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: 10159957
• 负责人: NOAH SHARTLE
• 金额: $ 74.82万
• 依托单位: FIRTILITY, 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 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10159957
• 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; 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; detection limit; home test; 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.

项目摘要 消费者越来越有兴趣了解自己的健康状况。一个最 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 为另一种疾病开发新的床旁诊断测试的实用方法 生殖健康需要-男性生育能力的评估。传统上，男性不太可能 比女性伴侣更容易因生育问题寻求医疗照顾（尽管千禧年男性 对生育测试更感兴趣）。男性因素不孕症的诊断延迟可能会延长 不孕不育治疗过程中的夫妇，并导致不必要的干预， 女合伙人 人工显微镜检测和计算机辅助精液分析（CASA）技术是 昂贵且需要相当的技术技能来使用。一个在家里，负担得起的测试的想法， 一个筛查异常精液分析的平台将减少诊所就诊的需要， 提供初步数据以指导转诊。 我们的原型设备已经用临床精液样本进行了广泛的测试。初步 所提供的结果是稳健和无偏倚的，患者结果是基于对 通过将我们的微芯片结果与标准方法进行比较，在这条快速通道中 SBIR项目，我们将进一步优化设计参数，并开发出一流的， 基于手机的精液分析设备，可以销售给a）用于家庭测试， B）在IVF诊所中作为CASA的廉价替代品。