患有慢性乙型肝炎病毒感染,全球流行率为3.5%。在乙型肝炎的几种病毒抗原中,乙型肝炎表面抗原(HBsAg)是一种重要的病毒抗原,被认为是检测乙型肝炎病毒的优良标记。为正确诊断感染以及管理和预防疾病,确定适当的检测试剂盒是必要的。目的:比较快速筛查试验与ELISA法诊断乙型肝炎表面抗原的结果。材料与方法:于2019年7月- 2019年8月在某三级医院进行横断面研究。取200份血样进行HBsAg离心检测。采用快速免疫层析卡(ICT)法(HEPAVIEW - HBsAg一步检测,Viola诊断系统,Tulip Diagnostics Pvt., Ltd.)和酶联免疫吸附测定(ELISA)法(Merilisa HBsAg- Meril Diagnostics Pvt., Ltd.)检测所有200份血样的血清HBsAg。记录快速卡法和酶联免疫吸附试验的数据并输入MS excel电子表格进行分析。结果:采用HbsAg快速卡检测的200份血样中,阳性5份,阴性195份。快速卡法敏感性为83.4%,特异性为100%,阳性预测值(PPV)为100%,阴性预测值(NPV)为99.4%;ELISA法敏感性、特异性、PPV和NPV均为100%。结论:快速ICT检测HBsAg的总体性能对ELISA的敏感性较低。因此,无论其发展和经济状况如何,只有ELISA才能在所有机构中得到鼓励,不仅可以预防乙型肝炎感染的并发症,而且可以早期诊断和更好地治疗患者。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Comparison of Rapid Screening Test and ELISA for the Diagnosis of Hepatitis B Surface Antigen in Patients Attending a Tertiary Care Hospital, Tamil Nadu, India
Introduction: Hepatitis B virus infection is a major public health problem and leading cause of death worldwide. World Health Organisation (WHO) estimates that in 2015 about 257 million population were living with chronic Hepatitis B virus infection with a global prevalence of 3.5%. Among the several viral antigens of Hepatitis B, Hepatitis B Surface Antigen (HBsAg) is an important viral antigen which is recognised as a superior marker for Hepatitis B virus detection. For proper diagnosis of infection as well as disease management and prevention, identification of appropriate test kit is necessary. Aim: To compare the results of rapid screening tests and ELISA for the diagnosis of HBsAg. Materials and Methods: A cross-sectional study was conducted from July 2019-August 2019 in a tertiary care hospital. A total of 200 blood samples received for HBsAg testing were centrifuged. Serum of all the 200 blood samples were tested for HBsAg using both rapid Immuno Chromatographic Card (ICT) method (HEPAVIEW - one step test for HBsAg, Viola Diagnostic System, A Division of Tulip Diagnostics Pvt., Ltd.) and Enzyme Linked Immuno Sorbent Assays (ELISA) (Merilisa HBsAg- Meril Diagnostics Pvt., Ltd.) method. Data for rapid card method and ELISA were noted and entered into MS excel spread sheet and analysed. Results: Among the total 200 blood samples tested by HbsAg rapid card, five samples were positive and the remaining 195 were negative. For rapid card test, the sensitivity was 83.4%, specificity 100%, Positive Predictive Value (PPV) 100% and Negative Predictive Value (NPV) 99.4% and for ELISA the sensitivity, specificity, PPV and NPV were all 100%. Conclusion: The overall performance of the rapid ICT for HBsAg was less sensitive to ELISA. So, only ELISA can be encouraged in all setups irrespective of their developmental and economical status not only to prevent the complications of Hepatitis B infection but also for early diagnosis and better treatment of patients.
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