治疗药影物监测汪荣军.ppt

（7）专属性： 生物基质的影响 药物代谢产物的影响 合并用药的影响 （8）测定实际样品 2. TDM质量保证体系的建立 （1）室内质控 ---实验室内为达到质量要求的操作技术和活动 ---包括从收集标本到报告结果的所有活动和步骤 ---用统计学方法、连续地评价本实验室工作的可靠程度 ---目的在于监控过程，排除所有环节中不良因素 室内质控准备工作 --- 培训工作人员：良好素质，专业培训，连续性 --- 建立SOP：操作规程化 --- 仪器的检定与校正：天平、量具、分析仪器，定期校验，专人负责 --- 质控品的选择：更换试剂校对 --- 质控品的正确使用和保存 实际操作 --- 设定靶值：确定总平均值 X --- 设定控制限：确定误差范围R ，±2SD； ±3SD； --- 绘制质控图和记录质控结果：中心线、2SD 警告线、3SD失控线 --- 质控规则的应用 室内质控 ---多数点应在中心线附近 ---点的分布大致为正态分布点的排列未发现有规律和异常 ---连续25个点应全部在管理线内，连续35个点只允许有1个点在 管理线外 ---连续7个点以上，或连续11个点中有10个，或连续20个点中有16个在中心线的同侧要查原因 失控情况的处理和原因分析 --- 失控情况的处理 填写失控报告 分析原因, 重作质控样品 确定能否发分析报告 --- 失控原因分析 试剂过期或污染 校准品或质量控过期 仪器不良 人员操作失误 谢 谢！ * * * * * * * Emit is a registered trademark and is also an acronym for Enzyme Multiplied Immunoassay Technique. As we shall see in another module, it was developed in the 1970’s by Syva Co. for the detection of Morphine. In overview, the assay principal is very simple. Drugs in the patient’s sample are detected by incubating an aliquot of the sample with an aliquot of each of the Reagents A and B. The result is read spectrophotometrically within a few minutes. The patient’s sample may be urine, serum or plasma although some researchers have tried other more exotic fluids such as aqueous humour from the eye!. Original Emit tests had to be performed manually using a hand pipette, a stopwatch and a spectrophotometer. The results were plotted on semi-log graph paper, the graph drawn and patient results extrapolated using a ruler and pencil. This was the accepted ‘norm’ up until the early 1980’s. Nowadays, almost every Emit test is performed automatically on a Clinical Chemistry Analyser. Emit tests may be performed on any Clinical Chemistry Analyser which allows sample and two reagent addition, has accurate temperature control and accurate pipetting and can measure light absorbance at 340nm. The set of instructions telling an instrument how to perform an Emit test is known as a Prot