Assessing the inactivation capabilities of two commercially available platelet component pathogen inactivation systems: effectiveness at end of shelf life.
Bacteria
/ drug effects
Blood Platelets
/ microbiology
Blood Safety
Drug Contamination
/ prevention & control
Escherichia coli
Humans
Klebsiella pneumoniae
Listeria monocytogenes
Platelet Transfusion
/ methods
Pseudomonas aeruginosa
Serratia marcescens
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus
Streptococcus bovis
Streptococcus mitis
Streptococcus pneumoniae
bacteria
blood safety
pathogen inactivation
platelet component
Journal
Vox sanguinis
ISSN: 1423-0410
Titre abrégé: Vox Sang
Pays: England
ID NLM: 0413606
Informations de publication
Date de publication:
Apr 2021
Apr 2021
Historique:
revised:
06
11
2020
received:
04
08
2020
accepted:
08
11
2020
pubmed:
23
2
2021
medline:
29
6
2021
entrez:
22
2
2021
Statut:
ppublish
Résumé
The inactivation capabilities of the two current commercially available pathogen inactivation (PI) systems for platelet components (PC), Mirasol and Intercept, were investigated by determination of the absence of viable bacteria at the end of shelf life by testing the entire contents of the PC by enrichment culture (terminal sterility). A pool-and-split method was used, with two treated units and one untreated control per inoculum concentration. Pairs of PC bags were inoculated with a single bacterial species. Three concentrations (n = 2 per concentration), which incremented tenfold, were tested initially based on published data from the manufacturer. Dependent on these results, the concentrations subsequently tested were either increased or decreased until the inactivation capability of the system was derived. Bacterial count was determined post-spiking, immediately prior to treatment (2 h from spiking), immediately after treatment and at the end of shelf life (day seven). Enrichment culture was performed immediately prior to treatment, after treatment and at the end of shelf life. The inactivation capabilities, in CFU/ml, of Intercept and Mirasol, respectively, at the end of PC shelf life were as follows: Staphylococcus aureus ≥ 10 The inactivation capability of Intercept was greater than that of Mirasol. Inactivation capability (by terminal sterility) is the most meaningful measure to evaluate a PI system for bacteria, rather than logarithmic reduction assessed immediately after treatment by plate count. PI offers a possible alternative to bacterial screening if treatment is performed at an appropriate time dependent on the inactivation capabilities of the system.
Sections du résumé
BACKGROUND AND OBJECTIVES
OBJECTIVE
The inactivation capabilities of the two current commercially available pathogen inactivation (PI) systems for platelet components (PC), Mirasol and Intercept, were investigated by determination of the absence of viable bacteria at the end of shelf life by testing the entire contents of the PC by enrichment culture (terminal sterility).
METHODS
METHODS
A pool-and-split method was used, with two treated units and one untreated control per inoculum concentration. Pairs of PC bags were inoculated with a single bacterial species. Three concentrations (n = 2 per concentration), which incremented tenfold, were tested initially based on published data from the manufacturer. Dependent on these results, the concentrations subsequently tested were either increased or decreased until the inactivation capability of the system was derived. Bacterial count was determined post-spiking, immediately prior to treatment (2 h from spiking), immediately after treatment and at the end of shelf life (day seven). Enrichment culture was performed immediately prior to treatment, after treatment and at the end of shelf life.
RESULTS
RESULTS
The inactivation capabilities, in CFU/ml, of Intercept and Mirasol, respectively, at the end of PC shelf life were as follows: Staphylococcus aureus ≥ 10
CONCLUSION
CONCLUSIONS
The inactivation capability of Intercept was greater than that of Mirasol. Inactivation capability (by terminal sterility) is the most meaningful measure to evaluate a PI system for bacteria, rather than logarithmic reduction assessed immediately after treatment by plate count. PI offers a possible alternative to bacterial screening if treatment is performed at an appropriate time dependent on the inactivation capabilities of the system.
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
416-424Subventions
Organisme : NHSBT
Informations de copyright
© 2021 International Society of Blood Transfusion.
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