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临床实践中肝纤维化血液检测的可重复性。

Reproducibility of blood tests of liver fibrosis in clinical practice.

作者信息

Calès Paul, Veillon Pascal, Konaté Anselme, Mathieu Elisabeth, Ternisien Catherine, Chevailler Alain, Godon Alban, Gallois Yves, Joubaud Françoise, Hubert-Fouchard Isabelle, Oberti Frédéric, Réaud Stéphane, Hunault Gilles, Mauriat Françoise, Lunel-Fabiani Françoise

机构信息

Laboratoire HIFIH, UPRES 3859, IFR 132, Université d'Angers, 49045 Angers Cedex, France.

出版信息

Clin Biochem. 2008 Jan;41(1-2):10-8. doi: 10.1016/j.clinbiochem.2007.08.009. Epub 2007 Aug 24.

Abstract

OBJECTIVES

To evaluate the inter-laboratory reproducibility of blood test for liver fibrosis: FibroMeter, Fibrotest, APRI and their composites variables.

DESIGN AND METHODS

Four studies, including 147 patients, were performed: study #1 included 2 metachronous blood samples and 2 laboratories; studies #2, #3 and #4 included synchronous samples with assays delayed at day 1 in 12 laboratories, at day 0 in 10 laboratories and at day 0 or 1 in 2 laboratories, respectively. Agreement was evaluated by the intraclass correlation coefficient (r(ic)).

RESULTS

In studies #1, #2 and #4, r(ic) for FibroMeter was 0.893, 0.942 and 0.991, respectively. In study #3, the r(ic) were: FibroMeter: 0.963, Fibrotest: 0.984, APRI: 0.949. Large simulated variations in composite variables had a weak impact on FibroMeter.

CONCLUSIONS

When blood marker limits are controlled, inter-laboratory agreement of blood tests is excellent in clinical practice conditions. Blood tests are robust against the variability of composite blood variables.

摘要

目的

评估用于肝纤维化血液检测的实验室间重复性:FibroMeter、Fibrotest、APRI及其复合变量。

设计与方法

开展了四项研究,包括147名患者:研究1包括2份不同时间采集的血液样本和2个实验室;研究2、3和4分别包括在12个实验室于第1天延迟检测、在10个实验室于第0天检测以及在2个实验室于第0天或第1天检测的同步样本。通过组内相关系数(r(ic))评估一致性。

结果

在研究1、2和4中,FibroMeter的r(ic)分别为0.893、0.942和0.991。在研究3中,r(ic)分别为:FibroMeter:0.963,Fibrotest:0.984,APRI:0.949。复合变量的大幅模拟变化对FibroMeter的影响较弱。

结论

当血液标志物限值得到控制时,在临床实践条件下血液检测的实验室间一致性极佳。血液检测对复合血液变量的变异性具有较强的耐受性。

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