免疫荧光干式定量法检测可溶性生长刺激表达基因2蛋白性能验证  

The Performance Evaluation of Soluble Growth Stimulated Expression Gene 2 Protein(sST2) Detected by ImmunofluorescenceDry Quantitative Assay

作　　者：左蒙 易婉婉 刘瑾[2] 白威峰[1] 吕中伟[2] 柴丽[2] ZUO Meng;YI Wanwan;LIU Jin;BAI Weifeng;LYU Zhongwei;CHAI Li(Department of Nuclear Medicine,Bengbu First People’s Hospital,Bengbu 233000,China;Department of Nuclear Medicine,The Tenth People’s Hospital of Tongji University,Shanghai 200072,China)

机构地区：[1]蚌埠市第一人民医院核医学科,安徽蚌埠233000 [2]同济大学附属第十人民医院核医学科,上海200072

出　　处：《标记免疫分析与临床》2023年第9期1596-1600,共5页Labeled Immunoassays and Clinical Medicine

基　　金：上海申康医院发展中心(编号:2022SKLY-09)。

摘　　要：目的 对免疫荧光干式定量法检测可溶性生长刺激表达基因2蛋白(sST2)进行临床分析性能验证。方法 依据国家卫生行业标准WS/T492-2016及参考美国临床和实验室标准化协会(CLSI)相关文件要求,对实验室免疫荧光干式定量法检测sST2的精密度、正确度、线性范围、参考区间进行评价。结果 sST2的高低两水平的批内精密度分别为3.48%和1.62%,实验室总精密度分别为4.19%和1.47%,两校准品偏倚分别为-1.95%和-0.40%,精密度与正确度均符合行业标准要求;在分析测量范围内线性良好(R2=0.9998),参考区间验证R=100%验证通过。结论 sST2免疫荧光干式定量法的各项性能指标均符合要求,适于临床样本分析。Objective To evaluate the clinical performance of immunofluorescence dry quantitative assay for the detection of soluble growth stimulatory expressed gene 2 protein(sST2).Methods According to the national health industry standard WS/T492-2016 and the relevant documents of the Clinical and Laboratory Standards Institute(CLSI),the precision,accuracy,linear range,and reference interval of sST2 detection by laboratory immunofluorescence dry quantitative method were evaluated.Results The intra-run precision of the high and low levels of sST2 were 3.48%and 1.62%,while total laboratory precision were 4.19%and 1.47%,and the bias of the two calibrators were-1.95%and-0.40%,respectively.The precision and accuracy met the requirements of industry standards;The linearity fit well within the analysis and measurement range(R 2=0.9998),and the reference interval validation(R=100%)passed the validation.Conclusion All the performance indexes of the sST2 immunofluorescence dry quantitative method meet the requirements,which is suitable for the clinical sample analysis.

关 键 词：免疫荧光干式定量法 可溶性生长刺激表达基因2蛋白 精密度 正确度 线性范围 

分 类 号：R-331[医药卫生]