Kone Bourahima, Sarro Yeya S, Baya Bocar, Dabitao Djeneba, Coulibaly Nadie, Wague Mamadou, Diarra Bassirou, Guindo Oumar, Sanogo Moumine, Togo Antieme Cg, Kone Amadou, Goita Drissa, Diabate Seydou, Kodio Ousmane, Belson Michael, Dao Sounkalo, Orsega Susan, Murphy Robert L, Diallo Souleymane, Doumbia Seydou, Siddiqui Sophia, Maiga Mamoudou
University Clinical Research Center (UCRC) - SEREFO Laboratory, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
National Institute of Allergic and Infectious Diseases (NIAID), Bethesda, Maryland, USA.
Infect Dis Diagn Treat. 2019;3(1). Epub 2019 Dec 18.
Diagnosis of HIV infections in resource-limited countries like Mali is based on Rapid Diagnostic Tests (RDTs). The RDTs are diagnostic assays designed for use at the Point-Of-Care (POC), which is quick, cost-effective and easy to perform. However, in these countries, the tests are commonly used without any initial evaluation or monitoring of their performance despite high levels of HIV strain diversity and rapid evolution of the virus. In this study, the reliability and accuracy of HIV RDTs (Determine, Multispot, SD Bioline) used in Mali, where HIV-1 and HIV-2 co-exist, were evaluated from August 2004 to November 2017. A total of 1303 samples from new HIV-suspect patients in Bamako were tested for HIV-1 and HIV-2 using the RDT Determine, followed by ELISA and Western Blot (WB). The Determine test showed a robust diagnostic sensitivity of 98.7% [CI 95: 97.59-99.37] and a diagnostic specificity of 99.2% [CI 95: 98.22-99.67]. The Multispot assay showed a diagnostic sensitivity of 98.77% [CI 95: 97.59-99.37] and a diagnostic specificity of 99.2% [CI 95: 98.22-99.67]. The diagnostic sensitivity and specificity of SD Bioline HIV-1/2 were 100% [CI 95:72.25-100] and 88.89% [CI 95: 56.50- 98.71], respectively. These data indicate excellent performance for HIV RDTs in Mali and we recommend the use of Determine HIV-1/2 for HIV screening and Multispot™ for discriminating HIV-2 from HIV-1 infections.
在像马里这样资源有限的国家，艾滋病毒感染的诊断基于快速诊断检测（RDT）。RDT是设计用于即时检测（POC）的诊断检测方法，具有快速、经济高效且易于操作的特点。然而，在这些国家，尽管艾滋病毒毒株多样性高且病毒快速演变，但这些检测通常在没有对其性能进行任何初始评估或监测的情况下使用。在本研究中，对2004年8月至2017年11月期间在艾滋病毒-1和艾滋病毒-2共存的马里使用的艾滋病毒RDT（Determine、Multispot、SD Bioline）的可靠性和准确性进行了评估。使用RDT Determine对来自巴马科新的疑似艾滋病毒患者的总共1303份样本进行了艾滋病毒-1和艾滋病毒-2检测，随后进行酶联免疫吸附测定（ELISA）和免疫印迹法（WB）。Determine检测显示出强大的诊断敏感性为98.7%[95%置信区间：97.59 - 99.37]，诊断特异性为99.2%[95%置信区间：98.22 - 99.67]。Multispot检测显示诊断敏感性为98.77%[95%置信区间：97.59 - 99.37]，诊断特异性为99.2%[95%置信区间：98.22 - 99.67]。SD Bioline艾滋病毒-1/2的诊断敏感性和特异性分别为100%[95%置信区间：72.25 - 100]和88.89%[95%置信区间：56.50 - 98.71]。这些数据表明艾滋病毒RDT在马里表现出色，我们建议使用Determine艾滋病毒-1/2进行艾滋病毒筛查，并使用Multispot™区分艾滋病毒-2和艾滋病毒-1感染。
