一种免疫分析系统与液相色谱-串联质谱检测25-羟维生素D的一致性评价  

Measurement agreement of 25-hydroxyvitamin D results derived from Roche immunoassay and liquid chromatography tandem mass spectrometry

作　　者：龚美亮[1] 王科宇 陈瑞[1] 李晓霞[1] 周玉[1] 丛玉隆[1] 毛远丽 邓新立[1] Gong Meiliang;Wang Keyu;Chen Rui;Li Xiaoxia;Zhou Yu;Cong Yulong;Mao Yuanli;Deng Xinli(Department of Clinical Laboratory,Second Medical Center of Chinese PLA General Hospital,Beijing 100853,China;Department of Clinical Laboratory,Fifth Medical Center of Chinese PLA General Hospital,Beijing 100039,China)

机构地区：[1]解放军总医院第二医学中心检验科,北京100853 [2]解放军总医院第五医学中心检验科,北京100039

出　　处：《中华检验医学杂志》2021年第7期621-626,共6页Chinese Journal of Laboratory Medicine

基　　金：军委后勤保障部卫生局保健专项课题(17BJZ45);国家卫生健康委员会老龄健康司2019年资助项目。

摘　　要：目的比较临床常用的罗氏全自动免疫分析系统(评估方法)与液相色谱-串联质谱(LC-MS/MS,参比方法)检测25-羟基维生素D[25(OH)D]的一致性。方法收集2019年5—6月解放军总医院第二医学中心及第五医学中心健康查体剩余血清标本909份,分别由评估方法及LC-MS/MS检测25(OH)D。用Passing-Bablok回归、组内相关系数(ICC)、Bland-Altman图分析2种检测方法的一致性和偏差;加权Kappa检验分析评估方法用于临床判断维生素D正常、不足、缺乏与LC-MS/MS的一致性。结果评估方法检测结果与LC-MS/MS比较,差异有统计学意义(P<0.001)。评估方法与LC-MS/MS的Passing-Bablok回归方程斜率为0.962(95%CI 0.919~1.007),截距为-0.185(95%CI-1.191~0.745),提示评估方法与LC-MS/MS一致性较高。ICC为0.765(95%CI 0.735~0.792)。Bland-Altman图显示评估方法与LC-MS/MS的平均偏差为-0.902 ng/ml(0.300%)。评估方法判断维生素D正常、不足、缺乏与LC-MS/MS的总符合率为83.39%(758/909),加权Kappa=0.790。结论评估方法检测25(OH)D与LC-MS/MS相关性可以接受,一致性较好。临床在评价维生素D营养状况时应考虑不同方法学间存在的差异,建议临床检验实验室自建方法学相对应的参考范围。Objective To evaluate the measurement agreement of Roche 25(OH)D immunoassay(evaluation method)with LC-MS/MS(reference method).Methods A total of 909 residual serum samples from routine health check participants were collected from May to June in 2019.25(OH)D concentrations were measured by evaluation method and LC-MS/MS,respectively.Passing-bablok regression,intraclass correlation coefficient(ICC),Bland Altman plots and Kappa test were used to analyze the consistency and bias on the results derived from the two measurement methods.Results The 25(OH)D concentration derived from evaluation method was significantly different from those from LC-MS/MS method(P<0.001).Slope of regression for evaluation method and LC-MS/MS was 0.962(95%CI 0.919-1.007),while intercept was-0.185(95%CI-1.191-0.745).The ICC was 0.765(95%CI 0.735-0.792).Altman plot showed that the average deviation between evaluation method and LC-MS/MS was-0.902 ng/ml(0.300%).The coincidence rate of evaluation method′s judgment of vitamin D sufficiency,insufficiency and deficiency with LC-MS/MS was 83.39%,and the weighted Kappa values was 0.790.Conclusion Roche automatic 25(OH)D immunoassay shows acceptable correlation and agreement with LC-MS/MS,however,it is to note that the deviation between immunoassay and LC-MS/MS may lead to wrong judgment of vitamin D nutritional status.It is recommended that each laboratory should establish own corresponding reference values for 25(OH)D concentrations derived from these two methods.

关 键 词：25-羟维生素D 液相色谱串联质谱法 化学发光测定法 

分 类 号：R446.6[医药卫生—诊断学]