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Establishing sex- and age-related reference intervals of serum glial fibrillary acid protein measured by the fully automated lumipulse system

  • Luisa Agnello , Caterina Maria Gambino , Anna Maria Ciaccio , Rosaria Vincenza Giglio , Concetta Scazzone , Martina Tamburello , Giuseppina Candore , Giulia Accardi , Anna Aiello , Fabio Del Ben ORCID logo and Marcello Ciaccio EMAIL logo
Published/Copyright: March 11, 2025
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 7

Abstract

Objectives

To establish the reference intervals (RIs) of serum glial fibrillary acid protein (GFAP) measured by the fully automated Lumipulse system.

Methods

The study population consisted of 340 healthy individuals, including 251 blood donors and 89 outpatients, with a median age of 56 years. Serum GFAP levels were measured by the Lumipulse G GFAP assay on the fully automated platform Lumipulse G1200 (FUJIREBIO Inc., Tokyo, Japan). GFAP RIs (2.5th and 97.5th percentiles) were calculated for the overall population and stratified by age and sex groups. For the overall population, males, and females partitions, we employed the nonparametric methods, while for the age-and-sex groups we employed the “robust” method, as recommended by CLSI.

Results

The RI in the whole population was 10.4–92.0 ng/L. When considering sex differences, females showed higher levels of serum GFAP than males across all age groups. A positive correlation was observed between age and GFAP (Spearman’s rho=0.55, p<0.001). Specifically, the biomarker was stable until 60 years, while individuals aged>60 years demonstrated significantly and considerably higher levels than younger age groups. Additionally, in the 50–60 age group, we observed gender-related differences, with females having increased levels than males.

Conclusions

GFAP levels are influenced by both age and sex. Accordingly, we established RIs of serum GFAP, taking into consideration age and sex-related differences.

Keywords: glial fibrillary acid protein (GFAP); serum; alzheimer’s disease; biomarkers; astrocyte
Corresponding author: Marcello Ciaccio, Department of Biomedicine, Neurosciences and Advanced Diagnostics, Clinical Molecular Medicine, and Clinical Laboratory Medicine, Institute of Clinical Biochemistry, University of Palermo, Palermo, Italy; Department of Laboratory Medicine, University Hospital Paolo Giaccone, Palermo, Italy, E-mail:

  1. Research ethics: The study was approved by the local Ethical Committee.

  2. Informed consent: Residual biological material was used for all biochemical analyses, and data were anonymized before entering the study, so no written informed consent was required from participants.

  3. Author contributions: LA, Conceptualization and Study Design, Manuscript Writing – Original Draft Preparation; CMG, RVG, GC, GA, and AA: Data Collection and Curation, Manuscript Writing – Review and Editing; AMC and CS, Manuscript Writing – Review and Editing, FDB, statistical analysis and Manuscript Writing – Original Draft Preparation; MC, Conceptualization and StudyDesign, Supervision, and Manuscript Writing – Review and Editing. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: The data that support the findings of this study are available on request from the corresponding author.

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Received: 2025-01-23
Accepted: 2025-02-28
Published Online: 2025-03-11
Published in Print: 2025-06-26

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2025-0093
Keywords for this article
glial fibrillary acid protein (GFAP); serum; alzheimer’s disease; biomarkers; astrocyte

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. The journey to pre-analytical quality
  4. Manual tilt tube method for prothrombin time: a commentary on contemporary relevance
  5. Reviews
  6. From errors to excellence: the pre-analytical journey to improved quality in diagnostics. A scoping review
  7. Advancements and challenges in high-sensitivity cardiac troponin assays: diagnostic, pathophysiological, and clinical perspectives
  8. Opinion Paper
  9. Is it feasible for European laboratories to use SI units in reporting results?
  10. Perspectives
  11. What does cancer screening have to do with tomato growing?
  12. Computer simulation approaches to evaluate the interaction between analytical performance characteristics and clinical (mis)classification: a complementary tool for setting indirect outcome-based analytical performance specifications
  13. Genetics and Molecular Diagnostics
  14. Artificial base mismatches-mediated PCR (ABM-PCR) for detecting clinically relevant single-base mutations
  15. Candidate Reference Measurement Procedures and Materials
  16. Antiphospholipid IgG Certified Reference Material ERM®-DA477/IFCC: a tool for aPL harmonization?
  17. General Clinical Chemistry and Laboratory Medicine
  18. External quality assessment of the manual tilt tube technique for prothrombin time testing: a report from the IFCC-SSC/ISTH Working Group on the Standardization of PT/INR
  19. Simple steps to achieve harmonisation and standardisation of dried blood spot phenylalanine measurements and facilitate consistent management of patients with phenylketonuria
  20. Inclusion of pyridoxine dependent epilepsy in expanded newborn screening programs by tandem mass spectrometry: set up of first and second tier tests
  21. Analytical performance evaluation and optimization of serum 25(OH)D LC-MS/MS measurement
  22. Towards routine high-throughput analysis of fecal bile acids: validation of an enzymatic cycling method for the quantification of total bile acids in human stool samples on fully automated clinical chemistry analyzers
  23. Analytical and clinical evaluations of Snibe Maglumi® S100B assay
  24. Prevalence and detection of citrate contamination in clinical laboratory
  25. Reference Values and Biological Variations
  26. Temporal dynamics in laboratory medicine: cosinor analysis and real-world data (RWD) approaches to population chronobiology
  27. Establishing sex- and age-related reference intervals of serum glial fibrillary acid protein measured by the fully automated lumipulse system
  28. Hematology and Coagulation
  29. Performance of the automated digital cell image analyzer UIMD PBIA in white blood cell classification: a comparative study with sysmex DI-60
  30. Cancer Diagnostics
  31. Flow-cytometric MRD detection in pediatric T-ALL: a multicenter AIEOP-BFM consensus-based guided standardized approach
  32. Impact of biological and genetic features of leukemic cells on the occurrence of “shark fins” in the WPC channel scattergrams of the Sysmex XN hematology analyzers in patients with chronic lymphocytic leukemia
  33. Assessing the clinical applicability of dimensionality reduction algorithms in flow cytometry for hematologic malignancies
  34. Cardiovascular Diseases
  35. Evaluation of sex-specific 0-h high-sensitivity cardiac troponin T thresholds for the risk stratification of non-ST-segment elevation myocardial infarction
  36. Retraction
  37. The first case of Teclistamab interference with serum electrophoresis and immunofixation
  38. Letters to the Editor
  39. Is this quantitative test fit-for-purpose?
  40. Reply to “Is this quantitative test fit-for-purpose?”
  41. Short-term biological variation of coagulation and fibrinolytic measurands
  42. The first case of Teclistamab interference with serum electrophoresis and immunofixation
  43. Imlifidase: a new interferent on serum protein electrophoresis looking as a rare plasma cell dyscrasia
  44. Research on the development of image-based Deep Learning (DL) model for serum quality recognition
  45. Interference of hypertriglyceridemia on total cholesterol assay with the new CHOL2 Abbott method on Architect analyser
  46. Congress Abstracts
  47. 10th Annual Meeting of the Austrian Society for Laboratory Medicine and Clinical Chemistry (ÖGLMKC)
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