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

  • Yadwinder Kaur , Daniel Rosenkranz EMAIL logo , Anna Bloemer , Ozan Aykurt , Gunnar Brandhorst ORCID logo , Folker Spitzenberger and Astrid Petersmann
Published/Copyright: August 26, 2024
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 2

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.

Keywords: amended Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR); in vitro diagnostics; laboratory developed test (LDT); in-house IVD; Shiny; significant modification
Corresponding author: Daniel Rosenkranz, Institute for Clinical Chemistry and Laboratory Medicine, University Medicine Oldenburg, Oldenburg, Germany, E-mail:

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

  3. Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Competing interests: The authors state no competing interests.

  5. Research funding: None declared.

  6. Data availability: The full code is available online (https://github.com/kola8513/IVDCheckR).

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0477).

Received: 2024-04-17
Accepted: 2024-07-31
Published Online: 2024-08-26
Published in Print: 2025-01-29

© 2024 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

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  2. Editorial
  3. CD34+ progenitor cells meet metrology
  4. Reviews
  5. Venous blood collection systems using evacuated tubes: a systematic review focusing on safety, efficacy and economic implications of integrated vs. combined systems
  6. The correlation between serum angiopoietin-2 levels and acute kidney injury (AKI): a meta-analysis
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  10. Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement
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  18. The effects of drone transportation on routine laboratory, immunohematology, flow cytometry and molecular analyses
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  37. Letters to the Editor
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https://doi.org/10.1515/cclm-2024-0477
Keywords for this article
amended Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR); in vitro diagnostics; laboratory developed test (LDT); in-house IVD; Shiny; significant modification

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. CD34+ progenitor cells meet metrology
  4. Reviews
  5. Venous blood collection systems using evacuated tubes: a systematic review focusing on safety, efficacy and economic implications of integrated vs. combined systems
  6. The correlation between serum angiopoietin-2 levels and acute kidney injury (AKI): a meta-analysis
  7. Opinion Papers
  8. Advancing value-based laboratory medicine
  9. Clostebol and sport: about controversies involving contamination vs. doping offence
  10. Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement
  11. Perspectives
  12. An improved implementation of metrological traceability concepts is needed to benefit from standardization of laboratory results
  13. Genetics and Molecular Diagnostics
  14. Comparative analysis of BCR::ABL1 p210 mRNA transcript quantification and ratio to ABL1 control gene converted to the International Scale by chip digital PCR and droplet digital PCR for monitoring patients with chronic myeloid leukemia
  15. General Clinical Chemistry and Laboratory Medicine
  16. IVDCheckR – simplifying documentation for laboratory developed tests according to IVDR requirements by introducing a new digital tool
  17. Analytical performance specifications for trace elements in biological fluids derived from six countries federated external quality assessment schemes over 10 years
  18. The effects of drone transportation on routine laboratory, immunohematology, flow cytometry and molecular analyses
  19. Accurate non-ceruloplasmin bound copper: a new biomarker for the assessment and monitoring of Wilson disease patients using HPLC coupled to ICP-MS/MS
  20. Construction of platelet count-optical method reflex test rules using Micro-RBC#, Macro-RBC%, “PLT clumps?” flag, and “PLT abnormal histogram” flag on the Mindray BC-6800plus hematology analyzer in clinical practice
  21. Evaluation of serum NFL, T-tau, p-tau181, p-tau217, Aβ40 and Aβ42 for the diagnosis of neurodegenerative diseases
  22. An immuno-DOT diagnostic assay for autoimmune nodopathy
  23. Evaluation of biochemical algorithms to screen dysbetalipoproteinemia in ε2ε2 and rare APOE variants carriers
  24. Reference Values and Biological Variations
  25. Allowable total error in CD34 cell analysis by flow cytometry based on state of the art using Spanish EQAS data
  26. Clinical utility of personalized reference intervals for CEA in the early detection of oncologic disease
  27. Agreement of lymphocyte subsets detection permits reference intervals transference between flow cytometry systems: direct validation using established reference intervals
  28. Cancer Diagnostics
  29. Atypical cells in urine sediment: a novel biomarker for early detection of bladder cancer
  30. External quality assessment-based tumor marker harmonization simulation; insights in achievable harmonization for CA 15-3 and CEA
  31. Cardiovascular Diseases
  32. Evaluation of the analytical and clinical performance of a high-sensitivity troponin I point-of-care assay in the Mersey Acute Coronary Syndrome Rule Out Study (MACROS-2)
  33. Analytical verification of the Atellica VTLi point of care high sensitivity troponin I assay
  34. Infectious Diseases
  35. Synovial fluid D-lactate – a pathogen-specific biomarker for septic arthritis: a prospective multicenter study
  36. Targeted MRM-analysis of plasma proteins in frozen whole blood samples from patients with COVID-19: a retrospective study
  37. Letters to the Editor
  38. Generative artificial intelligence (AI) for reporting the performance of laboratory biomarkers: not ready for prime time
  39. Urgent need to adopt age-specific TSH upper reference limit for the elderly – a position statement of the Belgian thyroid club
  40. Sigma metric is more correlated with analytical imprecision than bias
  41. Utility and limitations of monitoring kidney transplants using capillary sampling
  42. Simple flow cytometry method using a myeloma panel that easily reveals clonal proliferation of mature B-cells
  43. Is sweat conductivity still a relevant screening test for cystic fibrosis? Participation over 10 years
  44. Hb D-Iran interference on HbA1c measurement
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