Clinical Laboratories Need More Information About Commercially Available Reagents to Prepare for the IVDR: A Call From the ICSH

IF 2.3 4区医学 Q3 HEMATOLOGY

International Journal of Laboratory Hematology Pub Date : 2025-06-26 DOI:10.1111/ijlh.14506

Dominique Lasne, Sophie Testa, Steve Kitchen, Chris Gardiner, Piet Meijer, François Mullier

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引用次数: 0

Abstract

Introduction

According to the new In Vitro Diagnostic Medical Device Regulation (EU) (IVDR) an In Vitro Medical Device (IVD) is considered as a laboratory developed test (LDT) if used outside of intended use. It is therefore essential that the information given by the manufacturer about the intended use is clear, precise, and well documented. For now, the only source of information for laboratories is the instructions for use (IFU). Our primary aim was to analyze the IFU provided by several manufacturers for a large panel of coagulation assays. The secondary objective was to provide a list of minimum information that must be accessible to clinical laboratories.

Methods

We analyzed 195 IFU for the main assays used in European hemostasis clinical laboratories commercialized by 12 manufacturers.

Results

The “intended use” section appears in almost all IFU, but the information given in this section is very heterogeneous. We observed disagreement for each of the assays assessed with some intended uses not supported by guidance or guidelines. Some indications in use by clinical laboratories are not provided by the manufacturers. We only found information on clinical performance for a limited number of assays. For some assays, data are available in the literature but are not reported in the IFU. The matrix and the importance of a pre-test probability are not systematically mentioned.

Conclusions

We urgently request access to the necessary information to know the intended use of a reagent according to the IVDR. We define the minimum information that should be available to laboratories. We call for joint discussions to maintain innovation and ensure the quality, safety, and accessibility of innovative diagnostics.

查看原文本刊更多论文

临床实验室需要更多关于市售试剂的信息，以准备IVDR：来自ICSH的呼吁。

简介：根据新的体外诊断医疗器械法规（EU）（IVDR），体外医疗器械（IVD）如果在预期用途之外使用，则被视为实验室开发的测试（LDT）。因此，制造商提供的有关预期用途的信息必须清晰、准确并有充分的文件记录。目前，实验室唯一的信息来源是使用说明书（IFU）。我们的主要目的是分析几家制造商提供的IFU，用于大型凝血试验。次要目标是提供临床实验室必须可获得的最低限度信息清单。方法：对欧洲12家商业化止血临床实验室主要检测方法的195个IFU进行分析。结果：“预期用途”部分几乎出现在所有IFU中，但该部分给出的信息非常不一致。我们观察到每种测定法的评估存在分歧，其中一些预期用途没有得到指南或指南的支持。临床实验室使用的一些适应症没有由制造商提供。我们只发现了有限数量检测的临床表现信息。对于一些检测，文献中有数据，但在IFU中没有报告。没有系统地提到矩阵和预测概率的重要性。结论：我们迫切要求获得必要的信息，以了解根据IVDR试剂的预期用途。我们定义了应该提供给实验室的最低限度的信息。我们呼吁进行联合讨论，以保持创新，确保创新诊断的质量、安全性和可及性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Laboratory Hematology 医学-血液学

CiteScore

4.50

自引率

6.70%

发文量

211

审稿时长

6-12 weeks

期刊介绍： The International Journal of Laboratory Hematology provides a forum for the communication of new developments, research topics and the practice of laboratory haematology. The journal publishes invited reviews, full length original articles, and correspondence. The International Journal of Laboratory Hematology is the official journal of the International Society for Laboratory Hematology, which addresses the following sub-disciplines: cellular analysis, flow cytometry, haemostasis and thrombosis, molecular diagnostics, haematology informatics, haemoglobinopathies, point of care testing, standards and guidelines. The journal was launched in 2006 as the successor to Clinical and Laboratory Hematology, which was first published in 1979. An active and positive editorial policy ensures that work of a high scientific standard is reported, in order to bridge the gap between practical and academic aspects of laboratory haematology.