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

描述(由申请人提供)：(PQA4)V-Chip暴露于肝细胞癌风险的护理点测试潜在的肝癌风险协同机制可能为高危个体提供有效和准确的肝癌预防策略。暴露在环境或生活方式危险因素中的人同时表现出肝癌发病率的增加。然而，肝癌的大部分负担与低收入人群有关，报告的发病率最高的地区是乙肝病毒(乙肝)感染流行的地区。因此，发展一种准确的、定量的、低成本的快速检测生物标志物的技术是肝癌风险评估的需要。在此，我们提出了一种基于ELISA法的新技术平台--多路容量条形图芯片(V-Chip)，用于检测血液样本中的生物标志物。所提出的V-Chip是基于微流控技术。集成的体积读数基于过氧化氢酶和过氧化氢反应产生的氧的测量，允许快速ELISA定量生物标志物，并在V-Chip上提供可视化条形图，而无需任何仪器、数据处理或图形绘制。V-Chip的准确性将在肝细胞癌病例和对照中使用标准的ELISA法进行验证。根据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，根据当前的风险状况预测一个人在未来5年和10年内发展为肝癌的可能性，并在患者的可改变的风险因素发生变化时降低风险。这一风险预测V 芯片特别适合在资源有限、肝癌发病率较高的地区应用。患者可以在家中使用V-Chip，并亲自监测肝硬变或乙肝病毒/丙型肝炎的发展情况，这可能会更早地将潜在的肝癌患者带到医院和专业人员那里，从而大大降低肝癌的成本和风险。

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.