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Andreu G, Boudjedir K, Meyer N, Carlier M, Drouet C, Py JY, Tacquard C, Mertes PM, Sandid I. Platelet Additive Solutions and Pathogen Reduction Impact on Transfusion Safety, Patient Management and Platelet Supply. Transfus Med Rev 2025; 39:150875. [PMID: 39919322 DOI: 10.1016/j.tmrv.2025.150875] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/09/2024] [Revised: 12/24/2024] [Accepted: 01/02/2025] [Indexed: 02/09/2025]
Abstract
Since 1998, leuko-reduction is used in France for all platelet concentrates (PCs), apheresis-derived (APCs) and pooled whole blood-derived buffy-coats (BCPCs). Platelet additive solutions (PAS), introduced in 2005, accounted for over 80% of the platelet supply from 2011 to 2017. The Intercept pathogen reduction technology (PR), started in a pilot study in 2007, was generalized in 2018. Between 2007 and 2021, the use of BCPCs increased steadily from 23% to 70% of the supply. Objectives: to analyze the impact of these modifications on adverse transfusion reactions (ATRs), patient management and blood transfusion organization. Results: The overall incidence of ATRs /105 PCs is significantly lower with PAS- and PR-PCs as compared to PCs in plasma (PL), with the decreasing hierarchy PL > PAS > PR. PAS- and PR-PCs lead to significantly lower incidences of allergy and alloimmunization to RBC antigens (RC-AI) ATRs. The incidence of bacteria transmission (TTBI) is significantly reduced by 95% with PR-PCs. APC-related ATR incidence is significantly higher than BCPC for allergy (+233%), TTBI (+100%), APTR (+75%), Major-ABO-II (+65%), HLA/HPA-AI (+38%), FNHTR (+22%), and life-threatening ATRs (+106%). A single diagnosis is significantly less associated with APCs: RC-AI (-47%). The generalization of PR-PCs, which exhibit a lower platelet content than PAS- and PL-PCs, is associated with a significant 9% decrease in the ATR incidence per PC, a 13% increase in the number of PCs transfused per patient, and a nonsignificant 3% increase in the ATR incidence per patient. The outdated PCs percentage declined significantly from 3.7% to 1.7%.
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Affiliation(s)
- Georges Andreu
- French National Agency for Medicines and Health Products Safety (ANSM), Saint Denis, France.
| | - Karim Boudjedir
- French National Agency for Medicines and Health Products Safety (ANSM), Saint Denis, France
| | - Nicolas Meyer
- CHU de Strasbourg, GMRC, Service de santé publique, Strasbourg, France; I-Cube - UMR 7357 - Laboratoire des sciences de l'ingénieur, de l'informatique et de l'imagerie, Université de Strasbourg, Strasbourg, France
| | - Monique Carlier
- Agence Régionale de Santé Grand Est, Châlons en Champagne, France
| | - Christian Drouet
- Institut Cochin, INSERM UMR1016, Université de Paris, Paris, France
| | - Jean-Yves Py
- Etablissement Français du Sang Campus EFS, France
| | - Charles Tacquard
- CHU de Strasbourg, Service d'anesthésie-réanimation du Nouvel Hôpital Civil, Strasbourg, France
| | - Paul Michel Mertes
- CHU de Strasbourg, Service d'anesthésie-réanimation du Nouvel Hôpital Civil, Strasbourg, France
| | - Imad Sandid
- French National Agency for Medicines and Health Products Safety (ANSM), Saint Denis, France
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Reddoch-Cardenas KM, Perez SL, Ferdin JN, Meledeo MA. Evaluation of platelets componentized with the Reveos Automated Blood Processing System and stored for 7 days at room temperature in a non-Di(2-ethylhexyl) phthalate (DEHP) platelet pooling set. Transfusion 2024; 64 Suppl 2:S146-S154. [PMID: 38491915 DOI: 10.1111/trf.17780] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/30/2023] [Revised: 02/29/2024] [Accepted: 03/01/2024] [Indexed: 03/18/2024]
Abstract
BACKGROUND Platelet concentrates (PCs) used for transfusion can be produced by apheresis or derived from whole blood (WB). The Reveos device is the first US Food and Drug Administration-approved automated blood processing system that can produce PCs. In this work, we evaluated the quality and function of Reveos-collected PCs stored for 7 days at room temperature. STUDY DESIGN AND METHODS WB was collected from healthy donors and componentized on the day of collection (Fresh) or after an overnight hold (Overnight). PCs were produced (n = 7 Fresh; n = 6 Overnight), stored at room temperature in plasma, and evaluated on days 1 and 7 for quality metrics, platelet activation, clot formation, and aggregation response. RESULTS Platelet count was comparable between Fresh and Overnight PCs. A drop in pH was reported in Fresh day 7 PCs (p < .001, vs. day 1) but not in Overnight. Overnight units displayed the lowest levels of P-selectin expression (p = .0008, vs. day 7 Fresh). Reduced clot strength and increased lysis were observed in both Fresh and Overnight units on day 7 (vs. day 1). Overnight-hold PCs resulted in the highest clot strength on day 7 (p = .0084, vs. Fresh). No differences in aggregation were reported between groups. CONCLUSION Reveos-processed PCs produced from overnight-hold WB performed better in hemostatic function assays and displayed reduced activation compared to fresh WB-derived PCs, although both PC groups maintained platelet quality throughout storage. Utilization of overnight WB for PC preparation with Reveos holds promise as an alternative method of producing platelets for transfusion purposes.
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Affiliation(s)
- Kristin M Reddoch-Cardenas
- Blood and Shock Resuscitation, U.S. Army Institute of Surgical Research, JBSA-FT, Sam Houston, Texas, USA
| | - Samantha L Perez
- Blood and Shock Resuscitation, U.S. Army Institute of Surgical Research, JBSA-FT, Sam Houston, Texas, USA
| | - Justin N Ferdin
- Blood and Shock Resuscitation, U.S. Army Institute of Surgical Research, JBSA-FT, Sam Houston, Texas, USA
| | - Michael A Meledeo
- Blood and Shock Resuscitation, U.S. Army Institute of Surgical Research, JBSA-FT, Sam Houston, Texas, USA
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Gravemann U, Handke W, Schulze TJ, Seltsam A. Growth and Distribution of Bacteria in Contaminated Whole Blood and Derived Blood Components. Transfus Med Hemother 2024; 51:76-83. [PMID: 38584696 PMCID: PMC10996057 DOI: 10.1159/000536242] [Citation(s) in RCA: 4] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/18/2023] [Accepted: 01/10/2024] [Indexed: 04/09/2024] Open
Abstract
Introduction Bacterial contamination of blood products presumably occurs mainly during blood collection, starting from low initial concentrations of 10-100 colony-forming units (CFUs) per bag. As little is known about bacterial growth behavior and distribution in stored whole blood (WB) and WB-derived blood products, this study aims to provide data on this subject. Methods WB units were inoculated with transfusion-relevant bacterial species (Acinetobacter baumannii, Bacillus cereus, Escherichia coli, Klebsiella pneumoniae, Listeria monocytogenes, Pseudomonas fluorescens, Serratia marcescens, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus dysgalactiae, Streptococcus pyogenes, Yersinia enterocolitica; n = 12 for each species), stored for 22-24 h at room temperature, and then centrifuged for separation into plasma, red blood cells (RBCs), and buffy coats (BCs). The latter were pooled with 3 random donor BCs and one unit of PAS-E each to yield plasma-reduced platelet concentrates (PCs). Samples for bacterial colony counting were collected after WB storage and immediately after blood component production. Sterility testing in PCs (n = 12 for each species) was performed by bacterial culture after 7 days of storage. Results Bacterial growth in WB varied remarkably between donations and species. Streptococcus species produced the highest titers in WB, whereas Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, and Pseudomonas fluorescens did not multiply. Centrifugation resulted in preferential accumulation of bacteria in BCs, with titers of up to 3.5 × 103 CFU/mL in BCs and up to ≤0.9 × 103 CFU/mL in BC-derived PCs. Overall, 72/144 PCs (50%) tested positive for bacteria after storage. Sterility test results were species-dependent, ranging from 12 of 12 PCs tested positive for Streptococcus pyogenes to 1 of 12 PCs positive for Escherichia coli. Bacterial contamination of RBC and plasma units was much less common and was associated with higher initial bacterial counts in the parent WB units. Conclusions Bacterial growth in WB is species-dependent and varies greatly between donations. Preferential accumulation of bacteria in BCs during manufacturing is a critical determinant of the contamination risk of BC-derived pooled PCs.
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Affiliation(s)
- Ute Gravemann
- German Red Cross Blood Service NSTOB, Institute Springe, Springe, Germany
| | - Wiebke Handke
- Bavarian Red Cross Blood Service, Institute Nuremberg, Nuremberg, Germany
| | - Torsten J. Schulze
- German Red Cross Blood Service NSTOB, Institute Springe, Springe, Germany
| | - Axel Seltsam
- Bavarian Red Cross Blood Service, Institute Nuremberg, Nuremberg, Germany
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Braathen H, Sivertsen J, Lunde THF, Strandenes G, Lindemann PC, Assmus J, Hervig TA, Apelseth TO. Effect of leukoreduction and temperature on risk of bacterial growth in CPDA-1 whole blood: A study of Escherichia coli. Transfusion 2021; 61 Suppl 1:S80-S89. [PMID: 34269444 DOI: 10.1111/trf.16499] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/02/2020] [Revised: 02/01/2021] [Accepted: 02/01/2021] [Indexed: 02/02/2023]
Abstract
BACKGROUND Collection of non-leukoreduced citrate-phosphate-dextrose-adenine (CPDA-1) whole blood is performed in walking blood banks. Blood collected under field conditions may have increased risk of bacterial contamination. This study was conducted to examine the effects of WBC reduction and storage temperature on growth of Escherichia coli (ATCC® 25922™) in CPDA-1 whole blood. METHODS CPDA-1 whole blood of 450 ml from 10 group O donors was inoculated with E. coli. Two hours after inoculation, the test bags were leukoreduced with a platelet-sparing filter. The control bags remained unfiltered. Each whole blood bag was then split into three smaller bags for further storage at 2-6°C, 20-24°C, or 33-37°C. Bacterial growth was quantified immediately, 2 and 3 h after inoculation, on days 1, 3, 7, and 14 for all storage temperatures, and on days 21 and 35 for storage at 2-6°C. RESULTS Whole blood was inoculated with a median of 19.5 (range 12.0-32.0) colony-forming units per ml (CFU/ml) E. coli. After leukoreduction, a median of 3.3 CFU/ml (range 0.0-33.3) E. coli remained. In the control arm, the WBCs phagocytized E. coli within 24 h at 20-24°C and 33-37°C in 9 of 10 bags. During storage at 2-6°C, a slow self-sterilization occurred over time with and without leukoreduction. CONCLUSIONS Storage at 20-24°C and 33-37°C for up to 24 h before leukoreduction reduces the risk of E. coli-contamination in CPDA-1 whole blood. Subsequent storage at 2-6°C will further reduce the growth of E. coli.
