口腔黏膜渗出液快速诊断试剂与血清ELISA试剂检测不同人群HIV-1抗体的评价

中华皮肤科杂志 ›› 2011, Vol. 44 ›› Issue (5): 302-305.

口腔黏膜渗出液快速诊断试剂与血清ELISA试剂检测不同人群HIV-1抗体的评价

吴焱¹,王克荣²,韩晶²,赵红心²,曾辉³,徐克沂⁴,刘彦春⁵,闫会文⁶,伦文辉¹

1. 北京地坛医院
2.
3. 北京地坛医院传染病研究所
4. 北京地坛医院性传播疾病中心
5. 北京地坛医院性病/艾滋病中心
6. 北京地坛医院STD/AIDS中心

收稿日期:2010-05-20 修回日期:2010-07-10 出版日期:2011-05-15 发布日期:2011-05-03
通讯作者: 伦文辉 E-mail:lunwenhui@163.com
基金资助:
国家科技重大专项——艾滋病和病毒性肝炎等重大传染病防治

A comparison study on the detection of anti-human immunodeficiency virus type 1 （HIV-1） antibodies in different populations with a new rapid test using oral mucosal transudate samples versus enzyme linked immunosorbent assay （ELISA） using serum samples

Received:2010-05-20 Revised:2010-07-10 Online:2011-05-15 Published:2011-05-03
Contact: LUN Wen-Hui E-mail:lunwenhui@163.com

摘要/Abstract

摘要：

目的探讨口腔黏膜渗出液（OMT）快速诊断试剂与酶联免疫吸附试验（ELISA）试剂检测不同人群HIV-1抗体的一致性。方法对已经过生物梅里埃ELISA试剂检测血清HIV-1抗体阳性并经蛋白印迹（WB）试验确诊的HIV感染者200例（HIV阳性组），和经过生物梅里埃ELISA试剂检测血清HIV-1抗体阴性的健康人群600例（HIV阴性组）采集OMT标本，使用OMT快速诊断试剂进行HIV-1抗体检测。同时评价口腔黏膜渗出液快速诊断试剂在实际应用中的影响因素。结果 HIV阳性组200例中198例OMT标本检测为阳性，其中192例（96%）检测线清楚，易做阳性结果判断。4例（2%）“模糊”，2例（1％）“很模糊”，需经专业人员判断；2例（1%）检测线“看不见”，为阴性。HIV阴性组600例OMT标本检测HIV抗体全为阴性。结论口腔黏膜渗出液快速诊断试剂与生物梅里埃血清ELISA诊断试剂检测HIV-1抗体相比，在HIV阳性标本中检测一致性为99.0%，在HIV阴性标本中检测一致性为100%，总体一致性为99.75%。

关键词: 酶联免疫吸附试验

Abstract:

Objective To evaluate the consistence in the detection of antibodies against HIV-1 between a new rapid test using oral mucosal transudate （OMT） samples and ELISA using serum samples. Methods Two-hundred patients who were positive for anti-HIV-1 antibodies by serum ELISA and confirmed by Western blot to be infected with HIV, and 600 healthy human controls negative for anti-HIV-1 antibodies by serum ELISA, were eligible for this study. OMT samples were collected from these subjects and subjected to a rapid test for anti-HIV-1 antibodies. The factors influencing the performance of the rapid test were analyzed. Results Of the 200 OMT specimens from HIV-infected patients, 198 showed positive reaction, 2 showed negative reaction. Among the 198 positive reactions, 192 （96%） were "clear" and easy to make decisions, 4 （2%） were "faint", 2 （1%） were "very faint" and required professionals to make decisions. The rapid test was negative in all the 600 OMT specimens from the control group. Conclusions The consistence in the detection of anti-HIV-1 antibodies between the OMT rapid test and serum ELISA was 99% in HIV-positive specimens, 100% in HIV-negative specimens, and 99.75% in all the specimens.

Key words: ELISA

吴焱王克荣韩晶赵红心曾辉徐克沂刘彦春闫会文伦文辉. 口腔黏膜渗出液快速诊断试剂与血清ELISA试剂检测不同人群HIV-1抗体的评价[J]. 中华皮肤科杂志, 2011, 44(5): 302-305.

参考文献

【参考文献】 1. Holm-Hansen C, Constantine NT, Haukenes G. Detection of antibodies to HIV in homologous sets of plasma, urine and oral mucosal transudate samples using rapid assays in Tanzania. Clinical and Diagnostic Virology 1993; 1(3):207-214. 2. Granade TC, Phillips SK, Parekh B, et al. Oral fluid as a specimen for detection and confirmation of antibodies to human immunodeficiency virus type 1. Clinical and Diagnostic Laboratory Immunology 1995; 2(4):395-399. 3. Alta L，Constantine N，Griffin Deeds B，et a1．Evaluation of youth preferences for rapid and innovative human immunodeficiency virus antibody tests[J]．Arch Pediatr Adolese Med，2001，155(7)：838—843. 4. Tamashiro H, Constantine N T Serological diagnosis infection using oral fluid samples. Bulletin of the World Health Organization, 1994, 72 (1):135-143 5. WW Emmons, SF Paparello, CF Decker, et al. A modified ELISA and Western blot accurately determine anti-human immunodeficiency virus type 1 antibodies in oral fluids obtained with a special collecting device. J Infect Dis. 171 (1995), 1406-1410. 6. Gottfried, TD, Mink RW, Phanuphak P. Calypte Aware HIV-1 OMT antibody test using oral fluid: special challenges of rapid of HIV testing in the developing world[J]. Expert Rev Mol Daign, 2006,6(2):139-144. 7. Reynolds SJ,Muwonga J. OraQuick ADVANCE Rapid HIV-1 antibody test[J]. Expert Rev Mol Diagn,2004,4(5):587-591. 8. Alemnji GA, Ngulefac GA, Ndumbe PM, et al. Field Evaluation of Calypte's AWARE Blood Serum Plasma (BSP) and Oral Mucosal Transudate (OMT) Rapid Tests for Detecting Antibodies to HIV-1 and 2 in Plasma and Oral Fluid. Open AIDS J. 2009,3:14-8 9. Stekler JD, Swenson PD, Coombs RW, et al. HIV testing in a high-incidence population: is antibody testing alone good enough? Clin Infect Dis. 2009，49(3):444-53. 10. Holguín A, Gutiérrez M, Portocarrero N, et al. Performance of OraQuick Advance Rapid HIV-1/2 Antibody Test for detection of antibodies in oral fluid and serum/plasma in HIV-1+ subjects carrying different HIV-1 subtypes and recombinant variants. J Clin Virol. 2009;45(2):150-2. 11. 《全国艾滋病检测技术规范》 2009年修订版中国疾病预防控制中心.

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