您的位置:山东大学 -> 科技期刊社 -> 《山东大学学报(医学版)》

山东大学学报 (医学版) ›› 2021, Vol. 59 ›› Issue (8): 92-98.doi: 10.6040/j.issn.1671-7554.0.2021.0555

• • 上一篇    下一篇

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

李晓非1,惠星星2,冯晓燕3,吕松琴1,黄山1,杨永锐1   

  • 出版日期:2021-08-10 发布日期:2021-09-16
  • 通讯作者: 杨永锐. E-mail:595144613@qq.com
  • 基金资助:
    国家“十三五”传染病防治重大专项(2018ZX10732101-001-005)

Establishment and clinical evaluation of a dry fluorescent luminescence technique for joint detection of HBsAg, HCV-Ab, TP-Ab and HIV-Ab

LI Xiaofei1, HUI Xingxing2, FENG Xiaoyan3, LYU Songqin1, HUANG Shan1,YANG Yongrui1   

  1. 1. The Third Peoples Hospital of Kunming / The Infectious Disease Clinical Medicine Center of Yunnan, Kunming 650041, Yunnan, China;
    2. Shanghai Rongsheng Biotech Co., Ltd., Shanghai 201108, China;
    3. Medical Institute of Oriental Ocean(Beijing), Beijing 100041, China
  • Online:2021-08-10 Published:2021-09-16

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
[1] 张拥军, 陈爱平, 凌华, 等. 输血后新发再发病毒感染的现状与挑战[J]. 中华实验和临床病毒学杂志, 2020, 34(3): 327-332. ZHANG Yongjun, CHEN Aiping, LING Hua, et al. Status and challenges of post-transfusion infections with emerging and reemerging viruses [J]. Chinese Journal of Experimental and Clinical Virology, 2020, 34(3): 327-332.
[2] 缪希莉, 高贵民, 徐瑞, 等. 输血前感染性指标检测对患者输血感染的影响分析[J]. 中华医院感染学杂志, 2018, 28(9): 1371-1373. MIAO Xili, GAO Guimin, XU Rui, et al. Influence of detection of infectious indexes before blood transfusion on blood transfusion infections [J]. Chinese Journal of Nosocomiology, 2018, 28(9): 1371-1373.
[3] 王健. 输血前行输血相关传染病血清感染性指标检测临床意义[J]. 创伤与急危重病医学, 2019, 7(5): 281-283. WANG Jian. Clinical significance of detection of serum infectious indexes of transfusion-related infectious diseases before transfusion [J]. Trauma and Critical Care Medicine, 2019, 7(5): 281-283.
[4] 王彦朝, 张文艳. 患者输血前及术前传染病检测结果分析[J]. 深圳中西医结合杂志, 2020, 30(14): 76-77. WANG Yanchao, ZHANG Wenyan. Analysis of infectious diseases of patients before blood transfusion and surgery [J]. Shenzhen Journal of Integrated Traditional Chinese and Western Medicine, 2020, 30(14): 76-77.
[5] 胡润琴. 患者输血前感染性指标检测的临床意义[J]. 中国社区医师, 2020, 36(4): 141-142. HU Runqin. Clinical significance of the detection of infectious indicators in patients before transfusion[J]. Chinese Community Doctors, 2020, 36(4): 141-142.
[6] Nasir M, Wu GY. HEV and HBV dual infection: a review[J]. J Clin Transl Hepatol, 2020, 8(3): 313-321.
[7] Spearman CW, Dusheiko GM, Hellard M, et al. Hepatitis C [J]. Lancet, 2019, 394(10207): 1451-1466.
[8] Ghanem KG, Ram S, Rice PA. The Modern Epidemic of Syphilis [J]. N Engl J Med, 2020, 382(9): 845-854.
[9] Wu ZY, Chen JF, Scott SR, et al. History of the HIV epidemic in China[J]. Curr HIV/AIDS Rep, 2019, 16(6): 458-466.
[10] 唐立红, 杨桂淇, 陈洁晶, 等. 丙型肝炎流行病学及临床检验技术研究进展[J]. 实验与检验医学, 2019, 37(4): 553-556. TANG Lihong, YANG Guiqi, CHEN Jiejing, et al. Research progress in epidemiology and clinical detection of hepatitis C[J]. Experimental and Laboratory Medicine, 2019, 37(4): 553-556.
[11] 蓝蔚蔚, 陈颖, 蓝海鹰. 不同检测法对血清梅毒螺旋体抗体的检测价值[J]. 现代实用医学, 2020, 32(5): 479-481. LAN Weiwei, CHEN Ying, LAN Haiying. Value of different methods in detecting serum Treponema Pallidum antibody [J]. Modern Practical Medicine, 2020, 32(5): 479-481.
[12] 赖玉玲, 黄丽芳, 雷兴. 时间分辨荧光免疫法检测梅毒螺旋体抗体的临床应用研究[J]. 中国医药科学, 2019, 9(7): 111-115. LAI Yuling, HUANG Lifang, LEI Xing. Research on clinical application of time-resolved fluorescence immunoassay for detection of treponema pallidum antibody[J]. China Medicine and Pharmacy, 2019, 9(7): 111-115.
[13] 李明友, 黎永新, 李高辉, 等. 抗-HIV、抗-HCV、抗-TP、HBsAg联合检测试剂盒的临床应用评价[J]. 检验医学与临床, 2011, 8(3): 269-270,273. LI Mingyou, LI Yongxin, LI Gaohui, et al. Clinical performance of combination detection reagent kits of anti-HIV, anti-HCV, anti-TP and HBsAg [J]. Lab Med Clin, 2011, 8(3): 269-270, 273.
[14] Suryoprabowo S, Liu L, Kuang H, et al. Fluorescence based immunochromatographic sensor for rapid and sensitive detection of tadalafil and comparison with a gold lateral flow immunoassay [J]. Food Chem, 2021, 342: 128255. doi: 10.1016/j.foodchem.2020.128255.
[15] 谭玉华, 雷泽洪, 郑丹, 等. 双抗原夹心时间分辨荧光免疫法检测梅毒螺旋体特异性总抗体的性能研究[J]. 现代检验医学杂志, 2018, 33(2): 97-100. TAN Yuhua, LEI Zehong, ZHENG Dan, et al. Evaluation of double antigen sandwich time-resolved fluoroimmunoassay for specific total antibodies to Treponema Pallidum [J]. Journal of Modern Laboratory Medicine, 2018, 33(2): 97-100.
[16] 陈泽衍, 马雯, 张立俊, 等. 荧光免疫层析法检测全血2019-nCoV IgM 和IgG 抗体在新型冠状病毒肺炎诊断中的应用[J]. 现代检验医学杂志, 2020, 35(3): 84-86, 93. CHEN Zeyan, MA Wen, ZHANG Lijun, et al. Application of 2019-nCoV IgM and IgG tests by fluorescence immunochromatography in the diagnosis of 2019-nCoV infections [J]. Journal of Modern Laboratory Medicine, 2020, 35(3): 84-86, 93.
[17] 王云龙, 米亚双, 李玉林, 等. CA19-9 时间分辨荧光免疫层析检测方法的建立[J]. 生物工程学报, 2018, 34(6): 1012?1018. WANG Yunlong, Mi Yashuang, Li Yulin, et al. Establishment of time-resolved fluorescence immunochromatographic assay for detection of carbohydrate antigen 19-9 [J]. Chin J Biotech, 2018, 34(6): 1012-1018.
[18] 彭健灵, 温小良, 苏海. NT-proBNP检测试剂荧光免疫层析法临床性能评价[J]. 国际检验医学杂志, 2017, 38(7): 984-986. PENG Jianling, WEN Xiaoliang, SU Hai. Clinical evaluation of NT-proBNP fluorescence immunochromatography detection method [J]. International Journal of Laboratory Medicine, 2017, 38(7): 984-986.
[19] 梁梦婷. 丙型肝炎病毒抗体检测中酶联免疫和胶体金法的应用效果[J]. 临床医学研究与实践, 2018, 3(14): 134-135. LIANG Mengting. Application effect of enzyme-linked immunoassay and colloidal gold method in antibody detection of hepatitis C virus [J]. Clinical Research and Practice, 2018, 3(14): 134-135.
[1] 刘毅,孙颖浩,王林辉,高旭,李香铁,张爱民,郝俊文 . α1肾上腺素受体拮抗剂对前列腺癌DU-145细胞生长的影响及机理研究[J]. 山东大学学报(医学版), 2007, 45(10): 1004-1007.
Viewed
Full text


