摘要
目的比较化学发光免疫分析法(化学发光法)和液相色谱-串联质谱法(液相质谱法)检测儿童血清25-羟基维生素D[25(OH)D]的一致性。方法前瞻性选取2016年9月至2017年9月于民航总医院儿科健康体检的155名1~14岁儿童为研究对象。留取血清,化学发光法直接测定25(OH)D含量,液相质谱法分别测定25(OH)D2含量和25(OH)D3含量,再求和得到25(OH)D含量。应用Passing-Bablock回归、组内相关系数(ICC)、Bland-Altman分析比较检测结果,用加权Kappa评价两种方法诊断维生素D营养状态的一致性。结果液相质谱法检测血清25(OH)D含量平均为(29.34±6.93)ng/mL,高于化学发光法[(27.74±8.06)ng/mL],差异有统计学意义(P<0.05)。组内相关系数ICC为0.913,两个检测方法具有一致性。Bland-Altman分析显示两种检测方法的差值平均为1.6 ng/mL,95%CI:-6.2~9.4。化学发光法和液相质谱法呈线性相关,R 2=0.760,P<0.010,回归方程为Y=1.285X-9.813。化学发光法与液相质谱法的Passing-Bablock回归方程斜率为1.285(95%CI:1.177~1.406),截距为-9.813(95%CI:-13.256~6.623)。化学发光法判断维生素D营养水平与液相质谱法总体符合率为92.90%(144/155),加权Kappa=0.412,两者检测方法不一致可接受。结论化学发光法和液相质谱法评估健康儿童25(OH)D的相关性和一致性可接受。在评价和监测儿童维生素D营养状况时,应充分考虑不同方法学间各自存在的差异,兼顾准确性和可行性。
Objective To compare the consistency between chemiluminescence immunoassay(chemiluminescence)and liquid chromatography-tandem mass spectrometry(LC-MS/MS)in detecting serum 25-hydroxyvitamin D[25(OH)D]in children.Methods A total of 155 children(1-14 years old)who underwent pediatric physical examination in Civil Aviation General Hospital from September 2016 to September 2017 were prospectively selected as the subjects.The serums from children were collected,the concentration of 25(OH)D was determined by chemiluminescence immunoassay,and the concentrations of 25(OH)D2 and 25(OH)D3 were determined by LC-MS/MS,and then summed up to obtain the content of 25(OH)D.The test results were compared using Passing Bablock regression,intra group correlation coefficient(ICC),and Blank Altman analysis.The consistency of the two methods in diagnosing vitamin D nutritional status was evaluated using weighted Kappa method.Results The average serum 25(OH)D content detected by LC-MS/MS was(29.34±6.93)ng/mL,which was higher than that detected by chemiluminescence[(27.74±8.06)ng/mL],and the difference was statistically significant(P<0.05).The intra group correlation coefficient(ICC)was 0.913,indicating consistency between the two detection methods.The Bland Altman plot showed that the average difference between the two detection methods was 1.6 ng/mL,95%CI:-6.2-9.4.There was a linear correlation between chemiluminescence and liquid chromatography-mass spectrometry,R 2=0.760,P<0.010,and the regression equation was Y=1.285X-9.813.The slope of the Passing Bablock regression equation for chemiluminescence and liquid chromatography-mass spectrometry was 1.285(95%CI:1.177-1.406),and the intercept was-9.813(95%CI:-13.256-6.623).The overall agreement rate between the chemiluminescence method for determining vitamin D nutritional levels and liquid chromatography-mass spectrometry was 92.90%(144/155),weighted Kappa=0.412.Conclusion The correlation and consistency between chemiluminescence and LC-MS/MS in evaluating 25(OH)D in healthy children are acceptable.When we assess and monitor vitamin D nutrition,it is necessary to consider the difference between testing method and to further ensure the accuracy and feasibility.
作者
马少杰
毕颖薇
胡文娟
时琰丽
韩颖
王红
MA Shao-jie;BI Ying-wei;HU Wen-juan(Department of Pediatric,Civil Aviation General Hospital,Beijing 100123,China)
出处
《临床和实验医学杂志》
2024年第1期91-94,共4页
Journal of Clinical and Experimental Medicine
基金
首都卫生发展青年基金(编号:首发2014-4-6031)。
