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The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications

  • Paul C.D. Bank , Leo H.J. Jacobs EMAIL logo , Sjoerd A.A. van den Berg , Hanneke W.M. van Deutekom , Dörte Hamann , Richard Molenkamp , Claudia A.L. Ruivenkamp , Jesse J. Swen , Bastiaan B.J. Tops , Mirjam M.C. Wamelink , Els Wessels and Wytze P. Oosterhuis
Published/Copyright: November 23, 2020
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 59 Issue 3

Abstract

The in vitro diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of in vitro diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passages of the IVDR was drafted to help laboratories prepare for the impact of this new legislation. Feedback from interested parties and stakeholders was collected and used to further improve the document. Here we would like to present our approach to our European colleagues and inform them about the impact of the IVDR and, importantly we would like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs.

Keywords: diagnostic test approval; diagnostic medical devices regulation (IVDR); implementation; laboratory developed test; laboratory medicine; legislation; medical device legislation; quality assessment
Corresponding author: Leo HJ. Jacobs, Chair Dutch Task Force IVDR, Department Laboratory of Clinical Chemistry, Meander Medical Center 3813 TZ, Amersfoort, The Netherlands, Phone: +31 (0)33 850 5050, E-mail:

  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.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2020-1384).

Received: 2020-09-14
Accepted: 2020-10-20
Published Online: 2020-11-23
Published in Print: 2021-02-23

© 2020 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Complex analytical procedures in diagnostic laboratories and the IVDR
  4. Review
  5. Re-examining ferritin-bound iron: current and developing clinical tools
  6. Opinion Papers
  7. Designing a diagnostic Total Testing Process as a base for supporting diagnostic stewardship
  8. The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications
  9. EFLM Papers
  10. The Academy of the European Federation of Clinical Chemistry and Laboratory Medicine and the European Register of Specialists in Laboratory Medicine: guide to the Academy and the Register, version 4 – 2020
  11. A proposed Common Training Framework for Specialists in Laboratory Medicine under EU Directive 2013/55/EC (The Recognition of Professional Qualifications)
  12. Guidelines and Recommendations
  13. High-sensitivity cardiac troponin I and T methods for the early detection of myocardial injury in patients on chemotherapy
  14. General Clinical Chemistry and Laboratory Medicine
  15. Measurement of serum 17-hydroxyprogesterone using isotope dilution liquid chromatography-tandem mass spectrometry candidate reference method and evaluation of the performance for three routine methods
  16. Evaluation of carbohydrate-deficient transferrin measurements on the V8 capillary electrophoresis system and comparison with the IFCC approved HPLC reference method and N-Latex immunonephelometric assay
  17. The clinical relevance of anti-dsDNA antibodies determined by the Elia™ dsDNA assay in patients with negative indirect immunofluorescence on the HEp-2 cell
  18. A hierarchical bivariate meta-analysis of diagnostic test accuracy to provide direct comparisons of immunoassays vs. indirect immunofluorescence for initial screening of connective tissue diseases
  19. Individual uromodulin serum concentration is independent of glomerular filtration rate in healthy kidney donors
  20. Comparison of iohexol plasma clearance formulas vs. inulin urinary clearance for measuring glomerular filtration rate
  21. Overweight-obesity is associated with decreased vitamin K2 levels in hemodialysis patients
  22. Cardiovascular Diseases
  23. Evaluating the performance of an updated high-sensitivity troponin T assay with increased tolerance to biotin
  24. Infectious Diseases
  25. The anti-inflammatory cytokine response characterized by elevated interleukin-10 is a stronger predictor of severe disease and poor outcomes than the pro-inflammatory cytokine response in coronavirus disease 2019 (COVID-19)
  26. Quantification of the HIV-1 total reservoir in the peripheral blood of naïve and treated patients by a standardised method derived from a commercial HIV-1 RNA quantification assay
  27. Comparison of the reliability of Gram-negative and Gram-positive flags of the Sysmex UF-5000 with manual Gram stain and urine culture results
  28. Evaluation of a turbidimetric C-reactive protein assay to monitor early-onset neonatal sepsis in South Kivu (Democratic Republic of the Congo)
  29. Corrigendum
  30. Corrigendum to: Procalcitonin (PCT)-guided antibiotic stewardship in Asia-Pacific countries: adaptation based on an expert consensus meeting
  31. Letters to the Editor
  32. Decision-making based on sFlt-1/PlGF ratios: are immunoassay results interchangeable for diagnosis or prognosis of preeclampsia?
  33. Inter-center agreement in the interpretation of oligoclonal bands
  34. A new founder BRCA1 haplotype identified in the Puglia region is associated with a specific age-related cancer onset in three unrelated families
  35. Predictive values of D-dimer for adverse pregnancy outcomes: a retrospective study
  36. A very uncommon haemoglobin value resulting from a severe acute malnutrition in a 16-month-old child in Ethiopia
  37. Ionized calcium measurements during continuous renal replacement therapy with regional citrate anticoagulation
  38. The hairy cell leukaemia oxymoron: monocytotic monocytopenia
  39. Perchlorate interference with electrolyte analysis
  40. False decrease in serum triglyceride and cholesterol due to massive ascorbate in a bowel preparation solution
https://doi.org/10.1515/cclm-2020-1384
Keywords for this article
diagnostic test approval; diagnostic medical devices regulation (IVDR); implementation; laboratory developed test; laboratory medicine; legislation; medical device legislation; quality assessment

