Filice G, Soldini L, Orsolini P, Razzini E, Gulminetti R, Campisi D, Chiapparoli L, Cattaneo E, Achilli G
Department of Infectious Diseases, University of Pavia, IRCCS Policlinico S. Matteo.
Microbiologica. 1991 Jul;14(3):185-94.
We have developed two immunoassay systems, one designated HIV (p24, p66, gp41) ELISA that uses as antigens the immunodominant epitopes mixed from each of three major groups of HIV-1 proteins: the core (p24), the pol (p66) and the env (gp41) gene. The other immunoassay system consists of four separate ELISAs for detection of single antibodies to HIV gag gene (p24), HIV pol gene (p66) and HIV env gene (gp41 and gp120). In the present study 200 specimens from patients with AIDS and 200 specimens from patients with ARC were repeatedly positive by HIV (p24, p66, gp41) ELISA. 1425 specimens from HIV drug addicts positive at W.B. were positive at HIV (p24, gp41, p66) ELISA. In addition, 60 samples that were indeterminate by W.B., were repeatedly positive at HIV (p24, p66, gp41) ELISA. The sensitivity and specificity of HIV (p24, p66, gp41) is estimated to be 100%. In this study 1507 specimens from HIV drug addicts, positive at W.B., were all positive (more than one test positive) at HIV p24 ELISA, HIV gp41 ELISA, HIV p66 ELISA and HIV gp120 ELISA used in combination. 135 samples from HIV positive drug addicts, positive at standard ELISA but indeterminate at W.B., were positive by HIV p24 ELISA, HIV gp41 ELISA, HIV p66 ELISA and HIV gp120 ELISA using the same criteria as in W.B. interpretation. The specificity (defined in terms of percentage of non-reacting persons in a low risk population) of HIV p24 ELISA, HIV gp41 ELISA, HIV p66 ELISA, HIV gp120 ELISA is 100%. In this work we demonstrated that: a) HIV (p24, p66, gp41) ELISA could be used as an adjunct or reliable alternative to standard ELISA for detection or confirmation of HIV antibodies in human sera; b) the specificity and sensitivity of antibodies to p24, p66, gp41, gp120 by ELISA used alone and/or in combination, is equal to or greater than W.B.
我们研发了两种免疫测定系统，一种是HIV（p24、p66、gp41）ELISA，它使用从HIV-1三种主要蛋白组（核心蛋白（p24）、聚合酶蛋白（p66）和包膜蛋白（gp41）基因）的每种蛋白中混合的免疫显性表位作为抗原。另一种免疫测定系统由四种独立的ELISA组成，用于检测针对HIV gag基因（p24）、HIV pol基因（p66）和HIV env基因（gp41和gp120）的单一抗体。在本研究中，200份艾滋病患者标本和200份艾滋病相关综合征（ARC）患者标本通过HIV（p24、p66、gp41）ELISA检测均呈反复阳性。1425份经蛋白印迹法（W.B.）检测呈阳性的HIV吸毒者标本在HIV（p24、gp41、p66）ELISA检测中也呈阳性。此外，60份经W.B.检测结果不确定的样本在HIV（p24、p66、gp41）ELISA检测中呈反复阳性。HIV（p24、p66、gp41）ELISA的敏感性和特异性估计为100%。在本研究中，1507份经W.B.检测呈阳性的HIV吸毒者标本在联合使用的HIV p24 ELISA、HIV gp41 ELISA、HIV p66 ELISA和HIV gp120 ELISA检测中均呈阳性（不止一项检测呈阳性）。135份HIV阳性吸毒者标本，在标准ELISA检测中呈阳性但在W.B.检测中结果不确定，按照与W.B.判读相同的标准，在HIV p24 ELISA、HIV gp41 ELISA、HIV p66 ELISA和HIV gp120 ELISA检测中呈阳性。HIV p24 ELISA、HIV gp41 ELISA、HIV p66 ELISA、HIV gp120 ELISA的特异性（根据低风险人群中无反应者的百分比定义）为100%。在本研究中我们证明：a）HIV（p24、p66、gp41）ELISA可作为标准ELISA的辅助手段或可靠替代方法，用于检测或确认人血清中的HIV抗体；b）单独和/或联合使用ELISA检测针对p24、p66、gp41、gp120的抗体的特异性和敏感性等于或高于蛋白印迹法。
