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<p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 16px;">校准品、标准品、质控品三者同为参考物质。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><br /></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 16px;">参考物质是一种材料或者物质，某一种或多种特性值只够均匀并被良好确定，用于校准测量系统，评价测量程序或为材料赋值。但三者并非用一个概念，他们有各自不同的应用场合。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><br /></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 16px;">临床上常常有很多错误的应用，例如将不同厂商的校准品应用于检测系统；使用给定值的质控品评价检测系统；使用质控品来校准检测系统等等。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><br /></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 16px;">本文内容详细介绍了校准品、标准品、质控品的来源及定值方式，得出正确使用三种参考物质的方法。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><br /></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">一、传统的方法的缺点</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 传统的检验项目，要使得检验结果可靠或者有依据，往往会使用一个已知浓度的标准品同样品一同测定。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">例如：血清铜测定</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><table cellspacing="0" cellpadding="0" width="915" style="width: 556px;"><tbody style="overflow-wrap: break-word;"><tr style="overflow-wrap: break-word;"><td valign="top" width="196" style="overflow-wrap: break-word;"><br /></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">空白管</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">标准管</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">测定管</span></p></td></tr><tr style="overflow-wrap: break-word;"><td valign="top" width="196" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">血清</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">—</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">—</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">1.0</span></p></td></tr><tr style="overflow-wrap: break-word;"><td valign="top" width="196" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">铜标准液</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">—</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">1.0</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">—</span></p></td></tr><tr style="overflow-wrap: break-word;"><td valign="top" width="196" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">去离子水</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">1.0</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">—</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">—</span></p></td></tr><tr style="overflow-wrap: break-word;"><td valign="top" width="196" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">2mol/L HCL</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">0.7</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">0.7</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">0.7</span></p></td></tr><tr style="overflow-wrap: break-word;"><td valign="top" width="588" colspan="4" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;"><span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;">充分混匀，室温静置</span>10min</span></p></td></tr><tr style="overflow-wrap: break-word;"><td valign="top" width="196" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">200g/L <span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;">三氯醋酸</span></span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">1.0</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">1.0</span></p></td><td valign="top" width="131" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;">1.0</span></p></td></tr><tr style="overflow-wrap: break-word;"><td valign="top" width="588" colspan="4" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;"><span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;">用玻棒混匀，在室温静置</span>10min<span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;">，</span>3000r/min<span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;">离心，取上清液</span>2.0ml+<span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;">缓冲液</span>2.8ml<span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;">铜试剂</span>0.2ml</span></p></td></tr><tr style="overflow-wrap: break-word;"><td valign="top" width="588" colspan="4" style="overflow-wrap: break-word;"><p style="text-align:center;overflow-wrap: break-word;"><span style="font-size: 16px;"><span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;">室温静置</span>20min<span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;">后，</span>620nm<span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;">比色空白调零</span></span></p></td></tr></tbody></table><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 计算结果：</span></p><table cellspacing="0" cellpadding="0" width="915" style="width: 556px;"><tbody style="overflow-wrap: break-word;"><tr style="overflow-wrap: break-word;"><td width="65" rowspan="2" style="overflow-wrap: break-word;"><p style="overflow-wrap: break-word;"><br style="overflow-wrap: break-word;" /><span style="font-size: 