Measurement agreement of 25-hydroxyvitamin D results derived from Roche immunoassay and liquid chromatography tandem mass spectrometry
10.3760/cma.j.cn114452-20201210-00892
- VernacularTitle: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
- Author:
Meiliang GONG
1
;
Keyu WANG
;
Rui CHEN
;
Xiaoxia LI
;
Yu ZHOU
;
Yulong CONG
;
Yuanli MAO
;
Xinli DENG
Author Information
1. 解放军总医院第二医学中心检验科,北京 100853
- Keywords:
25-Hydroxyvitamin D;
Liquid chromatography tandem-mass spectrometry;
Chemiluminescent measurements
- From:
Chinese Journal of Laboratory Medicine
2021;44(7):621-626
- CountryChina
- Language:Chinese
-
Abstract:
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.