Clinical Chemistry and Laboratory Medicine | September 8, 2022

Tybirk, L., Hviid, C. V. B., Knudsen, C. S. and Parkner, T.

Clinical Chemistry and Laboratory Medicine (CCLM), vol. 60, no. 11, 2022, pp. 1830-1838

https://doi.org/10.1515/cclm-2022-0646

This study was performed using the Quanterix HD-1 Analyzer.

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.