全血C反应蛋白检测系统性能评价的多中心研究  

Evaluation of the performance of systems for whole blood C-reactive protein detection:a multi-center study

作　　者：程娟 李怀远[1] 刘海鹏 王雨新 徐锦 佘尚扬[5] 渠巍 吴亦栋 李贵霞[8] 杨俊梅 莫丽亚[10] 向赟[11] 柯江维[12] 奎莉越[13] 郑磊[14] 陈红兵[15] 杨治理 吕欣 张泓[18] 唐振华[19] 马丽娟[20] 罗红权[21] 李向阳[22] 张文利 贾卉 叶辉铭[25] 田礼军 潘秋辉 Cheng Juan;Li Huaiyuan;Liu Haipeng;Wang Yuxin;Xu Jin;She Shangyang;Qu Wei;Wu Yidong;Li Guixia;Yang Junmei;Mo Liya;Xiang Yun;Ke Jiangwei;Kui Liyue;Zheng Lei;Chen Hongbing;Yang Zhili;Lyu Xin;Zhang Hong;Tang Zhenhua;Ma Lijuan;Luo Hongquan;Li Xiangyang;Zhang Wenli;Jia Hui;Ye Huiming;Tian Lijun;Pan Qiuhui(Department of Clinical Laboratory,Shanghai Children′s Medical Center,Shanghai Jiaotong University School of Medicine,Shanghai 200127,China;Department of Clinical Laboratory,Anhui Provincial Children′s Hospital,Hefei 230051,China;Department of Clinical Laboratory,Dalian Municipal Women and Childen′s Medical Center(Group),Dalian 116033,China;Department of Clinical Medical Laboratory,Children′s Hospital of Fudan University,Shanghai 201102,China;Laboratory Department,Children′s Hospital,Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region,Nanning 530002,China;Department of Clinical Laboratory,Guiyang Maternal and Child Health Hospital/Guiyang Children′s Hospital,Guiyang 550003,China;Clinical Laboratory,Hangzhou Children′s Hospital,Hangzhou 310014,China;Department of Laboratory Medicine,Children′s Hospital of Hebei Province,Shijiazhuang 050031,China;Department of Laboratory,Henan Children′s Hospital Zhengzhou Children′s Hospital,Zhengzhou 450018,China;Department of Clinical Laboratory Center,Hunan Children′s Hospital,Changsha 410007,China;Department of Clinical Laboratory,Tongji Medical College,Huazhong University of Science&Technology,Wuhan 430016,China;Department of Clinical Laboratory,Jiangxi Provincial Children′S Hospital,Nanchang 330006,China;Department of Clinical Laboratory,Kunming Children′s Hospital,Kunming 650000,China;Department of Laboratory Medicine,Nanfang Hospital,Southern Medical University,Guangzhou 510515,China;Department of Clinical Laboratory,Children′s Hospital of Nanjing Medical University,Nanjing 210008,China;Department of Clinical Laboratory,Inner Mongolia Maternity and Child Health Care Hospital,Huhehaote 010010,China;Clinical Laboratory,Qilu Children�

机构地区：[1]上海交通大学医学院附属上海儿童医学中心检验科,上海200127 [2]安徽省儿童医院实验检验医学中心,合肥230051 [3]大连市妇女儿童医疗中心(集团)医学检验中心,大连116033 [4]复旦大学附属儿科医院临床检验中心,上海201102 [5]广西壮族自治区妇幼保健院检验科,南宁530002 [6]贵阳市妇幼保健院/贵阳市儿童医院检验科,贵阳550003 [7]杭州市儿童医院检验科,杭州310014 [8]河北省儿童医院检验科,石家庄050031 [9]河南省儿童医院郑州儿童医院检验科,郑州450018 [10]湖南省儿童医院检验中心,长沙410007 [11]华中科技大学同济医学院附属武汉儿童医院医学检验部,武汉430016 [12]江西省儿童医院检验科,南昌330006 [13]昆明市儿童医院检验科,昆明650000 [14]南方医科大学南方医院检验科,广州510515 [15]南京医科大学附属儿童医院检验科,南京210008 [16]内蒙古自治区妇幼保健院检验科,呼和浩特010010 [17]山东大学齐鲁儿童医院检验科,济南250022 [18]上海交通大学附属儿童医院检验科,上海200063 [19]上海交通大学医学院附属国际和平妇幼保健院检验科,上海200030 [20]首都儿科研究所附属儿童医院检验中心,北京100020 [21]四川省妇幼保健院检验科,成都610031 [22]温州医科大学附属第二医院检验科,温州325000 [23]乌鲁木齐儿童医院检验科,乌鲁木齐830002 [24]西北妇女儿童医院医学检验科,西安710061 [25]厦门大学附属妇女儿童医院(厦门市妇幼保健院)医学检验科,厦门361004 [26]徐州市儿童医院检验科,徐州221006

