免疫分析系统与液相色谱串联质谱检测25-羟基维生素D的一致性评价  

Consistency evaluation between immunoassay system and LC-MS/MS in detecting 25-(OH)-D

作　　者：龚美亮[1] 李晓霞[1] 陈瑞[1] 王科宇 周玉[1] 丛玉隆[1] 邓新立[1] GONG Mei-liang;LI Xiao-xia;CHEN Rui(Department of Clinical Laboratory,Second Medical Center of Chinese PLA General Hospital,Beijing 100853,China;不详)

机构地区：[1]解放军总医院第二医学中心检验科,北京100853

出　　处：《中国医学装备》2021年第5期30-33,共4页China Medical Equipment

基　　金：军委后勤保障部卫生局保健专项课题(17BJZ45)“七十岁以上老年人不同年龄段常用检验指标参考范围的调查”;国家卫生健康委员会老龄健康司2019年资助项目“老年特殊人群常用检验结果测定值大数据调查”。

摘　　要：目的:比较临床常用的索灵(Sorin,LIAISON XL)全自动免疫分析系统(索灵)与液相色谱串联质谱(LC-MS/MS)系统检测25-羟基维生素D[25(OH)D]的一致性。方法:收集医院健康查体者剩余血清样本810份,分别用索灵及LC-MS/MS系统检测25(OH)D水平。对索灵与LC-MS/MS系统检测结果进行一致性评价:采用配对符号秩和检验分析两种系统检测结果的差异;分析索灵检测偏差随25(OH)D浓度变化的趋势;采用Passing-Bablok回归、组内相关系数(ICC)分析两种系统检验的一致性;采用Kappa检验分析索灵用于临床判断维生素D缺乏及不足与LC-MS/MS系统的一致性。结果:索灵与LC-MS/MS系统检测25(OH)D结果分别为(18.66±7.32)ng/ml和(23.31±9.29)ng/ml,差异有统计学意义;索灵检测结果的平均偏差为-4.65 ng/ml(-16.5%),且偏差存在浓度依赖性。索灵与LC-MS/MS系统的Passing-Bablok回归方程斜率为0.785,95%置信区间(95%CI)为0.753~0.818;截距为0.146,95%CI为-0.505~0.799;ICC=0.660,95%CI为0.255~0.820。索灵判断维生素D缺乏及不足与LC-MS/MS系统的符合率分别为73.09%、84.20%,Kappa值分别为0.483、0.362。结论:索灵与LC-MS/MS系统检测25(OH)D的相关性较好。索灵判定维生素D营养状况可能出现的归类错误风险,可以通过与LC-MS/MS系统建立的回归方程得到一定程度的纠正。Objective:To compare the consistency between the clinically common Sorin full-automatic immunoassay system and liquid chromatogram tandem mass spectrum(LC-MS/MS)in detecting 25-hydroxyvitamin D[25-(OH)-D].Methods:810 residual serum samples from health persons who received physical examination were selected.And the 20-(OH)-D levels of them were detected by Sorin full-automatic immunoassay system and LC-MS/MS,respectively.The consistent evaluation was adopted for the detection results of Sorin and LC-MS/MS,and the paired signed rank sum test was adopted to analyze the difference of the detection results between two kinds of systems.And the trend of the deviation of Sorin detection with the change of 20-(OH)-D concentration was analyzed,and the Passing-Bablok regression and interclass correlation coefficient were adopted to analyze the consistency between the two kinds of system test.In addition,Kappa test was adopted to analyze the consistency between Sorin and LC-MS/MS in the clinical judgments of Vitamin D deficiency and insufficiency.Results:The results of 25-(OH)-D concentration of Sorin and LC-MS/MS were(18.66±7.32)ng/ml and(23.31±9.29)ng/ml,respectively,and the difference of these results between two methods was significant.And the average deviation of Sorin detection results was[-4.65ng/ml(-16.5%)],and there was concentration dependency in deviation.The slope of Passing-Bablok regression equation of Sorin and LC-MS/MS was 0.785,and the 95%confidence interval(95%CI)was 0.753-0.820,and the intercept was 0.146,and the 95%CI was-0.505-0.799,and ICC was 0.660,and 95%CI was 0.255-0.820.The consistency rates of Vitamin D deficiency and insufficiency between Sorin and LC-MS/MS system were 73.09%and 84.20%,respectively,and the Kappa values of them were 0.483 and 0.362,respectively.Conclusion:Sorin full automatic immunoassay system showed favorable correlation with LC-MS/MS in detecting 25-(OH)-D.The possible risk of misclassification of Sorin in judging Vitamin D nutrition situation can be corrected by the regressi

关 键 词：25-羟基维生素D(25(OH)D) 全自动免疫分析系统 LC-MS/MS系统 方法比对 

分 类 号：R197.39[医药卫生—卫生事业管理]