SBIR Phase II: Novel progesterone biosensor for monitoring fertility health

这个小型企业创新研究(SBIR)第二阶段项目为美国770多万患有不孕症的女性提供了一种量化的、负担得起的方法来评估她们的排卵健康状况。这种黄体酮生物传感器是平台技术的第一个成果，该平台技术旨在改善家庭血液诊断和远程医疗实施。该项目将生产一种新型的廉价、实时和护理点式生物传感器。该产品的商业化还可能增加公众对生物传感器和家庭诊断的参与度和舒适度。结合信息视频、网站页面和研讨会，该产品的商业化将提高科学素养。最后，这种产品的可负担性可能有助于缩小获得生育技术的差距，从而使更多的社会经济弱势和服务不足的人口有平等的机会评估他们的生育能力。这一小型企业创新研究(SBIR)第二阶段项目正在开发一种新型的孕酮生物传感器。需要解决的技术障碍是首先将光学转换技术转化为低成本的纸条，然后确定生物传感器作为纸条的有效性。然后，该团队将开发一种低成本、便携式的测量设备，可以读取纸张的横向流条。预期的技术成果是一种横向流动试条装置，它可以从从未怀孕的妇女、多囊卵巢综合征(PCOS)妇女、绝经前妇女和绝经后妇女的临床血液样本中测量孕酮，直到表明成功排卵的水平。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

This Small Business Innovation Research (SBIR) Phase II project provides more 7.7 million women in the U.S. struggling with infertility a quantitative and affordable way to assess their ovulatory health. This progesterone biosensor is the first outcome of a platform technology built to improve at-home blood diagnostics and telehealth implementation. This project will produce a novel class of inexpensive, real-time, and point-of-care biosensors. The commercialization of this product may also increase public engagement and comfort with biosensors and at-home diagnostics. In concert with informational videos, website pages, and workshops the commercialization of this product will improve scientific literacy. Finally, the affordability of this product may help narrow the disparity of access to fertility technology allowing for more socioeconomically disadvantaged and underserved populations equal opportunity to assess their fertility.This Small Business Innovation Research (SBIR) Phase II project is developing a novel class of biosensors for progesterone. The technical hurdles to be addressed are to first translate optical transduction technology onto low-cost paper strips, then to determine the efficacy of the biosensors as paper test strips. The team will then develop a low-cost and portable measurement device which reads the paper lateral flow strips. The anticipated technical results are a lateral-flow strip device which can measure progesterone from clinical blood samples of women who have never been pregnant, women with Polycystic Ovary Syndrome (PCOS), pre-menopausal women, and post-menopausal women down to levels which indicate successful ovulation.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.