Biswas Sujay K, Chatterjee Subhamoy, Bandyopadhyay Soumya, Kar Shantimoy, Som Nirmal K, Saha Satadal, Chakraborty Suman
School of Medical Science and Technology, Indian Institute of Technology Kharagpur, Kharagpur 721302, India.
Electronics and Electrical Communication Engineering, Indian Institute of Technology Kharagpur, Kharagpur 721302, India.
ACS Sens. 2021 Mar 26;6(3):1077-1085. doi: 10.1021/acssensors.0c02361. Epub 2021 Feb 26.
We report a simple, affordable (∼0.02 US $/test), rapid (within 5 min), and quantitative paper-based sensor integrated with smartphone application for on-spot detection of hemoglobin (Hgb) concentration using approximately 10 μL of finger-pricked blood. Quantitative analytical colorimetry is achieved via an Android-based application (Sens-Hb), integrating key operational steps of image acquisition, real-time analysis, and result dissemination. Further, feedback from the machine learning algorithm for adaptation of calibration data offers consistent dynamic improvement for precise predictions of the test results. Our study reveals a successful deployment of the extreme point-of-care test in rural settings where no infrastructural facilities for diagnostics are available. The Hgb test device is validated both in the controlled laboratory environment ( = 200) and on the field experiments ( = 142) executed in four different Indian villages. Validation results are well correlated with the pathological gold standard results ( = 0.9583) with high sensitivity and specificity for the healthy ( = 136) (>11 g/dL) (specificity: 97.2%), mildly anemic ( = 55) (<11 g/dL) (sensitivity: 87.5%, specificity: 100%), and severely anemic (n = 9) (<7 g/dL) (sensitivity: 100%, specificity: 100%) samples. Results from field trials reveal that only below 5% cases of the results are interpreted erroneously by classifying mildly anemic patients as healthy ones. On-field deployment has unveiled the test kit to be extremely user friendly that can be handled by minimally trained frontline workers for catering the needs of the underserved communities.
我们报告了一种简单、经济实惠（约0.02美元/测试）、快速（5分钟内）且定量的纸质传感器，该传感器与智能手机应用程序集成，可使用约10微升指尖采血进行血红蛋白（Hgb）浓度的现场检测。通过基于安卓的应用程序（Sens-Hb）实现定量分析比色法，该程序集成了图像采集、实时分析和结果传播等关键操作步骤。此外，机器学习算法用于校准数据适配的反馈为测试结果的精确预测提供了持续的动态改进。我们的研究表明，在没有诊断基础设施的农村地区成功部署了即时检测。Hgb检测设备在受控实验室环境（n = 200）和在印度四个不同村庄进行的现场实验（n = 142）中均得到验证。验证结果与病理金标准结果高度相关（r = 0.9583），对健康人群（n = 136）（>11 g/dL）具有高灵敏度和特异性（特异性：97.2%），对轻度贫血人群（n = 55）（<11 g/dL）（灵敏度：87.5%，特异性：100%）以及重度贫血人群（n = 9）（<7 g/dL）（灵敏度：100%，特异性：100%）样本也是如此。现场试验结果表明，将轻度贫血患者误分类为健康患者的情况仅占结果的5%以下。现场部署表明该检测试剂盒极其用户友好，经过最少培训的一线工作人员即可操作，以满足服务不足社区的需求。
