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Review of Quality Control质量控制概要 We will cover(内容) Terminology 术语 Characteristics of Analytical Methods 分析方法特性 Types of QC samples and how they relate to the characteristics QC样品类型和特性 Definition of Quality质量的定义 Quality Control vs. Quality Assurance(质量控制与质量保证) Quality control is a series of measurements used to assess the quality of the analytical data 质量控制是一系列测量,以评价分析数据的质量 How well is the test fulfilling requirements? 试验满足要求的程度如何? Quality Control vs. Quality Assurance (质量控制与质量保证) Quality assurance is a management plan to ensure the integrity of data (a system) 质量保证是一种管理计划,以确保数据的完整性(一种体系) Provides confidence that requirements will be fulfilled 为要求是否得到满足提供信心 Qualities of Analytical Methods分析方法的质量 Accuracy(准确度) Degree of agreement between the “true” value and the measured value(真值与测量值之间的一致程度) Accuracy (准确度) What is the “true” value?(什么是真值) Theoretical(理论值) Consensus(公议值) Accepted / Assigned(可接受/赋值) Accuracy (准确度) Expressed as (表示为) the ratio between the assayed value and the “true” value (% recovery) 分析值与真值间的比(%回收率) the difference between the assay and the accepted true value (% Error) 分析与可接受真值间的差(%误差) Precision(精密度) Closeness of agreement between measurements(测量间的一致程度) Repeatability (r) – same conditions, short time interval (same run) – short term precision 重复性(r)-相同条件下\短时间间隔-短期内精密度 Intermediate precision – same lab different day, analyst, instrument 中间精密度-同一实验室不同日期,分析人员,仪器 Reproducibility (R) – agreement between batches or between labs 复现性?-批间或实验室间的一致性 Precision (精密度) Expressed as Standard Deviation, Relative Standard Deviation or Relative Percent Difference 表示为标准偏差、相对标准偏差、相对百分差 Sensitivity（灵敏度） Degree of response to a change in analyte concentration – resolution 被分析物浓度变化的响应变化程度-分辩率 Lowest concentration that can be distinguished from background noise – detection limit 能从背景噪音识别出的最低浓度-检测限 Sensitivity （灵敏度） Limit of detection vs. Limit of quantification（检测限与定量限） Limit of detection (LOD) is the level that we can say whether an analyte is present or not 检测限是我们判