HBsAg、抗-HCV、抗-HIV和抗-TP干式荧光发光四联检技术的建立及临床评价

doi:10.6040/j.issn.1671-7554.0.2021.0555

摘要/Abstract

摘要： 目的建立一种干式荧光发光传染病四联检技术,并评价其临床应用性能。方法基于免疫层析和荧光发光平台,采用夹心法原理检测乙型肝炎病毒表面抗原(HBsAg)、丙型肝炎病毒抗体(抗-HCV)、人免疫缺陷病毒抗体(抗-HIV)及梅毒螺旋体抗体(抗-TP)。采用国家参考品进行评估,并与酶联免疫法平行检测临床样本,比较该技术的检测性能。结果干式荧光发光法传染病四联检技术符合国家参考品的标准要求。在临床性能评价中,对四项指标的检测灵敏度均大于95%,特异性HBsAg、抗-HIV和抗-TP大于95%,抗-HCV检测特异性为91%。四项检测指标的受试者工作特征(ROC)曲线下面积(AUC)值均接近于1。与酶联免疫法检测试剂相比较,四项检测指标的总符合率均在94%以上,Kappa指数均在0.9~1.0之间。结论建立的干式荧光发光传染病四联检技术与酶联免疫法检测结果具有高度一致性,是一种具有很好敏感性和特异性的现场快速简便的检测方法,能够满足临床检测需要。

关键词: 干式荧光发光法, HBsAg, 抗-HCV, 抗-TP, 抗-HIV, 临床评价

Abstract: Objective To establish a dry fluorescent luminescence technique for the joint detection of HBsAg, HCV-Ab, TP-Ab and HIV-Ab, and to evaluate its clinical application. Methods Based on immunochromatography and fluorescence luminescence technique, HBsAg, anti-HCV, anti-HIV and anti-TP were detected with double sandwich method. National reference materials were adopted, and clinical samples were tested in parallel with enzyme linked immunosorbent assay(ELISA)to evaluate the performance of the dry fluorescent luminescence technique. Results The detection results of HBsAg, HCV-Ab, TP-Ab and HIV-Ab reference samples met the requirements of national reference standards. In clinical performance evaluation, the detection sensitivities of HBsAg, HCV-Ab, TP-Ab and HIV-Ab were all higher than 95%; the detection specificities of HBsAg, TP-Ab and HIV-Ab were higher than 95%, and the detection specificity of HCV-Ab was 91%. The AUC of the ROC curves were all close to 1. Compared with the ELISA, this technique had total coincidence rates of HBsAg, HCV-Ab, TP-Ab and HIV-Ab all above 94%, and their Kappa values ranged from 0.9 to 1.0. Conclusion The dry fluorescent luminescence technique for the joint detection of HBsAg, HCV-Ab, TP-Ab and HIV-Ab can produce results which are highly consistent with those of ELISA. It is a rapid and simple point-of-care testing method with high sensitivity and specificity, and can meet the needs of clinical detection.

Key words: Dry fluorescent luminescence, HBsAg, HCV-Ab, TP-Ab, HIV-Ab, Clinical evaluation

中图分类号:

R-331

李晓非,惠星星,冯晓燕,吕松琴,黄山,杨永锐. HBsAg、抗-HCV、抗-HIV和抗-TP干式荧光发光四联检技术的建立及临床评价[J]. 山东大学学报 (医学版), 2021, 59(8): 92-98.

LI Xiaofei, HUI Xingxing, FENG Xiaoyan, LYU Songqin, HUANG Shan,YANG Yongrui. Establishment and clinical evaluation of a dry fluorescent luminescence technique for joint detection of HBsAg, HCV-Ab, TP-Ab and HIV-Ab[J]. Journal of Shandong University (Health Sciences), 2021, 59(8): 92-98.

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