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Affiliation(s)
- Hanne Braathen
- Department of Immunology and Transfusion Medicine, Haukeland University Hospital, Bergen, Norway.,Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway
| | - Joar Sivertsen
- Department of Immunology and Transfusion Medicine, Haukeland University Hospital, Bergen, Norway.,Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway
| | - Turid Helen Felli Lunde
- Department of Immunology and Transfusion Medicine, Haukeland University Hospital, Bergen, Norway
| | - Geir Strandenes
- Department of Immunology and Transfusion Medicine, Haukeland University Hospital, Bergen, Norway.,Department of War Surgery and Emergency Medicine, Norwegian Armed Forces Medical Services, Oslo, Norway
| | | | - Jörg Assmus
- Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway
| | - Tor Audun Hervig
- Department of Immunology and Transfusion Medicine, Haukeland University Hospital, Bergen, Norway.,Department of Clinical Sciences, University of Bergen, Bergen, Norway.,Department of Immunology and Transfusion Medicine, Haugesund Hospital, Haugesund, Norway
| | - Torunn Oveland Apelseth
- Department of Immunology and Transfusion Medicine, Haukeland University Hospital, Bergen, Norway.,Department of War Surgery and Emergency Medicine, Norwegian Armed Forces Medical Services, Oslo, Norway
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Ojha S, Tirlotkar A, Gupta AM, S H S, Chavan P, Poojary M. Comparative analysis of platelet concentrates prepared after two hours and overnight storage of buffy coat at room temperature. Transfus Apher Sci 2020; 60:103014. [PMID: 33262053 DOI: 10.1016/j.transci.2020.103014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/21/2020] [Revised: 10/14/2020] [Accepted: 11/11/2020] [Indexed: 11/30/2022]
Abstract
INTRODUCTION The overnight storage of the buffy coat (BC) at room temperature has logistic and operational advantages for the blood centre. The present study aimed to evaluate the impact of an overnight hold (stored) of BC at room temperature in comparison with the 2-hour hold (fresh) of buffy coats on the platelet concentrate (PC) characteristics. METHODS A total of 60 BCs were included in the study, 30 PCs (fresh) were prepared after two hours holding time of the BCs and the other 30 PCs (stored) were prepared after the overnight BC storage at room temperature. The primary endpoint of PCs evaluation was the platelet yield, volume, pH, WBC count, RBC count, and platelet swirling in the PC and the secondary endpoints were glucose concentration, lactate, LDH, and sterility of the PCs. All the tests were performed on the day+1 of the blood collection. RESULTS There was no difference concerning the volume, RBC count, and swirling between the two groups (P>0.05). The PCs from the fresh BC had higher pH and glucose concentration (P<0.05). On the other hand, the overnight hold of BC produced higher platelet counts, WBC counts, lactate, and LDH levels (P<0.05). All the 60 PCs did not record any bacterial growth on the culture media for the sterility results. CONCLUSION The overnight hold of BC produces a higher platelet yield with higher storage lesions. This may also allow better supervision, ensuring better quality control.
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Affiliation(s)
- Shashank Ojha
- Department of Transfusion Medicine, Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre, Homi Bhabha National Institute, Navi, Mumbai 410210, India.
| | - Amol Tirlotkar
- Department of Transfusion Medicine, Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre, Homi Bhabha National Institute, Navi, Mumbai 410210, India.
| | - Abhaykumar Malind Gupta
- Department of Transfusion Medicine, Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre, Homi Bhabha National Institute, Navi, Mumbai 410210, India.
| | - Sumathi S H
- Department of Transfusion Medicine, Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre, Homi Bhabha National Institute, Navi, Mumbai 410210, India.
| | - Priti Chavan
- Composite Laboratory, Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre, Homi Bhabha National Institute, Navi, Mumbai, 410210, India.
| | - Minal Poojary
- Composite Laboratory, Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre, Homi Bhabha National Institute, Navi, Mumbai, 410210, India.
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Quality Assessment of Platelet-Rich Fibrin-Like Matrix Prepared from Whole Blood Samples after Extended Storage. Biomedicines 2017; 5:biomedicines5030057. [PMID: 28926988 PMCID: PMC5618315 DOI: 10.3390/biomedicines5030057] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/20/2017] [Revised: 09/11/2017] [Accepted: 09/14/2017] [Indexed: 12/15/2022] Open
Abstract
The platelet-rich fibrin–like matrix (PRFM) is usually prepared onsite and immediately used for regenerative therapy. Nonetheless, to meet the clinical necessity of preserving the PRFM without quality deterioration, we developed a method for preparation of PRFMs from short-term-stored whole blood (WB) samples. In this study, to evaluate the practical expiration date of storage, we extended the storage time of WB samples from 2 to 7 days and assessed the quality of the resulting PRFMs. WB samples collected with acid-citrate-dextrose were stored with gentle agitation at ambient temperature. To prepare PRFMs, the stored WB samples were mixed with CaCl2 in glass tubes and centrifuged. Fibrin fiber networks, CD41 and CD62P expression, and Platelet Derived Growth Factor-BB (PDGF-BB) levels were examined by scanning electron microscopy (SEM), flow cytometry, and an Enzyme-Linked ImmunoSorbent Assay (ELISA), respectively. Long-term storage had no significant effect on either blood cell counts or platelet functions tested. The resulting PRFMs were visually identical to freshly prepared ones. PDGF-BB levels did not markedly decrease in a time-dependent manner. However, fibrin fibers gradually became thinner after storage. Although the coagulation activity may diminish, we propose that PRFMs can be prepared—without evident loss of quality—from WB samples stored for up to 7 days by our previously developed method.
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Taha M, Culibrk B, Kalab M, Schubert P, Yi QL, Goodrich R, Ramirez-Arcos S. Efficiency of riboflavin and ultraviolet light treatment against high levels of biofilm-derived Staphylococcus epidermidis in buffy coat platelet concentrates. Vox Sang 2017; 112:408-416. [PMID: 28378343 DOI: 10.1111/vox.12519] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/22/2016] [Revised: 03/03/2017] [Accepted: 03/05/2017] [Indexed: 12/22/2022]
Abstract
BACKGROUND AND OBJECTIVES Staphylococcus epidermidis forms surface-attached aggregates (biofilms) in platelet concentrates (PCs), which are linked to missed detection during PC screening. This study was aimed at evaluating the efficacy of riboflavin-UV treatment to inactivate S. epidermidis biofilms in buffy coat (BC) PCs. MATERIALS AND METHODS Biofilm and non-biofilm cells from S. epidermidis ST-10002 and S. epidermidis AZ-66 were individually inoculated into whole blood (WB) units (~106 colony-forming units (CFU)/ml) (N = 4-5). One spiked and three unspiked WB units were processed to produce a BC-PC pool. Riboflavin was added to the pool which was then split into two bags: one for UV treatment and the second was untreated. Bacterial counts were determined before and after treatment. In vitro PC quality was assessed by flow cytometry and dynamic light scattering. RESULTS Bacterial counts were reduced during BC-PC production from ~106 CFU/ml in WB to 103 -104 CFU/ml in PCs (P < 0·0001). Riboflavin-UV treatment resulted in significantly higher reduction of S. epidermidis AZ-66 than strain ST-10002 (≥3·5 log reduction and 2·6-2·8 log reduction, respectively, P < 0·0001). Remaining bacteria post-treatment were able to proliferate in PCs. No differences in S. epidermidis inactivation were observed in PCs produced from WB inoculated with biofilm or non-biofilm cells (P > 0·05). Platelet activation was enhanced in PCs produced with WB inoculated with biofilms compared to non-biofilm cells (P < 0·05). CONCLUSION Riboflavin-UV treatment was similarly efficacious in PCs produced from WB inoculated with S. epidermidis biofilm or non-biofilm cells. Levels of biofilm-derived S. epidermidis ≥103 CFU/ml were not completely inactivated; however, further testing is necessary with lower (real-life) bacterial levels.
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Affiliation(s)
- M Taha
- Canadian Blood Services, Ottawa, ON, Canada
| | - B Culibrk
- Canadian Blood Services, Ottawa, ON, Canada
| | - M Kalab
- Agriculture and Agri-Food Canada, Ottawa, ON, Canada
| | - P Schubert
- Canadian Blood Services, Ottawa, ON, Canada
| | - Q-L Yi
- Canadian Blood Services, Ottawa, ON, Canada
| | - R Goodrich
- Infectious Disease Research Center, Colorado State University, Fort Collins, CO, USA
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Perez-Ferrer A, Gredilla-Díaz E, de Vicente-Sánchez J, Navarro-Suay R, Gilsanz-Rodríguez F. Vancomycin added to the wash solution of the cell-saver. Effect on bacterial contamination. REVISTA ESPANOLA DE ANESTESIOLOGIA Y REANIMACION 2017; 64:185-191. [PMID: 28094033 DOI: 10.1016/j.redar.2016.10.002] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/23/2016] [Revised: 10/10/2016] [Accepted: 10/13/2016] [Indexed: 06/06/2023]
Abstract
OBJECTIVES The aim of this study is to test whether the addition of a low-dose of antibiotic (vancomycin) to the wash solution (saline) of the cell-saver reduces the incidence of bacterial contamination of the autologous red blood cell (RBCs) concentrate recovered. MATERIAL AND METHOD Experimental, randomized, double-blind, parallel group study performed on 20 consecutive patients scheduled for posterior spinal fusion surgery. Intraoperative bleeding was processed through a cell-saver: HaemoLite® 2+, in which the RBCs were washed according to randomization group, with saline (control group) or saline+10μg/ml-1 vancomycin (vanco group). Data regarding age, weight, processed and recovered volume, blood count, blood culture, and vancomycin concentration in RBCs concentrates obtained and incidence of fever after reinfusion were collected. RESULTS Processed volume was 843±403ml and recovered volume 121±29ml, with haemoglobin concentration 10.4±5.0g/dl-1 and haematocrit 29.1±15.9% (mean±SD). Recovered RBC concentrate cultures were positive for coagulase-negative Staphylococcus in 5 cases (50%) of the control group while all cultures were negative in the vanco group (P=.016). The difference between the theoretical concentration of vancomycin administered and the concentration determined in the recovered RBC concentrate was 1.31μg/ml-1 (95% CI 1.19 to 1.43; P=.074). CONCLUSIONS The addition of vancomycin at a concentration of 10ug/ml-1 to the wash solution of the cell-saver achieved similar concentrations in the autologous blood concentrate recovered allowing for bacterial removal, with negative blood cultures in all cases.
