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; p = 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; p = 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.

中文翻译：

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通过智能手机和纸质比色诊断设备对不孕症患者进行即时精液分析

男性不育症影响着全世界数百万男性，并且由于社会和环境条件的影响，其患病率正在上升。然而，由于社会耻辱，男性常常感到尴尬而不敢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-四唑溴化物试纸，用于区分总活动精子浓度低的精液样本与正常活动精子的精液样本专注。这是一种护理点比色精液分析方法，具有一步、廉价、无需设备的评估过程，并且在 42 个样本的临床试验中验证了足够的准确性。在这项研究中，结果通过视觉和智能手机应用程序进行评估。采用目视观察方法，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%，阴性预测值为净现值（NPV）为59.4%，准确度为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%，准确度为80.9%。这项工作展示了一种筛查工具，可以将精液分析提升到常规医疗保健的水平，并提供私人的家庭自我评估。