高效液相色谱法、酶免疫测定法、放射免疫测定法和免疫化学发光系统血清25-羟基维生素D检测结果的一致性：一项多中心研究。

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

作者信息

Nikooyeh Bahareh, Samiee Siamak M, Farzami Marjan R, Alavimajd Hamid, Zahedirad Maliheh, Kalayi Ali, Shariatzadeh Nastaran, Boroumand Nasrin, Golshekan Elham, Gholamian Yalda, Neyestani Tirang R

机构信息

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.

Health Reference Laboratories (HRL), Iran Ministry of Health, Tehran, Iran.

出版信息

J Clin Lab Anal. 2017 Nov;31(6). doi: 10.1002/jcla.22117. Epub 2017 Feb 7.

DOI:10.1002/jcla.22117

PMID:28169461

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6817016/

Abstract

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.

摘要

背景

25-羟基维生素D[25(OH)D]检测的不同系统之间存在显著差异，这使得临床和社区干预的决策变得非常困难。本研究旨在使不同25(OH)D检测系统获得的结果趋于一致。

方法

使用DIAsource酶免疫分析（EIA）、DIAsource放射免疫分析（RIA）、罗氏电化学发光（ECL）、索灵化学发光免疫分析（CLIA）以及作为参考方法的高效液相色谱（HPLC）对总共275份血清样本进行25(OH)D分析。所有样本还检测了血清完整甲状旁腺激素（iPTH）。使用Bland-Altman分析、受试者工作特征（ROC）和回归分析评估系统间的一致性和一致性调整。

结果

研究系统之间血清25(OH)D平均浓度和维生素D状态的频率分布存在显著差异（两者P<0.001）。所有系统的血清25(OH)D检测结果均与HPLC结果相关。与HPLC相比，ECL显示正偏差（+3.8 nmol/L），而CLIA有负偏差（-11.9 nmol/L）。EIA和RIA均显示出或多或少相似的正偏差（分别为8.0和8.1 nmol/L）。使用基于血清iPTH的25(OH)D临界值时，只有ECL结果与HPLC结果具有可比性且无显著差异。然而，当使用回归方程根据HPLC结果定义特定系统的临界值时，与其他方法相比，25(OH)D平均值和维生素D状态的频率分布更加一致。