Abstract
Objectives
Alzheimer’s disease (AD) is considered the most common cause of dementia in older people. Cerebrospinal fluid (CSF) Aβ1-42, Aβ1-40, total Tau (t-Tau), and phospho Tau (p-Tau) are important biomarkers for the diagnosis, however, they are highly dependent on the pre-analytical conditions. Our aim was to investigate the potential influence of different storage conditions on the simultaneous quantification of these biomarkers in a fully-automated platform to accommodate easier pre-analytical conditions for laboratories.
Methods
CSF samples were obtained from 11 consecutive patients. Aβ1-42, Aβ1-40, p-Tau, and t-Tau were quantified using the LUMIPULSE G600II automated platform.
Results
Temperature and storage days significantly influenced Aβ1-42 and Aβ1-40 with concentrations decreasing with days spent at 4 °C. The use of the Aβ1-42/Aβ1-40 ratio could partly compensate it. P-Tau and t-Tau were not affected by any of the tested storage conditions. For conditions involving storage at 4 °C, a correction factor of 1.081 can be applied. Diagnostic agreement was almost perfect in all conditions.
Conclusions
Cutoffs calculated in samples stored at −80 °C can be safely used in samples stored at −20 °C for 15–16 days or up to two days at RT and subsequent freezing at −80 °C. For samples stored at 4 °C, cutoffs would require applying a correction factor, allowing to work with the certainty of reaching the same clinical diagnosis.
Funding source: CIBERDEM
Funding source: CIBERNED
Funding source: Instituto de Salud Carlos III
Award Identifier / Grant number: PI21/00140
Award Identifier / Grant number: PI18/00435
Award Identifier / Grant number: INT19/00016
Award Identifier / Grant number: PI17/01896
Award Identifier / Grant number: AC19/00103
Funding source: Fondo Europeo de Desarrollo Regional
Funding source: Unión Europea
Funding source: Generalitat de Catalunya
Award Identifier / Grant number: 2017-SGR-547
Award Identifier / Grant number: SLT006/17/125
Award Identifier / Grant number: SLT002/16/408
Funding source: Marató TV3
Award Identifier / Grant number: 20142610
Acknowledgments
We thank all the participants of this study and all the members of the clinical and biochemical teams involved in the study.
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Research funding: This work was supported by CIBERDEM and CIBERNED and Instituto de Salud Carlos III (PI21/00140 to FB-V and MT, PI18/00435 and INT19/00016 to DA, PI17/01896 and AC19/00103 to AL), funded by Fondo Europeo de Desarrollo Regional (FEDER), Unión Europea, “Una manera de hacer Europa”. This work was also supported by Generalitat de Catalunya (2017-SGR-547, SLT006/17/125 to DA, SLT002/16/408 to AL) and “Marató TV3” foundation grants 20142610 to AL. We thank Fujirebio Europe NV for kindly providing the necessary reagents to perform the study.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Ethical approval: All participants gave written informed consent before enrollment in accordance with the guidelines of the local Ethics Committee.
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