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Affiliation(s)
- A Perez-Ferrer
- Servicio de Anestesiología y Reanimación, Hospital Universitario La Paz, Madrid, España.
| | - E Gredilla-Díaz
- Servicio de Anestesiología y Reanimación, Hospital Universitario La Paz, Madrid, España
| | - J de Vicente-Sánchez
- Servicio de Anestesiología y Reanimación, Hospital Universitario La Paz, Madrid, España
| | - R Navarro-Suay
- Servicio de Anestesiología y Reanimación, Hospital Central de la Defensa Gómez Ulla, Madrid, España
| | - F Gilsanz-Rodríguez
- Servicio de Anestesiología y Reanimación, Hospital Universitario La Paz, Madrid, España
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Mizutani M, Samejima H, Terunuma H, Kino-oka M. Experience of contamination during autologous cell manufacturing in cell processing facility under the Japanese Medical Practitioners Act and the Medical Care Act. Regen Ther 2016; 5:25-30. [PMID: 31245497 PMCID: PMC6581811 DOI: 10.1016/j.reth.2016.06.004] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/31/2016] [Revised: 06/16/2016] [Accepted: 06/23/2016] [Indexed: 11/24/2022] Open
Abstract
Cell therapy and regenerative medicine technologies require strict cell manufacturing procedures to be defined and addressed. Maintenance of the aseptic environment is critical to preclude extrinsic contamination risks, similar to conventional pharmaceutical manufacturing. However, intrinsic contamination risks exist in all cell manufacturing processes owing to the use of cells as the raw materials that cannot be sterilized, thus giving rise to the primary and secondary risks of cell contamination and cross-contamination, respectively. Analysis of contamination risks was conducted on experienced batches (29,858 batches) for the production of immune cells derived from autologous blood mononuclear cells under the Medical Practitioners Act and the Medical Care Act in Japan. From these batches, 0.06% (18 cases) of contamination occurred, representing low probability of contamination incidence during cell processing. Almost all the causes of these contaminations were regarded to be from the collected blood (intrinsic contamination), and subsequent cross-contaminations were prevented, considering that the secondary contamination risk can be reduced by adequate managements of operational procedures for changeover in aseptic environment.
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Affiliation(s)
- Manabu Mizutani
- Division of Science and Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka, 565-0871, Japan
- Biotherapy Institute of Japan, 2-4-8 Edagawa, Koto-ku, Tokyo, 135-0051, Japan
| | - Hazuki Samejima
- Biotherapy Institute of Japan, 2-4-8 Edagawa, Koto-ku, Tokyo, 135-0051, Japan
| | - Hiroshi Terunuma
- Biotherapy Institute of Japan, 2-4-8 Edagawa, Koto-ku, Tokyo, 135-0051, Japan
| | - Masahiro Kino-oka
- Division of Science and Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka, 565-0871, Japan
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Seheult JN, Triulzi D, Yazer MH. I am the 9%: Making the case for whole-blood platelets. Transfus Med 2016; 26:177-85. [DOI: 10.1111/tme.12312] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/02/2016] [Revised: 04/15/2016] [Accepted: 04/18/2016] [Indexed: 11/30/2022]
Affiliation(s)
- J. N. Seheult
- Department of Pathology; University of Pittsburgh School of Medicine; Pittsburgh PA USA
| | - D.J. Triulzi
- Department of Pathology; University of Pittsburgh School of Medicine; Pittsburgh PA USA
- The Institute for Transfusion Medicine; Pittsburgh PA USA
| | - M. H. Yazer
- Department of Pathology; University of Pittsburgh School of Medicine; Pittsburgh PA USA
- The Institute for Transfusion Medicine; Pittsburgh PA USA
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Loonen AJM, Wolffs PFG, de Bresser M, Habraken M, Bruggeman CA, Hermans MHA, van den Brule AJC. Tuf mRNA rather than 16S rRNA is associated with culturable Staphylococcus aureus. World J Clin Infect Dis 2015; 5:86-93. [DOI: 10.5495/wjcid.v5.i4.86] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/09/2015] [Revised: 04/20/2015] [Accepted: 06/11/2015] [Indexed: 02/06/2023] Open
Abstract
AIM: To study the presence of various nucleic acids targets of Staphylococcus aureus (S. aureus) during bacterial growth and antibiotic induced killing in relation to viability.
METHODS: S. aureus was cultured to log phase and spiked in Todd Hewitt (TH) broth and whole blood of healthy human volunteers. Viability of S. aureus after flucloxacillin treatment (0, 1, 3 and 6 d) was assessed by culture on bloodagar plates. DNA and RNA were isolated from 200 μL. cDNA synthesis was performed by using random primers. The presence of S. aureus DNA, rRNA, and mRNA were determined by real-time polymerase chain reaction of the 16S rDNA and tuf gene (elongation factor Tu).
RESULTS: S. aureus spiked in TH broth without antibiotics grew from day 0-6 and DNA (tuf and 16S), and 16S rRNA remained detectable during this whole period. During flucloxacillin treatment S. aureus lost viability from day 3 onwards, while the 16S rRNA-gene and its RNA transcripts remained detectable. DNA and rRNA can be detected in flucloxacillin treated S. aureus cultures that do not further contain culturable bacteria. However, tuf mRNA became undetectable from day 3 onwards. Tuf mRNA can only be detected from samples with culturable bacteria. When spiking S. aureus in whole blood instead of broth no bacterial growth was seen, neither in the absence nor in the presence of flucloxacillin. Accordingly, no increase in DNA and RNA levels of both 16S rDNA and the tuf gene were detected.
CONCLUSION: Tuf mRNA expression is associated with culturable S. aureus and might be used to monitor antibiotic effects.
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13
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van der Meer PF, de Korte D. The Effect of Holding Times of Whole Blood and Its Components During Processing on In Vitro and In Vivo Quality. Transfus Med Rev 2015; 29:24-34. [DOI: 10.1016/j.tmrv.2014.10.001] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2014] [Revised: 10/14/2014] [Accepted: 10/17/2014] [Indexed: 11/25/2022]
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Lafeuillade B, Eb F, Ounnoughene N, Petermann R, Daurat G, Huyghe G, Vo Mai MP, Caldani C, Rebibo D, Weinbreck P. Residual risk and retrospective analysis of transfusion-transmitted bacterial infection reported by the French National Hemovigilance Network from 2000 to 2008. Transfusion 2014; 55:636-46. [DOI: 10.1111/trf.12883] [Citation(s) in RCA: 35] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/30/2013] [Revised: 08/13/2014] [Accepted: 08/18/2014] [Indexed: 01/26/2023]
Affiliation(s)
- Bruno Lafeuillade
- Direction of Advanced Therapies, Human Products and Vaccines; French National Agency of Medicine and Health Products Safety-ANSM (ex Afssaps); Saint-Denis France
| | - François Eb
- Direction of Advanced Therapies, Human Products and Vaccines; French National Agency of Medicine and Health Products Safety-ANSM (ex Afssaps); Saint-Denis France
| | - Nadra Ounnoughene
- Direction of Advanced Therapies, Human Products and Vaccines; French National Agency of Medicine and Health Products Safety-ANSM (ex Afssaps); Saint-Denis France
| | - Rachel Petermann
- Direction of Advanced Therapies, Human Products and Vaccines; French National Agency of Medicine and Health Products Safety-ANSM (ex Afssaps); Saint-Denis France
| | - Gérald Daurat
- Direction of Advanced Therapies, Human Products and Vaccines; French National Agency of Medicine and Health Products Safety-ANSM (ex Afssaps); Saint-Denis France
| | - Gérard Huyghe
- Direction of Advanced Therapies, Human Products and Vaccines; French National Agency of Medicine and Health Products Safety-ANSM (ex Afssaps); Saint-Denis France
| | - Mai-Phuong Vo Mai
- Direction of Advanced Therapies, Human Products and Vaccines; French National Agency of Medicine and Health Products Safety-ANSM (ex Afssaps); Saint-Denis France
| | - Cyril Caldani
- Direction of Advanced Therapies, Human Products and Vaccines; French National Agency of Medicine and Health Products Safety-ANSM (ex Afssaps); Saint-Denis France
| | - Danielle Rebibo
- Direction of Advanced Therapies, Human Products and Vaccines; French National Agency of Medicine and Health Products Safety-ANSM (ex Afssaps); Saint-Denis France
| | - Pierre Weinbreck
- Direction of Advanced Therapies, Human Products and Vaccines; French National Agency of Medicine and Health Products Safety-ANSM (ex Afssaps); Saint-Denis France
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15
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Evaluation of Random Donor Platelets Produced from Buffy Coat Stored for 24 h at Ambient Temperature: Should This be Implemented in India? Indian J Hematol Blood Transfus 2014; 31:264-8. [PMID: 25825570 DOI: 10.1007/s12288-014-0437-6] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2013] [Accepted: 07/10/2014] [Indexed: 10/25/2022] Open
Abstract
Whole blood derived platelets are made from platelet rich plasma (PRP) method or buffy coat (BC) method. In India majority of random donor platelets (RDPs) are prepared by PRP method. However, BC method offers the advantage of less platelet activation and fewer WBC contamination. Presently in India RDPs are prepared within 8 h of whole blood collection, whereas, in Europe this time limit is up to 24 h. Our aim was to evaluate the platelet count, WBC contamination, platelet CD62P expression, and biochemical parameters of RDPs prepared from BC within 8 h and within 24 h of collection. We prepared 40 units of RDP by the BC method from whole blood stored at room temperature within 8 h of collection (fresh BC), and another 40 units from BC stored at 22 °C for <24 h (stored BC). We analyzed the platelet counts, CD62P expression, WBC counts, glucose levels, pH, PO2, PCO2 in both the groups of RDPs, 24 h after respective preparation. The platelet counts from stored BC was higher in fresh BC. CD62P expression was low in stored BC compared to fresh BC. There were no differences of pH, pO2, pCO2 and glucose levels in fresh BC and stored BC. WBC contamination was more in fresh BC. Our study stored BC contained higher platelet counts, less WBC contamination and less platelet activation. We conclude that RDP prepared from stored BC is the better method for RDP production.
