AIR Option 1: Technology Translation: KS-Detect: A complete "sample-in, answer-out" solution to the diagnosis of Kaposi's Sarcoma

这个PFI：空气技术翻译项目的重点是翻译我们的KS检测系统，这将是第一个完整的？样本输入-答案？在有限的资源环境中诊断Kaposi肉瘤(KS)的解决方案。翻译后的KS检测系统结合了我们(1)？注射器上的实验室？其中包括：(1)用于活组织提取和样本处理的技术；(2)用于极低功率核酸扩增的太阳能-热聚合酶链式反应(聚合酶链式反应)；(3)用于结果量化的基于纳米颗粒的比色智能手机分析。该系统专为现场护士设计，可在低资源设置的情况下解决卡波西？S肉瘤诊断的诸多挑战，包括：现场采集和处理活检样本的能力，通过使用太阳光驱动热循环过程，一次电池充电可执行的诊断反应数量至少增加10倍，以及消除对专业仪器的依赖，使系统能够由操作员在现场进行修复。该项目通过构建一个完整的原型来实现其目标，从而实现临床前的优化，这是临床实施之前的关键评估阶段。该伙伴关系聘请有限资源设置诊断方面的专家提供实地需求方面的指导，因为这些需求涉及将KS-Detect系统转化为可能导致竞争性商业现实的途径的潜力。从长远来看，潜在的经济影响预计将是显著的，该项目将有助于提高美国在生物医学诊断方面的竞争力。从长远来看，卡波西？S肉瘤的更好诊断将产生社会影响。卡波西肉瘤是撒哈拉以南非洲男性的头号癌症和女性的第二大癌症。KS很难与其他血管增生性疾病区分开来，特别是在非洲，在那里，只有少数几家医院才能找到训练有素的病理学家，免疫组织化学几乎不存在。多项研究表明，在没有免疫组织化学的情况下，基于聚合酶链式反应的皮肤活检组织中卡波西-S肉瘤疱疹病毒(KSHV)的核酸鉴定是进行明确诊断的最佳方法。除了这里提出的研究活动外，我们还将开发一系列社交媒体工具，以促进在有限资源设置的诊断方面的最新科技进步在全球范围内共享。像Facebook和Twitter这样的服务现在是在世界各地传播信息的主要方式，但它们被科学界采用的速度慢得令人痛苦。在这里，我们将使用这些工具来建立一个由对有限资源设置诊断感兴趣的医生、科学家、工程师、技术专家和现场工作人员组成的虚拟社区。新技术、新闻文章、临床研究结果和其他感兴趣的信息将通过这些工具传播给这个社区。

This PFI: AIR Technology Translation project focuses on translating our KS-Detect system which will represent the first complete ?sample-in-answer-out? solution for the diagnosis of Kaposi's sarcoma (KS) in limited resource settings. The translated KS-Detect system combines our (1) ?lab-on-a-syringe? technology for biopsy extraction and sample processing, (2) solar-thermal PCR (polymerase chain reaction) for extremely low-power nucleic acid amplification, and (3) a nanoparticle based colorimetric smartphone assay for the quantification of the results. The system is designed to be used by a field nurse and addresses a number of challenges with low resource setting diagnosis of Kaposi?s sarcoma including: the ability to take and process a biopsy sample in the field, providing at least a 10-fold increase in the number of diagnostic reactions that can be performed on a single battery charge by using sunlight to drive the thermal cycling process, and elimination of the reliance on specialized instrumentation enabling the system to be fixed in the field by the operator. The project accomplishes its objectives by constructing a complete prototype resulting in pre-clinical optimization which is a critical evaluation stage prior to clinical implementation. The partnership engages experts in limited resource setting diagnostics to provide guidance in the field requirements as they pertain to the potential to translate the KS-Detect system along a path that may result in a competitive commercial reality. The potential economic impact is expected to be significant in the long term and the project will contribute to the U.S. competitiveness in biomedical diagnostics. The societal impact, long term, will be better diagnostics of Kaposi?s sarcoma. Kaposi's sarcoma is the leading cancer in men and the second leading cancer in women in sub-Saharan Africa. KS is difficult to distinguish from other angioproliferative diseases, particularly in Africa where access to trained pathologists is limited to few hospitals and immunohistochemistry is practically non-existent. Multiple studies have shown that PCR based nucleic acid identification of Kaposi?s sarcoma herpesvirus (KSHV) in skin biopsies represents the best method of performing an unambiguous diagnosis in the absence of immunohistochemistry. In addition to the research activities proposed here, we will develop a series of social media tools to facilitate world-wide sharing of recent scientific and technological advances in limited resource setting diagnostics. Services like Facebook and Twitter are now the dominant method by which information is disseminated across the world, but their adoption by the scientific community has been painfully slow. Here we will use these tools to establish a virtual community of doctors, scientists, engineers, technologists, and field workers interested in limited resource setting diagnostics. New technologies, news articles, results of clinical studies, and other information of interest will be disseminated through these tools to this community.