摘要
目的:评价i4000SR型化学发光免疫分析仪对乙型肝炎病毒血清标志物5项检测的分析性能。方法:依据行业标准和规范文件,对i4000SR型化学发光免疫分析仪(包括模块一和模块二)在检测乙型肝炎表面抗原(HBsAg)、乙型肝炎表面抗体(HBsAb)、乙型肝炎e抗原(HBeAg)、乙型肝炎e抗体(HBeAb)、乙型肝炎核心抗体(HBcAb)(乙肝五项)的精密度、临界值分析物浓度重复性、准确度、分析测量范围、参考区间、分析灵敏度、携带污染、最大稀释度等9项性能进行评价。结果:i4000SR型化学发光免疫分析仪两个模块检测乙肝五项的批内及批间精密度均符合厂商要求;检测HBeAg、HBeAb、HBcAb临界值附近浓度标本阳性、阴性结果出现频率均>0.95。乙肝五项2个水平室间质评(EQA)检测结果均与反馈结果相符;与I2000SR型比对实验结果一致性可满足要求。HBsAg、HBsAb项目两个模块间比较偏差均<1/2允许总误差(Tea)(15.0%),HBsAg携带污染量均小于允许误差范围。HBsAg、HBsAb项目两个模块参考个体测定值均在厂家提供的参考区间内。HBsAg分析灵敏度为0.03 IU/ml,小于厂家的给定值(0.05 IU/ml);HBsAg最大稀释度为1∶200,参考区间验证结果一致率为100%。结论:i4000SR型化学发光免疫分析仪检测乙型肝炎血清标志物的精密度、临界值分析物浓度重复性、准确度、比对实验、分析测量范围、参考区间、分析灵敏度、携带污染和最大稀释度等性能均达到质量文件和临床检验要求,可用于临床标本的常规检测。
Objective:To evaluate the analytical performance of Abbott i4000sr chemiluminescent immunity analyzer in detecting 5 items of serum markers of hepatitis B virus.Methods:According to industry standards and specifications,the analytical performances of i4000sr chemiluminescent immunity analyzer(consisted of module 1 and module 2)were evaluated in detecting hepatitis B surface antigen(HBsAg),hepatitis B surface antibody(HBsAb),hepatitis B e antigen(HBeAg),hepatitis B e antibody(HBeAb)and hepatitis B core antibody(HBcAb),which included precision,repeatability of analyte concentration at cutoff value,accuracy,analytical measurement range,reference range,analytical sensitivity,carried pollution and maximum dilution.Results:Both within-run and betweenrun precisions of the two modules of i4000SR chemiluminescent immunity analyzer accorded with the requirement of manufacturer in detecting 5 items of hepatitis B.The frequency of occurrence both of positive and negative results of specimens which concentrations were nearby cutoff values of HBeAg,HBeAb and HBcAb were larger than 0.95.The detection results of external quality assessment(EQA)of 2 levels for the 5 items of hepatitis B agreed with the result of feedback.Compared with I2000SR,the consistency of experimental result of that could meet requirements.The deviations both of HBsAg and HBsAb between the two modules were less than 1/2 total error allowance(Tea)(15.0%).The amount of HBsAg carried pollution was less than the allowable error range.The referred individual measurement values of two modules for HBsAg and HBsAb were within the reference interval of manufacturer.The analytical sensitivity was 0.03 IU/mL for HBsAg,which was less than the set sensitivity of manufacturer(0.05 IU/mL).The maximum dilution of HBsAg was 1:200.And the consistency rate of validation results of reference interval was 100%.Conclusion:The performances,which include precision,repeatability of analyte concentration at cutoff value,accuracy,comparison experiment,analytical measurement range,reference range,analytical sensitivity,carried pollution and maximum dilution,of i4000 SR chemiluminescent immunity analyzer can achieve the requirements of relevant quality documents and clinical examination in detecting serum markers of hepatitis B,and they can be used for routine detection of clinical specimens.
作者
王艳萍
夏云
史静
WANG Yan-ping;XIA Yun;SHI Jing(Laboratory Department,The First Affiliated Hospital of Chongqing Medical University,Chongqing 400016,China)
出处
《中国医学装备》
2021年第12期32-37,共6页
China Medical Equipment
基金
国家重点研发计划(2017YFC0909902)“精准医疗数据集成技术研究与大数据分析系统建设”
重庆市自然科学基金面上项目(cstc2019jcyj-msxmX0349)“‘固有免疫分子R052’对乙型肝炎病毒复制的抑制作用及其机制研究”。
关键词
化学发光
乙型肝炎
血清标志物
性能验证
室间质评
Chemiluminescence
Hepatitis B
Serum markers
Performance verification
External quality assessment(EQA)
作者简介
王艳萍,女,(1987-),硕士,技师,从事临床免疫学研究工作;通信作者:史静,sj_677@163.com。