出　　处：《中华检验医学杂志》2021年第7期633-643,共11页Chinese Journal of Laboratory Medicine

基　　金：上海市儿科临床分子诊断重点实验室(20dz2260900);国家自然科学基金(81871727);上海市科学技术委员会优秀学术带头人计划(18XD1402600)。

摘　　要：目的研究目前常用的全血C反应蛋白(CRP)检测系统的性能,并给出建议的全血CRP检测系统性能要求。方法收集2019年3—4月26家妇幼及儿童医院7540份静脉血样本,研究5种常用全血CRP检测系统分析性能。5种全血CRP检测系统包括迈瑞BC-5390CRP全自动血液细胞分析仪、国赛Astep PLUS特定蛋白分析仪、奥普OTTOMAN-1000全自动特定蛋白即时检测分析仪、韩国i-CHROMA Reader免疫分析仪和芬兰Orion QuikRead go定量分析仪,均使用原装配套试剂,并分别以a、b、c、d、e随机顺序代表检测系统。5种全血CRP检测系统与采用血清模式的西门子特定蛋白分析仪的CRP检测结果进行比对,对检测系统的性能,包括空白测定、携带污染、重复性、中间精密度、线性范围、干扰实验、结果相关性、正确度和样本稳定性进行评价。结果5种常用的全血CRP检测系统空白测定值均<1.00 mg/L,携带污染<1.00%。重复性结果显示,CRP浓度在3.00~10.00 mg/L范围时,>97%的样本变异系数(CV)<10.00%;CRP浓度在10.00~30.00 mg/L范围时,>98%的样本CV<6.00%;CRP浓度>30.00 mg/L时,>98%的样本CV<5.00%;中间精密度均<10.00%;参与评估的检测系统线性理论值及实测值的相关系数(r)均>0.975,斜率在0.950~1.050。样本稳定性实验结果显示,样本在室温(18~25℃)或冷藏(2~8℃)保存72 h内,全血CRP检测结果相对偏差均在10.00%以内;干扰试验表明,除采用干化学免疫速率法的检测系统外,加入甘油三酯(TG)浓度<15.46 mmol/L时,加入TG与未加入TG样本CRP偏差均<10.00%;加入胆红素浓度<345.47μmol/L时,加入胆红素与未加入胆红素样本CRP偏差均<10.00%;在无血细胞比容(Hct)校正功能的检测系统中,Hct不同稀释浓度点与40%稀释浓度点相比相对偏差最高可达67.48%;5种全血CRP检测系统与西门子特定蛋白分析仪的CRP检测结果进行比对,0~300.00 mg/L范围内,各检测系统r均>0.975;使用上海市临床检验中心发放的�Objective To explore the performance of the commonly used whole blood C-reactive protein(CRP)detection systems and give related recommendation on the performance requirements of detection systems.Methods A total of 7540 venous blood samples from 26 maternal,child and children′s hospitals were collected to conduct this multi-center study on the analytical performance of 5 commonly used whole blood CRP detection systems from March to April in 2019.The blank check,carryover,repeatability,intermediate precision,linearity,sample stability,influence of hematocrit/triglyceride/bilirubin,comparison with SIEMENS specific protein analyzer and trueness were evaluated.The 5 systems included BC-5390CRP autohematology analyzer,AstepPLUS specific protein analyzer,Ottoman-1000 Automated Specific Protein POCT Workstation,i-CHROMA Immunofluorometer equipment Reader and Orion QuikRead go detecting instrument.The 5 systems were labeled as a,b,c,d and e randomly.Results Within the 5 systems,all values of blank check were less than 1.00 mg/L,the carryovers were lower than 1.00%.The repeatability of different ranges of CRP concentrations including 3.00-10.00,10.00-30.00 and>30.00 mg/L were less than 10.00%,6.00%and 5.00%,respectively,and the intermediate precision was less than 10.00%.The linearity correlation coefficients of the 5 systems were all above 0.975,while the slope was within 0.950-1.050.Whole blood samples were stable within 72 hours both at room temperature(18-25℃)and refrigerated temperature(2-8℃).The CRP results were rarely influenced by high triglyceride or bilirubin,except for the immmunoturbidimetric test based on microparticles coated with anti-human CRP F(ab)2 fragments.When triglyceride was less than 15.46 mmol/L,the deviation of CRP was less than 10.00%.When bilirubin was less than 345.47μmol/L,the deviation of CRP was less than 10.00%.CRP was more susceptible to Hct on the systems without Hct correction.The deviation of CRP between different Hct dilution concentration and 40%dilution concentration can reac

关 键 词：C反应蛋白 检测系统 性能评价 多中心研究 

分 类 号：R446.1[医药卫生—诊断学]