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Hahn S, Sireis W, Hourfar K, Karpova D, Dauber K, Kempf VAJ, Seifried E, Schmidt M, Bönig H. Effects of storage temperature on hematopoietic stability and microbial safety of BM aspirates. Bone Marrow Transplant 2013; 49:338-48. [PMID: 24185589 DOI: 10.1038/bmt.2013.176] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/22/2013] [Revised: 09/06/2013] [Accepted: 09/24/2013] [Indexed: 12/31/2022]
Abstract
Bone marrow (BM) remains a common source for hematopoietic SCT. Due to the transcutaneous approach, contamination with skin bacteria is common. The delay between harvest and transfusion can be considerable, potentially allowing for bacterial proliferation. The optimal transportation temperature, specifically with respect to bacterial growth and consequences thereof for hematopoietic quality, remain undefined. For 72 h, 66 individual BM samples, non-spiked/spiked with different bacteria, stored at 20-24 °C room temperature (RT) or 3-5 °C (cold), were serially analyzed for hematopoietic quality and microbial burden. Under most conditions, hematopoietic quality of BM was equal or better at RT: Typical BM contaminants (P. acnes and S. epidermidis) and E. coli were killed or bacterial proliferation was arrested at RT; hematopoietic quality was not impacted by the contamination. However, several pathogenic bacteria not typically found in BM (S. aureus and K. pneumoniae) proliferated dramatically at RT and impaired hematopoietic quality. Bacterial proliferation was arrested in the cold. The overwhelming majority of BM samples, that is, those that are sterile or contaminated only with skin commensals, will benefit from transportation at RT. Those bacteria that proliferate and perturb hematopoietic quality are not typically found in BM. Our data support recommendations for RT transportation and storage of BM.
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Affiliation(s)
- S Hahn
- German Red Cross Blood Service Baden-Wuerttemberg-Hessen and Institute for Transfusion Medicine and Immunohematology, Goethe University Medical Center, Frankfurt, Germany
| | - W Sireis
- German Red Cross Blood Service Baden-Wuerttemberg-Hessen and Institute for Transfusion Medicine and Immunohematology, Goethe University Medical Center, Frankfurt, Germany
| | - K Hourfar
- German Red Cross Blood Service Baden-Wuerttemberg-Hessen and Institute for Transfusion Medicine and Immunohematology, Goethe University Medical Center, Frankfurt, Germany
| | - D Karpova
- German Red Cross Blood Service Baden-Wuerttemberg-Hessen and Institute for Transfusion Medicine and Immunohematology, Goethe University Medical Center, Frankfurt, Germany
| | - K Dauber
- German Red Cross Blood Service Baden-Wuerttemberg-Hessen and Institute for Transfusion Medicine and Immunohematology, Goethe University Medical Center, Frankfurt, Germany
| | - V A J Kempf
- Institute for Medical Microbiology and Infection Control, Goethe University Medical Center, Frankfurt, Germany
| | - E Seifried
- German Red Cross Blood Service Baden-Wuerttemberg-Hessen and Institute for Transfusion Medicine and Immunohematology, Goethe University Medical Center, Frankfurt, Germany
| | - M Schmidt
- German Red Cross Blood Service Baden-Wuerttemberg-Hessen and Institute for Transfusion Medicine and Immunohematology, Goethe University Medical Center, Frankfurt, Germany
| | - H Bönig
- 1] German Red Cross Blood Service Baden-Wuerttemberg-Hessen and Institute for Transfusion Medicine and Immunohematology, Goethe University Medical Center, Frankfurt, Germany [2] Department of Medicine/Hematology, University of Washington, Seattle, WA, USA
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17
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Morel P, Deschaseaux M, Bertrand X, Naegelen C, Leconte des Floris MF, Bardiaux L. [Control of the bacterial risk of transfusion in France in 2013]. Transfus Clin Biol 2013; 20:174-81. [PMID: 23622838 DOI: 10.1016/j.tracli.2013.03.007] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/20/2013] [Accepted: 03/27/2013] [Indexed: 10/26/2022]
Abstract
Bacterial contamination of blood products (BP) remains the most important infectious risks of blood transfusion in 2013. Platelet concentrates (PC) are the blood products the most at risk, whether CPA or MCPS. In France, the residual risk has been steadily declining since 1994. For the platelets, the frequency of transfusion reaction due to bacterial contamination (TRBC) is now about at one per 50,000 CP distributed. The number of deaths has remained stable since 1994 with one death per year (300,000 distributed CP). The progressive decrease in the number of cases of TRBCs is the result of steady improvement of practices and prevention methods at all stages from collection to the transfusion of BP. But if all these improvements have significantly reduced the incidence of TRBCs, mortality is not changed with the CP and the reduction of this risk is a priority for the French Blood Establishment (EFS). Detection methods of CP contaminated or pathogen inactivation are two approaches available and can provide a significant reduction (for the former) or deletion (for seconds) of the risk of transfused contaminated CP. Currently, the choice is in favor of the detection of bacteria. New detection "rapid tests" methods were added to the panel of candidates and are being evaluated. Inactivation of pathogens remains the safest prospect of eliminating this adverse effect of transfusion. Implementation of one method for bacterial detection is probably a transitional measure.
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Affiliation(s)
- P Morel
- Établissement français du sang (EFS) Bourgogne-Franche-Comté, BP 1937, 1, boulevard Alexander-Fleming, 25000 Besançon cedex, France.
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18
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Harm SK, Delaney M, Charapata M, Aubuchon JP, Triulzi DJ, Yazer MH. Routine use of a rapid test to detect bacteria at the time of issue for nonleukoreduced, whole blood-derived platelets. Transfusion 2013; 53:843-50. [PMID: 22845719 DOI: 10.1111/j.1537-2995.2012.03818.x] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Abstract
BACKGROUND The Pan Genera detection (PGD) test is used to screen platelet (PLT) products for bacterial contamination. We report the experience of using the PGD test on whole blood-derived PLTs (WBPs) at two large centralized transfusion services (CTS). STUDY DESIGN AND METHODS Records of PGD test results were retrospectively reviewed. The PGD test was performed on individual WBP units or pools of WBPs ranging in size from 2 to 6 units at the time of issue. Bacterial culture was performed on PLT products with positive PGD tests, and at one CTS, the available cocomponents. RESULTS A total of 70,561 WBP pools were screened with the PGD test. There were seven true-positive PGD tests and 242 false-positive tests (positive predictive value of PGD test, 2.81%). The overall contamination rate was 99 per 10(6) WBP pools (1:10,080; 95% confidence interval [CI], 40-204), and the false-positive rate was 3430 per 10(6) WBP pools (1:292; 95% CI, 3011-3890). All seven bacterial isolates were Gram positive. The median age of the individual WBP units in the seven contaminated pools was 5 days (range, 3-5 days) compared to 4 days (range, 1-5 days) in the false-positive pools (p=0.0012). The same bacteria isolated from a positive PLT pool also grew in one red blood cell cocomponent. CONCLUSION After testing more than 70,000 WBP pools at two large CTSs, the rate of contaminated WBP pools detected by the PGD test was 99 per 10(6) pools (1:10,080).
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Affiliation(s)
- Sarah K Harm
- Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA
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19
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Vuk T, Barišić M, Hećimović A, Rukavina L, Batarilo I, Šarlija D, Jukić I. Bacterial contamination of blood products at the Croatian Institute of Transfusion Medicine: results of eleven-year monitoring. Transfus Med 2012; 22:432-9. [PMID: 23020303 DOI: 10.1111/j.1365-3148.2012.01190.x] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/19/2012] [Revised: 05/14/2012] [Accepted: 09/05/2012] [Indexed: 11/28/2022]
Abstract
OBJECTIVES The aim of this study is to present the results and experiences of the Croatian Institute of Transfusion Medicine (CITM) in blood product testing for the presence of bacterial contamination. This is the first study analysing the results of bacterial testing of blood products in Croatia. METHODS Results of monitoring blood products for the presence of bacterial contamination during an 11-year period (2000-2010) were retrospectively analysed. As universal screening of platelet concentrates for bacterial contamination is not mandatory in Croatia, the results presented refer to the products tested within the frame of statistical process control. RESULTS A total of 23,130 blood products were tested during the study period. There were 122 (0·53%) initially positive and 41 (0·18%) confirmed positive blood products, whereas suspicion of bacterial contamination could be neither confirmed nor ruled out in 8 (0·03%) blood products. While the frequency of bacterial contamination of plasma products was very low (0·03%), there was no statistically significant difference between bacterial contamination of platelet concentrates (0·26%) and RBC concentrates (0·20%). There were 73 (0·32%) false-positive blood products, with nearly equal proportion of causes related to laboratory contamination (n = 34; 0·15%) and those related to the testing system (n = 39; 0·17%). CONCLUSION The results obtained in the study did not differ significantly from literature data. A number of measures to reduce the risk of bacterial contamination of blood products have been implemented at CITM. The introduction of universal screening of platelet concentrates for the presence of bacterial contamination should be taken into consideration.
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Affiliation(s)
- T Vuk
- Croatian Institute of Transfusion Medicine, Zagreb, Croatia.
