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Transport stability profiling – a proposed generic protocol

  • Lars Willems , Michael Paal ORCID logo and Michael Vogeser EMAIL logo
Published/Copyright: May 2, 2022
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 60 Issue 7

Abstract

Objectives

Diagnostic samples are exposed to a spectrum of variables during transport to laboratories; therefore, the evaluation of a rather comprehensive stability profile of measurands is warranted. While appropriate testing standards have been established for pharmaceuticals and reagents, this is not the case for diagnostic samples. The aim of our work was to develop and evaluate a protocol applicable to diagnostic samples.

Methods

An isochronous approach with representation of temperature and exposure duration in a two-dimensional matrix was established. The deviations of the measurement results from the baseline associated with the exposure are evaluated with respect to the measurement uncertainty of the analytical measurement procedure applied. Variables of the experiment are documented in a standardized matrix. As a proof-of-concept, we profiled the stability patterns of a number of measurands at four temperature levels over up to 72 h in primary serum sample tubes.

Results

The protocol proved to be workable and allowed the description of a comprehensive stability profile of a considerable number of compounds based on 21 small-volume primary samples collected from each volunteer and exposed according to this protocol.

Conclusions

A straightforward and feasible isochronous protocol can be used to investigate in detail the effects of different pre-processing conditions on the stability of measurands in primary samples during transport to diagnostic laboratories. This is of significance as pre-analytical logistics become increasingly important with the centralization of analytical services.

Keywords: isochronous; pre-analytical processes; sample stability; sample transport
Corresponding author: Prof. Dr. med. Michael Vogeser, University Hospital, LMU Muenchen, Marchioninistr. 15, 81375 Munich, Germany, Phone: +49 89 4400 73221, E-mail:

Acknowledgments

We thank Prof. Klaus Parhofer, Department of Internal Medicine IV, and Dr. Florian Arend, Institute of Laboratory Medicine, University Hospital, LMU Munich, for reviewing the manuscript and their valuable input.

  1. Research funding: No funding.

  2. Author contribution: 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. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: The investigation was approved by the Institutional Review Board.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0032).

Received: 2022-01-11
Accepted: 2022-04-06
Published Online: 2022-05-02
Published in Print: 2022-06-27

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2022-0032
Keywords for this article
isochronous; pre-analytical processes; sample stability; sample transport

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. The never-ending quest for antibody assays standardization and appropriate measurement units
  4. Review
  5. Glycated albumin in diabetes mellitus: a meta-analysis of diagnostic test accuracy
  6. Opinion Paper
  7. Ad interim recommendations for diagnosing SARS-CoV-2 infection by the IFCC SARS-CoV-2 variants working group
  8. Guidelines and Recommendations
  9. Recommendations for IVDR compliant in-house software development in clinical practice: a how-to paper with three use cases
  10. General Clinical Chemistry and Laboratory Medicine
  11. Comparison between polynomial regression and weighted least squares regression analysis for verification of analytical measurement range
  12. Transport stability profiling – a proposed generic protocol
  13. Impact of ultra-low temperature long-term storage on the preanalytical variability of twenty-one common biochemical analytes
  14. Development of a liquid chromatography mass spectrometry method for the determination of vitamin K1, menaquinone-4, menaquinone-7 and vitamin K1-2,3 epoxide in serum of individuals without vitamin K supplements
  15. TSH-receptor autoantibodies in patients with chronic thyroiditis and hypothyroidism
  16. Evaluation of the AFIAS-1 thyroid-stimulating hormone point of care test and comparison with laboratory-based devices
  17. Lack of analytical interference of dydrogesterone in progesterone immunoassays
  18. A comprehensive comparison between ISAC and ALEX2 multiplex test systems
  19. Detection of subarachnoid haemorrhage with spectrophotometry of cerebrospinal fluid – a comparison of two methods
  20. Importance of cerebrospinal fluid storage conditions for the Alzheimer’s disease diagnostics on an automated platform
  21. Estimating urine albumin to creatinine ratio from protein to creatinine ratio using same day measurement: validation of equations
  22. An automated, rapid fluorescent immunoassay to quantify serum soluble programmed death-1 (PD-1) protein using testing-on-a-probe biosensors
  23. Hematology and Coagulation
  24. The VES-Matic 5 system: performance of a novel instrument for measuring erythrocyte sedimentation rate
  25. Cancer Diagnostics
  26. Is thyroglobulin a reliable biomarker of differentiated thyroid cancer in patients treated by lobectomy? A systematic review and meta-analysis
  27. Cardiovascular Diseases
  28. The intra-individual variation of cardiac troponin I: the effects of sex, age, climatic season, and time between samples
  29. Infectious Diseases
  30. A cohort analysis of SARS-CoV-2 anti-spike protein receptor binding domain (RBD) IgG levels and neutralizing antibodies in fully vaccinated healthcare workers
  31. Patients with severe COVID-19 do not have elevated autoantibodies against common diagnostic autoantigens
  32. Cerebrospinal fluid markers of inflammation and brain injury in Lyme neuroborreliosis – a prospective follow-up study
  33. Letters to the Editors
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