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[分析前阶段与认可:多站点实验室样本的验收标准]

[Preanalytical phase and accreditation: acceptance criteria for samples of multisite laboratory].

作者信息

Dialma Pascale, Piaulenne Stéphane, Baty Sonia, Zeitoun Thierry

机构信息

SELAS HB et CF, Paris, France.

出版信息

Ann Biol Clin (Paris). 2013 Jan-Feb;71(1):121-8. doi: 10.1684/abc.2012.0780.

Abstract

Performing high quality analyses in order to help physicians in their diagnoses and to ensure better patient care: this represents our routine mission for clinical lab. To achieve this goal, all steps from sampling to the final data transfer must be controlled. The preanalytical phase is one of the most crucial, but also one of the most complicated, especially in the context of a consolidated laboratory network. Transport conditions, delays, temperature, regulatory constraints are all criteria that we need to take into consideration in order to comply to ISO 15189, section 5.4. In this context, our laboratory would like to address the following issues: to control the transport conditions in order to guarantee optimal preservation of the samples, and to define an internal process and identify non-conforming situations linked to delay in sample delivery. An original study dealing with the stability in whole blood of common clinical chemistry and immunochemistry tests in defined transport conditions (delays, temperature, tube position) was performed on a panel of 100 patients' samples. This panel is intended to be a good reflection of the patients usually seen in multi-site laboratory. We observed that most of the analytes (35 of 41) were stable in whole blood; however, some of them demonstrated instability over time. All these results were integrated into our collection manual.

摘要

进行高质量分析以协助医生进行诊断并确保为患者提供更好的护理

这是我们临床实验室的日常任务。为实现这一目标,从采样到最终数据传输的所有步骤都必须得到控制。分析前阶段是最关键的阶段之一,但也是最复杂的阶段之一,尤其是在整合的实验室网络背景下。运输条件、延迟、温度、监管限制都是我们为符合ISO 15189第5.4节而需要考虑的标准。在此背景下,我们实验室希望解决以下问题:控制运输条件以保证样本的最佳保存,并定义内部流程并识别与样本交付延迟相关的不符合情况。针对100份患者样本进行了一项原创研究,研究在规定的运输条件(延迟、温度、试管位置)下常见临床化学和免疫化学检测在全血中的稳定性。该样本旨在很好地反映多站点实验室中常见的患者情况。我们观察到大多数分析物(41种中的35种)在全血中是稳定的;然而,其中一些随着时间的推移表现出不稳定性。所有这些结果都被纳入了我们的采集手册。

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