Laboratoire de Biologie Moléculaire et Cellulaire (LABMC), Université des Sciences et Techniques de Masuku, BP 943, Franceville, Gabon.
Centre Hospitalier Régional Georges RAWIRI (CHRGR), Lambaréné, Gabon.
Pan Afr Med J. 2022 Jul 11;42:194. doi: 10.11604/pamj.2022.42.194.35035. eCollection 2022.
in order to promote rapid care of HIV-positive people and to reduce the human immunodeficiency virus (HIV) transmission in Gabon, the national screening algorithm is essentially based on rapid diagnostic tests (RDTs). However, most of these RDTs are not evaluated. Their sensitivities and specificities remain unknown locally. The aim of this study was to determine the diagnostic performance of 3 RDTs used for HIV-1> screening in Gabon.
of the one hundred and sixteen (116) samples tested, 60 plasmas were HIV-1 positive with known genotypes and viral loads; 51 sera were HIV-1 negative while 5 had an undetermined serological status. All the samples were tested by quantitative RT-PCR (Gold standard) and by the following RDTs: Vikia, Alere Combo and Alere Determine. The sensitivities and specificities of the different RDTs were calculated using Epi Info version 6.04dfr. The level of agreement between tests was determined by Cohen´s Kappa test.
the three RDTs´ sensitivity according to HIV-1/M subtypes was 100% (95% CI: 92.6-100) while their specificities ranged from 94.6% (95% CI: 84.2-98.6) for the Vikia test to 96.4% (95% CI: 86.6-99.4) for the Alere Combo and Alere Determine tests, respectively. The concordances between the three RDTs were excellent with kappa values ranging from 0.931 (95% CI: 0.864-0.977) to 0.948 (95% CI: 0.890-1.00).
the three RDTs showed a maximum sensitivity of 100% and specificities ranging from 94.6% to 96.4%. The specificities obtained with these RDTs are lower than those recommended by the WHO for their inclusion in an HIV-1 screening algorithm.
为了促进艾滋病毒阳性者的快速护理，并减少加蓬的人类免疫缺陷病毒（HIV）传播，国家筛选算法主要基于快速诊断检测（RDT）。然而，这些 RDT 中的大多数都没有经过评估。其敏感性和特异性在当地尚不清楚。本研究旨在确定三种用于加蓬 HIV-1 筛查的 RDT 的诊断性能。
在 116 个测试样本中，60 个血浆 HIV-1 呈阳性，已知基因型和病毒载量；51 个血清 HIV-1 呈阴性，5 个血清学状态不确定。所有样本均通过定量 RT-PCR（金标准）和以下 RDT 进行检测：Vikia、Alere Combo 和 Alere Determine。使用 Epi Info 版本 6.04dfr 计算不同 RDT 的敏感性和特异性。通过 Cohen's Kappa 检验确定试验间的一致性。
三种 RDT 对 HIV-1/M 亚型的敏感性均为 100%（95%CI：92.6-100），特异性分别为 94.6%（95%CI：84.2-98.6）用于 Vikia 测试，96.4%（95%CI：86.6-99.4）用于 Alere Combo 和 Alere Determine 测试。三种 RDT 之间的一致性极好，kappa 值范围为 0.931（95%CI：0.864-0.977）至 0.948（95%CI：0.890-1.00）。
三种 RDT 的敏感性均达到 100%，特异性在 94.6%至 96.4%之间。这些 RDT 的特异性低于世界卫生组织推荐用于 HIV-1 筛选算法的特异性。
