<abstract xmlns="http://www.w3.org/1999/xhtml">

<p>Despite numerous measures, bacterial sepsis associated with the transfusion remains a major threat. The incidence of septic events induced by platelets transfusion is approximately 10 times higher than with transfused red blood cells due to their storage temperature. This caused new Standard that implements the methods for the detection and reduction of bacteria in the platelet concentrates (PC). The aim is to consider the possibility of wider application of this tests in order to extend the shelf-life of PC. Sterility testing of PC is done once or twice per month using BacT/Alert BPA and BacT/Alert BPN bottles. If positive, all products from the initial unit were tested to confirm or deny the status. During six years period, 67236 PC units were made and 872 of them were tested. Only two were found initially positive. After testing the other products from the same initial unit, results were negative so, final results proclaimed false positive. Pretransfusion bacterial detection is an important potential method for reducing the risk of bacteriemia and transfusion-associated septic reactions. In addition to routine measures, Mirasol PRT pathogen inactivation system, could be included. This allows certain amount of PC to be inactivated during the first 32 hours. Untreated PC units would be stored in standard conditions and for given time (three days) potentially present bacteria would reach a detectable level. This way the quantity of samples for sterility testing could be reduced, taking only 2 ml of each of four units of PC. Samples would be planted at the same vial-aerobic bottle, which would also, double the capacity in BacT/Alert 3D automated system.</p>
</abstract>

Despite numerous measures, bacterial sepsis associated with the transfusion remains a major threat. The incidence of septic events induced by platelets transfusion is approximately 10 times higher than with transfused red blood cells due to their storage temperature. This caused new Standard that implements the methods for the detection and reduction of bacteria in the platelet concentrates (PC). The aim is to consider the possibility of wider application of this tests in order to extend the shelf-life of PC. Sterility testing of PC is done once or twice per month using BacT/Alert BPA and BacT/Alert BPN bottles. If positive, all products from the initial unit were tested to confirm or deny the status. During six years period, 67236 PC units were made and 872 of them were tested. Only two were found initially positive. After testing the other products from the same initial unit, results were negative so, final results proclaimed false positive. Pretransfusion bacterial detection is an important potential method for reducing the risk of bacteriemia and transfusion-associated septic reactions. In addition to routine measures, Mirasol PRT pathogen inactivation system, could be included. This allows certain amount of PC to be inactivated during the first 32 hours. Untreated PC units would be stored in standard conditions and for given time (three days) potentially present bacteria would reach a detectable level. This way the quantity of samples for sterility testing could be reduced, taking only 2 ml of each of four units of PC. Samples would be planted at the same vial-aerobic bottle, which would also, double the capacity in BacT/Alert 3D automated system.

Sterility Testing of Platelets Concentrate Within Quality Control: Experiences and Opportunities to Extend the Application

Experimental and Applied Biomedical Research (EABR)

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Despite numerous measures, bacterial sepsis associated with the transfusion remains a major threat. The incidence of septic events induced by platelets...

Sterility Testing of Platelets Concentrate Within Quality Control: Experiences and Opportunities to Extend the Application

Publicado en línea: 05 abr 2023

Páginas: 27 - 32

Recibido: 10 feb 2020

Aceptado: 22 feb 2020

DOI: https://doi.org/10.2478/sjecr-2020-0014

Palabras clave
Platelets, bacterial sepsis, sterility control, shelf life

© 2023 Dragana Gojkov et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Sterility Testing of Platelets Concentrate Within Quality Control: Experiences and Opportunities to Extend the Application

Publicado en línea: 05 abr 2023

Páginas: 27 - 32

Recibido: 10 feb 2020

Aceptado: 22 feb 2020

DOI: https://doi.org/10.2478/sjecr-2020-0014

Palabras clavePlatelets, bacterial sepsis, sterility control, shelf life

© 2023 Dragana Gojkov et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Palabras clave
Platelets, bacterial sepsis, sterility control, shelf life