检验医学
因为专业所以权威
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]。
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。
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。
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]。
参考文献
1.LippiG, Blanckaert N, Bonini P, et al. Haemolysis: an overview of theleading cause of unsuitable specimens in clinical laboratorie [J].Clin Chem Lab Med, 2008, 46(6):764-772.
2.PeterJH, Christopher MLehman, Bruce AJ,et al. Clinical laboratory qualitypractices when hemolysis occurs [J]. Arch Pathol LabMed,2015,139(7):901-906.
3.GreenSF. The cost of poor blood specimen quality and errors inpreanalytical processes [J]. Clinical Biochemistry.2013,46 (13-14):1175-1179.
4.JanneCadamuro, Helmut Wiedemann, Cornelia Mrazek,et al. The economicburden of hemolysis [J]. Clin Chem Lab Med, 2015,53(11):e285-288.
5.PeterJH, Christopher MLehman, Bruce AJ,et al. Clinical Laboratory QualityPractices When Hemolysis Occurs [J]. Arch Pathol LabMed,2015,139(7):901-906.
6.Clinicaland Laboratory Standards Institute (CLSI).Haemolysis, Icterus, andLipemia/Turbidity Indices as Indicators of interference in ClinicalLaboratory Analysis:Approved Guideline, First Edition CLSI C56-A[S].Wayne,PA, USA: CLSI; 2012.
7.BadrickT, Barden H, Callen S,et al. Consensus Statement for the Managementand Reporting of Haemolysed Specimens[J].Clin Biochem Rev, 2016, 37(4):140-142.
8.GiuseppeLippi, Janne Cadamuro, Alexander von Meyer,et al. On behalf of theEuropean Federation of Clinical Chemistry and Laboratory Medicine(EFLM) Working Group for Preanalytical Phase (WG-PRE) Practicalrecommendations for managing hemolyzed samples in clinical chemistrytesting[J]. Clinical Chemistry and LaboratoryMedicine,2018,5(1):1-10.
9.PeterJ. Howanitz, MD; Christopher M. Lehman, MD. Practices for identifyingand rejecting hemolyzed specimens are highly variable in clinicallaboratories [J]. Arch Pathol Lab Med. 2015;139(8):1014–1019.
10.LingLi, Elia Vecellio, Stephanie Gay, et al. Making sense of a haemolysismonitoring and reporting system,a nationwide longitudinal multimethodstudy of 68 Australian laboratory participant organisations [J]. ClinChem Lab Med 2018; 56(4): 565–573.
11.夏良裕,程歆琦,刘茜,等.临床实验室生化免疫项目自动审核程序的建立与应用[J].中华检验医学杂志,2016,13(5):616-621.
12.HeiremanL, Van Geel P, Musger L, Heylen E,et al. Causes, consequences andmanagement of sample hemolysis in the clinical laboratory[J].. Clin Biochem 2017,50(18):1317-1322.
13.LippiG, Plebani M, Di Somma S, et al. Hemolyzed specimens: a majorchallenge for emergency departments and clinical laboratories[J]. Crit Rev Clin Lab Sci.2011;48(3):143-153.
14.FernandezP,Llopis MA, Perich C, et al. Harmonization in hemolysisdetection and prevention, A working group of the Catalonian HealthInstitute (ICS) experience [J]. Clin Chem Lab Med, 2014; 52(11):1557–1568.
15.FarrellCJ, Carter AC. Serum indices: managing assay interference [J].AnnClin Biochem, 2016, 53(5):527-538.
16．GiuseppeLippi. Systematic Assessment of the Hemolysis Index: Pros and Cons[J]. Advances in Clinical Chemistry, 2015, 71(5): 157-170.
17.PlumhoffEA, Masoner D, Dale JD. Preanalytic laboratory errors: identificationand prevention[J]. Mayo Medical LaboratoriesCommuniqué,2008,33(12):1-7.
18.LuksicAH, Nikolac Gabaj N, Miler M, et al. Visual assessment of hemolysisaffects patient safety[J]. ClinChem Lab Med 2017.56(4):1-7.
19.AlbertoDolci, Mauro Panteghini. Harmonization of automated hemolysis indexassessment and use: Is it possible? [J].Clinica Chimica Acta,2014,432 (15) :38–43.