16px;">血清铜=</span></p></td><td valign="top" width="103" style="overflow-wrap: break-word;"><p style="overflow-wrap: break-word;"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">测定管吸光度</span></p></td><td width="119" rowspan="2" style="overflow-wrap: break-word;"><p style="overflow-wrap: break-word;"><span style="font-size: 16px;">* <span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;">标准液铜浓度</span></span></p></td></tr><tr style="overflow-wrap: break-word;"><td valign="top" width="103" style="overflow-wrap: break-word;"><p style="overflow-wrap: break-word;"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">标准管吸光度</span></p></td></tr></tbody></table><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 传统的标准液用纯水配制，同血清相比，成份非常简单，除了待测物质外只有水了。此时在将样品同标准品相比较时，引入了基质效应。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 基质效应：检体中的非测定物质对测定量的影响。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 换句通俗的话说也就是，检体中测定物外的其他物质对检测的干扰，使检测结果偏离真值。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 此时通过同无基质效应的标准品比较得出的有基质效应的样品检测值，将偏离于真值。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 是否能使用标准液取决于检测方法学，干扰极小的决定性方法或者某些已知干扰的参考方法可直接使用标准品。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">二、标准品的定值</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 一般而言，检验工作中使用的标准品属应用标准。将符合质量标准的纯品使用称量法和容量法配制成溶液。用决定性方法反复测定，结果在规定的范围内属合格。测定制的可靠性取决于鉴定方法，分析方法的可靠性不如公认的称量法和容量法。标准品值由称量和容量法计算确定。决不可将实测值替代修正。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">三、引入校准品</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 16px;"><span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;"> 为了克服纯标准品和病人样品间的基质差异，</span>20<span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;">年前开始应用具有与病人样品基质效应相似的校准品替代标准品，用于日常工作。</span></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">四、校准品的定值</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">1.校准品来源：</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 校准品大多来源为人样品的混合物，如混合血清。本身内含被检分析物，植被时刻添加某些分析物，增加含量。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 16px;">2.<span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;">定值方法：</span></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 校准品中被检分析物的含量无法由称量法和容量法确定，只能依赖于分析方法。校准品的校准值只能取决于分析方法和检测系统。但所有用于检验中的检测方法、仪器、试剂等都是用来监测病人的新鲜样品的，不是用来监测校准品这样处理过的样品的。所有校准品都是处理过的样品，和新鲜样品有着新的基质差异。若使用公认的参考方法去标化测定校准品，测定程序是严格的，测定只是可靠的，但不是校准值。使用该测定值去校准常规的检测系统时，校准品中的分析物被检测时的表现明显不同于新鲜病人样品，不能将参考方法系列的准确度通过校准品传递给病人。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 16px;"><span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;"> 如先使用公认的参考方法检测病人样品，再以具有参考值的病人样品去校准某检测系统。此时该检测系统在检测其他新鲜病人样品时，这些病人样品结果的溯源性可上溯至公认的参考方法。也即用新鲜病人样品是校准系统的最佳校准品。</span> </span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><br style="overflow-wrap: break-word;" /><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 但是具有参考值的新鲜病人样品无法用于常规工作所有方法、仪器、试剂或检测系统的校准；只能依靠现有的校准品，如何去确定校准品的校准值是关键。评级校准值可靠性的唯一要求是：被校准品校准后的检测系统，对病人样品检测的检验结果和某些指定参考方法对病人样品的检验结果具可比性。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 校准值不是测定值，是纠正的调整值。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">一、校准品的专用性</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 在以往的应用中用户往往不注意校准品的应用的专用性，任何方法或仪器、试剂使用一个校准品，严重影响检验质量。从上面的校准品定值方法中，我们可以知道，只有在使用了和定值时相同的检测系统，得出的结果才能同参考方法结果具可比性。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;">二、质控品定值</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 16px;">1. <span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;">质控品的来源：</span></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 质控品的来源同校准品大致相同，厂商可能会更具自己的要求添加了很多物质，此时有些物质的添加量常常达到病理状态的高浓度，在应用于某一项目时，对这个项目来说基质效应将更大。</span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"><br /></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-size: 16px;">2.<span style="font-size: 16px;font-family: 宋体;overflow-wrap: break-word;"> 定值方法：</span></span></p><p style="overflow-wrap: break-word;color: rgb(68, 68, 68);font-family: Tahoma, "Microsoft Yahei", Simsun;font-size: 14px;text-align: start;white-space: normal;background-color: rgb(255, 255, 255);"><span style="font-family: 宋体;overflow-wrap: break-word;font-size: 16px;"> 有些厂商会给自己的标准品定一个定值范围，这个定值范围是由厂商联合几家使用同样检测系统的临床用户，经多次测定得出的均值。此时如果将该质控品应用于另一个检测系统，由于方法学的不同，可能得出同厂商给出值有较大差异的值。此时不能认为该检测系统的准确度不佳。此时需要强调的是检测系统都是用来测定新鲜血清的，不是用来测定质控品或其他物质的。检测系统只有在检测新鲜血清时得出的结果才具有溯源性。不同检测系统之间只有在检测新鲜血清时才具可比性。</span></p><p style="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;"><img data-type="png" class="" data-ratio="0.6100178890876565" data-w="559" src="http://mmbiz.qpic.cn/mmbiz_png/A1DicCH9Vl6MK5Q8sxibcIbgTPECicmaSpkdc8Z9sZ08Rp4HCzAicktdjPgic7Q7trLRwDf6Z3zz8icJhxWHoCn4iaN0w/640?wx_fmt=png" style="box-sizing: border-box !important;overflow-wrap: break-word !important;visibility: visible !important;width: 559px !important;" /></span></p><p style="margin-top: 10px;max-width: 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发表于 2020-10-21 12:20:59