Establishment of the first International Repository for Transfusion-Relevant Bacteria Reference Strains: ISBT Working Party Transfusion-Transmitted Infectious Diseases (WP-TTID), Subgroup on Bacteria

• Published in: Vox sanguinis Vol. 102; no. 1; pp. 22 - 31
• Main Authors: Störmer, M., Arroyo, A., Brachert, J., Carrero, H., Devine, D., Epstein, J. S., Gabriel, C., Gelber, C., Goodrich, R., Hanschmann, K.-M., Heath, D. G., Jacobs, M. R., Keil, S., de Korte, D., Lambrecht, B., Lee, C.-K., Marcelis, J., Marschner, S., McDonald, C., McGuane, S., McKee, M., Müller, T. H., Muthivhi, T., Pettersson, A., Radziwon, P., Ramirez-Arcos, S., Reesink, H. W., Rojo, J., Rood, I., Schmidt, M., Schneider, C. K., Seifried, E., Sicker, U., Wendel, S., Wood, E. M., Yomtovian, R. A., Montag, T.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.01.2012; S. Karger AG
• Subjects: Adoption; Bacteria; bacteria reference strains; bacterial contamination; Bacterial Infections - prevention & control; Bacterial Typing Techniques - methods; Bacteriological Techniques; Biological Specimen Banks; Blood Component Transfusion - methods; Blood Platelets - cytology; Blood Platelets - microbiology; Blood Transfusion; Blood transfusions; Contamination; Escherichia coli; Escherichia coli - metabolism; Firing pattern; Humans; Infectious diseases; International Cooperation; international reference material; Klebsiella pneumoniae; Klebsiella pneumoniae - metabolism; pathogen reduction; Pathogens; platelet screening; Platelets; Quality Assurance, Health Care - methods; repository; Reproducibility of Results; Staphylococcus epidermidis; Staphylococcus epidermidis - metabolism; Streptococcus pneumoniae; Streptococcus pyogenes; Streptococcus pyogenes - metabolism; validation
• ISSN: 0042-9007; 1423-0410
• DOI: 10.1111/j.1423-0410.2011.01510.x

Background  Bacterial contamination of platelet concentrates (PCs) still remains a significant problem in transfusion with potential important clinical consequences, including death. The International Society of Blood Transfusion Working Party on Transfusion‐Transmitted Infectious Diseases, Subgroup on Bacteria, organised an international study on Transfusion‐Relevant Bacteria References to be used as a tool for development, validation and comparison of both bacterial screening and pathogen reduction methods. Material and Methods  Four Bacteria References (Staphylococcus epidermidis PEI‐B‐06, Streptococcus pyogenes PEI‐B‐20, Klebsiella pneumoniae PEI‐B‐08 and Escherichia coli PEI‐B‐19) were selected regarding their ability to proliferate to high counts in PCs and distributed anonymised to 14 laboratories in 10 countries for identification, enumeration and bacterial proliferation in PCs after low spiking (0·3 and 0·03 CFU/ml), to simulate contamination occurring during blood donation. Results  Bacteria References were correctly identified in 98% of all 52 identifications. S. pyogenes and E. coli grew in PCs in 11 out of 12 laboratories, and K. pneumoniae and S. epidermidis replicated in all participating laboratories. The results of bacterial counts were very consistent between laboratories: the 95% confidence intervals were for S. epidermidis: 1·19–1·32 × 107 CFU/ml, S. pyogenes: 0·58–0·69 × 107 CFU/ml, K. pneumoniae: 18·71–20·26 × 107 CFU/ml and E. coli: 1·78–2·10 × 107 CFU/ml. Conclusion  The study was undertaken as a proof of principle with the aim to demonstrate (i) the quality, stability and suitability of the bacterial strains for low‐titre spiking of blood components, (ii) the property of donor‐independent proliferation in PCs, and (iii) their suitability for worldwide shipping of deep frozen, blinded pathogenic bacteria. These aims were successfully fulfilled. The WHO Expert Committee Biological Standardisation has approved the adoption of these four bacteria strains as the first Repository for Transfusion‐Relevant Bacteria Reference Strains and, additionally, endorsed as a project the addition of six further bacteria strain preparations suitable for control of platelet contamination as the next step of enlargement of the repository.