20.MarioPlebani, Giuseppe Lipp. Hemolysis index: quality indicator orcriterion for sample rejection? [J]. Clin Chem Lab Med2009;47(8):899–902.
21.LippiG, Cadamuro J: Visual assessment of sample quality: quo usque tandem?[J]. Clin Chem Lab Med 2018,56(4):513-515.
22.Ana-MariaSi, Elizabeta Topi, Nora Nikolac, et al. Hemolysis detection andmanagement of hemolyzed specimens[J]. Biochemia Medica2010;20(2):154-159.
23.NikolacGN; Miler Marijana; Vrtarić Alen,et al. Precision, accuracy, crossreactivity and comparability of serum indices measurement on AbbottArchitect c8000, Beckman Coulter AU5800 and Roche Cobas 6000 c501clinical chemistry analyzers[J]. Clinical Chemistry and LaboratoryMedicine, 2018,56 (5):776-788.
24.GiuseppeLippi, JanneCadamuro, Alexandervon Meyer, et al. Localquality assurance of serum or plasma (HIL) indices. on behalf of theEuropean Federation of Clinical Chemistry Laboratory Medicine (EFLM)Working Groupfor Preanalytical Phase (WG-PRE) [J]. ClinicalBiochemistry, 2018,54(4): 112-118.
25.AlbertoDolci, Mauro Panteghini. Harmonization of automated hemolysis indexassessment and use: Is it possible? [J]. Clinica Chimica Acta,2014,432 (15) :38–43.
26.PennyPetinos, Stephanie Gay, Tony Badrick. Variation in laboratoryreporting of haemolysis – a need for harmonisation, Clin. Biochem[J].. Rev. 2015,36 (4):133–137.
27.GiuseppeLippi, Paola Avanzini,Daniele Campioli,et al. Systematical assessmentof serum indices does not impair efficiency of clinical chemistrytesting: A multicenter study[J]. Clinicalbiochemistry,2013,46(6)13-14.
28.FatmaEK, Ayfer Meral, Havva Kocak. Assessment of Serum IndicesImplementation on Roche Cobas 6000 Analyzer [J]. Eur J Med Sci. 2014, 1(2): 43-52.
29.ShwetaAgarwal, German Vargas, Cristina Nordstrom ,et al. Effect ofinterference from hemolysis, icterus and lipemia on routine pediatricclinical chemistry assays. Clinica Chimica Acta 438 (2015) 241–245.
30.Clinicaland Laboratory Standards Institute, Interference Testing in ClinicalChemistry; Approved Guideline, second ed[S]. Clinical and LaboratoryStandards Institute, Wayne, PA, 2005.
31.TanuGoyal, Christine L. Schmotzer. Validation of Hemolysis IndexThresholds Optimizes Detection of Clinically SignificantHemolysis[J]. Am J Clin Pathol 2015;143(4):579-583.
32.Killilea DW, Rohner F, Ghosh S,et al.Identification of a Hemolysis Threshold That Increases Plasma andSerum Zinc Concentration[J]. JNutr, 2017, 147(6):1218-1225.
33.YongKL, Young JC. Proposal of Modified HIL-indices for DeterminingHemolysis, Icterus and Lipemia Interference on the Beckman CoulterAU5800 Automated Platform. Lab Med Online,2017,7(2) 66-72.
34.夏良裕，徐二木，曹新策，等. 溶血对41个生化免疫项目的影响评估及溶血警告指数的确立[J].中华检验医学杂志,2017,40(12):947-952.
35.FernandezP,Llopis MA, Perich C, et al. Harmonization in hemolysisdetection and prevention. A working group of the Catalonian HealthInstitute (ICS) experience[J]. Clin Chem Lab Med, 2014; 52(11):1557–1568.
36.GiuseppeLippi, Gian LS,Norbert Blanckaert,et al. Multicenter evaluation ofthe hemolysis index in automated clinical chemistry systems [J]. ClinChem Lab Med 2009;47(8):934–939.
37.GiuseppeLippi. Systematic Assessment of the Hemolysis Index: Pros and Cons.Advances in Clinical Chemistry 2015, 71(5): 157-170.
38.JanneCadamuro, Ana-Maria Simundic, Eva Ajzner, et al. A pragmatic approachto simple acceptance and rejection[J]. Clinical Biochemistry. 2017,50(10-11) 579–581.