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20
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Slichter SJ, Corson J, Jones MK, Christoffel T, Pellham E, Bolgiano D. Platelet concentrates prepared after a 20- to 24-hour hold of the whole blood at 22°C. Transfusion 2012; 52:2043-8. [PMID: 22320682 DOI: 10.1111/j.1537-2995.2011.03546.x] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Abstract
BACKGROUND The Food and Drug Administration (FDA) requires that red blood cells must be refrigerated within 8 hours of whole blood collection. Longer storage of whole blood at 22°C before component preparation would have many advantages. STUDY DESIGN AND METHODS Two methods of holding whole blood for 20 to 24 hours at room temperature were evaluated, refrigerated plates or a 23°C incubator. After extended whole blood storage, platelet (PLT) concentrates were prepared from PLT-rich plasma on Day 1 postdonation, and the PLTs were stored for 6 more days. On Day 7 of PLT storage, blood was drawn from each subject to prepare fresh PLTs. The stored and fresh PLTs were radiolabeled and transfused into their donor. RESULTS Eleven subjects' whole blood was stored using refrigerated butanediol plates (Compocool, Fresenius), and 10 using an incubator. Poststorage PLT recoveries averaged 47 ± 13% versus 53 ± 11% and survivals averaged 4.6 ± 1.7 days versus 4.7 ± 0.9 days for Compocool versus incubator storage, respectively (p = NS). With all results, poststorage PLT recoveries averaged 75 ± 10% of fresh and survivals 57 ± 13% of fresh; PLT recoveries met FDA guidelines for poststorage PLT viability but not survivals. CONCLUSION Seven-day poststorage PLT viability is comparable when whole blood is stored for 22 ± 2 hours at 22°C using either refrigerated plates or an incubator to maintain temperature before preparing PLT concentrates.
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Affiliation(s)
- Sherrill J Slichter
- Puget Sound Blood Center and University of Washington School of Medicine, Seattle, Washington 98104-1256, USA.
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21
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Chou ML, Wu YW, Su CY, Lee LW, Burnouf T. Impact of solvent/detergent treatment of plasma on transfusion-relevant bacteria. Vox Sang 2011; 102:277-84. [PMID: 22092109 DOI: 10.1111/j.1423-0410.2011.01560.x] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022]
Abstract
BACKGROUND A solvent/detergent (S/D) treatment in a medical device has been developed for pathogen reduction of plasma for transfusion. Impact of S/D on bacterial growth and on the capacity of complement to kill bacteria has been investigated in this study. STUDY DESIGN AND METHODS A pool of apheresis plasma from four donors was spiked with eight transfusion-relevant bacteria. Plasma was treated with 1% tri(n-butyl) phosphate and 1% Triton X-45 at 31°C for 90 min and then extracted by oil at 31°C for 70 min. Decomplemented plasma and Phosphate Buffer Saline were used as controls. Bacterial count was determined in samples taken immediately after spiking, or after S/D and oil treatment. Similar experiments were conducted using three individual recovered plasma donations. Bacteria growth inhibition tests were performed using discs soaked with plasma samples whether containing the S/D agents or not. RESULTS The mean reduction factors of Escherichia coli, Pseudomonas aeruginosa, and Klebsiella pneumoniae due to complement during S/D treatment were >8·75, 4·71, and 4·18 log in pooled plasma and >7·42, 2·24 and >6·08 log in individual plasmas, respectively. Bacillus cereus and Bacillus subtilis were inactivated by S/D (>7·04 and 1·60 log in pooled, and >6·06 and 2·39 in individual plasmas, respectively). Staphylococcus aureus, Staphylococcus epidermidis and Enterobacter cloacae did not multiply during S/D treatment of plasma. Growth inhibition tests revealed an inhibition of three gram-negative bacteria by complement and all gram-positive by S/D. CONCLUSION The S/D treatment of plasma does not alter the bactericidal activity of complement, and inactivates some gram-positive bacteria.
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Affiliation(s)
- M-L Chou
- Department of Microbiology and Immunology, Taipei Medical University, Taipei, Taiwan
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22
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Walther-Wenke G, Däubener W, Heiden M, Hoch J, Hornei B, Volkers P, von König CHW. Effect of Safety Measures on Bacterial Contamination Rates of Blood Components in Germany. ACTA ACUST UNITED AC 2011; 38:231-235. [PMID: 22016691 DOI: 10.1159/000330417] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/31/2011] [Accepted: 06/29/2011] [Indexed: 11/19/2022]
Abstract
SUMMARY: Requirements for bacterial testing of blood components on a defined quantity as part of routine quality control were introduced in Germany by the National Advisory Committee Blood of the German Federal Ministry of Health in 1997. The philosophy was to establish standardized methods for bacterial testing. Numerous measures to reduce the risk of bacterial contamination were implemented into the blood donation and manufacturing processes between 1999 and 2002. German Blood establishments performed culture-based bacterial testing on random samples of platelet concentrates (PCs), red blood cells (RBCs) and fresh frozen plasma (FFP) and reported data out of the production periods 1998, 2001 and 2005/2006. While the bacterial contamination rate of apheresis PCs remained nearly unchanged, it decreased by 70% for pooled PCs to a rate of 0.158% in the last observation period. Leukocyte-depleted RBCs with diversion of the initial blood volume showed a contamination rate of 0.029% which is significantly lower than that of RBCs without leukocyte depletion and diversion (0.157%). The contamination rate of plasma decreased by 80%. Preventive measures resulted in a significant reduction of bacterial contamination of blood components. Long-term monitoring with standardized methods for bacteria testing supports evaluation of the cumulative effect of contamination reducing measures.
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Abstract
Blood services routinely separate whole blood into components that are then stored under different conditions. The storage conditions used for whole blood prior to separation must therefore be a compromise between the needs of the red cells (which benefit from refrigeration) and plasma and platelets (which are better preserved at ambient temperature). For many years, the approach has been to manufacture plasma and platelet components on the day of blood collection, and to refrigerate any unprocessed blood for manufacture into red cell components on the following day. However, this can make it challenging to maintain adequate stocks of all components. The European practice of 'ambient hold' of whole blood for up to 24 hours prior to processing allows greater flexibility in blood component manufacture, and the data reviewed suggest there is relatively little impact on the quality of red cell or plasma components, and an improvement in the quality of platelet components.
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Affiliation(s)
- Stephen Thomas
- Components Development Laboratory, NHS Blood and Transplant, Brentwood, Essex, UK.
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24
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van der Meer PF, Cancelas JA, Cardigan R, Devine DV, Gulliksson H, Sparrow RL, Vassallo RR, de Wildt-Eggen J, Baumann-Baretti B, Hess JR. Evaluation of overnight hold of whole blood at room temperature before component processing: effect of red blood cell (RBC) additive solutions on in vitro RBC measures. Transfusion 2011; 51 Suppl 1:15S-24S. [PMID: 21223291 DOI: 10.1111/j.1537-2995.2010.02959.x] [Citation(s) in RCA: 33] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Abstract
BACKGROUND Whole blood (WB) can be held at room temperature (18-25°C) up to 8 hours after collection; thereafter the unit must be refrigerated, rendering it unsuitable for platelet (PLT) production. Overnight hold at room temperature before processing has logistic advantages, and we evaluated this process in an international multicenter study for both buffy coat (BC)- and PLT-rich plasma (PRP)-based blood components and compared three red blood cell (RBC) additive solutions (ASs) for their ability to offset effects of overnight hold. STUDY DESIGN AND METHODS Nine centers participated; seven used the BC method, and two used the PRP method. Four WB units were pooled and split; 1 unit was processed less than 8 hours from collection (Group A), and the other three (Groups B, C, and D) were held at room temperature and processed after 24 to 26 hours. RBCs in Groups A and B were resuspended in saline-adenine-glucose-mannitol, Group C in phosphate-adenine-guanosine-glucose-saline-mannitol, and Group D in ErythroSol-4 RBCs were stored at 2 to 6°C for 49 days. RESULTS RBCs from overnight-held WB had lower 2,3-diphosphoglycerate (2,3-DPG) and higher adenosine triphosphate (ATP). At the end of storage there were no differences between groups, apart from a slightly higher hemolysis in Group B. ErythroSol-4 showed a slightly higher initial ATP and 2,3-DPG content, but at the end of storage no differences were found. CONCLUSION Overnight hold of WB before processing has no lasting deleterious effects on in vitro quality of subsequently prepared components. The use of different RBC ASs did not appear to offer significant advantages in terms of RBC quality at the end, regardless of the processing method.
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Affiliation(s)
- Pieter F van der Meer
- Department of Product and Process Development, Sanquin Blood Bank North West Region, Amsterdam, the Netherlands.
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25
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Dijkstra-Tiekstra M, van der Meer P, Cardigan R, Devine D, Prowse C, Sandgren P, de Wildt-Eggen J. Platelet concentrates from fresh or overnight-stored blood, an international study. Transfusion 2011; 51 Suppl 1:38S-44S. [DOI: 10.1111/j.1537-2995.2010.02973.x] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
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26
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Shinar E, Etlin S, Frenkel O, Yahalom V. The implementation of rapid cooling and overnight hold of whole blood at ambient temperature before processing into components in Israel. Transfusion 2011; 51 Suppl 1:58S-64S. [DOI: 10.1111/j.1537-2995.2010.02964.x] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022]
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27
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Walther-Wenke G, Wirsing von König CH, Däubener W, Heiden M, Hoch J, Hornei B, Volkers P. Monitoring bacterial contamination of blood components in Germany: effect of contamination reduction measures. Vox Sang 2010; 100:359-66. [DOI: 10.1111/j.1423-0410.2010.01432.x] [Citation(s) in RCA: 26] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/28/2022]
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28
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Gewinnung, Herstellung und Lagerung von Blut und Blutkomponenten. TRANSFUSIONSMEDIZIN UND IMMUNHÄMATOLOGIE 2010. [PMCID: PMC7123830 DOI: 10.1007/978-3-642-12765-6_16] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 11/19/2022]
Abstract
Blutspender leisten einen wertvollen Dienst für die Gemeinschaft: Die ständige Verfügbarkeit von Blutkomponenten ist zur unverzichtbaren Voraussetzung für viele Bereiche der Medizin geworden. Nicht nur die Gewinnung und Aufarbeitung von Blut und Blutbestandteilen zur Sicherstellung einer qualitativ wie quantitativ guten Versorgung, sondern auch die kompetente Betreuung der Spender ist eine der großen Aufgaben der Transfusionsmedizin.
