Harmonization of serum 25-hydroxycalciferol assay results from high-performance liquid chromatography, enzyme immunoassay, radioimmunoassay, and immunochemiluminescence systems: A multicenter study.

Autor:	Nikooyeh B; Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran., Samiee SM; Health Reference Laboratories (HRL), Iran Ministry of Health, Tehran, Iran., Farzami MR; Health Reference Laboratories (HRL), Iran Ministry of Health, Tehran, Iran., Alavimajd H; Department of Biostatistics, Faculty of Paramedicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran., Zahedirad M; Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran., Kalayi A; Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran., Shariatzadeh N; Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran., Boroumand N; Department of Biostatistics, Faculty of Paramedicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran., Golshekan E; Health Reference Laboratories (HRL), Iran Ministry of Health, Tehran, Iran., Gholamian Y; Health Reference Laboratories (HRL), Iran Ministry of Health, Tehran, Iran., Neyestani TR; Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Jazyk:	angličtina
Zdroj:	Journal of clinical laboratory analysis [J Clin Lab Anal] 2017 Nov; Vol. 31 (6). Date of Electronic Publication: 2017 Feb 07.
DOI:	10.1002/jcla.22117
Abstrakt:	Background: Remarkable disagreement among different systems of 25-hydroxy vitamin D 25(OH)D assay makes decision making for both clinical and community interventions very difficult. This study aimed to harmonize the results obtained from different 25(OH)D assay systems. Methods: A total of 275 serum samples were analyzed for 25(OH)D using DIAsource-enzyme immunoassay (EIA), DIAsource-radioimmunoassay (RIA), Roche-electrochemiluminescence (ECL), Diasorin-chemiluminescent immunoassay (CLIA), and high-performance liquid chromatography (HPLC), as the reference method. Serum intact parathyroid hormone (iPTH) was also measured in all samples. Between-system agreement and harmonization were evaluated using Bland-Altman analysis, receiver operating characteristic (ROC), and regression analysis. Results: Mean serum 25(OH)D concentrations and frequency distribution of vitamin D status showed a significant difference among the studied systems (P<.001 for both). Serum 25(OH)D assay results from all systems correlated with those from HPLC. As compared with HPLC, ECL showed a positive bias (+3.8 nmol/L), whereas CLIA had a negative bias (-11.9 nmol/L). Both EIA and RIA showed a more or less similar positive bias (8.0 and 8.1 nmol/L, respectively). Using serum iPTH-based 25(OH)D cutoff points, only ECL results became comparable to and without significant difference with HPLC. However, when system-specific cutoffs were defined based on HPLC results using regression equations, mean 25(OH)D and frequency distribution of vitamin D status were more harmonized compared with the other methods. Conclusion: Our findings showed that with adjustment of circulating 25(OH)D based on HPLC, frequency distribution of vitamin D status, as judged by different methods, can be well harmonized with no statistically significant inter-system difference. (© 2017 Wiley Periodicals, Inc.)
Databáze:	MEDLINE
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