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参考变化值:基于生物学变异解读系列检测中实验室报告的一项提议。

The reference change value: a proposal to interpret laboratory reports in serial testing based on biological variation.

作者信息

Ricós C, Cava F, García-Lario J V, Hernández A, Iglesias N, Jiménez C V, Minchinela J, Perich C, Simón M, Domenech M V, Alvarez V

机构信息

Laboratoris Clínics Hospital Vall d'Hebron, Barcelona, Spain.

出版信息

Scand J Clin Lab Invest. 2004;64(3):175-84. doi: 10.1080/00365510410004885.

Abstract

BACKGROUND

A proposal to calculate and use the reference change value (RCV) as an objective guide for interpreting the numerical results obtained in clinical laboratory serial testing is introduced in this study.

METHODS

A database showing the results of a compilation of 191 publications on biological variation and including information on a number of analytes provided the standardized criterion based on biology for calculating the RCVs.

RESULTS

For each of the 261 analytes included in the study, the RCV was determined using Harris's formula, replacing analytical imprecision with the desirable specification of analytical quality based on half the within-subject biological variation at 95% probability levels. The result is a guide for a common criterion to identify clinically significant changes in serial results.

CONCLUSIONS

The RCV concept is an approach that can be offered by laboratories to assess changes in serial results. The RCV data in this study are presented as a point of departure for a widely applicable objective guide to interpret changes in serial results.

摘要

背景

本研究引入了一项建议,即计算并使用参考变化值(RCV)作为解释临床实验室系列检测所得数值结果的客观指南。

方法

一个展示了191篇关于生物学变异的出版物结果且包含多种分析物信息的数据库,为基于生物学计算RCV提供了标准化标准。

结果

对于该研究中包含的261种分析物中的每一种,使用哈里斯公式确定RCV,在95%概率水平下,用基于个体内生物学变异一半的理想分析质量规范替代分析不精密度。结果是一个用于识别系列结果中具有临床意义变化的通用标准指南。

结论

RCV概念是实验室可提供的一种评估系列结果变化的方法。本研究中的RCV数据作为一个广泛适用的客观指南的出发点呈现,用于解释系列结果的变化。

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