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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?
A sandwich biosensor was developed with high sensitivity, good accuracy, small sample volume (one drop of blood or venous blood, ≥25μL) and rapid measurement (cholesterol, 60s; glucose, 30s). It is a current-based biosensing system consisting of a bi-mediate multi-enzyme biocatalytic redox system. The sensor can measure the body from normal to abnormal blood total cholesterol / glucose content range, the clinical evaluation has been done by the Chinese Ministry of Health Clinical Laboratory. The test results show that the developed cholesterol / glucose sensor and its supporting test equipment can achieve a simple and direct determination of total cholesterol / total blood sugar. For normal to highly abnormal blood glucose levels, the relative error of measurement (CV) was 7.5-3.9%; for normal to highly abnormal blood cholesterol levels, the relative error of measurement (CV) was 7.6% -5 .8%; this precision has been able to meet the daily measurement requirements to a considerable extent. The correlation analysis (n≥40) of the measurement results made by the large-scale instruments shows that the correlation coefficient (r) between the accuracy of this method and the reference method is 0.9881 for the determination of blood glucose; the accuracy of this method and the reference method The correlation coefficient (r) was 0.954 9. This proves that the accuracy of the biosensors and their ancillary equipment developed in this study is close to that of the conventional enzymatic spectrophotometry of large analytical instruments. Therefore, the instrument can be used to determine the blood glucose / cholesterol level of a doctor’s clinic or the patient himself or herself as a diagnostic tool or self-monitoring of certain conditions (including diabetes mellitus, coronary heart disease, etc.)