IVDCheckR - simplifying documentation for laboratory developed tests according to IVDR requirements by introducing a new digital tool.

IF 3.8 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Yadwinder Kaur, Daniel Rosenkranz, Anna Bloemer, Ozan Aykurt, Gunnar Brandhorst, Folker Spitzenberger, Astrid Petersmann
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引用次数: 0

Abstract

Objectives: A recent challenge for clinical laboratories is the lack of clear guidelines for handling significant modifications of CE-marked assays. The modifications may involve, for example, extending measurement intervals, changing dilution procedures or using non-validated sample materials. The challenge arises due to the amended Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which is now poised for implementation, despite the extended transition periods. The IVDR application imposes challenges not only for diagnostic companies but also for clinical laboratories when using laboratory developed tests (LDTs), often referred to as in-house assays. In this context, a coherent and meticulously structured LDT documentation is highly beneficial. While laboratories are obliged to meet the IVDR requirements, the absence of a streamlined framework or guideline hampers the ability to gain a comprehensive overview on the requirements and possible options for their fulfilment.

Methods: To address this issue, we introduce a web based digital tool powered by an R Shiny web application. This tool facilitates a seamless implementation of IVDR requirements for LDTs across diverse laboratory environments in terms of their transparency and validity. Our approach focuses on adequate handling of significant modifications of CE-marked in vitro diagnostic medical devices (IVD).

Results: IVDRCheckR is an open-source tool that is easily accessible and free from system dependencies. The tool promotes a seamless process and a guide to enhance transparency, reliability, and validity of laboratory examination results based on LDTs. Additionally, the tool further provides modules for evaluating quality control data and quantitative method comparison data.

Conclusions: Our Shiny web application-based platform is a digitised, user-friendly tool that simplifies the documentation for LDTs according to IVDR requirements with special emphasis on solutions for handling modifications to CE-marked assays.

IVDCheckR - 通过引入一种新的数字工具,简化了根据 IVDR 要求进行的实验室开发测试的文档记录。
目的:临床实验室最近面临的一个挑战是缺乏明确的指导原则来处理 CE 认证检测方法的重大修改。例如,修改可能涉及延长测量间隔、改变稀释程序或使用未经验证的样本材料。尽管延长了过渡期,但体外诊断医疗器械(IVDR)的修订法规(欧盟)2017/746 目前已准备实施,这就带来了挑战。IVDR 的应用不仅给诊断公司带来了挑战,也给临床实验室在使用实验室开发的检测项目(LDT)(通常称为内部检测)时带来了挑战。在这种情况下,一份连贯且结构严谨的 LDT 文档将大有裨益。虽然实验室有义务满足 IVDR 的要求,但由于缺乏精简的框架或指南,因此无法全面了解相关要求以及满足这些要求的可行方案:为了解决这个问题,我们引入了一个基于 R Shiny 网络应用程序的网络数字工具。该工具有助于在不同的实验室环境中无缝执行 IVDR 对 LDT 的透明度和有效性的要求。我们的方法侧重于充分处理 CE 认证体外诊断医疗器械(IVD)的重大修改:结果:IVDRCheckR 是一种开源工具,易于访问且不依赖系统。该工具提供了一个无缝流程和指南,以提高基于 LDT 的实验室检查结果的透明度、可靠性和有效性。此外,该工具还提供了用于评估质量控制数据和定量方法比较数据的模块:我们基于 Shiny 网络应用程序的平台是一种数字化、用户友好型工具,可根据 IVDR 的要求简化 LDT 的文档记录,特别强调处理 CE 标记检测方法修改的解决方案。
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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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