Thévenot D R, Toth K, Durst R A, Wilson G S
Centre d'Enseignement et de Recherche sur l'Eau, la Ville et l'Environnement (Cereve), Faculté de Sciences et de Technologie, Université Paris XII-Val de Marne, Créteil, Paris, France.
Biosens Bioelectron. 2001 Jan;16(1-2):121-31. doi: 10.1016/s0956-5663(01)00115-4.
Two Divisions of the International Union of Pure and Applied Chemistry (IUPAC), namely Physical Chemistry (Commission 1.7 on Biophysical Chemistry formerly Steering Committee on Biophysical Chemistry) and Analytical Chemistry (Commission V.5 on Electroanalytical Chemistry) have prepared recommendations on the definition, classification and nomenclature related to electrochemical biosensors: these recommendations could, in the future, be extended to other types of biosensors. An electrochemical biosensor is a self-contained integrated device, which is capable of providing specific quantitative or semi-quantitative analytical information using a biological recognition element (biochemical receptor) which is retained in direct spatial contact with an electrochemical transduction element. Because of their ability to be repeatedly calibrated, we recommend that a biosensor should be clearly distinguished from a bioanalytical system, which requires additional processing steps, such as reagent addition. A device that is both disposable after one measurement, i.e. single use, and unable to monitor the analyte concentration continuously or after rapid and reproducible regeneration, should be designated a single use biosensor. Biosensors may be classified according to the biological specificity-conferring mechanism or, alternatively, to the mode of physico-chemical signal transduction. The biological recognition element may be based on a chemical reaction catalysed by, or on an equilibrium reaction with macromolecules that have been isolated, engineered or present in their original biological environment. In the latter cases. equilibrium is generally reached and there is no further, if any, net consumption of analyte(s) by the immobilized biocomplexing agent incorporated into the sensor. Biosensors may be further classified according to the analytes or reactions that they monitor: direct monitoring of analyte concentration or of reactions producing or consuming such analytes; alternatively, an indirect monitoring of inhibitor or activator of the biological recognition element (biochemical receptor) may be achieved. A rapid proliferation of biosensors and their diversity has led to a lack of rigour in defining their performance criteria. Although each biosensor can only truly be evaluated for a particular application, it is still useful to examine how standard protocols for performance criteria may be defined in accordance with standard IUPAC protocols or definitions. These criteria are recommended for authors. referees and educators and include calibration characteristics (sensitivity, operational and linear concentration range, detection and quantitative determination limits), selectivity, steady-state and transient response times, sample throughput, reproducibility, stability and lifetime.
国际纯粹与应用化学联合会（IUPAC）的两个部门，即物理化学部（原生物物理化学指导委员会现生物物理化学委员会1.7）和分析化学部（电分析化学委员会V.5），已经就电化学生物传感器的定义、分类和命名法制定了建议：这些建议未来可能会扩展到其他类型的生物传感器。电化学生物传感器是一种独立的集成装置，它能够利用与电化学转换元件保持直接空间接触的生物识别元件（生化受体）提供特定的定量或半定量分析信息。由于它们能够进行反复校准，我们建议将生物传感器与生物分析系统明确区分开来，生物分析系统需要额外的处理步骤，如添加试剂。一种在一次测量后即一次性使用且无法连续监测分析物浓度或在快速且可重复再生后监测分析物浓度的装置，应被指定为一次性使用生物传感器。生物传感器可以根据赋予生物特异性的机制进行分类，或者根据物理化学信号转导的模式进行分类。生物识别元件可以基于由分离、设计或存在于其原始生物环境中的大分子催化的化学反应，或者基于与这些大分子的平衡反应。在后一种情况下，通常会达到平衡，并且固定在传感器中的生物络合剂不会进一步（如果有的话）净消耗分析物。生物传感器还可以根据它们监测的分析物或反应进一步分类：直接监测分析物浓度或产生或消耗此类分析物的反应；或者，可以实现对生物识别元件（生化受体）的抑制剂或激活剂的间接监测。生物传感器的迅速激增及其多样性导致在定义其性能标准方面缺乏严谨性。尽管每个生物传感器只能针对特定应用进行真正评估，但根据IUPAC标准协议或定义来研究如何定义性能标准的标准协议仍然是有用的。这些标准推荐给作者、审稿人和教育工作者，包括校准特性（灵敏度、操作和线性浓度范围、检测和定量测定限）、选择性、稳态和瞬态响应时间、样品通量、重现性、稳定性和寿命。