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Storage of whole blood overnight in different blood bags preceding preparation of blood components: in vitro effects on red blood cells. BLOOD TRANSFUSION = TRASFUSIONE DEL SANGUE 2009; 7:210-5. [PMID: 19657485 DOI: 10.2450/2009.0074-08] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Subscribe] [Scholar Register] [Received: 11/19/2008] [Accepted: 03/19/2009] [Indexed: 11/21/2022]
Abstract
BACKGROUND Routines for the storage of whole blood (WB) overnight for the preparation of blood components on the following day are of increasing interest primarily for logistic reasons. The present study focuses on in vitro effects during storage for 6 weeks on red blood cells (RBC) prepared in different blood containers after being held overnight. STUDY DESIGN AND METHODS Five different blood collection systems were used with either inline leucocyte reduction red cell filters for the preparation of RBC, buffy coat (BC) and plasma or WB filters for the preparation of RBC and plasma. A new container with an integrated WB filter removing leucocytes but not platelets was also included for the preparation of leucocyte-reduced RBC, BC and plasma units. Standard CPD solution (63 or 70 mL) and SAG-M solution (100 or 110 mL) were used for the collection of either 450 or 500 mL blood. All WB units were stored at room temperature, either overnight for 18-24 hours (test groups, n=104) or for up to 8 hours (reference groups, n=20). In addition, five test units were stored overnight under refrigeration. RESULTS In test groups (overnight storage at room temperature) we found significantly lower levels of extracellular potassium, 2,3-DPG and pH (up to day 28). During storage, higher levels of ATP (Terumo, CaridianBCT until day 35, Fresenius until day 14, Fenwal throughout storage) were seen in test groups than in reference groups. When WB was stored overnight at 2-6 degrees C before WB filtration, the levels of ATP and haemolysis were higher than in the corresponding reference. CONCLUSION Significant differences in in vitro parameters were observed between RBC prepared within 8 hours and 18-24 hours after blood collection. The results were consistent irrespective of the blood container used. New alkaline solutions may decrease the differences.
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30
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Gulliksson H, Vesterinen M, Payrat JM, Mayaudon V. Extended storage of whole blood before the preparation of blood components:in vitroeffects on red blood cells in Erythro-Sol environment. Vox Sang 2009; 96:199-205. [DOI: 10.1111/j.1423-0410.2008.01152.x] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
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31
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Andreu G, Caldani C, Morel P. Reduction of septic transfusion reactions related to bacteria contamination without implementing bacteria detection. ACTA ACUST UNITED AC 2008. [DOI: 10.1111/j.1751-2824.2008.00147.x] [Citation(s) in RCA: 14] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022]
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32
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Use of random versus apheresis platelet concentrates. Transfus Clin Biol 2008; 14:514-21. [PMID: 18417401 DOI: 10.1016/j.tracli.2008.01.004] [Citation(s) in RCA: 28] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2007] [Accepted: 01/18/2008] [Indexed: 11/21/2022]
Abstract
The respective use of random (RPC) and apheresis (APC) platelet concentrates is highly heterogeneous among countries, ranging from 10 to 98% RPC in countries supposed to provide a similar transfusion service to patients. Moreover, when considering each country in the past 10 years, one can observe that some have changed their policy, switching from a majority of APC to RPC or vice versa. This presentation intends to analyse which factors may impact such decisions. For many years, the only available platelet component was a RPC obtained from whole blood donation by a two centrifugation steps process, the "platelet rich plasma" or PRP method. Since the beginning of the 1970s, APCs became available, with in fact many different techniques leading to many APCs that may not be equivalent. Since the end of the 1980s, a new method of RPC preparation was developed, using the buffy-coat (BC-PC), providing a blood component with highly preserved platelet functions as compared to RPCs prepared by the PRP technique. Finally, the use of each of these components either native, or leuco-reduced, or suspended in a storage solution, or processed with a pathogen inactivation technique adds new layers of complexity to compare them. Innumerable references can be found in the literature describing in vitro functional parameters of platelet concentrates. Although it is clear that BC-RPC retain much more their in vitro functions than PRP-RPC, indicating that no one should use the latter any more, it is much more difficult to distinguish differences between other PCs. Conversely, only a very few studies have been published related to a comparison of clinical efficacy of RPC versus APC, the endpoints being mainly CCI. Similarly to the in vitro studies, although RPC prepared with the PRP method show the lowest CCIs, no clear difference exists between "modern" RPC and APC. Another factor that may impact policy decision is the occurrence of adverse reactions in recipients. When considering only comparable data, for example leuco-reduced RPC versus leuco-reduced APC, there is now evidence that the latter is more associated with adverse reactions in recipients: data from hemovigilance in France show that, although no difference is noted for febrile non haemolytic transfusion reactions, nor for bacteria contamination, the incidence of allergic adverse reactions is about four times higher with APC as compared with RPC. Other aspects may impact the decision: the fact that using APC in place of RPC reduces the total donor exposure of patients was considered critical in some countries to reduce the risk of transmission of blood transmissible disease. Finally, the cost of the components, much higher for APC may be considered.
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Murphy WG, Foley M, Doherty C, Tierney G, Kinsella A, Salami A, Cadden E, Coakley P. Screening platelet concentrates for bacterial contamination: low numbers of bacteria and slow growth in contaminated units mandate an alternative approach to product safety. Vox Sang 2008; 95:13-9. [PMID: 18393945 DOI: 10.1111/j.1423-0410.2008.01051.x] [Citation(s) in RCA: 137] [Impact Index Per Article: 8.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Abstract
BACKGROUND AND OBJECTIVES We introduced 100% screening of platelets for bacterial contamination in 2005 to reduce the risk of clinical sepsis from platelet transfusion. We test all outdating units again at expiry to assess the sensitivity of the initial test. MATERIALS AND METHODS We test all platelet concentrates prior to release for clinical use using a large volume automated culture technique on the day after manufacture. All units that expire unused are retested. Platelets still in stock on day 4 of storage may have a repeat culture performed, and are returned to stock with two extra days of shelf life. RESULTS Of 43,230 platelet units screened, 35 (0.08%) were positive; of 8282 expired unused, 18 (0.22%) were positive; and of 3310 day-4 retests, four (0.12%) were positive. Overall sensitivity of the initial screening test was 29.2% (95% confidence interval 19.4 to 39.1%). Thirteen of the 35 positive screening tests would have been expected to grow in both aerobic and anaerobic bottles; eight grew in aerobic culture only and five grew in anaerobic culture only, indicating that the likely number of bacteria in the contaminated platelet units at the time of sampling was less than 60 colony-forming unit per platelet unit. CONCLUSIONS Screening platelet concentrates for bacterial contamination using the most sensitive method available has a sensitivity of less than 40% because of the low numbers of bacteria in the initial contamination. Effective resolution of this problem will require a pathogen-inactivation technique.
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Affiliation(s)
- W G Murphy
- Irish Blood Transfusion Service, National Blood Centre, James's Street, Dublin 8, Ireland.
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McDonald CP. Bacterial risk reduction by improved donor arm disinfection, diversion and bacterial screening. Transfus Med 2007; 16:381-96. [PMID: 17163869 DOI: 10.1111/j.1365-3148.2006.00697.x] [Citation(s) in RCA: 44] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Abstract
The Interventions of improved donor arm disinfection, diversion and bacterial screening have been implemented by blood services and shown to have substantial benefit. The major source of bacterial contamination is donor arm derived. Blood services are now introducing best practice donor arm disinfection techniques. Diversion has been shown to substantially reduce bacterial contamination in the order of 40-88%. Diversion, together with improved donor arm disinfection, has shown to improve the percentage of reduction in contamination from 47% to 77%. Residual contamination levels after the Introduction of diversion and improved donor arm disinfection may be in the order of 30-40%. Numerous countries have now implemented screen testing programmes for platelet concentrates, which are the major source of bacterial transfusion transmission. Pathogen reduction systems have been developed and are under development. At present, concerns remain with these systems regarding cost, process control, ability to inactivate high titres of viruses, killing of bacterial spores, product damage, genotoxicity and mutagenicity. The interventions of diversion, improved donor arm disinfection and bacterial screen testing are currently available, As such they can be implemented now to increase blood safety with no associated patient risk.
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Affiliation(s)
- C P McDonald
- National Bacteriology Laboratory, National Blood Service, Colindale, London, UK.
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Mohr H, Bayer A, Gravemann U, Müller TH. Elimination and multiplication of bacteria during preparation and storage of buffy coat-derived platelet concentrates. Transfusion 2006; 46:949-55. [PMID: 16734811 DOI: 10.1111/j.1537-2995.2006.00827.x] [Citation(s) in RCA: 40] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/28/2022]
Abstract
BACKGROUND The prevalence of bacterial contamination of random-donor platelet concentrates (PCs) is considerably lower than that of blood donations. Which key steps of the preparation procedure contribute to the elimination of bacteria was investigated. STUDY DESIGN AND METHODS Ten bacteria species were used. Blood donations were spiked with bacteria and stored at 22 degrees C for 8 hours. The buffy coats were kept for 6 hours. PCs were prepared from pools of 4 buffy coats. At each preparation step and during PC storage, bacteria contents were measured. In additional experiments, the titers of spiked blood and buffy coats were determined after storage at 20, 22, or 24 degrees C for 8 and up to 24 hours, respectively. RESULTS Enterobacter cloacae, Escherichia coli, Pseudomonas aeruginosa, Serratia marcescens, and Yersinia enterocolitica were completely inactivated during storage in blood or buffy coats. Titer reduction was between 3.32 and 4.62 log. Bacillus cereus, Propionibacterium acnes, Staphylococcus aureus, and Staphylococcus epidermidis did not multiply. Compared with their values in spiked blood the titers in the PCs were reduced by 1.7 to 2.8 log. Klebsiella pneumoniae was the only species that grew in blood. With the exception of P. acnes, those species that were not removed by the preparation process multiplied in the PCs. Remarkable donor-to-donor variations of the bactericidal activities of buffy coats were detected when the storage time was prolonged to 24 hours. CONCLUSIONS Bacteria are significantly eliminated by the preparation procedure for random donor PCs. Also, blood and buffy coats are bactericidal for most species. When buffy-coat storage is prolonged, it cannot, however, be predicted whether specific strains vanish or multiply.
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Affiliation(s)
- Harald Mohr
- Blood Center of the German Red Cross Chapters of NSTOB, Institutes Springe and Gera, Springe, Germany.
