Tsao Yu-Ting, Yang Chung-Yao, Wen Yun-Chiao, Chang Ting-Chang, Matsuura Koji, Chen Yu, Cheng Chao-Min
Institute of Biomedical Engineering National Tsing Hua University Hsinchu Taiwan.
Department of Education Chang Gung Memorial Hospital Linkou Branch Taoyuan Taiwan.
Bioeng Transl Med. 2020 Aug 18;6(1):e10176. doi: 10.1002/btm2.10176. eCollection 2021 Jan.
Male infertility affects millions of males worldwide and is rising in prevalence due to social and environmental conditions. However, men often feel too embarrassed to receive a semen analysis in the hospital due to social stigmas. To overcome this problem, we developed a 3-(4,5-Dimethyl-2-thiazolyl)-2,5-diphenyl-2H-tetrazolium bromide test strip to distinguish semen samples with low total motile sperm concentration from those with normal motile sperm concentration. This is a point-of-care colorimetric semen analytical method with a one-step, inexpensive, equipment-free evaluation process, and adequate accuracy validated in a 42-sample clinical trial. In this study, results were evaluated visually and with a smartphone application. Using visual observation methods, the area under the curve (AUC) was 0.71 (95% of confidence interval = 0.55-0.86; = 0.021), sensitivity was 41%, specificity was 95%, positive predictive value was 90%, negative predictive value (NPV) was 59.4%, and accuracy was 67%. Using a smartphone recording and analytical system, AUC was 0.766 (95% of confidence interval = 0.612-0.92; = 0.003), sensitivity was 96%, specificity was 65%, PPV was 75%, NPV was 92.9%, and accuracy was 80.9%. This work demonstrated a screening tool that could elevate semen analysis to the level of routine healthcare and provide for private, in-home self-assessment.
男性不育影响着全球数百万男性，并且由于社会和环境因素，其患病率正在上升。然而，由于社会 stigma，男性往往羞于在医院接受精液分析。为了克服这个问题，我们开发了一种 3-(4,5-二甲基-2-噻唑基)-2,5-二苯基-2H-四氮唑溴盐测试条，以区分总活动精子浓度低的精液样本和活动精子浓度正常的精液样本。这是一种即时检测的比色精液分析方法，具有一步式、低成本、无需设备的评估过程，并且在一项 42 样本的临床试验中验证了足够的准确性。在本研究中，通过视觉和智能手机应用程序对结果进行评估。使用视觉观察方法，曲线下面积（AUC）为 0.71（95%置信区间 = 0.55 - 0.86；P = 0.021），敏感性为 41%，特异性为 95%，阳性预测值为 90%，阴性预测值（NPV）为 59.4%，准确性为 67%。使用智能手机记录和分析系统，AUC 为 0.766（95%置信区间 = 0.612 - 0.92；P = 0.003），敏感性为 96%，特异性为 65%，PPV 为 75%，NPV 为 92.9%，准确性为 80.9%。这项工作展示了一种筛查工具，它可以将精液分析提升到常规医疗保健水平，并提供私密的家庭自我评估。
