94% of researchers rate our articles as excellent or good
Learn more about the work of our research integrity team to safeguard the quality of each article we publish.
Find out more
BRIEF RESEARCH REPORT article
Front. Mol. Biosci.
Sec. Molecular Diagnostics and Therapeutics
Volume 12 - 2025 | doi: 10.3389/fmolb.2025.1491239
Determination of sample stability for a broad panel of coagulation parameters and factor assays on the Cobas t 711 analyzer starting from fresh-never-frozen plasma
Provisionally accepted
Michael Hoffmann 1*
Norbert Gottschalk 1
Philipp Huber 2
Vanessa Scheling 3
Nicole von Allmen 3
Kolja Johannes Hegel 3- 1 Roche Diagnostics GmbH, Penzberg, Germany
- 2 Roche Diagnostics International Ltd, Rotkreuz, Switzerland
- 3 Labor Berlin Charité Vivantes GmbH, Berlin, Berlin, Germany
Background: Preanalytical procedures can affect the accuracy of coagulation assay results. Recommended plasma storage temperatures and durations need to be defined for individual coagulation assays. Here, we evaluated the effect of commonly applied plasma storage conditions for a broad panel of 23 basic coagulation parameters as well as specialized factor assays developed for the Cobas® t 711 analyzer (Roche Diagnostics International Ltd, Rotkreuz, Switzerland).Methods: This single-center, prospective, observational study used anonymized, residual, platelet-poor plasma samples as well as pseudonymized plasma samples to obtain rare ranges of certain analytes. Fresh-never-frozen plasma samples processed within 4 h were tested in triplicate at time zero (t0), with measurements repeated at various predefined timepoints after storage at 18–25°C, 2–8°C, or under freezing and deep freezing. Mean deviation from t0, expressed as a percentage or as absolute change in signal at very low analyte levels, was assessed against predefined, assay-specific acceptance criteria for each analyte.Results: The sample stability results under the examined storage conditions for all 23 assays met or exceeded the requirements for routine laboratory coagulation testing and the respective acceptance criteria for each individual assay were fulfilled. Fresh-never-frozen samples were used to reflect real-life laboratory settings, enabling the early detection of out-of-specification results.Conclusion: Sample stability was determined for a broad panel of assays on the t 711 analyzer, for application in routine coagulation testing practice.
Keywords: Blood Coagulation, Coagulation testing, fresh-never-frozen plasma, Cobas t 711 analyzer, Sample stability, Storage duration, temperature
Received: 10 Sep 2024; Accepted: 19 Feb 2025.
Copyright: © 2025 Hoffmann, Gottschalk, Huber, Scheling, von Allmen and Hegel. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Michael Hoffmann, Roche Diagnostics GmbH, Penzberg, Germany
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.