Esin Avci1, Süleyman Demir1, Diler Aslan1, Rukiye Nar1, Hande Şenol2. 1. Pamukkale University, Faculty of Medicine, Department of Biochemistry, Denizli, Turkey. 2. Pamukkale University, Faculty of Medicine, Department of Biostatistics, Denizli, Turkey.
Abstract
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 (LCMS/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. 2020 Esin Avci, Süleyman Demir, Diler Aslan, Rukiye Nar, Hande Şenol, published by CEON/CEES.
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 (LCMS/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. 2020 Esin Avci, Süleyman Demir, Diler Aslan, Rukiye Nar, Hande Şenol, published by CEON/CEES.
Entities:
Keywords:
25-Hydroxyvitamin D; deficiency; insufficiency; method comparison; vitamin D
Authors: Daria V Smirnova; Colin D Rehm; Ronald D Fritz; Inga S Kutepova; Maria S Soshina; Yulia A Berezhnaya Journal: Sci Rep Date: 2022-10-05 Impact factor: 4.996