Kashosi Théophile Mitima, Kyambikwa Céléstin Bisangamo, Mulongo Philémon Mbarabara, Nachega Jean Bisimwa
Evangelic University in Africa, Bukavu, Democratic Republic of the Congo.
Institute of Higher Education for Medical Techniques, Bukavu, Democratic Republic of the Congo.
J Infect Dev Ctries. 2018 Jun 30;12(6):471-476. doi: 10.3855/jidc.9774.
Rapid diagnostic tests (RDTs) are widely used for point-of-care. point-of-care diagnosis of HIV infection in resource-limited settings. However, there are no data about their field diagnostic performance in Eastern Democratic Republic of the Congo (DRC), especially in the context of blood banks screening for transfusion safety purpose.
Blood specimens were collected from blood donors in Bukavu, Eastern DRC, from May the 1st to June the 30th, 2015, to evaluate the accuracy of Alere Determine HIV-1/2, Trinity Biotech Uni-Gold HIV, and DoubleCheckGold Ultra HIV 1 and 2 compared to the laboratory-based 4th generation ELISA apDia HIV Ag/Ab assay. Sensitivity, specificity, positive and negative predictive values, and related 95% confidence intervals were calculated using MedCalc statistical software version 15.1. Reliability was evaluated using Cohen's Kappa Statistic, K.
Among 312 participants who provided blood bags, 96/312 (30.7%) were female and the mean age (SD) was 31.7 years (±8.1 years). Sensitivity for the three tests was 57.1% (95% CI: 18.4-90.1). The specificity was 99.7% (95% CI: 18.4-90.1) for Alere Determine HIV 1/2, 100% (95% CI: 98.8-100.0) for Uni-Gold HIV, and (100% (95% CI: 98.8-100.0) for DoubleCheckGold Ultra HIV 1 and 2. Cohen's Kappa Statistic showed moderate agreement between the 4th generation ELISA apDia HIV Ag/Ab and RDTs Alere Determine HIV 1/2 and Uni-Gold HIV (K = 0.66; 95% CI: 0.55-0.76) but good agreement for DoubleCheckGold Ultra HIV 1 and 2 (K = 0.72; 95% CI: 0.61-0.82).
Compared to the laboratory-based ELISA apDia HIV Ag/Ab assay, the currently used 3rd generation HIV RDTs showed poor field accuracy results in a context of blood donors screening. These data support the need for 4th generation Ag-Ab RDTs in transfusion blood qualification.
快速诊断检测（RDTs）广泛用于资源有限环境下的即时护理点艾滋病毒感染诊断。然而，在刚果民主共和国东部（DRC），尚无关于其现场诊断性能的数据，尤其是在血库出于输血安全目的进行筛查的背景下。
于2015年5月1日至6月30日从刚果民主共和国东部布卡武的献血者中采集血样，以评估Alere Determine HIV-1/2、Trinity Biotech Uni-Gold HIV以及DoubleCheckGold Ultra HIV 1和2与基于实验室的第4代ELISA apDia HIV Ag/Ab检测相比的准确性。使用MedCalc统计软件版本15.1计算敏感性、特异性、阳性和阴性预测值以及相关的95%置信区间。使用科恩kappa统计量（K）评估可靠性。
在提供血袋的312名参与者中，96/312（30.7%）为女性，平均年龄（标准差）为31.7岁（±8.1岁）。这三种检测的敏感性为57.1%（95%置信区间：18.4 - 90.1）。Alere Determine HIV 1/2的特异性为99.7%（95%置信区间：18.4 - 90.1），Uni-Gold HIV的特异性为100%（95%置信区间：98.8 - 100.0），DoubleCheckGold Ultra HIV 1和2的特异性为100%（95%置信区间：98.8 - 100.0）。科恩kappa统计量显示，第4代ELISA apDia HIV Ag/Ab与RDTs中的Alere Determine HIV 1/2和Uni-Gold HIV之间存在中度一致性（K = 0.66；95%置信区间：0.55 - 0.76），但与DoubleCheckGold Ultra HIV 1和2之间存在良好一致性（K = 0.72；95%置信区间：0.61 - 0.82）。
与基于实验室的ELISA apDia HIV Ag/Ab检测相比，目前使用的第3代艾滋病毒RDTs在献血者筛查背景下显示出较差的现场准确性结果。这些数据支持在输血血液鉴定中需要第4代抗原 - 抗体RDTs。
