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Impact of ultra-low temperature long-term storage on the preanalytical variability of twenty-one common biochemical analytes

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Published/Copyright: April 26, 2022
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 60 Issue 7

Abstract

Objectives

Retrospective studies frequently assume analytes long-term stability at ultra-low temperatures. However, these storage conditions, common among biobanks and research, may increase the preanalytical variability, adding a potential uncertainty to the measurements. This study is aimed to evaluate long-term storage stability of different analytes at <−70 °C and to assess its impact on the reference change value formula.

Methods

Twenty-one analytes commonly measured in clinical laboratories were quantified in 60 serum samples. Samples were immediately aliquoted and frozen at <−70 °C, and reanalyzed after 11 ± 3.9 years of storage. A change in concentration after storage was considered relevant if the percent deviation from the baseline measurement was significant and higher than the analytical performance specifications.

Results

Preanalytical variability (CVP) due to storage, determined by the percentage deviation, showed a noticeable dispersion. Changes were relevant for alanine aminotransferase, creatinine, glucose, magnesium, potassium, sodium, total bilirubin and urate. No significant differences were found in aspartate aminotransferase, calcium, carcinoembryonic antigen, cholesterol, C-reactive protein, direct bilirubin, free thryroxine, gamma-glutamyltransferase, lactate dehydrogenase, prostate-specific antigen, triglycerides, thyrotropin, and urea. As nonnegligible, CVP must remain included in reference change value formula, which was modified to consider whether one or two samples were frozen.

Conclusions

After long-term storage at ultra-low temperatures, there was a significant variation in some analytes that should be considered. We propose that reference change value formula should include the CVP when analyzing samples stored in these conditions.

Keywords: biobank; long-term storage; magnitude stability; preanalytical variability; reference change value; ultra-low temperatures
Corresponding author: Álvaro González, PhD, Service of Biochemistry, Clínica Universidad de Navarra, Avenida Pío XII 36, 31008 Pamplona, Spain, Phone: +34 948 255400, Fax: +34 948 296 500, E-mail:
Estibaliz Alegre and Nerea Varo contributed equally to this work.

Funding source: Roche Diagnostics

Acknowledgments

We thank Sonia Irisarri, Ruben del Campo, and Dra. María Romero for their technical assistance.

  1. Research funding: This study was partially supported by Roche Diagnostics, Barcelona, Spain.

  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: Not applicable.

  5. Ethical approval: Sample collection and storage was approved by the local Ethics Committee (project 14/2004 and 111/2010 and collection ISCIII C.0003132).

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0063).

Received: 2022-01-22
Accepted: 2022-04-11
Published Online: 2022-04-26
Published in Print: 2022-06-27

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2022-0063
Keywords for this article
biobank; long-term storage; magnitude stability; preanalytical variability; reference change value; ultra-low temperatures

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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  36. COVID-19 related mortality and religious denomination vs. genetics
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