Holm-Hansen C, Constantine N T, Haukenes G
Centre for International Health, The Gade Institute, University of Bergen, Norway.
Clin Diagn Virol. 1993 Oct;1(4):207-14. doi: 10.1016/0928-0197(93)90002-m.
The aim of this study was to evaluate the performance of commercially available anti-HIV assays when testing plasma, urine and oral mucosal transudate (OMT) samples for the presence of antibodies to HIV. Homologous sets of plasma, urine and oral mucosal transudate specimens were collected from 288 hospitalized patients in northern Tanzania and tested for antibodies to HIV using a routine enzyme immunoassay (Recombinant 3rd Generation EIA, Abbott) and two rapid assays (Testpack HIV-1/HIV-2; Abbott and SUDS HIV-1, Murex). Incubation times and/or sample volumes when testing OMT or urine were increased as compared to those recommended for plasma. The corresponding plasma specimens from all repeatedly reactive samples and samples presenting discordant results were subjected to confirmational testing by an HIV-1/2 Western blot. A total of 15.3% (44/288) of the plasma samples were anti-HIV-1 positive by Western blot. The sensitivity using plasma was 100% by all assays, 69.7-97.7% using urine, and 92.7-100% using oral transudate specimens. The sensitivity of both rapid assays was excellent and higher than the EIA when testing OMT. Specificities ranged from 98.8-100% for plasma, 99-100% for urine and were 100% by all assays using oral samples. The results obtained using oral mucosal transudate specimens and rapid assays were at least comparable to those obtained with plasma, while the use of urine specimens produced suboptimal sensitivities with two of the three assays. The testing of alternative body fluids for antibodies to HIV is yet another strategy that may be applicable, particularly in developing countries.
本研究的目的是评估市售抗HIV检测方法在检测血浆、尿液和口腔黏膜渗出液(OMT)样本中HIV抗体时的性能。从坦桑尼亚北部288名住院患者中收集了同源的血浆、尿液和口腔黏膜渗出液标本,并使用常规酶免疫测定法(重组第三代酶免疫测定法,雅培公司)和两种快速检测法(Testpack HIV-1/HIV-2;雅培公司和SUDS HIV-1,Murex公司)检测HIV抗体。与血浆检测推荐的孵育时间和/或样本量相比,检测OMT或尿液时的孵育时间和/或样本量有所增加。对所有反复反应性样本和结果不一致的样本的相应血浆标本进行HIV-1/2免疫印迹确认检测。通过免疫印迹法,共有15.3%(44/288)的血浆样本抗HIV-1呈阳性。所有检测方法检测血浆时的灵敏度均为100%,检测尿液时为69.7 - 97.7%,检测口腔渗出液标本时为92.7 - 100%。检测OMT时,两种快速检测法的灵敏度都很高,且高于酶免疫测定法。血浆的特异性范围为98.8 - 100%,尿液为99 - 100%,所有检测口腔样本的方法的特异性均为100%。使用口腔黏膜渗出液标本和快速检测法获得的结果至少与使用血浆获得的结果相当,而使用尿液标本时,三种检测方法中有两种的灵敏度不理想。检测HIV抗体的替代体液是另一种可能适用的策略,特别是在发展中国家。