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Serum GFAP – reference interval and preanalytical properties in Danish adults

  • Lea Tybirk ORCID logo EMAIL logo , Claus Vinter Bødker Hviid , Cindy Soendersoe Knudsen und Tina Parkner
Veröffentlicht/Copyright: 8. September 2022
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Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 60 Heft 11

Abstract

Objectives

Glial fibrillary acidic protein (GFAP) is a promising biomarker that could potentially contribute to diagnosis and prognosis in neurological diseases. The biomarker is approaching clinical use but the reference interval for serum GFAP remains to be established, and knowledge about the effect of preanalytical factors is also limited.

Methods

Serum samples from 371 apparently healthy reference subjects, 21–90 years of age, were measured by a single-molecule array (Simoa) assay. Continuous reference intervals were modelled using non-parametric quantile regression and compared with traditional age-partitioned non-parametric reference intervals established according to the Clinical and Laboratory Standards Institute (CLSI) guideline C28-A3. The following preanalytical conditions were also examined: stability in whole blood at room temperature (RT), stability in serum at RT and −20 °C, repeated freeze-thaw cycles, and haemolysis.

Results

The continuous reference interval showed good overall agreement with the traditional age-partitioned reference intervals of 25–136 ng/L, 34–242 ng/L, and 5–438 ng/L for the age groups 20–39, 40–64, and 65–90 years, respectively. Both types of reference intervals showed increasing levels and variability of serum GFAP with age. In the preanalytical tests, the mean changes from baseline were 2.3% (95% CI: −2.4%, 6.9%) in whole blood after 9 h at RT, 3.1% (95% CI: −4.5%, 10.7%) in serum after 7 days at RT, 10.4% (95% CI: −6.0%, 26.8%) in serum after 133 days at −20 °C, and 10.4% (95% CI: 9.5%, 11.4%) after three freeze-thaw cycles.

Conclusions

The study establishes age-dependent reference ranges for serum GFAP in adults and demonstrates overall good stability of the biomarker.

Keywords: glial fibrillary acidic protein (GFAP); preanalytical; reference range; serum; stability
Corresponding author: Lea Tybirk, MD, Department of Clinical Biochemistry, Aarhus University Hospital, Palle Juul Jensens Boulevard 99, 8200 Aarhus, Denmark, E-mail:

Funding source: Department of Clinical Biochemistry, Aarhus University Hospital

Acknowledgments

The authors sincerely thank Charlotte Nørby Pedersen and laboratory technicians Katrine Bremer for organizing the collection and analysis of blood samples, and the technicians in the blood bank and blood sampling unit for their assistance in collecting the reference samples.

  1. Research funding: This study was funded by the Department of Clinical Biochemistry, Aarhus University Hospital.

  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.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: The local Institutional Review Board deemed the study exempt from review.

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Received: 2022-07-06
Accepted: 2022-08-24
Published Online: 2022-09-08
Published in Print: 2022-10-26

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2022-0646
Schlagwörter für diesen Artikel
glial fibrillary acidic protein (GFAP); preanalytical; reference range; serum; stability

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Measuring FGF23 in clinical practice: dream or reality?
  4. Reviews
  5. Fibroblast growth factor 23: translating analytical improvement into clinical effectiveness for tertiary prevention in chronic kidney disease
  6. Pursuing appropriateness of laboratory tests: a 15-year experience in an academic medical institution
  7. General Clinical Chemistry and Laboratory Medicine
  8. Moving average quality control of routine chemistry and hematology parameters – a toolbox for implementation
  9. Practical application of European biological variation combined with Westgard Sigma Rules in internal quality control
  10. Total bilirubin assay differences may cause inconsistent treatment decisions in neonatal hyperbilirubinaemia
  11. Early predictors of abnormal MRI patterns in asphyxiated infants: S100B protein urine levels
  12. Interlaboratory comparison study of immunosuppressant analysis using a fully automated LC-MS/MS system
  13. Analytical evaluation and bioclinical validation of new aldosterone and renin immunoassays
  14. Improving clinical performance of urine sediment analysis by implementation of intelligent verification criteria
  15. Clinical evaluation of the OC-Sensor Pledia calprotectin assay
  16. Serous body fluid evaluation using the new automated haematology analyser Mindray BC-6800Plus
  17. Analysis of cryoproteins with a focus on cryofibrinogen: a study on 103 patients
  18. Reference Values and Biological Variations
  19. Within-subject biological variation estimates using an indirect data mining strategy. Spanish multicenter pilot study (BiVaBiDa)
  20. Short-term biological variation of serum glial fibrillary acidic protein
  21. Reference ranges for GDF-15, and risk factors associated with GDF-15, in a large general population cohort
  22. Serum GFAP – reference interval and preanalytical properties in Danish adults
  23. Determination of pediatric reference limits for 10 commonly measured autoantibodies
  24. Hematology and Coagulation
  25. Arterial and venous blood sampling is equally applicable for coagulation and fibrinolysis analyses
  26. Infectious Diseases
  27. Free urinary sialic acid levels may be elevated in patients with pneumococcal sepsis
  28. Letters to the Editor
  29. Thyroid stimulating hormone: biased estimate of allowable bias
  30. Letter to the Editor relating to Clin Chem Lab Med 2022;60(9):1365–72
  31. Reply to the Letter of Sun et al. [1] relating to Clin Chem Lab Med 2022;60(9):1365–72
  32. Prognostic significance of smudge cell percentage in chronic lymphocytic leukemia. Facts or artifacts? Methodological considerations and literature review
  33. Detection of a monoclonal component after pediatric liver transplantation: a case report
  34. Reporting magnesium critical results: clinical impact on pregnant women and neonates
  35. Congress Abstracts
  36. 54th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)
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