Abstract

Cited

  Shared   
  Discussed   
[1] 索东阳,申飞,郭皓,刘力畅,杨惠敏,杨向东. Tim-3在药物性急性肾损伤动物模型中的表达及作用机制[J]. 山东大学学报 (医学版), 2020, 1(7): 1 -6 .
[2] 张宝文,雷香丽,李瑾娜,罗湘俊,邹容. miR-21-5p靶向调控TIMP3抑制2型糖尿病肾病小鼠肾脏系膜细胞增殖及细胞外基质堆积[J]. 山东大学学报 (医学版), 2020, 1(7): 7 -14 .
[3] 龙婷婷,谢明,周璐,朱俊德. Noggin蛋白对小鼠脑缺血再灌注损伤后学习和记忆能力与齿状回结构的影响[J]. 山东大学学报 (医学版), 2020, 1(7): 15 -23 .
[4] 付洁琦,张曼,张晓璐,李卉,陈红. Toll样受体4抑制过氧化物酶体增殖物激活受体γ加重血脂蓄积的分子机制[J]. 山东大学学报 (医学版), 2020, 1(7): 24 -31 .
[5] 马青源,蒲沛东,韩飞,王超,朱洲均,王维山,史晨辉. miR-27b-3p调控SMAD1对骨肉瘤细胞增殖、迁移和侵袭作用的影响[J]. 山东大学学报 (医学版), 2020, 1(7): 32 -37 .
[6] 李宁,李娟,谢艳,李培龙,王允山,杜鲁涛,王传新. 长链非编码RNA AL109955.1在80例结直肠癌组织中的表达及对细胞增殖与迁移侵袭的影响[J]. 山东大学学报 (医学版), 2020, 1(7): 38 -46 .
[7] 史爽,李娟,米琦,王允山,杜鲁涛,王传新. 胃癌miRNAs预后风险评分模型的构建与应用[J]. 山东大学学报 (医学版), 2020, 1(7): 47 -52 .
[8] 肖娟,肖强,丛伟,李婷,丁守銮,张媛,邵纯纯,吴梅,刘佳宁,贾红英. 两种甲状腺超声数据报告系统诊断效能的比较[J]. 山东大学学报 (医学版), 2020, 1(7): 53 -59 .
[9] 丁祥云,于清梅,张文芳,庄园,郝晶. 胰岛素样生长因子II在84例多囊卵巢综合征患者颗粒细胞中的表达和促排卵结局的相关性[J]. 山东大学学报 (医学版), 2020, 1(7): 60 -66 .
[10] 徐玉香,刘煜东,张蓬,段瑞生. 101例脑小血管病患者脑微出血危险因素的回顾性分析[J]. 山东大学学报 (医学版), 2020, 1(7): 67 -71 .