临床实验室标本溶血检测与应用专家共识（征求意见稿）

因为专业所以权威

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2018年6月28日，在2018中国医师协会检验医师年会检验前规范化管理与中医检验专题论坛、中国医师协会检验医师分会中医检验医学专业委员会（简称中医检验专委会）学术交流会上，中医检验专委会组织研讨了由中医检验专委会、中华中医药学会检验医学分会、北京中医药学会中医检验专委会组织编写的《临床实验室标本溶血检测与应用专家共识（征求意见稿）》（简称《共识》）。中医检验专委会寿好长主任委员对《共识》的制定与应用做了说明。

临床实验室标本溶血检测与应用

专家共识（征求意见稿）

标本溶血是临床实验室（简称实验室）最常见的误差来源，是标本拒收的主要原因[1-2]。因标本溶血发出错误结果报告可能造成误诊误治，重新抽血给患者增加痛苦、报告周期延长，复测造成人力、物力、经济损失[3-5]。

目前国际上已有标本溶血相关检测与应用标准、共识发布[6-8]。由于经济水平、文化习惯上的差异，国际相关标准、指南难以符合各国的实际需求，有必要制定适合国情的标本溶血检测与临床应用专家共识，以指导相关检验及临床实践[9-11]。中国医师协会检验医师分会中医检验医学专委会、中华中医药学会检验医学分会、北京中医药学会中医检验专委会组织专家讨论，制定《临床实验室标本溶血检测与临床应用专家共识》，主要基于目前血清(或血浆)标本溶血检测与临床应用的相关研究文献及我国实际，以满足临床需求为导向，对现有资料不足、争议较大问题采用专家共识的方法解决。本共识的主要目的是利用现有的循证医学依据，为规范临床实验室标本溶血检测及临床应用提供指导和帮助。随着技术发展、认识深化，本共识将持续更新，以满足检验及临床实践需求。

1标本溶血干扰信息

1.1标本溶血干扰检验结果

标本溶血红细胞破坏，由于细胞内容物释放、光学干扰、与试剂成分发生化学反应等机制对检验结果产生干扰，可导致检验结果假性升高或降低，对临床诊疗产生不良影响[12-13]。

1.2标本溶血干扰阈值

标本溶血干扰阈值是指溶血造成检验结果显著改变，超出允许偏差的血清（或血浆）血红蛋白浓度值（常以溶血指数表示）。标本溶血干扰阈值因检验项目及检测系统、方法而异，制造商推荐的标本溶血干扰阈值的检验结果改变允许偏差通常为10%[14-16]。

2标本溶血检测

2.1目测法

2.1.1目测法观察标本溶血程度简单易行，当仪器法溶血指数不可用时，可利用标本溶血比色卡目测溶血程度，实验室应对使用标本溶血比色卡的人员进行培训、能力评估[6-8，17]。

2.1.2实验室应评估所选用标本溶血比色卡适用于所用检测系统，标本溶血比色卡溶血程度分级应与所用检测系统溶血指数对应[7-8,18]。示例见附图1-4。

▲附图1 溶血比色卡示例1

▲附图2 溶血比色卡示例2

▲附图3 溶血比色卡示例3

▲附图4 溶血比色卡示例4

2.2仪器法

2.2.1仪器法检测标本溶血，常用测定标本血红蛋白特定波长吸光度值法检测血红蛋白浓度，结果以溶血指数表示，检测准确、快速，可避免目测法个体差异大，结果准确性差、重复性差缺陷[19-20]。实验室应首选仪器法检测标本溶血指数[21-22]。

2.2.2实验室应开展仪器法检测标本溶血指数的性能验证、校准、室内质控，参加实验室间比对计划[23-26]。

2.2.3仪器法检测标本溶血程度不影响检验项目报告周期、检验工作效率，不增加实验室成本[27-28]。

3标本溶血检验报告

3.1实验室应建立所开展检验项目的标本溶血干扰说明，包括标本溶血干扰阈值及溶血干扰检验结果改变如升高、降低或无显著改变等方向趋势信息[6,29-31]。

3.2检验项目标本溶血干扰说明信息可通过制造商、学术组织、实验室内部研究等获得,实验室应评估其适用性[28-29,32-34]。示例见附表1。

▼附表1 检验项目溶血干扰信息表示例

3.3检验项目标本溶血干扰信息因检验方法、检验系统而异，实验室应评估所选用标本溶血干扰信息的适用性[35-36]。

3.4实验室发布标本溶血检验报告前，应结合实测标本溶血指数、溶血干扰阈值及必要的临床信息审核,标本溶血指数低于检验项目溶血干扰阈值，实验室应报告检验结果，不应拒收标本[37-38]。

3.5标本溶血指数高于溶血干扰阈值的检验项目：实验室应建议重新采集标本送检；可报告结果并应标注标本溶血，干扰说明信息明确的应备注溶血干扰检验结果的解释性注释，及时与临床作必要联系沟通[39-40]。示例见附图5-7。

▲附图5 标本溶血检验报告备注提示示例1

▲附图6 标本溶血检验报告备注提示示例2

▲附图7 标本溶血检验报告备注提示示例3

3.6实验室如发布包含标本溶血指数结果检验报告，应向临床提供溶血指数临床意义及相关说明[7]。

3.7以溶血指数干扰检测结果回归方程计算矫正检测结果，仅可用于临床咨询参考，不建议用作报告纠正后的检验结果[6,8,41]。

3.8可整合编制审核规则，将标本溶血指数、干扰报警阈值信息传输至检验信息系统，自动选择审核检验结果、添加备注提示信息[42-45]。

4标本溶血质量指标监控

4.1目测法轻度溶血检出率低，容易低估溶血率[18,46]。

4.2仪器法溶血指数质量指标如溶血率、溶血指数中位数等，可作为评价检验前过程工作能力水平的客观量化指标[47-49]。

4.3实验室应与相关人员沟通，分析溶血指数质量指标结果，结合采血人员技能、患者人群、工作模式等客观实际，查找缺陷原因，采取针对性改进措施[50-53]。

5标本溶血干扰检测应用管理

实验室质量体系文件应包含标本溶血检测及检测结果临床应用的操作规程、记录等要求内容[54-55]。

本专家共识（征求意见稿）由中华中医药学会检验医学分会授权发布。欢迎各位检验同仁在留言区提出宝贵意见。未经许可，禁止转载。

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《临床实验室标本溶血检测与临床应用专家共识》课题组

中国医师协会检验医师分会中医检验医学专业委员会

中华中医药学会检验医学分会

北京中医药学会中医检验专委会

2018年6月

编辑：徐少卿 审校：陈雪礼

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