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Time-dependent characteristics of analytical measurands

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Published/Copyright: July 8, 2024
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 62 Issue 12

Abstract

Objectives

Biological variation is a relevant component of diagnostic uncertainty. In addition to within-subject and between-subject variation, preanalytical variation also includes components that contribute to biological variability. Among these, daily recurring, i.e., diurnal physiological variation is of particular importance, as it contains both a random and a non-random component if the exact time of blood collection is not known.

Methods

We introduce four time-dependent characteristics (TDC) of diurnal variations for measurands to assess the relevance and extent of time dependence on the evaluation of laboratory results.

Results

TDC address (i) a threshold for considering diurnality, (ii) the expected relative changes per time unit, (iii) the permissible time interval between two blood collections at different daytimes within which the expected time dependence does not exceed a defined analytical uncertainty, and (iv) a rhythm-expanded reference change value. TDC and their importance will be exemplified by the measurands aspartate aminotransferase, creatine kinase, glucose, thyroid stimulating hormone, and total bilirubin. TDCs are calculated for four time slots that reflect known blood collection schedules, i.e., 07:00–09:00, 08:00–12:00, 06:00–18:00, and 00:00–24:00. The amplitude and the temporal location of the acrophase are major determinates impacting the diagnostic uncertainty and thus the medical interpretation, especially within the typical blood collection time from 07:00 to 09:00.

Conclusions

We propose to check measurands for the existence of diurnal variations and, if applicable, to specify their time-dependent characteristics as outlined in our concept.

Keywords: biological variation; diagnostic error; pre-analytical phase; diurnal variation
Corresponding author: Prof. Dr. med. Mustafa K. Özçürümez, Department of Internal Medicine, University Hospital Knappschaftskrankenhaus Bochum, Ruhr-University Bochum, Bochum, Germany; and Medizinische Klinik, Sektion Labormedizin, Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, In der Schornau 23-25, 44892, Bochum, Germany, E-mail:

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

  3. Author contributions: MKÖ: Conceived and designed the analysis; Contributed data or analysis tools; Performed the analysis; Wrote the paper. ACo: Contributed data or analysis tools; Wrote the paper. FA: Conceived and designed the analysis; Performed the analysis; Wrote the paper. TS: Contributed data or analysis tools; Wrote the paper. CQ: Contributed data or analysis tools; Performed the analysis; Wrote the paper. AC: Conceived and designed the analysis; Contributed data or analysis tools; Wrote the paper. OG: Contributed data or analysis tools; Wrote the paper. MBP: Conceived and designed the analysis; Contributed data or analysis tools; Wrote the paper. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Competing interests: The authors state no conflict of interest.

  5. Research funding: None declared.

  6. Data availability: Not applicable.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2023-1439).

Received: 2023-12-13
Accepted: 2024-06-02
Published Online: 2024-07-08
Published in Print: 2024-11-26

© 2024 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2023-1439
Keywords for this article
biological variation; diagnostic error; pre-analytical phase; diurnal variation

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. External quality assurance (EQA): navigating between quality and sustainability
  4. Reviews
  5. Molecular allergology: a clinical laboratory tool for precision diagnosis, stratification and follow-up of allergic patients
  6. Nitrous oxide abuse direct measurement for diagnosis and follow-up: update on kinetics and impact on metabolic pathways
  7. Opinion Papers
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  9. Point-of-care testing, near-patient testing and patient self-testing: warning points
  10. Navigating the path of reproducibility in microRNA-based biomarker research with ring trials
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  13. The value of Sigma-metrics in laboratory medicine
  14. Genetics and Molecular Diagnostics
  15. Analytical validation of the amplification refractory mutation system polymerase chain reaction-capillary electrophoresis assay to diagnose spinal muscular atrophy
  16. Can we identify patients carrying targeted deleterious DPYD variants with plasma uracil and dihydrouracil? A GPCO-RNPGx retrospective analysis
  17. General Clinical Chemistry and Laboratory Medicine
  18. Comparison of ChatGPT, Gemini, and Le Chat with physician interpretations of medical laboratory questions from an online health forum
  19. External quality assessment performance in ten countries: an IFCC global laboratory quality project
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