Characteristics of a rapid, point-of-care lateral flow immunoassay for the diagnosis of sickle cell disease.
Characteristics of a rapid, point-of-care lateral flow immunoassay for the diagnosis of sickle cell disease.
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DOI：
10.1002/ajh.24232
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发表时间：
2016-02
影响因子：
12.8
通讯作者：
Ware RE
中科院分区：
文献类型：
--
作者：
McGann PT;Schaefer BA;Paniagua M;Howard TA;Ware RE
镰状细胞病 (SCD) 是一种常见且危及生命的血液疾病，每年影响全球约 400,000 名新生儿。大多数 SCD 出生发生在资源匮乏的国家，特别是在撒哈拉以南非洲地区，这些国家获得准确诊断的机会有限，导致早期死亡。我们评估了一种新型、快速、低成本的即时护理 (POC) 诊断设备 (Sickle SCAN™) 原型免疫测定，旨在识别 HbA、HbS 和 HbC。三名蒙面观察员对总共 139 份血液样本进行了评分，并与毛细管区带电泳的结果进行了比较。检测 HbA、HbS 和 HbS 存在的灵敏度 (98.3–100%) 和特异性 (92.5–100%) 非常出色。该测试显示，诊断 HbSS 疾病的敏感性为 98.4%，特异性为 98.6%，诊断 HbSC 疾病的敏感性和特异性为 100%。大多数变异血红蛋白，包括具有高浓度 HbF 的样品，不会干扰检测 HbS 或 HbC 的能力。此外，HbS 和 HbC 在浓度低至 1-2% 时也能准确检测到。干燥的血斑样本产生清晰的阳性条带，且不损失敏感性或特异性，并且在 37°C 下储存的设备可提供可靠的结果。这些分析表明，Sickle SCAN POC 设备简单、快速且稳定，对于 HbA、HbS 和 HbC 检测具有高灵敏度和特异性。能够利用液体血液和干血斑（包括新生儿高 HbF 表型的血斑）获得快速、准确的结果，表明该 POC 设备适用于大规模筛查，并有可能在资源有限的情况下准确诊断 SCD。
Sickle cell disease (SCD) is a common and life-threatening hematological disorder, affecting approximately 400,000 newborns annually worldwide. Most SCD births occur in low-resource countries, particularly in sub-Saharan Africa, where limited access to accurate diagnostics results in early mortality. We evaluated a prototype immunoassay as a novel, rapid, and low-cost point-of-care (POC) diagnostic device (Sickle SCAN™) designed to identify HbA, HbS, and HbC. A total of 139 blood samples were scored by three masked observers and compared to results using capillary zone electrophoresis. The sensitivity (98.3–100%) and specificity (92.5–100%) to detect the presence of HbA, HbS, and HbS were excellent. The test demonstrated 98.4% sensitivity and 98.6% specificity for the diagnosis of HbSS disease and 100% sensitivity and specificity for the diagnosis of HbSC disease. Most variant hemoglobins, including samples with high concentrations of HbF, did not interfere with the ability to detect HbS or HbC. Additionally, HbS and HbC were accurately detected at concentrations as low as 1–2%. Dried blood spot samples yielded clear positive bands, without loss of sensitivity or specificity, and devices stored at 37°C gave reliable results. These analyses indicate that the Sickle SCAN POC device is simple, rapid, and robust with high sensitivity and specificity for the detection of HbA, HbS, and HbC. The ability to obtain rapid and accurate results with both liquid blood and dried blood spots, including those with newborn high-HbF phenotypes, suggests that this POC device is suitable for large-scale screening and potentially for accurate diagnosis of SCD in limited resource settings.
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