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Complex analytical procedures in diagnostic laboratories and the IVDR
  4. Review
  5. Re-examining ferritin-bound iron: current and developing clinical tools
  6. Opinion Papers
  7. Designing a diagnostic Total Testing Process as a base for supporting diagnostic stewardship
  8. The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications
  9. EFLM Papers
  10. The Academy of the European Federation of Clinical Chemistry and Laboratory Medicine and the European Register of Specialists in Laboratory Medicine: guide to the Academy and the Register, version 4 – 2020
  11. A proposed Common Training Framework for Specialists in Laboratory Medicine under EU Directive 2013/55/EC (The Recognition of Professional Qualifications)
  12. Guidelines and Recommendations
  13. High-sensitivity cardiac troponin I and T methods for the early detection of myocardial injury in patients on chemotherapy
  14. General Clinical Chemistry and Laboratory Medicine
  15. Measurement of serum 17-hydroxyprogesterone using isotope dilution liquid chromatography-tandem mass spectrometry candidate reference method and evaluation of the performance for three routine methods
  16. Evaluation of carbohydrate-deficient transferrin measurements on the V8 capillary electrophoresis system and comparison with the IFCC approved HPLC reference method and N-Latex immunonephelometric assay
  17. The clinical relevance of anti-dsDNA antibodies determined by the Elia™ dsDNA assay in patients with negative indirect immunofluorescence on the HEp-2 cell
  18. A hierarchical bivariate meta-analysis of diagnostic test accuracy to provide direct comparisons of immunoassays vs. indirect immunofluorescence for initial screening of connective tissue diseases
  19. Individual uromodulin serum concentration is independent of glomerular filtration rate in healthy kidney donors
  20. Comparison of iohexol plasma clearance formulas vs. inulin urinary clearance for measuring glomerular filtration rate
  21. Overweight-obesity is associated with decreased vitamin K2 levels in hemodialysis patients
  22. Cardiovascular Diseases
  23. Evaluating the performance of an updated high-sensitivity troponin T assay with increased tolerance to biotin
  24. Infectious Diseases
  25. The anti-inflammatory cytokine response characterized by elevated interleukin-10 is a stronger predictor of severe disease and poor outcomes than the pro-inflammatory cytokine response in coronavirus disease 2019 (COVID-19)
  26. Quantification of the HIV-1 total reservoir in the peripheral blood of naïve and treated patients by a standardised method derived from a commercial HIV-1 RNA quantification assay
  27. Comparison of the reliability of Gram-negative and Gram-positive flags of the Sysmex UF-5000 with manual Gram stain and urine culture results
  28. Evaluation of a turbidimetric C-reactive protein assay to monitor early-onset neonatal sepsis in South Kivu (Democratic Republic of the Congo)
  29. Corrigendum
  30. Corrigendum to: Procalcitonin (PCT)-guided antibiotic stewardship in Asia-Pacific countries: adaptation based on an expert consensus meeting
  31. Letters to the Editor
  32. Decision-making based on sFlt-1/PlGF ratios: are immunoassay results interchangeable for diagnosis or prognosis of preeclampsia?
  33. Inter-center agreement in the interpretation of oligoclonal bands
  34. A new founder BRCA1 haplotype identified in the Puglia region is associated with a specific age-related cancer onset in three unrelated families
  35. Predictive values of D-dimer for adverse pregnancy outcomes: a retrospective study
  36. A very uncommon haemoglobin value resulting from a severe acute malnutrition in a 16-month-old child in Ethiopia
  37. Ionized calcium measurements during continuous renal replacement therapy with regional citrate anticoagulation
  38. The hairy cell leukaemia oxymoron: monocytotic monocytopenia
  39. Perchlorate interference with electrolyte analysis
  40. False decrease in serum triglyceride and cholesterol due to massive ascorbate in a bowel preparation solution
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