(PQA4) Point-of-Care Test of Exposure to Hepatocellular Carcinoma Risk by V-Chip

描述（由申请方提供）：（PQA 4）通过V-Chip进行的肝细胞癌风险暴露的床旁检测HCC风险协同作用的基础机制可能为高风险个体提供有效和准确的HCC预防策略。暴露于环境或生活方式危险因素的人同时表现出HCC发展的发病率增加。然而，HCC的大部分负担与低收入人群相关，在B型肝炎病毒（HBV）感染流行的地区报告的发病率最高。因此，开发一种准确、定量且低成本的生物标志物快速检测技术是HCC风险评估的必要条件。 在此，我们提出了一种基于ELISA的新技术平台，多重体积条形图芯片（V-Chip），以检测血液样品中的生物标志物。所提出的V-Chip基于微流体技术。基于过氧化氢酶和过氧化氢之间反应产生的氧气测量的集成体积读数允许生物标志物的快速ELISA定量，并在V-Chip上提供可视化条形图，而无需仪器、数据处理或图形绘制的任何帮助。将使用标准ELISA测定法在HCC病例和对照中验证V-Chip的准确性。基于流行病学风险因素和V-chip上的生物标志物，我们将开发一个风险预测模型，以预测一个人在未来5年和10年内发生HCC的概率，基于当前的风险状况，以及如果患者的可改变的风险因素发生变化，风险降低。 预测V 芯片特别适合在HCC发病率较高的资源有限地区应用。患者可以在家中使用V-Chip，亲自监测肝硬化或HBV/HCV的发展，这可能会使潜在的HCC患者更早地到医院和专业人员，从而大大降低HCC的成本和风险。

DESCRIPTION (provided by applicant): (PQA4) Point-of-Care Test of Exposure to Hepatocellular Carcinoma Risk by V-Chip Underlying mechanisms for synergisms of HCC risks may provide efficient and accurate HCC prevention strategies for high-risk individuals. People exposed to environmental or life-style risk factors simultaneously exhibit the increased incidence of HCC development. However, most of the burden of HCC is associated with the group of people with low income, with the highest incidence rates reported in regions where infection with hepatitis B virus (HBV) is endemic. Therefore, developing an accurate, quantitative, and also low-cost technology for the rapid detection of biomarkers is required for HCC risk assessment. Herein, we propose an ELISA-based new technology platform, the multiplexed volumetric bar-chart chip (V- Chip), to detect biomarkers in blood samples. The proposed V-Chip is based on microfluidics technology. The integrated volumetric readouts, based on measurements of oxygen generated by a reaction between catalase and hydrogen peroxide, allow rapid ELISA quantitation of biomarkers and provide visualized bar charts on V- Chip without any assistance from instruments, data processing, or graphic plotting. The accuracy of the V-Chip will be validated in HCC cases and controls using standard ELISA assay. Based on epidemiological risk factors and biomarkers on V-chip, we will develop a risk prediction model to predict a person's probability of developing HCC in the next 5 and 10 years based on current risk profiles as well as risk reduction if the patient's modifiable risk factors change. This risks prediction V chip is particularly suitable for the application in resource-limited areas with higher HCC incidence. Patients can use V-Chip in home and personally monitor cirrhosis or HBV/HCV development by themselves, which may bring potential HCC patients to hospital and professionals earlier and thus greatly reduced the costs and risks of HCC.