Summary
Background
There is increasing requests of Vitamin D test in many clinical settings in recent years. However, immunoassay performance is still a controversial topic. Several diagnostic manufacturers have launched automated 25-hydroxyvitamin D (25-OH D) immunoassays in the past decade. We compared the performance of Abbott Architect 25-OH D Vitamin immunoassay with liquid chromatography-tandem mass spectrometry systems (LC-MS/MS) to evaluate immunoassay performance, especially in deficient groups.
Methods
Eighty human serum samples were analyzed with Architect 25-OH D vitamin kit (Abbott Diagnostics, Lake Forest, IL, USA) and LC-MS/MS systems (Zivak Technology, Istanbul, Turkey). The results of the immunoassay method were compared with the LC-MS/MS using Passing-Bablok regression analysis, Bland-Altman plots and correlation coefficient analysis. We also evaluated results in four levels of D vitamin as a severe deficiency, deficiency, insufficiency, and sufficiency.
Results
Architect showed 9.59% bias from LC-MS/MS with smaller mean. Passing-Bablok regression analysis demonstrated the value of 0.95 slope and had a constant bias with an intercept value of -4.25. Concordance correlation coefficient showed moderate agreement with the value of 0.918 (95% CI 0.878–0.945). Two methods revealed good interrater agreement (kappa = 0.738). While the smallest bias determined in deficiency (9.95%) group, the biggest was in insufficiency (15.15%).
Conclusions
Architect 25-OH D vitamin immunoassay can be used in routine measurements but had potential misclassification of vitamin D status in insufficient and deficient groups. Although there are recent standardization attempts in 25-OH D measurements, clinical laboratories must be aware of this method.
Performance Evaluation and Measurement Uncertainty Determination of the New Version of the Abbott ARCHITECT 25-OH Vitamin D 5P02 Assay
