Abrahim Saro Abdella, Girma Mulu, Habteselassie Abebe, Gezahegn Nigussie, Feleke Altaye, Berheto Tezera Moshago, Demissie Minilik, Belete Wudnesh, Deressa Tekalign
HIV/TB Research and Reference Laboratory Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia,
HIV AIDS (Auckl). 2019 Feb 11;11:17-22. doi: 10.2147/HIV.S184603. eCollection 2019.
Genetic diversities in different countries affect the performance of HIV test kits. Therefore, WHO recommends evaluation of every HIV test kit in countries' context before its use. Therefore, this study aimed to evaluate the performance of Genscreen ULTRA HIV Ag-Ab and Bioelisa.
The study had used 400 characterized plasma samples obtained from CDC Atlanta bio-bank derived from Africa, USA, and Thailand.
Diagnostic performance of both test kits under evaluation was assessed at 95% CI. Genscreen ULTRA HIV Ag-Ab had sensitivity and negative predictive value of 99.5% [95% CI, 97.2-99.9] and the specificity and positive predictive value of 98.5% [95% CI, 95.7-99.7]. Bioelisa HIV test kit had exhibited sensitivity and negative predictive value of 99% [95% CI, 96.4-99.7] and specificity and positive predictive value of 98.5% [95% CI, 95.7-99.7]. Both test kits were able to detect almost all samples with HIV-2, dual infections, and seroconversion.
Both the test kits were highly sensitive and specific in detecting HIV. However, there are still few samples containing HIV antibody which were not identified by both kits. Therefore, additional screening measures should be done in using these assays for blood transfusion and organ transplantation. In addition, the study can be used as a reference by other African countries.
不同国家的基因多样性会影响艾滋病毒检测试剂盒的性能。因此，世界卫生组织建议在使用前根据各国情况对每种艾滋病毒检测试剂盒进行评估。因此，本研究旨在评估Genscreen ULTRA HIV抗原-抗体检测试剂盒和Bioelisa的性能。
本研究使用了400份经过特征鉴定的血浆样本，这些样本取自美国疾病控制与预防中心亚特兰大生物样本库，来源地为非洲、美国和泰国。
在95%置信区间评估了两种待评估检测试剂盒的诊断性能。Genscreen ULTRA HIV抗原-抗体检测试剂盒的灵敏度和阴性预测值为99.5%[95%置信区间，97.2 - 99.9]，特异性和阳性预测值为98.5%[95%置信区间，95.7 - 99.7]。Bioelisa艾滋病毒检测试剂盒的灵敏度和阴性预测值为99%[95%置信区间，96.4 - 99.7]，特异性和阳性预测值为98.5%[95%置信区间，95.7 - 99.7]。两种检测试剂盒都能够检测几乎所有的HIV-2样本、双重感染样本和血清转化样本。
两种检测试剂盒在检测艾滋病毒方面都具有高度的敏感性和特异性。然而，仍有少数含有艾滋病毒抗体的样本未被两种试剂盒检测出来。因此，在将这些检测方法用于输血和器官移植时，应采取额外的筛查措施。此外，该研究可为其他非洲国家提供参考。
