LIAISON化学发光免疫分析仪检测的性能验证  

Performance verification of LIAISON chemiluminescence immunity analyzer

作　　者：陈兰兰[1] 邵婧[1] 刘义庆[1] 张培莉[1] 牛登冉 段文冰[1] 赵万辉[1] 张栋[2] 

机构地区：[1]山东大学附属省立医院临床医学检验部,济南250021 [2]山东大学附属省立医院泌尿外科,济南250021

出　　处：《国际检验医学杂志》2018年第2期149-152,共4页International Journal of Laboratory Medicine

基　　金：山东省自然科学基金资助项目(ZR2016HM52);山东省科学技术发展计划资助项目(2014GGH218041);山东省临床重点专科建设项目经费资助(鲁卫医字[2013]26号)

摘　　要：目的验证LIAISON化学发光免疫分析仪检测产前筛查优生四项(TORCH)的分析性能。方法参考美国临床和实验室标准化协会(NCCLS)系列文件和相关文献,结合工作实际,设计验证方案,并对LIAISON化学发光免疫检测系统测定弓形虫IgG抗体(Tox IgG)、弓形虫IgM抗体(Tox IgM)、风疹病毒IgG抗体(Rub IgG)、风疹病毒IgM抗体(Rub IgM)、巨细胞病毒IgG抗体(CMV IgG)、巨细胞病毒IgM抗体(CMV IgM)、单纯疱疹病毒IgG抗体(HSV IgG)、单纯疱疹病毒IgM抗体(HSV IgM)的精密度、准确度、分析线性范围、临床可报告范围和生物参考区间等进行验证和评价,并将实验结果与厂家(意大利索灵)提供的分析性能或公认的质量指标进行比较。结果批内不精密度CV值在3.58%~7.03%,均小于规定的范围;批间不精密度CV值在3.13%~10.73%。线性范围验证回归系数a值在0.97~1.03,r2>0.95,线性均符合要求。生物参考区间及可报告范围均符合要求。结论 LIAISON化学发光免疫检测系统检测分析性能符合临床要求,测定结果灵敏度高,特异度好,稳定性强,检测范围宽,有良好的准确性和重复性,适合应用于临床。Objective To verify the performance of LIAISON chemiluminescence immunoassay analyzer in the prenatal screening for TORCH. Methods Reference to the US Institute of Clinical and Laboratory Standards（NCCLS） series of documents and literature and combining with actual work,we designed the verification program,and tested and evaluated the LIAISON chemiluminescent immunoassay systems for the measurement precision,accuracy,linearity analysis, clinical reportable range and biological reference intervals of Tox IgG, Tox IgM,Rub IgG,Rub IgM,CMV IgG,CMV IgM, HSV IgG,HSV IgM. We also compared the results with analysis performance provided by manufacturers （Italy LIAISON） or recognized quality indicators. Results Intraassay imprecision CV values were between 3. 58% - 7. 03%, which were less than the predetermined range; interassay imprecision CV values were between 3. 13% - 10. 73%. Linear range validation regression coefficients a values were between 0. 97 - 1. 03 and r^2〉0. 95. The linear relationship met the requirements. Both biological reference interval and reportable range meet the requirements. Conclusion The performance of LIAISON chemiluminescence immunoassay detection system satisfied the clinical requirements , and the measurement results had advantages of high sensitivity, specificity, stability, wide detection range, good accuracy and repeatability,which was suitable for clinical application.

关 键 词：化学发光免疫分析 准确度 精密度 性能验证 

分 类 号：R392.33[医药卫生—免疫学]