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[声明:对富士瑞必欧-迈尔斯公司的Serodia-HIV和Serodia-ATLA检测试剂盒的评估]

[Statement: The evaluation of the Serodia-HIV and Serodia-ATLA FUJIREBIO-MILES kits].

作者信息

Catalan F, Ly T D, Milovanovic A

机构信息

Institut Alfred-Fournier, Paris.

出版信息

Ann Biol Clin (Paris). 1990;48(3):207-9.

PMID:2353752
Abstract

A new test, based on agglutination of gelatin particles (PA), sensitized with viral antigens of HIV, was applied on detection of the human immunodeficiency virus (HIV 1) antibody. Sensitivity compared to the ELISA tests (Organon, Dupond de Nemours and/or Elavia 2) was the same during the screening test (97.7 p. cent). Specificity was also acceptable when compared to the same tests (94 p. cent). This specificity remains acceptable with African sera (96 p. cent). During screening, 11.8 p. cent of tested sera were declared falsely positive by the Elisa classical techniques, against only 1.96 p. cent with the PA assay. The six sera remained positive with ELISA (false positives), whereas this positivity was not confirmed with the PA assay. Moreover, all the positive sera were confirmed with the Western blot HIV 1 assay (55.84 p. cent), HIV 1 + 2 (31.17 p. cent) or HIV 2 (13.0 p. cent). Amongst the five false positives pointed out in the european sera, all of them have shown in the Western blot the presence of one or two bands of the GAG protein. In this case, the assay whose easy use is attractive, can be adopted in screening serology and could be useful in African regions, as no further equipment is needed.

摘要

一种基于用HIV病毒抗原致敏的明胶颗粒凝集反应(PA)的新检测方法,被用于检测人类免疫缺陷病毒(HIV-1)抗体。在筛查试验中,与酶联免疫吸附测定法(Organon、杜邦·德内穆尔公司和/或Elavia 2)相比,其灵敏度相同(97.7%)。与相同检测方法相比,其特异性也可接受(94%)。对于非洲血清,这种特异性仍然可接受(96%)。在筛查过程中,经典酶联免疫吸附测定技术将11.8%的检测血清判定为假阳性,而PA检测法仅为1.96%。有6份血清用酶联免疫吸附测定法仍呈阳性(假阳性),而PA检测法未确认这种阳性。此外,所有阳性血清均通过HIV-1蛋白免疫印迹法(55.84%)、HIV-1+2蛋白免疫印迹法(31.17%)或HIV-2蛋白免疫印迹法(13.0%)得到确认。在欧洲血清中指出的5例假阳性中,所有样本在蛋白免疫印迹法中均显示存在一条或两条GAG蛋白条带。在这种情况下,该检测方法使用简便,具有吸引力,可用于血清学筛查,并且在非洲地区可能会有用,因为无需额外设备。

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