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实验室是否遵循心力衰竭的建议和指南,我们是否有所改进?欧洲心脏标志物指南应用研究(CARMAGUE)。

Do laboratories follow heart failure recommendations and guidelines and did we improve? The CARdiac MArker Guideline Uptake in Europe (CARMAGUE).

机构信息

Central Institute for Medical and Chemical Laboratory Diagnosis, University Hospital Innsbruck, Austria.

出版信息

Clin Chem Lab Med. 2013 Jun;51(6):1301-6. doi: 10.1515/cclm-2012-0510.

DOI:10.1515/cclm-2012-0510
PMID:23334056
Abstract

BACKGROUND

Natriuretic peptides (NP) are well-established markers of heart failure (HF). During the past 5 years, analytical and clinical recommendations for measurement of these biomarkers have been published in guidelines. The aim of this follow-up survey was to investigate how well these guidelines for measurement of NP have been implemented in laboratory practice in Europe.

METHODS

Member societies of the European Federation of Clinical Chemistry and Laboratory Medicine were invited in 2009 to participate in a web-based audit questionnaire. The questionnaire requested information on type of tests performed, decision limits for HF, turn-around time and frequency of testing.

RESULTS

There was a moderate increase (12%) of laboratories measuring NP compared to the initial survey in 2006. The most frequently used HF decision limits for B-type NP (BNP) and N-terminal BNP (NT-proBNP) were, respectively, 100 ng/L and 125 ng/L, derived from the package inserts in 55%. Fifty laboratories used a second decision limit. Age or gender dependent decision limits were applied in 10% (8.5% in 2006). The vast majority of laboratories (80%) did not have any criteria regarding frequency of testing, compared to 33% in 2006.

CONCLUSIONS

The implementation of NP measurement for HF management was a slow process between 2006 and 2009 at a time when guidelines had just been established. The decision limits were derived from package insert information and literature. There was great uncertainty concerning frequency of testing which may reflect the debate about the biological variability which was not published for most of the assays in 2009.

摘要

背景

利钠肽(NP)是心力衰竭(HF)的既定标志物。在过去的 5 年中,这些生物标志物的分析和临床建议已在指南中发布。本随访调查的目的是调查这些 NP 测量指南在欧洲实验室实践中的实施情况。

方法

邀请欧洲临床化学和实验室医学联合会的成员协会于 2009 年参加基于网络的审核问卷调查。该问卷要求提供有关进行的测试类型,HF 的决策限制,周转时间和测试频率的信息。

结果

与 2006 年的初始调查相比,测量 NP 的实验室数量略有增加(增加了 12%)。B 型利钠肽(BNP)和 N 末端 BNP(NT-proBNP)的最常用 HF 决策限制分别为 100ng/L 和 125ng/L,源自 55%的包装插页。五十个实验室使用了第二个决策限制。在 10%的实验室中应用了年龄或性别相关的决策限制(2006 年为 8.5%)。与 2006 年的 33%相比,绝大多数实验室(80%)没有任何关于测试频率的标准。

结论

在指南刚刚建立的 2006 年至 2009 年期间,NP 测量用于 HF 管理的实施是一个缓慢的过程。决策限制源自包装插页信息和文献。测试频率存在很大的不确定性,这可能反映了关于生物学变异性的争论,而在 2009 年,大多数检测方法都没有公布这种变异性。

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