Nearly 7% of the world's population live with a hemoglobin variant. Hemoglobins S, C, and E are the most common and significant hemoglobin variants worldwide. Sickle cell disease, caused by hemoglobin S, is highly prevalent in sub-Saharan Africa and in tribal populations of Central India. Hemoglobin C is common in West Africa, and hemoglobin E is common in Southeast Asia. Screening for significant hemoglobin disorders is not currently feasible in many low-income countries with the high disease burden. Lack of early diagnosis leads to preventable high morbidity and mortality in children born with hemoglobin variants in low-resource settings. Here, we describe HemeChip, the first miniaturized, paper-based, microchip electrophoresis platform for identifying the most common hemoglobin variants easily and affordably at the point-of-care in low-resource settings. HemeChip test works with a drop of blood. HemeChip system guides the user step-by-step through the test procedure with animated on-screen instructions. Hemoglobin identification and quantification is automatically performed, and hemoglobin types and percentages are displayed in an easily understandable, objective way. We show the feasibility and high accuracy of HemeChip via testing 768 subjects by clinical sites in the United States, Central India, sub-Saharan Africa, and Southeast Asia. Validation studies include hemoglobin E testing in Bangkok, Thailand, and hemoglobin S testing in Chhattisgarh, India, and in Kano, Nigeria, where the sickle cell disease burden is the highest in the world. Tests were performed by local users, including healthcare workers and clinical laboratory personnel. Study design, methods, and results are presented according to the Standards for Reporting Diagnostic Accuracy (STARD). HemeChip correctly identified all subjects with hemoglobin S, C, and E variants with 100% sensitivity, and displayed an overall diagnostic accuracy of 98.4% in comparison to reference standard methods. HemeChip is a versatile, mass-producible microchip electrophoresis platform that addresses a major unmet need of decentralized hemoglobin analysis in resource-limited settings.

中文翻译：

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纸基微芯片电泳，用于即时点血红蛋白测试。

世界人口中有将近7％患有血红蛋白变异体。血红蛋白S，C和E是全世界最常见和最重要的血红蛋白变体。由血红蛋白S引起的镰状细胞病在撒哈拉以南非洲和印度中部的部落人群中非常普遍。血红蛋白C在西非很常见，而血红蛋白E在东南亚很常见。在许多疾病负担高的低收入国家，目前尚无法筛查重大的血红蛋白疾病。缺乏早期诊断会导致在资源贫乏地区血红蛋白变异出生的儿童可预防的高发病率和死亡率。在这里，我们介绍HemeChip，这是第一个小型的纸质，微芯片电泳平台，可在资源匮乏的医疗点方便，经济地识别最常见的血红蛋白变体。HemeChip测试可滴血。HemeChip系统通过动画屏幕说明逐步指导用户完成测试过程。血红蛋白的识别和定量是自动进行的，并且以易于理解的客观方式显示血红蛋白的类型和百分比。通过在美国，印度中部，撒哈拉以南非洲和东南亚的临床站点测试768个受试者，我们展示了HemeChip的可行性和高精度。验证研究包括在泰国曼谷进行的血红蛋白E测试，以及在印度恰蒂斯加尔邦和尼日利亚卡诺的血红蛋白S测试，镰刀状细胞疾病的负担是世界上最高的。测试是由本地用户（包括医护人员和临床实验室人员）进行的。研究设计，方法和结果根据报告诊断准确性的标准（STARD）进行介绍。HemeChip正确识别了所有血红蛋白S，C和E变异体的受试者，敏感性为100％，与参考标准方法相比，其总体诊断准确性为98.4％。HemeChip是一种通用的，可大量生产的微芯片电泳平台，可满足资源受限环境中分散血红蛋白分析的主要未满足需求。HemeChip正确识别了所有血红蛋白S，C和E变异体的受试者，敏感性为100％，与参考标准方法相比，其总体诊断准确性为98.4％。HemeChip是一种通用的，可大规模生产的微芯片电泳平台，可满足资源受限环境中对分散血红蛋白分析的主要未满足需求。HemeChip正确识别了所有血红蛋白S，C和E变异体的受试者，敏感性为100％，与参考标准方法相比，其总体诊断准确性为98.4％。HemeChip是一种多功能，可大量生产的微芯片电泳平台，可满足资源受限环境中对分散血红蛋白分析的主要未满足需求。