ISO15189体系下全自动血凝分析仪的3Q验证  

Research on the 3Q validation of automatic blood coagulation analyzer under ISO15189 system

作　　者：莎仁[1] 梁鱼 SHA Ren;LIANG Yu(Department of Clinical Laboratory,Bayannur Hospital,Inner Mongolia,Bayannur 015000,China;Inner Mongolia Medical University,Inner Mongolia,Hohhot 010110,China)

机构地区：[1]内蒙古自治区巴彦淖尔市医院检验科,内蒙古巴彦淖尔015000 [2]内蒙古医科大学,内蒙古呼和浩特010110

出　　处：《中国医药科学》2021年第5期237-240,共4页China Medicine And Pharmacy

摘　　要：目的以SysmexCS-2500全自动血凝分析仪为例,探究医学实验室质量和能力认可准则体系(ISO15189)下全自动血凝分析仪的3Q验证过程。方法严格按照ISO15189的要求,对SysmexCS-2500全自动血凝分析仪器的凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、凝血酶时间(TT)、纤维蛋白原(FIB)、D-二聚体五个指标进行批内精密度、日间精密度、准确性、线性范围、检测下限(灵敏度)、携带污染率性能验证。结果批内精密度:PT、APTT、TT、FIB、D-二聚体的正常质控CV值分别为0.34%、0.38%、0.62%、1.04%、3.32%;PT、APTT、FIB、D-二聚体的异常质控CV值分别为0.47%、0.41%、2.56%、9.70%;日间精密度:PT、APTT、TT、FIB、D-二聚体的正常质控CV值分别为2.81%、2.15%、3.72%、3.51%、5.67%;PT、APTT、FIB、D-二聚体异常质控CV值分别为2.21%、2.77%、4.40%、5.37%;准确性:PT、APTT、FIB、TT正常质控水平测试结果分别为12.1、25.6、2.71、19.7;PT与FIB异常质控水平测试结果为19.9、0.89;D-二聚体低值重复三次测试结果分别为0.28、0.29、0.29;D-二聚体高值重复三次测试结果分别为2.20、2.22、2.21;FIB与D-二聚体线性范围验证结果a值分别为0.9535、1.0162,R^(2)分别为0.9911、0.9975;灵敏度:D-二聚体与FIB的CV值分别为3.48%与2.57%;携带污染率最高值为2.65%。所有验证结果均符合要求,验证合格。结论通过ISO15189体系下的3Q验证,SysmexCS-2500全自动血凝分析仪的主要性能均符合要求,可用于临床凝血检测等工作。Objective To investigate the 3 Q validation process of automatic blood coagulation analyzer under Accreditation Criteria for the Quality and Competence of Medical Laboratories(ISO15189),by taking SysmexCS-2500 automatic blood coagulation analyzer as an example.Methods In strict accordance with the requirements of ISO15189,five indexes of SysmexCS-2500 automatic blood coagulation analyzer,namely,prothrombin time(PT),activated partial thromboplastin time(APTT),thrombin time(TT),fibrinogen(FIB)and D-dimer,were verified for performance on withinbatch precision,inter-day precision,accuracy,linear range,lower limit of detection(sensitivity)and residual contamination rate.Results In terms of within-batch precision,the normal quality control CV values of PT,APTT,TT,FIB and D-dimer were 0.34%,0.38%,0.62%,1.04%and 3.32%,respectively.The abnormal quality control CV values of PT,APTT,FIB and D-dimer were 0.47%,0.41%,2.56%and 9.70%,respectively.In terms of inter-day precision,the normal quality control CV values of PT,APTT,TT,FIB and D-dimer were 2.81%,2.15%,3.72%,3.51%and 5.67%,respectively.The abnormal quality control CV values of PT,APTT,FIB and D-dimer were 2.21%,2.77%,4.40%and 5.37%,respectively.In terms of accuracy,the test results of normal quality control level of PT,APTT,FIB and TT were 12.1,25.6,2.71 and 19.7 respectively.The abnormal quality control levels of PT and FIB were 19.9 and 0.89 respectively.The lower limit value of D-dimer was repeated three times,and the results were 0.28,0.29 and 0.29 respectively.The higher limit value of D-dimer was repeated three times,and the results were 2.20,2.22 and 2.21 respectively.The value of linear range validation results of FIB and D-dimer were 0.9535 and 1.0162 respectively,and R2 was 0.9911 and 0.9975 respectively.In terms of sensitivity,CV values of D-dimer and FIB were 3.48%and 2.57%respectively.The highest limit value of residual contamination rate was 2.65%.All validation results met the requirements and pass the validation.Conclusion Through the 3 Q validation unde

关 键 词：ISO15189 血凝分析仪 3Q验证 SysmexCS-2500 医学实验室 

分 类 号：R446.1[医药卫生—诊断学]