KS-Detect: A solar-powered and smartphone integrated instrument for point-of-care diagnosis of Kaposi's sarcoma

KS-Detect：一种太阳能和智能手机集成仪器，用于卡波西肉瘤的即时诊断

• 批准号: 8853635
• 负责人: Li Jiang
• 金额: $ 22.48万
• 依托单位: A'AS, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-20 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8853635
• 关键词: Address; Africa; Africa South of the Sahara; Archives; Biological Assay; Biopsy; Businesses; Cellular Phone; Clinic; Collaborations; Communicable Diseases; DNA; DNA amplification; Detection; Development; Devices; Diagnosis; Diagnostic; Disease; Elements; Engineering; Equipment; Feedback; Fluorescence; Foundations; Goals; Health Personnel; Health Services Accessibility; Heating; Herpesviridae; Human; Human Herpesvirus 8; Human Resources; Immunohistochemistry; Industry; Institutes; Kaposi Sarcoma; Kenya; Letters; Malignant Neoplasms; Marketing; Measures; Medical; Methods; Microfluidics; Nature; Nucleic Acid Amplification Tests; Nucleic Acids; Patients; Performance; Phase; Polymerase Chain Reaction; Population; Procedures; Process; Reading; Resources; Sampling; Sensitivity and Specificity; Signal Transduction; Site; Skin; Small Business Innovation Research Grant; Staging; Syringes; System; Techniques; Technology; Technology Transfer; Temperature; Test Result; Testing; Therapeutic; Time; Tissue Sample; Training; Travel; Uganda; United States National Institutes of Health; Universities; Validation; base; blind; clinical Diagnosis; clinical efficacy; cost; cost effective; experience; fight against; innovation; instrument; medical schools; member; mortality; operation; point of care; professor; prototype; public health relevance; screening; stem; technology development; tissue processing; user-friendly

 DESCRIPTION (provided by applicant): A'as [pronounced Ah z], in collaboration with Cornell University and Weill Cornell Medical College, aims to commercialize a solar-powered and smartphone-integrated system for performing nucleic acid- based analysis of Kaposi's sarcoma herpesvirus in limited resource settings. Our "KS-Detect" system comprises of (1) an instrument that performs PCR through solar heating of a microfluidic chip, (2) a small traveling case that contains the instrument and can be carried by a clinician to the patient, and (3) a smartphone "app" that reads the on-chip temperatures, operates sample flow inside the chip, and interprets the fluorescence signal of the sample to provide the user with the test results. KS is one of the most prevalent cancers in sub-Saharan Africa and is associated with high mortality rates. Often, patients are not diagnosed until they develop later stages of the disease, when available therapeutics lose much of their potency. In the absence of immunohistochemistry, polymerase chain reaction (PCR) identification of Kaposi's sarcoma-associated herpesvirus (KSHV) in skin biopsies represents the most reliable method of diagnosing a patient. Unfortunately, existing technologies cannot address the needs associated with biopsy based nucleic acid screening in limited resource settings. As part of the $1.3B nucleic acid test market, new instruments must be cost effective and portable in order to provide early on-site diagnosis for those who cannot access care at centralized facilities. The technologies behind KS-Detect, which were developed at Cornell University, allow PCR-based diagnostics to be performed on tissue samples in the field without the need for expensive equipment or reliable electrical power. This is achieved through the incorporation of "lab-on-a-syringe" tissue processing, solar thermal PCR, and smartphone-based operation and diagnostics. A prototype was built and tested in Kenya and Uganda in early 2014. In Phase I we will ruggedize the current system and perform validation tests using pseudo- biopsies. With NIH support we will focus on a four-stage path to market plan that involves: (1) Technology development building off preliminary results, (2) Human trials in collaboration with Weill Cornell, AMPATH and the Infectious Diseases Institute, (3) System deployment in large-scale human studies, and (4) Product release to healthcare providers and other foundations.

 描述（由申请人提供）：A'as [发音为Ah z]，与康奈尔大学和威尔康奈尔医学院合作，旨在商业化太阳能和智能手机集成系统，用于在有限的资源环境中进行卡波西肉瘤疱疹病毒的基于核酸的分析。我们的"KS-Detect"系统包括（1）通过微流体芯片的太阳能加热执行PCR的仪器，（2）包含仪器并且可以由临床医生携带到患者的小旅行箱，以及（3）智能手机"应用程序"，其读取芯片上的温度，操作芯片内的样品流，并解释样品的荧光信号以向用户提供测试结果。KS是撒哈拉以南非洲最流行的癌症之一，与高死亡率有关。通常，患者直到发展到疾病的后期才被诊断出来，此时可用的治疗方法失去了大部分效力。在缺乏免疫组化的情况下，皮肤活检中卡波西肉瘤相关疱疹病毒（KSHV）的聚合酶链反应（PCR）鉴定是诊断患者的最可靠方法。不幸的是，现有技术不能解决在有限的资源环境中与基于活检的核酸筛查相关的需求。作为13亿美元核酸检测市场的一部分，新仪器必须具有成本效益和便携性，以便为那些无法在集中设施获得护理的人提供早期现场诊断。KS-Detect背后的技术是由康奈尔大学开发的，它允许在现场对组织样本进行基于PCR的诊断，而不需要昂贵的设备或可靠的电力。这是通过结合"注射器实验室"组织处理、太阳能热PCR和基于智能手机的操作和诊断来实现的。2014年初在肯尼亚和乌干达建造并测试了原型。在第一阶段，我们将加固当前系统并使用伪活检进行验证测试。在NIH的支持下，我们将专注于一个四阶段的上市计划，包括：（1）建立在初步结果基础上的技术开发，（2）与Weill Cornell，AMPATH和传染病研究所合作的人体试验，（3）大规模人体研究中的系统部署，以及（4）向医疗保健提供者和其他基金会发布产品。