Compact Point-of-Care Aptamer-Based Sensor for Detection of Oral Disease Biomarkers in Saliva

 描述(由申请人提供)：用于唾液腺疾病唾液诊断的低成本、点护理工具在医学上是一个未得到满足的需求。目前在这一领域的研究和临床测试往往依赖于大型、昂贵的分析设备，而且周转时间很长。这增加了将唾液低温保存以便运送到非现场实验室所需的时间。吉纳建议开发一种紧凑型、高性价比的电化学传感器，用于Sjögren综合征等口腔疾病的即时诊断和治疗。低成本的设备将使更广泛的设备能够在一系列临床环境中使用，减少样本处理和运输时间。该方法使用具有成本效益、无标签的BIO-FET(场效应晶体管)传感器，利用高特异性适配子识别和捕获唾液生物标记物，用于所有牙科办公室早期检测严重口腔疾病和疾病，如干燥综合征(SS)。第一阶段可行性研究将证明检测到碳酸氢酶I(CA1)，这是最近报道的干燥综合征(SS)的一种唾液生物标志物。与微流控平台相结合，可以测量多个生物标记物以提高诊断确定性，同时在唾液中使用诊断生物标记物大大减少患者的压力，特别是在儿童中。概念验证将基于对低检测下限、响应稳定性、线性和快速周转的论证。设备读数将使用常规的酶联免疫吸附试验进行验证。第二阶段的微流控平台将紧凑、便携，设计成便于在唾液样本较少的牙科诊所进行操作。该设计将允许扩展，以包括从单一唾液样本确定的多个生物标记物。该传感器还将适用于对新的、有前景的生物标志物的探索性研究，对于这些生物标志物，可更换的传感器可以根据需要轻松地制造和校准。

 DESCRIPTION (provided by applicant): Low-cost, point-of-care tools for saliva diagnostics of salivary gland disorders represent an unmet need in medicine. Current research and clinical testing in this area often rely upon large, expensive analytical equipment with lengthy turnaround times. This time adds to the time needed to cryogenically preserve saliva for transport to an off-site laboratory. Giner proposes to develop a compact, cost-effective electrochemical sensor for point-of-care diagnosis and treatment of oral diseases such as Sjögren's Syndrome. A low-cost device will enable more widely available units for a range of clinical settings with reduced sample handling and transport time. The approach uses a cost-effective, label-free bio-FET (Field Effect Transistor) sensor utilizing high-specificity aptamers for recognition and capture of salivary biomarkers to be used in all dental offices for early detection of severe oral conditions and diseases such as Sjögren's Syndrome (SS). The Phase I feasibility study will demonstrate detection of carbonic anhydrase I (CA1), a recently reported salivary biomarker for Sjögren's Syndrome (SS). Combined with a microfluidic platform, multiple biomarkers can be measured for increased diagnostic certainty while the use of diagnostic biomarkers in saliva greatly reduces patient stress, especially in children. The proof of concept will be based on the demonstration of low detection limit, response stability, linearity and rapid turnaround. Device readings will be validated using conventional ELISA. The Phase II microfluidics platform will be compact, portable and designed for easy operation in dental clinics with small saliva specimens. The design will permit expansion to include multiple biomarkers determined from single specimens of saliva. The sensor will also be suitable for exploratory research into new, promising biomarkers for which replaceable sensors can easily be fabricated and calibrated as required.