An evaluation of the commonly used portable medical sensors performance in comparison to clinical test results for telehealth systems

Rafiqul Islam Maruf , Saori Tou , Rieko Izukura , Yoko Sato , Mariko Nishikitani , Kimiyo Kikuchi , Fumihiko Yokota , Subaru Ikeda , Rakibul Islam , Ashir Ahmed , Masashi Miyazaki , Naoki Nakashima
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Abstract

Background and Objective

One of the primary challenges faced by telehealth systems is the accurate transmission of patient information to remote doctors. In this context, portable medical sensors deployed at the remote patients' end play a crucial role in measuring vital information. There are many sensors available in the market. However, the accuracy of the sensors has been always a concern. The objective of this study is to verify different sensors and create awareness for using accurate sensors to avoid misdiagnosis for the patients’ safety.

Methods

This study considered the test result of a Japanese clinical pathology laboratory as the reference gold standard. The clinical pathology laboratory uses 1) Hexokinase UV method for blood glucose, 2) Enzymatic Determination method for cholesterol, 3) Automatic Analyzer (EDTA-2 K) of Hemoglobin, and 4) Uricase POD method for uric acid. To assess the performance of a medical sensor, its test results were compared to the gold standard test results obtained from the laboratory using the same sample. A Normalized Root Mean Square Error (NRMSE) threshold of less than 0.2 was established as the criterion for determining whether the medical sensor's performance fell within an acceptable range.

Results

Among the eight most commonly used blood glucose devices in the Asian market, only one device was deemed acceptable with NRMSE less than 0.2. However, all four devices found in the Japanese market showed their acceptability. In the case of cholesterol, hemoglobin, and uric acid devices, only a limited number of items were available in Asian markets. Some of the hemoglobin and uric acid devices were found to be somewhat acceptable, while all the cholesterol sensors were found erroneous.

Conclusions

This study has clearly shown the issues with the portable medical sensors and recommends the device approval authority of each country to approve sales of the quality sensors only for patients’ safety.

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将常用便携式医疗传感器的性能与远程医疗系统的临床测试结果进行对比评估
背景与目标 远程医疗系统面临的主要挑战之一是向远程医生准确传输病人信息。在这种情况下,部署在远程患者端的便携式医疗传感器在测量重要信息方面发挥着至关重要的作用。市场上有许多传感器。然而,传感器的准确性一直是个问题。本研究的目的是验证不同的传感器,提高人们使用准确传感器的意识,以避免误诊,保障患者的安全。该临床病理实验室使用 1) 紫外光六磷酸酶法检测血糖,2) 酶法测定胆固醇,3) 自动分析仪(EDTA-2 K)检测血红蛋白,4) 尿酸酶 POD 法检测尿酸。为评估医疗传感器的性能,将其测试结果与实验室使用相同样本获得的金标准测试结果进行比较。结果在亚洲市场最常用的八种血糖设备中,只有一种设备的归一化均方根误差(NRMSE)小于 0.2,被认为是可以接受的。然而,日本市场上的所有四种血糖仪都显示出其可接受性。至于胆固醇、血红蛋白和尿酸检测仪,亚洲市场上只有少量产品。这项研究清楚地表明了便携式医疗传感器存在的问题,建议各国的设备审批机构只批准销售高质量的传感器,以确保患者的安全。
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CiteScore
5.90
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0.00%
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审稿时长
10 weeks
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