摘要
目的:对迈克i3000全自动化学发光分析仪检测系统进行性能验证。方法:按照我国卫生行业标准相关指南对血清乙肝表面抗原(HBsAg)、乙肝表面抗体(HBsAb)、乙肝e抗原(HBeAg)、乙肝e抗体(HBeAb)、乙肝核心抗体(HBcAb)进行检测,评价其精密度、正确度、线性和灵敏度。结果:检测的5项指标实验室变异系数均低于厂家声明变异系数(CV<15%),其实验室内标准差小于验证值,精密度验证符合要求;i3000与雅培i1000比对HBeAb在<0.2COI浓度内符合率为92.3%,其余项目符合率为100%。乙肝病毒五项中线性良好(r^(2)>0.995),斜率a接近1,P<0.01;灵敏度验证空白限及检测限均符合厂家声明要求。结论:迈克i3000全自动化学发光分析仪检测性能良好,结果准确,可满足临床工作需求。
Objective:To verify the performance of Maker i3000 automatic chemiluminescence analyzer.Methods:According to China's health industry standards related to guide the evaluation precision,accuracy,linearity and sensitivity method,of hepatitis b surface antigen(HBsAg),hepatitis b surface antibody(HBsAb),hepatitis b e antigen(HBeAg),antibody of second livere(HBeAb),hepatitis b core antibody(HBcAb)for testing.Results:The laboratory variation coefficients of the five indicators tested are all lower than the manufacturer's declared coefficient of variation(CV<15%),and the standard deviation within the laboratory is less than the validation value.The precision verification meets the requirements.Compared with Abbott i1000,the coincidence rate of i3000 ratio HBeAb in<0.2COI concentration was 92.3%,and the coincidence rate of other items was 100%.The five items of hepatitis b virus had good linearity(r^(2)>0.995),slope a was close to 1,P<0.01.The sensitivity validation blank limit and detection limit meet the requirements of the manufacturer's declaration.Conclusion:The Maker i3000 automatic chemiluminescence analyzer has good detection performance and accurate results,which can meet the requirements of clinical work.
作者
刘道利
龙华婧
梁涯
曾亭亭
周伟青
LIU Dao-li;LONG Hua-jing;LIANG Ya(The Affiliated TCM Hospital of Guangzhou Medical University,Guangdong Guangzhou 510130)
出处
《医学检验与临床》
2024年第6期19-22,78,共5页
Medical Laboratory Science and Clinics
