Laboratory Evaluation of the Effectiveness of Pathogen Reduction Procedures for Bacteria.

SUMMARY

Bacterial contamination remains a leading factor for transfusion-associated serious morbidity and mortality. Pathogen reduction procedures offer a pro-active approach to prevent bacterial contamination of cellular blood components and especially of platelet concentrates. In the past, the laboratory evaluation of the effectiveness of the pathogen reduction procedures to minimise the bacterial load of blood components has been primarily based on log reduction assays similar to the assessment of antiviral activities. Bacteria strains with the ability to multiply in the blood components are seeded in highest possible cell numbers, the pathogen reduction procedure is applied, and the post-treatment number of bacteria is measured. The effectiveness of the procedure is characterised by calculating the log reduction of the post- to pre-treatment bacteria titres. More recently, protocols have been developed for experiments starting with a low bacteria load and monitoring the sterility of the blood component during the entire storage period of the blood component. Results for 3 different pathogen reduction technologies in these experimental models are compared and critical determinants for the results are addressed. The heterogeneity of results observed for different strains suggests that the introduction of international transfusion-relevant bacterial reference strains may facilitate the validity of findings in pathogen reduction experiments.