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Preparation and Pathogen Inactivation of Double Dose Buffy Coat Platelet Products using the INTERCEPT Blood System
Published on: December 7, 2012
Quality control of leucocyte-depleted platelet concentrates obtained by buffy-coat method
T Vuk1, M Strauss Patko, J Gulan-Harcet
1Croatian Institute of Transfusion Medicine, Zagreb, Croatia.
Insights
Platelet pool quality control results from 2005-2011 show high conformity with standards. Simple preparation improvements significantly enhance product quality and can redefine requirements.
Area of Science:
- Transfusion Medicine
- Hematology
- Quality Control
Background:
- Platelet transfusions are critical in managing bleeding disorders.
- Ensuring the quality of platelet products is essential for patient safety and therapeutic efficacy.
- Leukoreduced buffy-coat platelet pools are a common source for transfusion.
Purpose of the Study:
- To evaluate the quality control data of leukoreduced buffy-coat platelet pools over a seven-year period (2005-2011).
- To assess the overall quality and identify trends in platelet pool quality during the study period.
- To determine the conformity rates of platelet pools with established quality requirements.
Main Methods:
- Utilized data from the Quality Assurance Department of the Croatian Institute of Transfusion Medicine.
- Analyzed measurement results for all study parameters across the entire study period.
- Presented the rate of controlled platelet pools meeting specified quality requirements annually.
Main Results:
- Mean component volume: 50 ± 9 mL (91.5% conformable).
- Mean platelet count: 7.81 ± 1.26 × 10^10/unit (97.5% conformable).
- Mean leucocyte count: 0.01 ± 0.08 × 10^6/unit (99.6% conformable), mean pH: 7.45 ± 0.16 (99.4% conformable).
- Bacteriologic testing: 99.8% negative results.
Conclusions:
- Platelet pool quality control results demonstrated high conformity with specified requirements.
- Simple interventions in the preparation process can lead to significant product quality improvements.
- These improvements may necessitate the redefinition of quality requirements for platelet products.
Objectives:
Quality control results on leukoreduced buffy-coat platelet pools during the 7-year period (2005-2011) are presented with the aim to assess their overall quality and trends recorded during the study period.
Methods:
Data of the Quality Assurance Department, Croatian Institute of Transfusion Medicine were used in the study. Measurement results of all study parameters are presented for the entire study period, while the rate of controlled platelet pools consistent with the specified quality requirements is additionally presented for each study year.
Results:
The mean component volume was 50 ± 9 mL per 6 × 10(10) platelets (91.5% of conformable results), mean platelet count 7.81 ± 1.26 × 10(10) per single unit equivalent (97.5% of conformable results), mean leucocyte count 0.01 ± 0.08 × 10(6) per single unit equivalent (99.6% of conformable results), and mean pH 7.45 ± 0.16 (99.4% of conformable results). Bacteriologic testing showed negative result in 99.8% of tested components.
Conclusion:
Study results indicated the results of platelet pool quality control to be highly conformable with the specified quality requirements. It is illustrated how simple interventions in the preparation process can have significant impact on product quality improvement and thus on redefining quality requirements.
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