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目的建立尿液中性粒细胞明胶相关脂质运载蛋白(NGAL)时间分辨免疫荧光分析方法并应用于临床检测。方法根据美国临床和实验室标准化协会(CLSI)制定的相关EP系列评价文件,使用本实验建立的时间分辨免疫荧光分析方法,对尿液NGAL的最低检测限、精密度、准确度、稳定性、分析测量范围、Hook效应、生物参考区间进行检测评价。通过检测健康体检人员及临床急性肾损伤患者尿液样本与Abbott ARCHITECT化学发光法进行比对,使用SPSS软件进行统计学分析。结果本实验所建立的方法最低检测限为1.5 ng/ml,批内不精密度与总不精密度均<6.0%,回收率为93%~107%,当NGAL浓度高达3×10~5ng/ml时,无Hook效应(5×10~5ng/ml亦不会出现假阴性),该方法与Abbott ARCHITECT化学发光具有很强的相关性(r=0.989),且37℃加速7 d荧光信号保留率均>80%。结论本实验室研究方法检测尿液NGAL各项性能指标均满足临床要求,可应用于急性肾损伤患者的诊断。
Objective To establish a time-resolved immunofluorescence assay of urinary neutrophil gelatin-related lipocalin (NGAL) and apply it in clinical tests. Methods According to the relevant EP series evaluation documents established by the American Society of Clinical and Laboratory Standards (CLSI), the minimum detectable limit, precision, accuracy, stability, and stability of NGAL in urine were determined by using the time-resolved immunofluorescence analysis method established in this experiment. Analysis of measurement range, Hook effect, biological reference interval for evaluation. Urine samples were tested by Abbott ARCHITECT chemiluminescence assay for health examiners and clinical acute kidney injury patients, and SPSS software was used for statistical analysis. Results The detection limit of this method was 1.5 ng / ml. The intra-assay inaccuracy and total inaccuracy were both <6.0% and the recoveries were 93% -107%. When the NGAL concentration was as high as 3 × 10-5 ng / ml, there is no Hook effect (5 × 10 ~ 5ng / ml false negative will not occur), this method has strong correlation with Abbott ARCHITECT chemiluminescence (r = 0.989), and 7 d accelerated fluorescence signal retention Rate> 80%. Conclusion The laboratory tests of urine NGAL performance indicators meet the clinical requirements, can be applied to the diagnosis of acute kidney injury patients.