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
作者
程娟
李怀远
刘海鹏
王雨新
徐锦
佘尚扬
渠巍
吴亦栋
李贵霞
杨俊梅
莫丽亚
向赟
柯江维
奎莉越
郑磊
陈红兵
杨治理
吕欣
张泓
唐振华
马丽娟
罗红权
李向阳
张文利
贾卉
叶辉铭
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�
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
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)。
关键词
C反应蛋白
检测系统
性能评价
多中心研究
C-reactive protein
Detection system
Evaluation of performance
Multi-center study
