HIV-1 Molecular Epidemiology Laboratory, Microbiology and Parasitology Department, Hospital Universitario Ramón y Cajal-IRyCIS and CIBERESP, Madrid, Spain.
Hospital Universitario de Getafe, Madrid, Spain.
J Clin Virol. 2015 Feb;63:66-9. doi: 10.1016/j.jcv.2014.12.018. Epub 2014 Dec 27.
Confirmatory assays for HIV diagnosis are not well implemented in low-income countries with limited infrastructures. Geenius™ HIV 1/2 Confirmatory Assay is a single-use immunochromatographic test for the confirmation and differentiation of individual HIV-1/2 antibodies validated in venous whole blood, serum and plasma. However, dried blood specimens (DBS) are easier to collect, store and transport than plasma/serum in remote settings from limited resource countries and mobile populations.
To evaluate the confirmatory assay Geenius™ HIV 1/2 for HIV diagnosis using DBS specimens.
We collected DBS from 70 Guinean women previously diagnosed as HIV-1 infected by rapid tests using whole blood samples in Equatorial Guinea and from 25 HIV-negative Guinean women and HIV-exposed infants diagnosed by molecular testing in Madrid. Geenius HIV 1/2 was performed by eluting two drops of dried blood from each patient and following the manufacturer instructions for the assay but using 40μl of the eluted blood as specimen. The results obtained were confirmed by western blot.
Geenius™ HIV 1/2 successfully confirmed the HIV-1 positive and negative infection in all tested DBS specimens, providing 100% specificity [95% Confidence Interval (CI): 86.2%-100%]. No HIV 1/2 coinfections were found in the study cohort. This is the first report that proves a good performance of Geenius™ HIV 1/2 for the HIV-1 infection confirmation using only two drops of dried blood.
Our results approve the utility of this confirmatory assay using DBS when a lack of adequate infrastructure to collect, store or transport plasma/serum is found. DBS are a practical alternative to plasma/serum for HIV serological diagnosis.
基础设施有限的低收入国家并未很好地实施 HIV 诊断的确认性检测。Geenius™ HIV 1/2 确认检测试剂盒是一种单试剂免疫层析试验,用于确认和区分个体 HIV-1/2 抗体,已在静脉全血、血清和血浆中得到验证。然而,在资源有限的偏远地区和流动人群中,与血浆/血清相比,干血斑(DBS)更易于采集、储存和运输。
评估 Geenius™ HIV 1/2 确认检测试剂盒用于 DBS 标本的 HIV 诊断。
我们收集了来自赤道几内亚的 70 名之前使用全血样本的快速检测诊断为 HIV-1 感染的几内亚女性和来自马德里的 25 名 HIV 阴性几内亚女性和 HIV 暴露婴儿的 DBS,他们通过分子检测诊断。按照制造商的说明,用洗脱液洗脱每个患者的两滴血,用于检测,但洗脱液的标本用量为 40μl。所得结果用 Western blot 确认。
Geenius™ HIV 1/2 成功确认了所有检测的 DBS 标本中的 HIV-1 阳性和阴性感染,特异性为 100%[95%置信区间(CI):86.2%-100%]。研究队列中未发现 HIV 1/2 合并感染。这是首次证明仅使用两滴血的干血斑即可证明 Geenius™ HIV 1/2 用于 HIV-1 感染确认的良好性能。
当发现缺乏采集、储存或运输血浆/血清的适当基础设施时,我们的结果证明了这种使用 DBS 的确认检测试剂盒的实用性。DBS 是 HIV 血清学诊断的一种实用替代方法。