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36
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Mohr H, Lambrecht B, Bayer A, Spengler HP, Nicol SB, Montag T, Müller TH. Sterility testing of platelet concentrates prepared from deliberately infected blood donations. Transfusion 2006; 46:486-91. [PMID: 16533294 DOI: 10.1111/j.1537-2995.2006.00747.x] [Citation(s) in RCA: 16] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
BACKGROUND In general the bacterial count in freshly donated blood is low and even lower in the corresponding platelet concentrates (PCs). By use of flow cytometry (FACS) for sterility testing, the reliability of early versus later sampling times was evaluated. STUDY DESIGN AND METHODS Blood donations were spiked with various numbers of Staphylococcus epidermidis, Staphylococcus aureus, Bacillus cereus, and Klebsiella pneumoniae. The corresponding PCs were prepared by the buffy-coat method and stored at 22 degrees C. A 20-mL sample was collected from each PC directly after preparation and after 8 hours. Samples were stored at 35 degrees C. Sterility testing of both PCs and samples was by FACS analysis at different time points. RESULTS All stored PCs were found positive by FACS analysis, with detection times ranging between 8 and 24 hours (K. pneumoniae, B. cereus), 8 and 91 hours (S. aureus), and 144 hours (S. epidermidis). In the samples incubated at 35 degrees C, bacteria were detected after 8 to 19 hours (K. pneumoniae, B. cereus), 8 to 67 hours (S. aureus), and 19 to 43 hours (S. epidermidis). Some of the samples did not contain bacteria. CONCLUSION Detection times for slow-growing bacteria are significantly shortened when PC samples are incubated at 35 degrees C: the numbers of bacteria in freshly prepared PCs may, however, be so low that the samples drawn for sterility testing do not contain a single bacterium. Our results do not support a shortening of the 24-hour or greater sampling time recommended by the manufacturers of established test systems, because also for consistent detection by FACS, bacteria need to grow in the PCs to sufficient numbers.
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Affiliation(s)
- Harald Mohr
- Blood Center of the German Red Cross Chapters of NSTOB, Institutes Springe and Gera, Springe and Gera, Germany.
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37
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Nielsen HJ, Edvardsen L, Vangsgaardt K, Dybkjaer E, Skov PS. Time-dependent histamine release from stored human blood products. Br J Surg 2005. [DOI: 10.1046/j.1365-2168.1996.02119.x] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
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38
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Castro E, Bueno JL, Barea L, González R. Feasibility of implementing an automated culture system for bacteria screening in platelets in the blood bank routine. Transfus Med 2005; 15:185-95. [PMID: 15943703 DOI: 10.1111/j.1365-3148.2005.00571.x] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Abstract
Bacterial contamination of blood components is the principal infectious complication linked to transfusion. The aim of the study was to evaluate the applicability of an automated culture system for platelets. 10 141 platelet concentrates were cultured individually and in pools of five on storage days 1 and 7 using Bact/Alert system aerobic bottles. A modified collection bag was used for improved sampling. Five-millilitre samples were cultured at 37 degrees C for 7 days. Only those samples where the same bacteria were identified in reculture were considered true positives (TP). Homogeneity of proportions was tested by Fisher's exact test. The rate of TP was 30 per 100 000 (95% CI, 6.1-86.4) sampling on day 1; 33 per 100 000 (95% CI, 7-96) on day 7; and 40 per 100 000 (95% CI, 1.28-122.4) if the screening was based on taking both samples (day 1 and 7). Only one TP was detected in the pool testing. The time for detection among TPs on day 1 ranged between 30 and 134 h. The system is not considered practical for use as a routine screening method, as the time for detection is too long. Pool testing is insensitive. Faster screening methods or pathogen-inactivation systems are needed.
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Affiliation(s)
- E Castro
- Centro de Donación de Sangre Cruz Roja Española, Madrid, Spain.
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40
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Siblini L, Lafeuillade B, Ros A, Garraud O, Pozzetto B. Influence of blood prestorage conditions and white blood cell filtration on the bacterial load of blood deliberately inoculated with Gram-positive and Gram-negative pathogens. Vox Sang 2004; 87:241-249. [PMID: 15585019 DOI: 10.1111/j.1423-0410.2004.00565.x] [Citation(s) in RCA: 17] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Abstract
BACKGROUND AND OBJECTIVES Currently, the bacterial contamination of blood constitutes one of the major infectious risks of transfusion. The aim of this study was to evaluate the bactericidal effect of blood on various bacterial species and to determine the influence of prestorage conditions and white blood cell (WBC) filtration on the reduction of the bacterial load in isolated red blood cells (RBCs). MATERIALS AND METHODS The growth kinetics of eight different species of bacteria were studied at 20 degrees C in deliberately contaminated RBC units. Further experiments evaluated the effect of prestorage conditions and WBC filtration on the viability of two model bacteria (Klebsiella oxytoca and Staphylococcus epidermidis) in comparison to previous results obtained with Yersinia enterocolitica. RESULTS For bacteria susceptible to the bactericidal effect of blood (mainly Gram-negative rods), a reduction of the bacterial load was obtained within 2 h of prestorage at 20 degrees C. When the prestorage period was prolonged beyond 3 h at 20 degrees C, rapid growth was observed with some Enterobacteriaceae. Whereas WBC filtration reduced dramatically the viability of Y. enterocolitica, it had only a minimal effect on the viability of S. epidermidis and K. oxytoca. However, the two latter species of bacteria did not survive prolonged storage at 4 degrees C. CONCLUSIONS Experiments conducted under realistic conditions are needed to determine whether it would be worthwhile recommending the rapid storage of RBCs at 4 degrees C after WBC reduction of the blood product.
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Affiliation(s)
- L Siblini
- Laboratoire de Bactériologie-Virologie, Faculté de Médecine Jacques Lisfranc, Saint-Etienne, France
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41
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Schuetz A, Roback JD. Towards the prevention of transfusion-transmitted infectious diseases. Expert Rev Anti Infect Ther 2004; 1:267-74. [PMID: 15482122 DOI: 10.1586/14787210.1.2.267] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
Transfusion-transmission of viral infections, such as HIV and hepatitis C virus, were once the scourge of blood transfusion. However, due to remarkable progress over the last 30 years, tests for viral proteins, antibody responses and more recently, viral nucleic acids, have virtually eliminated these risks. This review summarizes these advances in an historical context, describes new methodologies on the horizon, and discusses residual infectious risks associated with blood transfusion.
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Affiliation(s)
- Audrey Schuetz
- Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA 30322, USA
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42
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Zavizion B, Serebryanik D, Chapman J, Alford B, Purmal A. Inactivation of Gram-negative and Gram-positive bacteria in red cell concentrates using INACTINE PEN110 chemistry. Vox Sang 2004; 87:143-9. [PMID: 15569065 DOI: 10.1111/j.1423-0410.2004.00556.x] [Citation(s) in RCA: 14] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022]
Abstract
BACKGROUND AND OBJECTIVES The risk of transfusion-transmitted bacterial infections as a result of the presence of bacteria in blood is one of the major concerns in transfusion medicine. The purpose of this study was to investigate whether bacteria inoculated into red blood cell concentrates can be inactivated by the INACTINE PEN110 pathogen-reduction process. Four bacterial species were chosen for the study: anaerobic Gram-positive Clostridium perfringens and Propionibacterium acnes, known to be transfusion-transmitted; and two Gram-negative species, Acinetobacter johnsonii and Acinetobacter lwoffii, recently reported to be a common cause of transfusion-associated infections in Europe. MATERIALS AND METHODS Identical units of leucoreduced red cell concentrates were inoculated with A. johnsonii, A. lwoffii, C. perfringens, or P. acnes. The 4 degrees C control units were put on storage immediately after receiving the spike. The test units were subjected to PEN110 treatment and then stored. The bacterial titre in all units was monitored during a 6-week storage period. RESULTS The PEN110 inactivation of all tested bacterial strains was time- and titre-dependent. For A. johnsonii and A. lwoffii, no viable bacteria were detected in the units spiked with up to 10(4) colony-forming units (CFU)/ml and treated with PEN110. For red cell units spiked with 10(4)-10(5) CFU/ml of C. perfringens and P. acnes, no viable bacteria were detected in the units treated with PEN110. In control units, there was a gradual decrease in A. johnsonii, A. lwoffii and C. perfringens titres during cold storage, while P. acnes titres remained stable. CONCLUSIONS The PEN110 pathogen-reduction process was demonstrated to inactivate high titres of A. johnsonii, A. lwoffii, C. perfringens and P. acnes in red cell concentrates.
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Affiliation(s)
- B Zavizion
- V. I. Technologies, Inc., Watertown, MA 02472, USA
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43
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Gewinnung, Herstellung und Lagerung von Blut und Blutkomponenten. TRANSFUSIONSMEDIZIN 2004. [DOI: 10.1007/978-3-662-10597-9_14] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/26/2022]
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Abstract
BACKGROUND AND OBJECTIVES Platelet concentrates are contaminated with residual leucocytes and may also be infected with viruses and bacteria. We investigated whether these pathogens can be inactivated by a two-step procedure comprising photodynamic treatment in the presence of the phenothiazine dye, thionine, followed by irradiation with ultraviolet light (UV-B, wavelength range 290-330 nm). MATERIALS AND METHODS Platelet concentrates were prepared from buffy coats. The concentrates were spiked with different viruses, bacteria and leucocytes, then illuminated with yellow light in the presence of thionine at dye concentrations between 1 and 5 microm and with UV-B at doses up to 2.4 J/cm2. The infectivity of samples and the viability of leucocytes were assayed before and after treatment. The influence of treatment on in vitro platelet function was also examined. RESULTS The inactivation of free viruses in platelet concentrates by photodynamic treatment with thionine/light was significantly enhanced when it was followed by irradiation with UV-B. The inactivation of leucocytes and of bacteria by UV-B was improved when it was preceded by thionine/light. Sterile platelet concentrates were prepared from buffy coats infected with Staphylococcus epidermidis. Platelet function and the storage stability of platelet concentrates were only moderately influenced by the two decontamination steps. CONCLUSIONS Photodynamic treatment in the presence of the phenothiazine dye, thionine, followed by low-dose UVB, has the potential to inactivate viruses, leucocytes and bacteria, which might contaminate platelet concentrates. Both treatments complement each other.
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Affiliation(s)
- H Mohr
- Blood Center of the German Red Cross Chapters of NSTOB, Institute Springe, Germany.
