A home-based, rapid, sensitive semen analyzer

家用、快速、灵敏的精液分析仪

• 批准号: 9375217
• 负责人: Hadi Shafiee
• 金额: $ 26.63万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-11 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9375217
• 关键词: Address; Affect; Algorithms; Anemia; Bedside Testings; Biological Assay; Caring; Cellular Phone; Chronic; Clinic; Clinical; Computer Assisted; Computer software; Cushing Syndrome; Detection; Developing Countries; Development; Diabetes Mellitus; Diagnosis; Diet Habits; Evaluation; Fertility; Goals; Guidelines; Home environment; Hospitals; Human; Image; Infertility; International; Kidney Diseases; Laboratories; Legal patent; Liver diseases; Male Infertility; Manuals; Measurement; Measures; Medical; Methods; Microfluidic Microchips; Microfluidics; Microscope; Morphology; Optics; Patients; Pharmaceutical Preparations; Phonation; Pregnancy Tests; Privatization; Procedures; Process; Resources; Sampling; Seminal; Seminal fluid; Sensitivity and Specificity; Smoking; Sperm Count Procedure; Sperm Motility; Stress; Systems Analysis; Techniques; Technology; Telephone; Test Result; Testing; Thyroid Diseases; Time; Training; Urologist; Vasectomy; Visit; Weight; Woman; base; cell motility; cost; design; diagnostic assay; experience; follow-up; global health; image processing; interest; lens; male; man; men; microchip; novel; point of care; point-of-care diagnostics; portability; screening; sperm analysis; sperm cell; tool; user-friendly

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.

项目概要 研究发现，超过 40% 的不孕不育病例中，男性是造成不孕的原因之一，而 30% 的不孕不育病例中，男性是唯一的原因。 精液分析被认为至关重要，在许多情况下是男性不育症评估的首要手段。 精液质量通过测定精子浓度、活力和形态来评估。手动的 基于显微镜的测试和计算机辅助精液分析（CASA）系统是当前的标准 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。一个 大多数生育诊所和小型医院无法负担昂贵的 CASA 平台 市场，因此使用不太准确和主观的手动方法进行精液分析。 CASA技术 需要训练有素的技术人员才能产生可​​靠且可重复的结果。另外，手动测试结果是 主观性使得很难比较不同诊所的结果。资源有限环境中的不孕症是 这也是一个全球性问题，需要能够提供常规的现场护理测试。全球健康专家 使不孕不育成为一个主要问题，并表示对低成本和简单的护理点检测感兴趣。 此外，大多数男性在输精管结扎手术后不会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 在医院的特殊病房里，他们经常会感到压力、尴尬、悲观和 失望。通过精子计数进行家庭男性不育检测的护理点诊断分析 活力测量至关重要，可以改变不孕症诊断和治疗的范式 发达国家和发展中国家的管理。据我们所知，目前尚无 市场或开发管道中的即时检测，可以高效、可靠和快速地测量 (i) 精子线性和曲线速度，(ii) 精子活力和渐进活力，以及 (iii) 精子浓度 以实时方式。在这里，我们建议开发第一个自动化、快速、灵敏且廉价的 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、简单、快速、 以及针对女性的私人妊娠测试。解决开发真正的技术挑战 护理点、家庭精液分析工具，我们发明了微芯片技术（国际实用程序） 专利# PHC 025685），使用两个非球面的独特组合独特地集成了（i）硬件光学器件 用于图像放大的透镜，(ii) 一种新颖的微流体设计，用于基于易于使用的精液样本处理 世界卫生组织关于由非专家用户进行精液分析的指南，以及 (iii) 一种新颖的图像处理算法 利用未稀释录制的视频实现快速（约 5 秒）电话图像处理， 未清洗的人类精液样本。