【正文】 Review of Quality Control 質(zhì)量控制概要 We will cover(內(nèi)容 ) – Terminology ? 術(shù)語 – Characteristics of Analytical Methods ? 分析方法特性 – Types of QC samples and how they relate to the characteristics ? QC樣品類型和特性 1 Definition of Quality 質(zhì)量的定義 ? To most of the world (普遍上 ) – degree of excellence(優(yōu)異程度 ) ? To the ISO world (在 ISO領(lǐng)域 ) – degree of agreement between characteristics and requirements ? 特性與要求的吻合程度 ? More importantly (更重要 ) – to our clients?(對客戶 ) 2 Quality Control vs. Quality Assurance(質(zhì)量控制與質(zhì)量保證 ) ? Quality control is a series of measurements used to assess the quality of the analytical data –質(zhì)量控制是一系列測量 ,以評價分析數(shù)據(jù)的質(zhì)量 – How well is the test fulfilling requirements? ? 試驗滿足要求的程度如何 ? 3 Quality Control vs. Quality Assurance (質(zhì)量控制與質(zhì)量保證 ) ? Quality assurance is a management plan to ensure the integrity of data (a system) –質(zhì)量保證是一種管理計劃 ,以確保數(shù)據(jù)的完整性 (一種體系 ) – Provides confidence that requirements will be fulfilled ? 為要求是否得到滿足提供信心 4 Qualities of Analytical Methods 分析方法的質(zhì)量 ? Accuracy(準確度 ) ? Precision(精密度 ) ? Selectivity(選擇性 ) ? Sensitivity(靈敏度 ) ? Linearity(線性 ) ? Range(范圍 ) ? Robustness / Ruggedness(穩(wěn)健性 /穩(wěn)度 ) 5 Accuracy(準確度 ) Degree of agreement between the ―true‖ value and the measured value(真值與測量值之間的一致程度 ) 6 Accuracy (準確度 ) What is the ―true‖ value?(什么是真值 ) ? Theoretical(理論值 ) ? Consensus(公議值 ) ? Accepted / Assigned(可接受 /賦值 ) 7 Accuracy (準確度 ) ? Expressed as (表示為 ) – the ratio between the assayed value and the ―true‖ value (% recovery) ? 分析值與真值間的比 (%回收率 ) – the difference between the assay and the accepted true value (% Error) ? 分析與可接受真值間的差 (%誤差 ) 8 Precision(精密度 ) ? Closeness of agreement between measurements(測量間的一致程度 ) – Repeatability (r) – same conditions, short time interval (same run) – short term precision ? 重復(fù)性 (r)相同條件下 \短時間間隔 短期內(nèi)精密度 – Intermediate precision – same lab different day, analyst, instrument ? 中間精密度 同一實驗室不同日期 ,分析人員 ,儀器 – Reproducibility (R) – agreement between batches or between labs ? 復(fù)現(xiàn)性 174。批間或?qū)嶒炇议g的一致性 9 Precision (精密度 ) ? Expressed as Standard Deviation, Relative Standard Deviation or Relative Percent Difference –表示為標準偏差、相對標準偏差、相對百分差 10 Sensitivity（ 靈敏度） ? Degree of response to a change in analyte concentration – resolution –被分析物濃度變化的響應(yīng)變化程度 分辯率 ? Lowest concentration that can be distinguished from background noise – detection limit –能從背景噪音識別出的最低濃度 檢測限 11 Sensitivity （ 靈敏度） ? Limit of detection vs. Limit of quantification（ 檢測限與定量限） – Limit of detection (LOD) is the level that we can say whether an analyte is present or not ? 檢測限是我們判斷被分析物是否存在的含量水平 – Limit of quantitation (LOQ) is the level that we can quantify the analyte with a specified accuracy (20%) ? 定量限是我們按規(guī)定準確度（ 20%）能對被分析物量化的含量水平 12 Selectivity（ 選擇性） ? Ability to detect the analyte in a plex matrix – 檢測復(fù)雜基體中被析物的能力 ? Ability to exclude nonanalyte species from signal – 通過信號排除非被分析物的能力 ? Usually inversely related to sensitivity – 通常與靈敏度成反比 13 Linearity（ 線性） ? Ability to produce a response that is directly proportional to the concentration of the analyte –所產(chǎn)生的反應(yīng)與被分析物濃度成正比的能力 ? Only holds true within a given range –只在給定范圍內(nèi)是真實的 14 Linearity （ 線性） ? Expressed as correlation coefficient (r) or coefficient of determination (r2) –表示為相關(guān)系數(shù) (r)或測定系數(shù) (r2) r2=ssxy2/ssxx ssyy 15 Range（ 范圍） ? The interval between the highest and lowest concentration for which the