Mitchell S W, Mboup S, Mingle J, Sambe D, Tukei P, Milenge K, Nyamongo J, Mubarak O K, Sankale J L, Hanson D S
Family Health International, Research Triangle Park Branch, Durham, North Carolina 27709.
Lancet. 1991 Jun 1;337(8753):1328-31. doi: 10.1016/0140-6736(91)92991-a.
A rapid immunobinding assay ('HIVCHEK', Ortho) and an agglutination assay ('Serodia-HIV', Fujirebio) were evaluated as an alternative to enzyme-linked immunosorbent assay (ELISA) and western blot under field conditions in Africa for detection of antibody to human immunodeficiency virus (HIV). 7106 specimens were tested at 25 laboratories in Kenya, Ghana, Senegal, and Zaire. HIVCHEK was used as a screening test, and serodia-HIV as a supplemental test to evaluate these assays in an alternative testing strategy to the standard ELISA/western blot testing procedure. In each country, HIVCHEK was more sensitive and specific than ELISA when compared with western blot. The sensitivity of HIVCHEK ranged from 87.0 to 96.3% and the specificity from 99.0 to 100%. The sensitivity and specificity of serodia-HIV ranged from 85 to 98% and from 88 to 98%, respectively. The sensitivity and specificity were affected by the presence of HIV-2 in Ghana and Senegal. Overall, with an HIV-1 prevalence of 14.8% in Kenya and 22.5% in Zaire, the sensitivities of the alternative strategy were 96.4% and 91.4%, the specificities 99.6% and 100%, the positive predictive values 97.6% and 100%, and the negative predictive values 99.3% and 97.9% for Kenya and Zaire, respectively. With this testing format there was an estimated average cost saving of up to 82% over the conventional strategy with ELISA/western blot. This procedure constitutes a reasonable alternative to the standard ELISA/western blot combination.
在非洲的现场条件下，对一种快速免疫结合试验（“HIVCHEK”，奥索公司）和一种凝集试验（“Serodia - HIV”，富士瑞必欧公司）进行了评估，以替代酶联免疫吸附测定（ELISA）和蛋白质印迹法，用于检测人类免疫缺陷病毒（HIV）抗体。在肯尼亚、加纳、塞内加尔和扎伊尔的25个实验室对7106份标本进行了检测。采用HIVCHEK作为筛查试验，Serodia - HIV作为补充试验，以评估这些检测方法相对于标准ELISA/蛋白质印迹检测程序的另一种检测策略。在每个国家，与蛋白质印迹法相比，HIVCHEK比ELISA更灵敏且更具特异性。HIVCHEK的灵敏度范围为87.0%至96.3%，特异性范围为99.0%至100%。Serodia - HIV的灵敏度范围为85%至98%，特异性范围为88%至98%。在加纳和塞内加尔，HIV - 2的存在影响了灵敏度和特异性。总体而言，肯尼亚的HIV - 1流行率为14.8%，扎伊尔为22.5%，该替代策略的灵敏度分别为96.4%和91.4%，特异性分别为99.6%和100%，阳性预测值分别为97.6%和100%，阴性预测值分别为99.3%和97.9%。采用这种检测形式，与传统的ELISA/蛋白质印迹策略相比，估计平均成本节省高达82%。该程序是标准ELISA/蛋白质印迹组合的合理替代方法。
