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呼吁制造商在血清指标声明中提高透明度:代表分析前阶段工作组(WG-PRE),欧洲临床化学和检验医学联合会(EFLM)。

Call for more transparency in manufacturers declarations on serum indices: On behalf of the Working Group for Preanalytical Phase (WG-PRE), European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).

机构信息

Institute for Laboratory Medicine, Kliniken Nordoberpfalz AG and Klinikum St. Marien, Weiden and Amberg, Germany.

Department of Laboratory Medicine, Paracelsus Medical University, Salzburg, Austria.

出版信息

Clin Chim Acta. 2018 Sep;484:328-332. doi: 10.1016/j.cca.2018.03.043. Epub 2018 Apr 2.

Abstract

The presence of interfering substances like free hemoglobin, bilirubin or lipids compromises sample quality and potentially affects laboratory analysis and test results. Recently, the use of serum indices for objectively assessing sample quality has become commonplace and many preanalytical platforms, as well as clinical chemistry and coagulation analyzers, are now equipped with this analytical feature. Nevertheless, some important drawbacks remain in this practice, mainly pertaining the measurement procedure, the approach for reporting interference data, the definition of objective thresholds of interference after which test results may be biased, and the lack of harmonized practices for describing how interference cut-offs have been identified. Therefore, this document aims to discuss these important caveats and propose some reliable solutions that may be adopted by manufacturers for increasing worldwide harmonization of serum indices.

摘要

干扰物质(如游离血红蛋白、胆红素或脂质)的存在会影响样本质量,并可能对实验室分析和测试结果产生影响。最近,使用血清指标客观评估样本质量已变得很普遍,许多分析前平台以及临床化学和凝血分析仪现在都配备了这种分析功能。然而,在这种做法中仍然存在一些重要的缺陷,主要涉及测量程序、报告干扰数据的方法、确定可能导致测试结果偏差的干扰客观阈值的定义,以及缺乏用于描述如何确定干扰截止值的统一实践。因此,本文旨在讨论这些重要的注意事项,并提出一些可靠的解决方案,制造商可以采用这些解决方案来增加全球范围内血清指标的协调一致。

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