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

 描述（由申请人提供）：用于唾液腺疾病的唾液诊断的低成本护理点工具代表了医学上未满足的需求。目前在这一领域的研究和临床试验往往依赖于大型，昂贵的分析设备，周转时间长。这个时间增加了低温保存唾液以运输到场外实验室所需的时间。Giner建议开发一种紧凑、具有成本效益的电化学传感器，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单位，为一系列的临床设置，减少样品处理和运输时间。该方法使用具有成本效益的无标记bio-FET（场效应晶体管）传感器，利用高特异性适体识别和捕获唾液生物标志物，用于所有牙科诊所早期检测严重的口腔疾病和疾病，如舍格伦综合征（SS）。I期可行性研究将证明碳酸酐酶I（CA 1）的检测，这是最近报道的干燥综合征（SS）的唾液生物标志物。与微流体平台相结合，可以测量多种生物标志物以提高诊断确定性，同时在唾液中使用诊断生物标志物大大降低了患者的压力，特别是在儿童中。概念验证将基于低检测限、响应稳定性、线性和快速周转的证明。将使用常规ELISA验证器械读数。第二阶段的微流体平台将是紧凑的，便携式的，设计用于在牙科诊所使用小唾液样本时易于操作。该设计将允许扩展以包括从单个唾液样本确定的多种生物标志物。该传感器还将适用于探索性研究新的，有前途的生物标志物，可更换的传感器可以很容易地制造和校准的要求。

 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.