KS-Detect: A sample-in, answer-out solution to the Diagnosis of Kaposi's Sarcoma

KS-Detect：卡波西肉瘤诊断的样本输入、答案输出解决方案

• 批准号: 8780631
• 负责人: David Carl Erickson
• 金额: $ 19.31万
• 依托单位: CORNELL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-12-06 至 2016-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8780631
• 关键词: AIDS Malignancy Consortium; Address; Africa; Africa South of the Sahara; Archives; Biological Assay; Biopsy; Biopsy Specimen; Cellular Phone; Charge; Cities; Clinical; DNA; Data; Detection; Development; Diagnosis; Diagnostic; Discipline of Nursing; Disease; Electricity; Engineering; Equipment; Eye; Goals; Health; Herpesviridae; Hospitals; Human; Immunohistochemistry; Individual; International Aspects; Kaposi Sarcoma; Laboratories; Letters; Malignant Neoplasms; Methods; Nucleic Acids; Pathologist; Patients; Performance; Population; Process; Reaction; Resources; Sampling; Sensitivity and Specificity; Series; Skin; Solutions; Sunlight; Syringes; System; Technology; Test Result; Testing; Time; Training; Uganda; Universities; Validation; Woman; Work; base; clinical Diagnosis; cost; design; exhaust; experience; instrument; instrumentation; lens; medical schools; men; nanoparticle; operation; pre-clinical; research study; sarcoma; screening

DESCRIPTION (provided by applicant): The goal of this project is to develop a complete "sample-in-answer-out" solution to the diagnosis of Kaposi's sarcoma (KS) in limited resource settings through the development of our KS-Detect system. 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 herpes virus (KSHV) in skin biopsies represents the best method of performing an unambiguous diagnosis in the absence of immunohistochemistry. The KS-Detect system combines our (1) "lab-on-a-syringe" technology for biopsy extraction and sample processing, (2) solar-thermal PCR 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 samples 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 requiring only a smartphone and a lens thereby enabling the system to be fixed in the field by the operator. We have already demonstrated each of the three technologies used in the KS-Detect system. The aims of this R21 effort are to optimize each of the technologies while integrating them into the workflow, and to perform a series of system level validation experiments using human samples. This pre-clinical optimization is critical prior to clinical implementation.

描述（由申请人提供）：该项目的目标是通过开发我们的KS-检测系统，在有限的资源环境中开发一个完整的“样本输入-回答”解决方案，以诊断卡波西肉瘤（KS）。卡波西肉瘤是撒哈拉以南非洲地区男性的主要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，训练有素的病理学家仅限于少数医院，免疫组织化学几乎不存在。多项研究表明，基于PCR的皮肤活检组织中卡波西肉瘤疱疹病毒（KSHV）的核酸鉴定是在缺乏免疫组织化学的情况下进行明确诊断的最佳方法。KS-Detect系统结合了我们的（1）用于活检提取和样品处理的“注射器实验室”技术，（2）用于极低功率核酸扩增的太阳能热PCR，以及（3）用于结果定量的基于纳米颗粒的比色智能手机测定。该系统旨在由现场护士使用，并解决了卡波西肉瘤诊断的低资源设置的许多挑战，包括：在现场采集和处理活检样本的能力，通过使用阳光驱动热循环过程，在单次电池充电时可以执行的诊断反应的数量增加至少10倍，并且消除了对仅需要智能电话和透镜的专用仪器的依赖，从而使得系统能够由操作者固定在现场。我们已经展示了KS-Detect系统中使用的三种技术。这项R21工作的目的是优化每项技术，同时将其集成到工作流程中，并使用人体样本进行一系列系统级验证实验。在临床实施之前，这种临床前优化至关重要。