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25-羟基维生素D测量自动化方法的比较

Comparison of automated methods for measurement of 25-hydroxyvitamin D.

作者信息

Martins-Costa Paula, Martins Helena, Bravo Fernanda, Cruz Madalena, Reis Júlia, Oliveira José Carlos

机构信息

Centro Hospitalar do Porto, Hospital de Santo António, Serviço de Química Clínica, Porto, Portugal.

出版信息

Clin Lab. 2013;59(7-8):885-91. doi: 10.7754/clin.lab.2012.120924.

Abstract

BACKGROUND

The objective of the study was to compare the analytical performance of three automated immunoassays for the determination of serum 25-hydroxyvitamin D.

METHODS

Quantitative determination of serum 25(OH)D were performed by "Vitamin D total" (n = 131) and "Vitamin D3(25-OH)" (n = 77) assays (Roche Diagnostics) on a Cobas e411 and by "25-OH Vitamin D" (n = 131) assay (Abbott Laboratories) on an Architect. The inter-assay precision was calculated and methods were compared by the Passing Bablok regression and Bland-Altman analysis.

RESULTS

The "Vitamin D total" demonstrated stronger correlation (r = 0.863) and better agreement (bias = -7.89 nmol/L) with the "25-OH Vitamin D" than with the "Vitamin D3(25-OH)" (r = 0.716; bias = +18.6 nmol/L). The inter-assay precision (% CV) for the "Vitamin D total" and "25-OH Vitamin D" assays, were respectively 3.47 to 6.14 and 4.27 to 8.56.

CONCLUSIONS

The results of this study demonstrate that Abbott "25-OH Vitamin D" and Roche "Vitamin D total" are rapid and precise methods for 25(OH)D serum measurement over a wide reportable range on automated immunoassay platforms. The Abbott assay exhibited better correlation and agreement with the new Roche assay than the "Vitamin D3(25-OH)" Roche assay. Between method differences observed in this study still indicates the need for standardization of 25(OH)D assays.

摘要

背景

本研究的目的是比较三种自动化免疫测定法测定血清25-羟基维生素D的分析性能。

方法

在Cobas e411上采用“总维生素D”(n = 131)和“维生素D3(25-OH)”(n = 77)测定法(罗氏诊断公司)对血清25(OH)D进行定量测定,并在Architect上采用“25-羟基维生素D”(n = 131)测定法(雅培实验室)进行测定。计算批间精密度,并通过帕氏-巴布洛克回归分析和布兰德-奥特曼分析对方法进行比较。

结果

与“维生素D3(25-OH)”(r = 0.716;偏差 = +18.6 nmol/L)相比,“总维生素D”与“25-羟基维生素D”的相关性更强(r = 0.863),一致性更好(偏差 = -7.89 nmol/L)。“总维生素D”和“25-羟基维生素D”测定法的批间精密度(%CV)分别为3.47至6.14和4.27至8.56。

结论

本研究结果表明,雅培的“25-羟基维生素D”和罗氏的“总维生素D”是在自动化免疫测定平台上对25(OH)D血清进行宽报告范围测量的快速、精确方法。与罗氏的“维生素D3(25-OH)”测定法相比,雅培的测定法与罗氏的新测定法具有更好的相关性和一致性。本研究中观察到的方法间差异仍表明25(OH)D测定法需要标准化。

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