Low cost, automated smartphone based assay for semen analysis

用于精液分析的低成本、基于智能手机的自动化检测

• 批准号: 10028296
• 负责人: KUMAR SUBRAMANIAN
• 金额: --
• 依托单位: PHOENIX BIOSYSTEM, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-07 至 2020-06-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10028296
• 关键词: American; Biological Assay; Capital; Cellular Phone; Clinic; Clinic Visits; Clinical; Computer Assisted; Custom; Data; Detection; Developed Countries; Developing Countries; Development; Devices; Diagnosis; Diagnostic tests; Evaluation; Feedback; Female; Fertility; Focus Groups; Freezing; Funding; Galaxy; General Hospitals; Gold; Grant; Health; Home environment; Image; Infertility; Intervention; Laboratories; Laboratory Personnel; Male Infertility; Manuals; Massachusetts; Methods; Microscopic; Modeling; Monitor; Needs Assessment; Optics; Patients; Phase; Predictive Value; Pregnancy Tests; Preparation; Process; Reporting; Reproducibility; Reproductive Health; Sampling; Seminal fluid; Sensitivity and Specificity; Slide; Small Business Innovation Research Grant; Specificity; Stains; System; Technical Expertise; Technology; Testing; Untrained Personnel; Validation; base; blind; cell motility; convolutional neural network; cost; design; infertility treatment; interest; male; male fertility; medical attention; meetings; men; microchip; neural network architecture; point-of-care diagnostics; prototype; smartphone Application; sperm analysis; sperm cell; sperm morphology; testing services

PROJECT SUMMARY Consumers are increasingly interested in knowing more about their own health. One of the most familiar direct to-consumer diagnostic tests has been the home pregnancy test. We report a practical approach towards developing a new point-of-care diagnostic test for another reproductive health need—the assessment of male fertility. Traditionally, men are less likely to seek medical attention for fertility concerns than their female partners (although millennial males are more interested in fertility testing). A delay in diagnosis of male factor infertility may prolong the infertility treatment process for the couple and result in unnecessary interventions for the female partner. Manual microscopic testing and computer-assisted semen analysis (CASA) technology are expensive and require significant technical skill to use. The idea of an at-home, affordable testing platform to screen for an abnormal semen analysis would obviate the need for a clinic visit and provide preliminary data to guide referrals. Our prototype device has been extensively tested with clinical semen samples. The preliminary results presented are robust and unbiased and patient results are based on blind evaluation of the technology by comparing our microchip results with standard methods. In this Fast Track SBIR project we will further optimize the design parameters and develop a best in class, cellphone-based semen analysis device that could be marketed to a) for home based testing and b) as an inexpensive alternative to CASA in IVF clinics.

项目概要 消费者越来越有兴趣更多地了解自己的健康。最有之一 熟悉的直接面向消费者的诊断测试是家庭妊娠测试。我们报告一个 为另一个人开发新的护理点诊断测试的实用方法 生殖健康需求——男性生育能力的评估。传统上，男性不太可能 与女性伴侣相比，她们因生育问题而寻求医疗救助（尽管千禧一代男性 对生育力测试更感兴趣）。男性因素不育症的延迟诊断可能会延长 夫妇的不孕不育治疗过程，并导致不必要的干预 女性伴侣。 手动显微镜检测和计算机辅助精液分析（CASA）技术 价格昂贵并且需要大量的技术技能才能使用。在家进行经济实惠的测试的想法 筛选异常精液分析的平台将消除前往诊所的需要 提供初步数据以指导转介。 我们的原型设备已经过临床精液样本的广泛测试。初步的 所呈现的结果稳健且公正，患者结果基于对以下因素的盲目评估 通过将我们的微芯片结果与标准方法进行比较来了解该技术。在这条快车道上 SBIR项目我们将进一步优化设计参数并开发出同类最佳的、 基于手机的精液分析设备，可销售给 a) 用于家庭测试和 b) 作为 IVF 诊所中 CASA 的廉价替代品。