Quality of the fibrinogen index in freeze-dried plasma for external blood coagulation testing programs
Keywords:
coagulation, quality assurance, fibrinogen, lyophilized, plasmaAbstract
Background: Lyophilized plasma is widely used in external quality assessment for fibrinogen testing, where sample homogeneity and stability are critical. This study evaluated these factors, addressing challenges in sample preparation to enhance the quality of medical services.
Objective: To assess the homogeneity and stability of fibrinogen in lyophilized plasma according to ISO 13528:2022 and ISO Guide 35:2010 standards.
Methods: The study utilized experimental freeze-dried control samples containing fibrinogen. Random sampling was performed using Microsoft Excel 16, and one-way ANOVA was applied to assess sample homogeneity. Stability at different time points and temperatures was evaluated using t-tests. Key variables included: Mean (central tendency), Standard Deviation (data dispersion), Homogeneity (consistency within a batch, assessed via P-values), and Stability (maintenance of values over time under varied storage conditions).
Results: The fibrinogen values of the standard samples demonstrated good homogeneity (p= 0.890> 0.05). Freeze-dried samples stored at 2–8°C remained stable over 5 months, with t-test p‑values of 0.114, 0.242, and 0.391, all > 0.05. Samples stored at –20°C were stable over 3 months (p= 0.520, 0.761, and 0.353). Additionally, short-term stability assessments on days 1, 3, 5, and 7 yielded p-values of 0.093, 0.742, 0.057, and 0.270, respectively, indicating no significant changes and confirming overall stability.
Conclusion: Lyophilized plasma containing the fibrinogen index is both homogeneous and stable when stored at 2-8°C and -20°C, as well as during transportation. These significant findings pave the way for further research and potential advancements in coagulation testing.
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