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光传输聚集法血小板功能检测:现行推荐意见及法国认证建议的立场文件。

Light transmission aggregometry for platelet function testing: position paper on current recommendations and French proposals for accreditation.

机构信息

Service d'Hématologie Biologique, PhyMedExp UMR UM - CNRS 9214 - Inserm U1046, CHU de Montpellier, Université de Montpellier, Montpellier, France.

Laboratoire d'Hématologie, CHU de Nice, Nice, France.

出版信息

Platelets. 2024 Dec;35(1):2427745. doi: 10.1080/09537104.2024.2427745. Epub 2024 Nov 18.

DOI:10.1080/09537104.2024.2427745
PMID:39555668
Abstract

Light transmission aggregometry (LTA) is a method used to investigate platelet functions in platelet-rich plasma (PRP), notably when screening for platelet disorders. Various national guidelines and recommendations help in setting up the LTA test in specialized laboratories. However, due to the nature of the sample matrix and its subsequent specificities, more accurate positions are needed to achieve LTA accreditation according to the standard NF EN ISO 15 189. We reviewed guidelines and recommendations as they can be useful in the accreditation process, and we conducted a survey on LTA practice among members of the ) in 2021. We formulated 28 proposals, which have been approved by vote within the SFTH. All aspects to take into consideration for the proper conduct of LTA assays and their accreditation have been covered. Notably, preanalytical, analytical and postanalytical aspects are depicted, including blood sampling, PRP preparation, instruments, agonists, performance assessment, personnel training and data interpretation. This document, essentially representing a French position paper on the current recommendations and subsequent proposals for LTA accreditation, might prove useful also outside France for relevant laboratories and auditors involved in LTA accreditation.

摘要

光传输聚集测定法(LTA)是一种用于研究富含血小板血浆(PRP)中血小板功能的方法,特别是在筛查血小板疾病时。各种国家指南和建议有助于在专门实验室中建立 LTA 测试。然而,由于样本基质的性质及其随后的特异性,根据标准 NF EN ISO 15 189 需要更准确的位置来实现 LTA 认证。我们审查了指南和建议,因为它们在认证过程中可能很有用,并且我们在 2021 年对 SFTH 成员的 LTA 实践进行了调查。我们制定了 28 条提案,并在 SFTH 内投票获得批准。已经涵盖了适当进行 LTA 测定及其认证所需考虑的所有方面。值得注意的是,描述了分析前、分析中和分析后方面,包括血液采样、PRP 制备、仪器、激动剂、性能评估、人员培训和数据解释。这份文件主要代表了法国关于当前 LTA 认证建议和随后提案的立场文件,对于涉及 LTA 认证的相关实验室和审核员来说,也可能在法国以外有用。

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