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Licensed Unlicensed Requires Authentication Published by De Gruyter July 21, 2020

The new IVD Regulation 2017/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab-developed tests to improve patient care

Pieter. Vermeersch, Tobias Van Aelst and Elisabeth M.C. Dequeker

Abstract

Objectives

The new European In Vitro Diagnostic (IVD) Regulation 2017/746 (IVDR) restricts the use of lab-developed tests (LDT) after 26th May 2022. There are no data on the impact of the IVDR on laboratories in the European Union.

Methods

Laboratory tests performed in UZ Leuven were divided in four groups: core laboratory, immunology, special chemistry, and molecular microbiology testing. Each test was classified as Conformité Européenne (CE)-IVD, modified/off-label CE-IVD, commercial Research Use Only (RUO) or LDT. Each matrix was considered a separate test.

Results

We found that 97.6% of the more than 11.5 million results/year were generated with a CE-IVD method. Of the 922 different laboratory tests, however, only 41.8% were CE-IVD, 10.8% modified/off-label CE-IVD, 0.3% RUO, and 47.1% LDT. Off-label CE-IVD was mainly used to test alternative matrices not covered by the claim of the manufacturer (e.g., pleural or peritoneal fluid). LDTs were mainly used for special chemistry, flow cytometry, and molecular testing. Excluding flow cytometry, the main reasons for the use of 377 LDTs were lack of a CE-IVD method (71.9%), analytical requirements (14.3%), and the fact the LDT was in use before CE-IVD available (11.9%).

Conclusions

While the large majority of results (97.6%) were generated with a CE-IVD method, only 41.8% of laboratory tests were CE-IVD. There is currently no alternative on the market for 71.5% of the 537 LDTs performed in our laboratory which do not fall within the scope of the current IVD directive (IVDD). Compliance with the IVDR will require a major investment of time and effort.


Corresponding author: Pieter Vermeersch, Clinical Department of Laboratory Medicine, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium; and Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium, E-mail:

Acknowledgments

We thank Dirk Stynen for critically reviewing the manuscript and hosting Tobias his internship. We also thank the biomedical science students who helped collect the data during their internship. PV is a senior clinical investigator of the FWO-Vlaanderen.

  1. Research funding: None declared.

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

  3. Competing interests: Authors state no conflict of interest.

  4. Ethical approval: The local Institutional Review Board deemed the study exempt from review.

References

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Received: 2020-05-28
Accepted: 2020-07-01
Published Online: 2020-07-21
Published in Print: 2021-01-26

© 2020 Walter de Gruyter GmbH, Berlin/Boston

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