Evaluation of a Density-Based Rapid Diagnostic Test for Sickle Cell Disease in a Clinical Setting in Zambia
Evaluation of a Density-Based Rapid Diagnostic Test for Sickle Cell Disease in a Clinical Setting in Zambia
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DOI：
10.1371/journal.pone.0114540
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发表时间：
2014-12-09
期刊：
影响因子：
3.7
通讯作者：
Whitesides, George M.
中科院分区：
文献类型：
--
作者：
Kumar, Ashok A.;Chunda-Liyoka, Catherine;Whitesides, George M.
虽然许多发展中国家存在简单和低成本的镰状细胞病干预措施，但与镰状细胞病相关的儿童死亡率仍然很高，部分原因是缺乏获得镰状细胞病诊断测试的机会。基于密度的测试使用水相系统（SCD-AMPS）是一个候选人的低成本，即时诊断SCD。在本文中，SCD-AMPS在赞比亚的一个大的病例对照研究（n=505）的现场评价进行了说明。在所用的两种SCD-AMPS中，最佳系统（SCD-AMPS-2）的灵敏度为86%（82-90%），特异性为60%（53-67%）。随后的分析确定了假阳性的潜在来源，包括凝血、SCD-AMPS批次之间的差异和运输条件。重要的是，SCD-AMPS-2在6个月至1岁儿童中检测SCD的灵敏度为84%（62-94%）。除了业绩评价外，还与赞比亚农村诊所的保健工作者一起对最终用户的可操作性进行了评估。这些卫生工作者认为SCD-AMPS检测与疟疾和艾滋病毒的侧流检测一样简单易用。
Although simple and low-cost interventions for sickle cell disease (SCD) exist in many developing countries, child mortality associated with SCD remains high, in part, because of the lack of access to diagnostic tests for SCD. A density-based test using aqueous multiphase systems (SCD-AMPS) is a candidate for a low-cost, point-of-care diagnostic for SCD. In this paper, the field evaluation of SCD-AMPS in a large (n=505) case-control study in Zambia is described. Of the two variations of the SCD-AMPS used, the best system (SCD-AMPS-2) demonstrated a sensitivity of 86% (82-90%) and a specificity of 60% (53-67%). Subsequent analysis identified potential sources of false positives that include clotting, variation between batches of SCD-AMPS, and shipping conditions. Importantly, SCD-AMPS-2 was 84% (62-94%) sensitive in detecting SCD in children between 6 months and 1 year old. In addition to an evaluation of performance, an assessment of end-user operability was done with health workers in rural clinics in Zambia. These health workers rated the SCD-AMPS tests to be as simple to use as lateral flow tests for malaria and HIV.