A home-based, rapid, sensitive semen analyzer

项目摘要 男性被发现在>40%的病例中导致不孕，并且在30%的病例中是唯一的原因。 精液分析被认为是至关重要的，在许多情况下是男性不育评估的第一手段。 通过测定精子浓度、活力和形态来评价精液质量。手动 基于显微镜的测试和计算机辅助精液分析（CASA）系统是目前的标准 测量精液质量的方法;然而，它们是劳动密集型的，昂贵的，并且基于实验室。一 大多数生育诊所和小医院负担不起昂贵的CASA平台， 市场等使用不太准确和主观的人工方法进行精液分析。CASA技术 需要训练有素的技术人员来产生可靠和可重复的结果。此外，手动测试结果 主观性使得难以比较来自不同诊所的结果。资源有限环境下的不孕症 这也是一个全球性的问题，需要能够提供常规的即时检验。全球卫生专家 使不孕症成为一个主要问题，并表示对低成本和简单的即时检测感兴趣。 此外，大多数男性在输精管切除术后不进行后续精液分析测试。男性 在生育诊所提供精液样本的经验很差。男性必须提供精液样本， 在医院的特殊房间里，他们经常经历压力，尴尬，悲观， 失望一种通过精子计数进行家庭男性不育检测的床旁诊断方法 和运动测量是至关重要的，可以改变不孕症诊断的模式， 在发达国家和发展中国家。据我们所知，目前没有 市场或开发管道中的即时检测，其可以有效、可靠和快速地测量（i） 精子直线和曲线速度，（ii）精子活力和前向活力，以及（iii）精子浓度 以实时的方式。在这里，我们建议开发第一个自动化的，快速的，灵敏的，廉价的 基于智能手机的诊断分析，有可能使男性生育力测试变得容易，容易，快速， 作为女性的怀孕测试。为了解决在开发一个真正的 即时，家庭为基础的精液分析工具，我们发明了一种微芯片技术（国际公用事业 专利号PHC 025685），其独特地集成了（i）使用两个非球面光学元件的独特组合的硬件光学元件 用于图像放大的透镜，（ii）用于易于使用的精液样本处理的新型微流体设计 由非专家用户进行精液分析的WHO指南，以及（iii）一种新的图像处理算法 这使得快速（~5秒），在手机上的图像处理，利用视频记录从未稀释， 未经清洗的人类精液样本

PROJECT SUMMARY Men are found to contribute to infertility in >40% of the cases and are solely the cause in 30% of the cases. Semen analysis is considered critical and in many instances is the first recourse in male infertility evaluation. Seminal quality is evaluated by determining the sperm concentration, motility, and morphology. Manual microscope-based testing and computer-assisted semen analysis (CASA) systems are the current standard methods to measure semen quality; however, they are labor-intensive, expensive, and laboratory-based. A majority of fertility clinics and small hospitals cannot afford the expensive CASA platforms available in the market and so use a less accurate and subjective manual method for semen analysis. CASA technique requires highly trained technicians for producing reliable and repeatable results. Also, manual test results are subjective making it difficult to compare results from different clinics. Infertility in resource-limited settings is also a global issue and being able to provide routine, point-of-care testing is needed. Global health experts have made infertility a major issue and have expressed interest in low-cost and simple point-of-care testing. Further, the majority of men don't go for follow up semen analysis tests after vasectomy procedure. Male experience in giving a semen sample at fertility clinics is poor. Men have to provide semen samples in the special rooms at a hospital, a situation in which they often experience stress, embarrassment, pessimism, and disappointment. A point-of-care diagnostic assay for home-based male infertility detection through sperm count and motility measurement is of paramount importance and can shift the paradigm in infertility diagnosis and management in both developed and developing countries. To the best of our knowledge, there is currently no point-of-care assay in the market or development pipeline that can efficiently, reliably, and rapidly measure (i) sperm linear and curvilinear velocities, (ii) sperm motility and progressive motility, and (iii) sperm concentration in a real-time fashion. Here, we propose to develop the first automated, rapid, sensitive, and inexpensive smartphone-based diagnostic assay with the potential to make men fertility testing as accessible, easy, fast, and private as pregnancy tests for women. To address all of the technical challenges in developing a true point-of-care, home-based semen analysis tool, we have invented a microchip technology (International utility patent# PHC 025685) that uniquely integrates (i) hardware optics using a unique combination of two aspheric lenses for image magnification, (ii) a novel microfluidic design for easy-to-use semen sample handling based on WHO guidelines for semen analysis done by a non-expert user, and (iii) a novel image processing algorithm that enables rapid (~5 seconds), on-phone image processing utilizing videos recorded from undiluted, unwashed human semen samples.