39.CadamuroJ, Mrazek C, Haschke-Becher E,et al. To report or not to report: aproposal on how to deal with altered test results in hemolyticsamples[J]. Clin Chem Lab Med,2017,55(8):1109-1111.
40.GiuseppeLippi, Gianfranco Cervellin ,Mario Plebani. Reporting altered testresults in hemolyzed samples: is the cure worse than the disease?[J]. Clin Chem Lab Med 2017; 55(8): 1112-1114.
41.MansourMM, Azzazy HM, Kazmierczak SC. Correction factors for estimatingpotassium concentrations in samples with in vitro hemolysis: adetriment to patient safety[J]. Arch Pathol Lab Med.2009;133(6):960-966.
42.DongHS, Juwon Kim, Young Uh ,et al. Development of an integratedreporting system for verifying hemolysis, icterus, and lipemia inclinical chemistry results[J]. Ann Lab Med,2014;34(4):307-312.
43.GiuseppeLippi, Janne Cadamuro, Alexander von Meyer,et al. on behalf of theEuropean Federation of Clinical Chemistry and Laboratory Medicine(EFLM) Working Group for Preanalytical Phase (WG-PRE),Practicalrecommendations for managing hemolyzed samples in clinical chemistrytesting[J]. Clinical Chemistry and LaboratoryMedicine,2018,5(1):1-10.
44.JessicaM. Boyd , Richard Krause, et al. Developing optimized automated rulesets for reporting hemolysis,icterus and lipemia based on a priorioutcomes analysis[J]. Clinica Chimica Acta, 2015,450 (10) 31-38.
45.夏良裕,程歆琦,刘茜,等.临床实验室生化免疫项目自动审核程序的建立与应用[J].中华检验医学杂志,2016,13(5):616-621.
46.FatmaEK, Ayfer Meral, Havva Kocak. Assessment of serum indicesimplementation on Roche Cobas 6000 analyzer [J]. Eur J Med Sci, 2014, 1(2): 43-52.
47.LeeEJ, Kim M, Kim HS ,et al. Developmentof a Novel quality improvement indicator based on the hemolysisindex[J]. Ann Lab Med, 2016,36(6):599-602.
48.Cadamuro J, von Meyer A, Wiedemann H,et al. Hemolysis rates in blood samples: differences between bloodcollected by clinicians and nurses and the effect of phlebotomytraining[J]. Clin Chem LabMed,2016, 54(12):1987-1992.
49.Moshkin AV. The hemolysis index asquality indicator for extra-laboratory part of preanalyticalphase[J]. Klin Lab Diagn,2012,57(11):63-64.
50.BoleniusK, Soderberg J, Hultdin J,et al. Minor improvement of venous bloodspecimen collection practices in primary health care after alarge-scale educational intervention[J].Clin Chem Lab Med, 2013, 51(2):303-310.
51.DoroticA, Antoncic D, Biljak VR, Nedic D, Beletic A: Hemolysis from anurses' standpoint--survey from four Croatian hospitals[J].Biochem Med (Zagreb), 2015, 25(3):393-400.
HasanKara,Aysegul Bayir,Ahmet Ak, et al. Hemolysis associated withpneumatic tube system transport for blood samples [J].Pak J MedSci,2014, 30(1): 50–58.
52.GiuseppeLippi, Camilla Mattiuzzi, Chiara Bovo,et al. Are we getting better atthe preanalytical phase or just better at measuring it? [J]. J LabPrecis Med 2018,5(2):1-6.
53.MichaelP. Phelan, Edmunds Z，Reineks,Jesse D. Schold, et al．Preanalyticfactors associated with hemolysis in emergency department bloodsamples[J]. Arch Pathol Lab Med,2018;142(2)：229-235.
54.GiuseppeLippi, Giuseppe Banfi, Mauro Buttarello, et al. Recommendations fordetection and management of unsuitable samples in clinicallaboratories[J]. Clin Chem Lab Med ,2007;45(6):728–736.
55.InternationalOrganization for Standardization. ISO15189 Medical laboratories –Requirements for quality and competence[J].Geneva: ISO, 2012.
《临床实验室标本溶血检测与临床应用专家共识》课题组
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
走之前，不妨为检验君点亮下面的爱心~
閱讀更多 中華檢驗醫學網 的文章
