摘要
目的验证及评估一种体外定量测定人血清中总25-羟基维生素D[25(OH)D]水平的方法学性能。方法使用贝克曼AU5800全自动生化分析仪对血清25-羟基维生素D采用胶乳免疫比浊分析法进行检测,并对建立的方法进行准确度、精密度、灵敏度、线性范围、携带污染、抗干扰以及方法学比对等性能评价。结果该方法准确度偏差和批内、批间精密度均小于10%;空白限及检测限的灵敏度验证在要求范围内,功能灵敏度为3.26ng/mL;在试剂线性范围验证的线性方程中,相关系数R^(2)为0.9983,斜率为1.0152;在抗干扰能力验证中,当胆红素浓度不大于40mg/dL、三酰甘油浓度不大于1000mg/dL、血红蛋白浓度不大于150mg/dL时,对样本检测结果不产生明显的干扰作用;携带污染率经过公式计算为零,在与西门子ADVIA CentaurXP全自动化学发光分析仪进行方法学比对后,两种方法的线性相关方程的相关系数R^(2)为0.972,斜率为0.737,一致性比对中有97%的结果在95%的一致性置信区间内。结论该方法检测性能良好,具有较好的重复性及精确性,可满足临床需求。
Objective To verify and evaluate the methodological performance of an in vitro quantitative determination of total 25-hydroxy vitamin D[25(OH)D]content in human serum.Methods Beckman AU5800 automatic biochemical analyzer was used to detect serum 25(OH)D by the latex immunoturbidimetric analysis method,and the performance evaluation of this established method through accuracy,precision,sensitivity,linearity,carrying pollution,anti-interference and methodology comparison were carried out.Results The method’s accuracy deviation and intra-batch and inter-batch precision were all less than 10%.The sensitivity validation of blank and detection limits was within the required range,and the functionalsensitivity was 3.26(ng/mL).In the linear equation verified by the reagent linear range,the correlation coefficient R^(2) was 0.9983,and the slope was 1.0152.In the anti-interference ability verification,when the bilirubin concentration was not more than 40mg/dL,the triglyceride concentration was not more than 1000mg/dL,and the hemoglobin concentration was not more than 150mg/dL.There was no observed interference to the sample detection results.The carry-over contamination rate was calculated to be zero by the formula.Based on the methodological comparison with Siemens ADVIA CentaurXP automatic chemiluminescence analyzer,the correlation coefficient R^(2) of the linear correlation equation of the two methods was 0.972,with the slope of 0.737,and 97%of the results in the consistency comparison were within the 95%confidence interval of consistency.Conclusion The studied method has a good detection performance,repeatability and accuracy,and can meet clinical needs.
作者
刘佳星
谷妍
刘杨
岳莉
戚应杰
LIU Jiaxing;GU Yan;LIU Yang;YUE Li;QI Yingjie(Anhui Provincial Hospital Infection Hospital,Hefei Infectious Disease Hospital)
出处
《标记免疫分析与临床》
CAS
2021年第12期2157-2161,共5页
Labeled Immunoassays and Clinical Medicine
基金
中关村国家自主创新示范区重大前沿原创技术成果转化和产业化项目(编号:2019F000G378)。
