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Polskie placówki, tj. Pracownia Biobank UŁ zaangażowana w realizacje projektu BBMRI.pl oraz Katedra Diagnostyki Neurodegeneracyjnej Uniwersytetu Medycznego w Białymstoku, obie zaangażowane w tworzenie Polskiej Sieci Biobanków, brały udział w międzynarodowym projekcie dotyczącym monitorowania biegłości stosowania Standardowych Procedur Operacyjnych (SOP). Sprawdzano, w jaki sposób metodyka opisana w wewnętrznych procedurach jednostek biorących udział w projekcie wpływa na końcowe wyniki badań nad markerami choroby Alzheimera. Badania prowadzono z wykorzystaniem płynu mózgowo-rdzeniowego (CSF). Uzyskane rezultaty i wnioski zostały opublikowane w Alzheimer's Research and Therapy (IF=5.015) w artykule Interlaboratory proficiency processing scheme in CSF aliquoting: implementation and assessment based on biomarkers of Alzheimer’s disease. Artykuł jest dostępny w trybie OPEN ACCESS. Zapraszamy do lektury.

 

 

Piotr Lewczuk1,2, Amélie Gaignaux3, Olga Kofanova3, Natalia Ermann1, Fay Betsou3, Sebastian Brandner4, Barbara Mroczko2, Kaj Blennow5,6, Dominik Strapagiel7,8, Silvia Paciotti9, Jonathan Vogelgsang10, Michael H. Roehrl11, Sandra Mendoza12, Johannes Kornhuber1 and Charlotte Teunissen13

 

1Department of Psychiatry and Psychotherapy, Laboratory for Clinical Neurochemistry and Neurochemical Dementia Diagnostics, Universitätsklinikum Erlangen, and Friedrich-Alexander Universität Erlangen-Nürnberg, Schwabachanlage 6, 91054 Erlangen, Germany.

2Department of Neurodegeneration Diagnostics, Department of Biochemical Diagnostics, Medical University of Bialystok, University Hospital of Bialystok, Bialystok, Poland.

3Integrated BioBank of Luxembourg, Dudelange, Luxembourg.

4Department of Neurosurgery, Universitätsklinikum Erlangen, and Friedrich-Alexander Universität Erlangen-Nürnberg, Erlangen, Germany.

5Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden.

6Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Mölndal, Sweden.

7Biobank Lab, Department of Molecular Biophysics, Faculty of Biology and Environmental Protection, University of Lodz, Lodz, Poland.

8BBMRI.pl Consortium, Wroclaw, Poland.

9Department of Experimental Medicine, University of Perugia, Perugia, Italy.

10Department of Psychiatry and Psychotherapy, University Medical Center Göttingen (UMG), Göttingen, Germany.

11Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.

12NYU Center for Biospecimen Research and Development (CBRD), New York, NY, USA. 13Neurochemistry Laboratory and Biobank, Department of Clinical Chemistry, VU University Medical Center, Amsterdam, The Netherlands.

 13Neurochemistry Laboratory and Biobank, Department of Clinical Chemistry, VU University Medical Center, Amsterdam, The Netherlands.

 

Background: In this study, we tested to which extent possible between-center differences in standardized operating procedures (SOPs) for biobanking of cerebrospinal fluid (CSF) samples influence the homogeneity of the resulting aliquots and, consequently, the concentrations of the centrally analyzed selected Alzheimer’s disease biomarkers.

Methods: Proficiency processing samples (PPSs), prepared by pooling of four individual CSF samples, were sent to 10 participating centers, which were asked to perform aliquoting of the PPSs into two secondary aliquots (SAs) under their local SOPs. The resulting SAs were shipped to the central laboratory, where the concentrations of amyloid beta (Aβ) 1–42, pTau181, and albumin were measured in one run with validated routine analytical methods. Total variability of the concentrations, and its within-center and between-center components, were analyzed with hierarchical regression models.

Results: We observed neglectable variability in the concentrations of pTau181 and albumin across the centers and the aliquots. In contrast, the variability of the Aβ1–42 concentrations was much larger

(overall coefficient of variation 31%), with 28% of the between-laboratory component and 10% of the within-laboratory (i.e., between-aliquot) component. We identified duration of the preparation of the aliquots and the centrifugation force as two potential confounders influencing within-center variability and biomarker concentrations, respectively.

Conclusions: Proficiency processing schemes provide objective evidence for the most critical preanalytical variables. Standardization of these variables may significantly enhance the quality of the collected biospecimens. Studies utilizing retrospective samples collected under different local SOPs need to consider such differences in the statistical evaluations of the data.