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NUMBER: standardized reference intervals in the Netherlands using a 'big data' approach.

Wendy P J den Elzen1, Nannette Brouwer2, Marc H Thelen3,4

  • 1Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Postal Zone E2-P, P.O. Box 9600, 2300 RC Leiden, TheNetherlands, Phone: +31 71 526 2278.

Clinical Chemistry and Laboratory Medicine
|September 16, 2018
PubMed
Summary

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A national initiative in the Netherlands successfully established traceable reference intervals for 18 general chemistry tests using a big-data approach. This system aims to improve test result interpretation and reduce patient harm.

Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Metrology

Background:

  • External quality assessment (EQA) programs have evolved, reducing inter-laboratory variation in the Netherlands.
  • Despite progress, standardized national reference intervals for general chemistry tests are still lacking.
  • The NUMBER (Nederlandse UniforMe Beslisgrenzen En Referentie-intervallen) project was initiated to create a sustainable system for these intervals.

Purpose of the Study:

  • To establish a sustainable system for determining standardized, metrologically traceable reference intervals in the Netherlands.
  • To develop national reference intervals for general chemistry tests using a big-data approach.

Main Methods:

  • A 'big-data' approach utilizing millions of patient test results from general practitioners.
Keywords:
big data approachreference intervalsstandardization

Related Experiment Videos

  • Selection of 21 medical tests traceable to SI or JCTLM standards.
  • Statistical analysis including outlier exclusion, data transformation, and calculation of pooled means and standard deviations (SDs) to generate reference intervals (mean±2 SD).

    • Main Results:

    • Data from 16 clinical laboratories (n=7,574,327) were analyzed.
    • Consensus was reached on reference intervals for 18 general chemistry tests, including necessary partitioning by sex, age, matrix, and/or method.
    • Further evaluation was deemed necessary for two tests; for glucose, the clinical decision limit was recommended.

    Conclusions:

    • A big-data approach successfully determined traceable reference intervals for 18 general chemistry tests.
    • Nationwide implementation of these intervals can enhance the unambiguous interpretation of test results.
    • This initiative has the potential to significantly reduce patient harm by standardizing laboratory diagnostics.