摘要
目的 探讨国产德赛C反应蛋白(CRP)试剂盒在贝克曼全自动生化仪上应用的可行性,以及在急性冠脉综合征(ACS)患者中的应用评估。方法 选择笔者医院冠心病重症监护治疗病房(CCU)30例ACS患者以及体检中心25例健康对照者,收集临床资料,用贝克曼库尔特(Beckman Coulter)公司的试剂盒与上海德赛试剂盒同时对上述55份临床血液标本在贝克曼仪器上进行检测,通过精密度试验、正确度试验、低值检测限、线性试验、生物参考区间验证试验以及干扰试验对德赛CRP试剂盒进行性能验证;同时比较分析两种试剂盒在30例ACS患者中的检测应用。结果 德赛CRP检测值的批内变异系数小于1/4CLIA'88,偏差小于1/2CLIA'88;德赛CRP的低值检测限为0.257mg/L;德赛与Beckman原装试剂盒的相关性良好(r=0.996),检测结果比较,差异无统计学意义(P>0.05);德赛CRP试剂盒在0.0~340.0mg/L范围内,线性良好;生物参考区间验证合格;一定程度的溶血、黄疸及脂血对检测结果无明显干扰;两种试剂盒在ACS患者中的检测结果比较,差异无统计学意义(P>0.05)。结论德赛CRP试剂盒在贝克曼仪器上的性能验证结果准确可靠,该试剂盒能安全可靠的应用于临床,尤其适用于ACS患者的疾病监测。
Objective To investigate the application ability of a C-reactive protein（CRP） reagent kit produced by De Sai company in Beckman Coulter biochemical auto-analyzer and evaluate the clinical application in patients with acute coronary syndrome（ACS）,in order to assure safety and reliability for clinical laboratory usage. Methods A total of 30 patients diagnosed as ACS hospitalized in Coronary Care Unit and 25 healthy controls from Physical Examination Center were enrolled from Beijing Tongren Hospital. The clinical data were collected and the 55 samples were measured through Beckman Coulter biochemical auto-analyzer by using De Sai CRP and Beckman Coulter reagent kit. The precision,accuracy,functional sensitivity,linear range,biological reference interval and interference of reagent kit were analyzed. Meanwhile,the results of CRP from 30 patients with ACS measured by the two reagent kits were compared. Results The average intra-assay coefficients of variation（CV） were lower than 1/4 CLIA＇88,with deviation lower than 1/2 CLIA＇88. The functional sensitivity of the reagent kit is 0.257 mg/L. The CRP concentrations determined by the CRP reagent kit was in correlation with Beckman Coulter reagent kit（r = 0.999,P〉 0.05）. The linear range is 0.0-340.0 mg/L. All randomly sampling CRP concentrations were within the biological reference interval. No interference was indicated as hemolysis,jaundice and lipoidemia under a certain level.There were no significant differences in the tests of patients with ACS by the two reagents kits（P 〉0.05）. Conclusion The result of performance verification of CRP reagent kit from De Sai company through Beckman Coulter biochemical auto-analyzer is precise,accurate and demonstrates reliability for clinical use,especially for those patients with ACS.
作者
杨大伟
金静
于珊
陈锐
王志海
文江平
鲁辛辛
Yang Dawei;Jin Jing;Yu Shan(Department of Clinical Laboratory,Beijing Tongren Hospital, Capital Medical University, Beijing 100760, China)
出处
《医学研究杂志》
2018年第4期121-125,共5页
Journal of Medical Research
关键词
C反应蛋白
性能验证
急性冠脉综合征
C - reactive protein （CRP）
Performance verification
Acute coronal7 syndrome （ACS）