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45
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Andreu G, Morel P, Forestier F, Debeir J, Rebibo D, Janvier G, Hervé P. Hemovigilance network in France: organization and analysis of immediate transfusion incident reports from 1994 to 1998. Transfusion 2002; 42:1356-64. [PMID: 12423521 DOI: 10.1046/j.1537-2995.2002.00202.x] [Citation(s) in RCA: 206] [Impact Index Per Article: 9.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
BACKGROUND Hemovigilance networks have been introduced in several countries to improve knowledge of blood transfusion-related morbidity and mortality. The general organization of the French network and its results from 1994 through March 1999 are presented here. STUDY DESIGN AND METHODS The hemovigilance network relies on blood transfusion centers and hospital correspondents, who analyze unexpected and untoward blood transfusion-related effects and transmit a Transfusion Incident Report (TIR) to a national database (Transfusion Incident Reports Electronic Data Management [GIFIT]). RESULTS As of March 1, 1999, the GIFIT database contained 24,234 TIRs related to incidents that occurred from the start of the hemovigilance network until December 31, 1998. The network was not fully implemented until 1996; but the reporting rate seems to have since stabilized at approximately 7000 per year (2.5 reports per 1000 blood components). The highest reporting rate is observed with platelet concentrates (4.02/1000), followed by RBCs (1.71/1000) and FFP (0.34/1000). Bacterial contamination quickly appeared as a major cause of morbidity and mortality (185 cases and 18 fatalities). However, a general trend of reduction in this type of incident was observed over time, which can be attributed to adoption of several preventive measures. In contrast, major ABO mismatchings during RBC transfusion remained at a constant rate throughout this period and accounted for six fatalities. After the implementation of universal WBC reduction, some incidents known to be related to WBCs, such as nonhemolytic febrile transfusion reactions (NHFTR) and HLA immunization, were dramatically reduced. CONCLUSION Hemovigilance is an important tool not only to analyze blood transfusion incidents, but also to measure the effects of new processes or corrective actions at a national level.
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Affiliation(s)
- Georges Andreu
- French Blood Establishment-Atlantique Region, 2 Boulevard Tonnellé, 37020 Tours Cedex, France.
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Abstract
BACKGROUND Routine leukocyte-depletion (LD) of cellular blood products, and even plasma, is currently being implemented in most European countries, as a result of the fear that the variant Creutzfeldt-Jakob-disease (vCJD) might be transmissible by transfusion. However, not only is the scientific evidence supporting such a notion scarce, but the benefits of applying this procedure to all patients also remain unfounded. METHODS A MEDLINE-research for studies dealing with the indications for LD was performed. In addition, the guidelines and recommendations of national and international health authorities were scrutinized. RESULTS To date,the only proven benefit of LD that can be applied to all patients is the reduction of non-hemolytic febrile transfusion reactions. In addition, LD reduces HLA-immunization and platelet refractoriness in multi-transfused patients. In immunocompromized patients, LD reduces transfusion-transmitted CMV-disease. Furthermore, a minority of 5-10% of transfusion-related-acute-lung-injury cases can be prevented by LD. However, the potential of reducing the immunomodulating effects of transfusion such as postoperative infection, cancer-recurrence-related or overall mortality and of reducing septicemia due to bacterial contamination is still at issue. AIDS patients do not benefit from LD, at least. The suitability of LD for preventing the transmission of vCJD is at best hypothetical. Potential risks of LD like increased leakages have not been taken into account adequately to date. CONCLUSIONS At present, the scientific evidence does not justify the introduction of LD as a routine measure. In times of limited health care resources, this costly procedure might limit access to medical services with proven effectiveness and efficiency. In addition, the loss of 5-10% of the red cell pool is predicted to lead to more blood supply shortages than previously seen.
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Affiliation(s)
- Ralf Karger
- Institut für Transfusionsmedizin und Hämostaseologie, Klinikum der Philipps Universität Marburg, Germany
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47
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Siblini L, Lafeuillade B, Ros A, Le Petit JC, Pozzetto B. Reduction of Yersinia enterocolitica load in deliberately inoculated blood: the effects of blood prestorage temperature and WBC filtration. Transfusion 2002; 42:422-427. [PMID: 12076288 DOI: 10.1046/j.1525-1438.2002.00066.x] [Citation(s) in RCA: 21] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
BACKGROUND Yersinia enterocolitica is known to cause severe infections in patients who receive transfusions. STUDY DESIGN AND METHODS The aim of the study was to define the best strategy for reducing the bacterial load in blood that was deliberately contaminated with Y. enterocolitica by combining prestorage temperature and WBC filtration with conditions of blood processing close to those applied in blood banks. RESULTS The effects of three prestorage temperatures (4 degrees C, 20 degrees C, 37 degrees C) were evaluated at various times after infection. The best reduction of bacterial load was achieved after 3 hours at 20 degrees C. In further experiments, conducted according to the former specifications, filtration of whole blood from eight and six donors with an inoculum of 100 and 500 to 1000 CFUs per mL, respectively, resulted in a total inhibition of bacterial growth up to 42 days after infection. After fractionation of blood components, in contrast to plasma and RBCs, filtration was shown to reduce dramatically the bacterial growth in buffy coats, demonstrating that the antibacterial effect of filtration was supported by the removal of infected WBCs from blood samples. CONCLUSION These results provide support for the systematic use of blood filtration in the preparation of blood components to prevent Y. enterocolitica infection of patients receiving transfusions.
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Affiliation(s)
- Loubna Siblini
- Laboratory of Bacteriology-Virology, Faculty of Medicine Jacques Lisfranc, and the Auvergne-Loire Blood Center, French National Blood Service, Saint-Etienne, France
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McDonald CP, Roy A, Lowe P, Robbins S, Hartley S, Barbara JA. Evaluation of the BacT/Alert automated blood culture system for detecting bacteria and measuring their growth kinetics in leucodepleted and non-leucodepleted platelet concentrates. Vox Sang 2001; 81:154-60. [PMID: 11703857 DOI: 10.1046/j.0042-9007.2001.00104.x] [Citation(s) in RCA: 43] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
BACKGROUND AND OBJECTIVE To evaluate the BacT/Alert automated blood culture system for the detection of bacteria in platelet concentrates, and to determine bacterial growth kinetics in leucodepleted and non-leucodepleted units. MATERIALS AND METHODS Apheresis (Cobe Leucocyte Reduction System [LRS]) and pooled buffy coat-derived (Optipress) platelet concentrates (PCs) were tested. Six organisms were used for spiking the PCs: Clostridium perfringens, Bacillus cereus, Group B Streptococcus, Staphylococcus epidermidis, Staphylococcus aureus and Escherichia coli. Units were inoculated to give a final concentration of approximately equal to 1 and 50 colony-forming units (CFU)/ml. On days 0, 2 and 5, BacT/Alert standard aerobic and anaerobic bottles were inoculated with a 5-ml fill volume and bacteria were enumerated. RESULTS The BacT/Alert Automated blood culture system gave rapid determination times of spiked units, with all positives detected within 48 h and 98.1% detected within 24 h. In general, as the inoculum concentration increased, the detection time decreased. Rapid growth was obtained with all organisms tested except for B. cereus, which failed to grow on four occasions. Bacterial numbers on day 2 ranged from 10(5) to 10(11) CFU/ml and on day 5 ranged from 10(4) to 10(12) CFU/ml. Growth was not significantly greater in leucodepleted units. CONCLUSIONS The study confirmed that PCs are an excellent growth medium for bacteria. Rapid and substantial growth was obtained with all organisms under test. Leucodepletion does not appear to enhance bacterial proliferation. The BacT/Alert automated blood culture system could rapidly detect contamination of units. Bacterial screening using an automated blood culture system is therefore a potential option.
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Affiliation(s)
- C P McDonald
- Bacteriology Laboratory, National Blood Service, North London, Colindale Avenue, London NW9 5BG, UK.
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49
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de Korte D, Marcelis JH, Soeterboek AM. Determination of the degree of bacterial contamination of whole-blood collections using an automated microbe-detection system. Transfusion 2001; 41:815-8. [PMID: 11399826 DOI: 10.1046/j.1537-2995.2001.41060815.x] [Citation(s) in RCA: 51] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
BACKGROUND The prevalence of bacterial contamination in whole-blood collections, either with immediate sampling or sampling after overnight storage as whole blood at 20 degrees C, is determined. STUDY DESIGN AND METHODS Whole blood was collected under blood bank conditions in special five-bag systems, allowing sampling in a closed system for culture bottles. Samples were taken within 2 hours after collection (Group 1) or after overnight storage of the whole blood at 20 degrees C (Group 2). Culture bottles were incubated for 7 days, and positive samples were entered on agar plates for confirmation and determination. RESULTS In Group 1, 9219 units were tested; 27 units were positive with positive subculture, that is, 0.29 percent with a 95% CI of 0.19 to 0.42 percent. In Group 2, 9038 units were tested; 36 units were positive with positive subculture, that is, 0.39 percent with a 95% CI of 0.28 to 0.55 percent. No significant difference could be found between the two test groups. The majority of bacteria were either Staphylococcus (all coagulase-negative) or Propionibacterium species. CONCLUSION For a total of 18,257 units, 0.34 percent (CI, 0.25-0.44) of whole-blood collections appeared to have bacterial contamination (mainly skin-derived). Overnight storage of whole blood at 20 degrees C did not have a significant effect on the prevalence of bacterial contamination.
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Affiliation(s)
- D de Korte
- CLB and the De Meierij Blood Bank, Sanquin Blood Supply Foundation, Amsterdam, the Netherlands.
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Holden F, Foley M, Devin G, Kinsella A, Murphy WG. Coagulase-negative staphylococcal contamination of whole blood and its components: the effects of WBC reduction. Transfusion 2000; 40:1508-13. [PMID: 11134572 DOI: 10.1046/j.1537-2995.2000.40121508.x] [Citation(s) in RCA: 28] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
BACKGROUND Most bacteria present in blood components are normal skin flora, particularly Staphylococcus epidermidis and other coagulase-negative staphylococci. Growth patterns of these bacteria and the effects of different methods of component preparation may depend on variations in behavior between different isolates of the same species. STUDY DESIGN AND METHODS Whole-blood units were inoculated with 19 different coagulase-negative staphylococcus (CNS) isolates at 1 to 10 and 10 to 100 CFUs per mL. After overnight holding at 22 degrees C, the units were processed into components. The components were cultured before inoculation and during processing, including before and after WBC reduction. RESULTS At low inoculum levels, CNS was detected in 15 (79%) of 19 whole-blood units and in 12 (63%) of 19 RBCs after separation; after filtration, bacteria were detected in 3 (16%) of 19 (p = 0.0069). For platelet concentrates, 6 (32%) of 19 grew bacteria before filtration and 1 of 18 after filtration (difference not statistically significant). