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欧洲实验室中用于凝血检测的溶血、黄疸和脂血样本的实际处理。来自欧洲实验室医学外部质量保证提供者组织(EQALM)的一项合作调查。

Practical handling of hemolytic, icteric and lipemic samples for coagulation testing in European laboratories. A collaborative survey from the European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM).

作者信息

Kristoffersen Ann Helen, Hollestelle Martine J, Cadamuro Janne, Hillarp Andreas, Jennings Ian, Marrington Rachel, Gidske Gro, Kesseler Dagmar, Meijer Piet

机构信息

The Norwegian Organization for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway.

Department of Medical Biochemistry and Pharmacology, 60498 Haukeland University Hospital , Bergen, Norway.

出版信息

Clin Chem Lab Med. 2025 May 22. doi: 10.1515/cclm-2025-0319.

DOI:10.1515/cclm-2025-0319
PMID:40418797
Abstract

OBJECTIVES

Coagulation test results may be affected by hemolysis, icterus and/or lipemia (HIL). Detailed guidelines for HIL-management are missing, both for manual and automatic HIL-checks. The aim of this survey was to provide an overview of the practical procedures for the detection and handling of HIL-samples used by laboratories in Europe in the context of coagulation testing.

METHODS

A SurveyMonkey questionnaire was sent from the Haemostasis Working Group in the European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM) to European external quality assurance organizers, who in turn forwarded the link to their participating laboratories. Questions were asked regarding detection and handling of HIL-samples, comment- and reject-levels, and the guidance used by the laboratories.

RESULTS

A written procedure for HIL-management was available in 55-67 % of laboratories, and each sample was checked for HIL in 73-83 % (lowest percentage for icterus, highest for hemolysis). Manual visual inspection as the only method to detect HIL was used by up to 38 % of laboratories, with most relying on personal experience for HIL-level classification. All other laboratories used some type of automated HIL-detection, alone or in combination with visual check. The terms used for classification and the HIL comment- and reject-levels varied widely, even among laboratories using the same manufacturer. Most laboratories state that they use the manufacturer's guidance.

CONCLUSIONS

There is wide heterogeneity in HIL-detection, handling and reporting among European laboratories, which calls for an urgent collaboration among laboratories and manufacturers to harmonize the HIL-management in coagulation testing.

摘要

目的

凝血试验结果可能会受到溶血、黄疸和/或脂血(HIL)的影响。无论是手动还是自动HIL检查,均缺少详细的HIL管理指南。本次调查的目的是概述欧洲实验室在凝血检测中用于检测和处理HIL样本的实际操作流程。

方法

欧洲实验室医学外部质量保证提供者组织(EQALM)的止血工作组向欧洲外部质量保证组织者发送了一份SurveyMonkey调查问卷,这些组织者又将链接转发给其参与实验室。问卷涉及HIL样本的检测和处理、注释和拒收水平以及实验室使用的指南。

结果

55%-67%的实验室有HIL管理的书面程序,73%-83%的实验室会对每个样本进行HIL检查(黄疸检查的比例最低,溶血检查的比例最高)。高达38%的实验室仅使用人工目视检查作为检测HIL的方法,大多数实验室依靠个人经验对HIL水平进行分类。所有其他实验室都使用了某种类型的自动HIL检测方法,单独使用或与目视检查结合使用。即使在使用同一制造商产品的实验室之间,用于分类的术语以及HIL注释和拒收水平也存在很大差异。大多数实验室表示他们使用制造商的指南。

结论

欧洲实验室在HIL检测、处理和报告方面存在很大差异,这就需要实验室和制造商之间紧急合作,以统一凝血检测中的HIL管理。

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