高灵敏度双介体基胆固醇/葡萄糖生物传感器的研制及其临床试验结果

Development of Highly Sensitive Biosensors of Cholesterol/Glucosea and Results from Some Clinic Trials

研制了灵敏度高、准确性好、取样量小（一滴指血或静脉血，≥２５μＬ）、测量迅速（胆固醇， ６０ｓ；葡萄糖，３０ｓ）的夹心式生物传感器。它是由双介体多酶生物催化一氧化还原体系构成的电流型生物传感系统。本传感器可测量到人体从正常到异常的所有血总胆固醇／葡萄糖的含量范围，其临床评价工作已由中国卫生部临床检验中心完成。检验结果表明：所研制的胆固醇／葡萄糖传感器及其配套的测试仪器可实现总胆醇／总血糖的简便而又直接的测定。对正常到高度异常的血糖含量，其测量相对误差（ＣＶ）是７．５～３．９％；对正常到高度异常的血胆固醇含量，其测量相对误差（ＣＶ）是７．６％～５．８％；这样的精密度已经能够相当程度地满足日常测量要求。用大型仪器所作的测量结果相关性分析（ｎ≥４０）表明：对血糖测定，本法与参照方法准确性的相关系数（ｒ）为０．９８８１；对胆固醇测定，本法与参照方法准确性的相关系数（ｒ）为０．９５４ ９。由此证明，本研究所研制的两种生物传感器及其配套设备可获得准确性与大型分析仪器常规酶光度法的测试结果相接近。故此仪器可用于医生诊所或者病患者本人的血糖／胆固醇水平的测定，以作为医生诊断的辅助工具或者病患自我监控某些病情（包括糖尿病、冠心?

Amperometric, highly sensitive, accurate and fast response Cholesterol and Glucose biosensors were developed. This novel biosensor technology is based on biomediator, bi-or tri-enzymes redox systems. An innovative, truly sandwich sensor configuration significantly enhances its sensitivity. It is shown from the clinical trials that the variation coefficients of testing results are in the range of 7. 5%-3. 9% for glucose from 120 mg/dL to 350 mg/dL concentration and 7. 6%-5. 8% for cholesterol from 120 mg/dL to 270 mg/dL concentration. And relationship coefficients(r) are 0. 988 1 (glucose) and 0. 954 9 (cholesterol to a large analytical instrumental method (Hitachi 7170A, n≥40).