QUALITY CONTROL EVALUATION OF LEUCODEPLETED RED BLOOD CELL COMPONENTS PREPARATION WITH TOP AND BOTTOM TECHNIQUE IN GSH BLOOD BANK IN SAO PAULO, BRAZIL

Abstract

Objectives: To evaluate the quality of leukodepleted red cell concentrates (LD-RCC) obtained with top and bottom systems from the whole blood collected and processed in the GSH blood bank Sao Paulo, during 22 – 26 April 2024, verifying local and the European Directorate for the Quality of Medicines & HealthCare (EDQM) Blood Guide. Material and methods: The study was performed following European guidelines for blood processing during collection day, after resting at 22°C. Whole blood (WB) was collected using Top and bottom (T&B) quadruple CDP/SAGM with in-line filter bags (n = 60, 450 ml), (LQT610L® system Macopharma; France) in GSH blood bank between April 22 - 26 2024. WB was centrifuged on day 0 at 3,500 rpm (Sorval RC 3C Plus) for 15 min. Blood components were separated with Fractiomatic Plus 2 separator (Grifols, Spain) to obtain pre-filtered red cell concentrate (RCC), plasma (PL), and buffy coat (BC). After T&B separation process, the RCC prefilter system was hung to ensure the transfer of SAGM solution into the RCC before filtration (priming). After priming, the system was put upside down, so the complete content of RCC was filtered by gravity and stored at 4ºC in the final bag. All Leukodepleted Red Cell Concentrates (LD-RCC) were tested for cell blood count (Cell Dyn- Esmerald, Abbot), residual leucocytes (rWBC) (n = 58) (Nageotte camera, Blaubrand), and microbiological culture. Samples excluded due to incomplete data (n = 2). Results: LD-RCC average volume was 262.8 ml (> 220 ml). The average Hemoglobin (Hb) content and hematocrit (Ht) per unit were 50.64 grams (gr) and 58.21%, respectively, surpassing minimum threshold of 40gr and 50% per unit. The average rWBC count per unit was 0.0264 × 106, below the maximum allowable limit of 1x106 wbc/unit. All samples showed negative results in microbiological culture (compliance 100%), indicating an effective and safe product. According to local and European standards (EDQM), these results presented more than 90% compliance, as follows: Volume: 99.98%, Hb: 99.95%, rWBC: 100%. Discussion: The production of blood components each day faces a significant challenge: meeting the community's transfusion demands while ensuring that the blood products maintain the high quality necessary to support the recovery of all recipients. Through this validation, GSH demonstrates that the quality of blood components with top and bottom technique is a methodology applicable to the reality of blood banks in Brazil, not only increasing the quality of the components but also optimizing resources, since meeting quality standards can reduce wastage due to rejected units and improves the efficient use of blood bank reserves. Conclusion: These results demonstrate that In-line T&B process produces high-quality RCC, with low concentration of leukocytes (cells responsible for transmission of cell-associated infectious agents, febrile non-hemolytic transfusion reactions, etc.), which can lead to significant benefits by reducing adverse transfusion reactions, potentially shortening hospital stays, and decreasing the potential additional costs related to complications. In summary, LD-RCC preparation met or exceeded local and international quality control standards.