Ultrasensitive PSA Quantitation Using Smartphone to Reduce Prostate Cancer Monitoring Disparities

使用智能手机进行超灵敏 PSA 定量以减少前列腺癌监测差异

• 批准号: 10481587
• 负责人: Ping Wang
• 金额: $ 34.17万
• 依托单位: INSTANOSIS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-06 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10481587
• 关键词: Antibodies; Biological; Biological Assay; Blood; Blood specimen; Cancer Etiology; Cancer Patient; Cellular Phone; Chinese; Clinical; Communities; Complex; Detection; Development; Devices; Diagnostic; Diagnostic Sensitivity; Drops; Economics; FDA Emergency Use Authorization; FDA approved; Fingers; Funding; Goals; Healthcare; Home; Hospitals; Hydrogen Peroxide; Image; Infrastructure; Laboratories; Language; Legal patent; Lighting; Liquid substance; Malignant neoplasm of prostate; Microbubbles; Microfluidic Microchips; Microfluidics; Monitor; Neoplasm Metastasis; Operative Surgical Procedures; Outcome; Oxygen; Patients; Pennsylvania; Performance; Phase; Platinum; Process; Prostate specific antigen measurement; Prostate-Specific Antigen; RADx; Radiation therapy; Radical Prostatectomy; Recurrence; Resources; S100 Proteins; SARS-CoV-2 antigen; Sampling; San Francisco; Technology; Temperature; Testing; Time; Underserved Population; University Hospitals; Urologist; Validation; antigen detection; base; cancer care; cancer health disparity; clinical application; cost; diagnostic assay; digital; follow-up; health care quality; health disparity; innovation; instrument; laboratory facility; machine learning algorithm; magnetic beads; medically underserved; medically underserved population; men; microchip; mortality; nanoparticle; new technology; portability; protein biomarkers; tool; tumor; underserved community; usability

Project Summary Prostate cancer is a leading cause of cancer mortality in medically underserved men, due to limited access to quality health care resources. Longitudinal monitoring of very low blood prostate specific antigen (PSA) concentrations (tens of pg/mL) is an important tool for clinical surveillance of patients post radical prostatectomy or radical radiotherapy. Such monitoring requires high sensitivity diagnostic assays. However, it is challenging for underserved patients suffering from health disparities to get access to the state-of-the-art diagnostic resources. Lacking the appropriate resources and infrastructure results in loss-to-follow-up, increased tumor recurrence and metastasis without surveillance. Residents in Chinatown communities across the US represent such medically underserved populations suffering from health disparities, due to language, cultural and economic barriers. Our goal is to reduce prostate cancer care disparities by providing access to high sensitivity PSA measurement with minimal infrastructure needs, by further developing and validating an ultrasensitive, convenient, low-cost and widely deployable Microbubbling PSA Platform. This platform builds on our innovative Microbubbling Digital Assay technology, capable of quantitating femtomolar concentrations of protein biomarkers in various biological fluids, including blood, using smartphones. We have demonstrated that, using blood samples from prostate cancer patients, the Microbubbling PSA assay has comparable accuracy, but ~200 fold higher sensitivity than central laboratory state-of-the-art. The clinical feasibility and viability of the technology has also been successfully proven for various clinical applications, including bhCG detection and RADx-funded and FDA EUA-submitted SARS-CoV-2 antigen detection. In addition, we have developed and demonstrated feasibility of an automated microfluidics platform that integrates all Microbubbling assay steps. We propose to (Aim 1) integrate the Microbubbling PSA Assay into the automated microfluidics platform suitable for home or urologist office use, without infrastructure or sophisticated instrument needs. This platform only requires a few drops of fingerstick blood as input and a smartphone for high sensitivity quantitative PSA readout in 20 min. (Aim 2) By collaborating with the central clinical laboratory at Hospital of the University of Pennsylvania, we will validate the clinical performance of the Microbubbling PSA Platform by comparing with FDA- approved state-of-the-art, using clinical blood samples. Furthermore, we will collaborate with Dr. Wenwu Jin, a urologist, Chief of Surgery and local expert practicing in Chinese Hospital in San Francisco Chinatown to validate the usability of the platform in medically underserved Chinatown residents.

项目摘要 前列腺癌是医疗服务不足的男性癌症死亡的主要原因，由于 有限的优质医疗资源。极低血流量的纵向监测 前列腺特异性抗原（PSA）浓度（数十pg/mL）是临床诊断的重要工具， 根治性乳腺癌切除术或根治性放疗后患者的监测。这种监测 需要高灵敏度的诊断分析。然而，对于服务不足的患者来说， 健康状况不平等的人，来获得最先进的诊断资源。缺乏 适当的资源和基础设施导致失访，增加肿瘤 复发和转移而不监测。唐人街社区的居民 由于医疗服务不足，美国代表了遭受健康差异的人群， 语言、文化和经济障碍。 我们的目标是通过提供高水平的前列腺癌治疗， 灵敏度PSA测量与最小的基础设施需求，通过进一步开发和 验证超灵敏、方便、低成本和可广泛部署的微泡PSA 平台该平台基于我们创新的微泡数字分析技术， 定量各种生物流体中蛋白质生物标志物的飞摩尔浓度， 包括血液，使用智能手机我们已经证明，使用来自 对于前列腺癌患者，微泡PSA测定具有相当的准确性，但约200倍 灵敏度高于中心实验室最先进水平。 该技术也已被成功地证明用于各种临床应用，包括bhCG 检测和RADx资助和FDA EUA提交的SARS-CoV-2抗原检测。此外，本发明还提供了一种方法， 我们已经开发并证明了自动化微流体平台的可行性， 集成了所有微泡检测步骤。 我们建议（目标1）将微泡PSA测定集成到自动化的 适用于家庭或泌尿科医生办公室使用的微流体平台，无需基础设施或 复杂的仪器需求。这个平台只需要几滴手指血， 输入和智能手机，可在20分钟内实现高灵敏度的PSA定量读数（目标2） 与宾夕法尼亚大学医院的中心临床实验室合作，我们 将通过与FDA进行比较来验证微泡PSA平台的临床性能- 使用临床血液样本进行检测此外，我们将与博士合作。 Wenwu Jin，泌尿科医生，外科主任和当地专家，在San Francisco的中国医院执业 弗朗西斯科唐人街验证该平台在医疗服务不足的唐人街的可用性 居民