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

这个PFI: AIR技术翻译项目的重点是翻译我们的KS-Detect系统，这将是第一个完整的“样本输入-答案输出”系统。在资源有限的情况下诊断卡波西肉瘤（KS）的解决方案。翻译后的KS-Detect系统结合了我们的(1)？(2)极低功率核酸扩增的光热PCR（聚合酶链反应）技术，以及(3)用于结果定量的基于纳米颗粒的智能手机比色测定技术。该系统的设计目的是供现场护士使用，并解决了卡波西病诊断资源不足的一些挑战。S肉瘤包括：能够在现场采集和处理活检样本，提供至少10倍的诊断反应数量，可以通过使用阳光驱动热循环过程进行一次电池充电，并且消除对专用仪器的依赖，使系统能够由操作员在现场固定。该项目通过构建完整的原型来实现其目标，从而实现临床前优化，这是临床实施之前的关键评估阶段。该合作伙伴关系聘请了有限资源环境诊断方面的专家，为现场需求提供指导，因为他们涉及将KS-Detect系统转化为可能导致竞争激烈的商业现实的潜力。从长远来看，潜在的经济影响预计将是巨大的，该项目将有助于提高美国在生物医学诊断方面的竞争力。长期的社会影响将是更好地诊断卡波西？肉瘤。卡波西氏肉瘤是撒哈拉以南非洲地区男性的主要癌症，也是女性的第二大癌症。KS很难与其他血管增生性疾病区分开来，特别是在非洲，训练有素的病理学家仅限于少数几家医院，免疫组织化学几乎不存在。多项研究表明，基于PCR的核酸鉴定卡波西？在没有免疫组织化学检查的情况下，皮肤活检中的疱疹病毒肉瘤（KSHV）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会媒体工具，以促进在全球范围内分享资源有限的诊断方面的最新科学和技术进展。像Facebook和Twitter这样的服务现在是信息在世界范围内传播的主要方式，但它们被科学界采用的速度却非常缓慢。在这里，我们将使用这些工具建立一个虚拟社区，由医生、科学家、工程师、技术人员和对有限资源环境诊断感兴趣的现场工作人员组成。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到这个社区。

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.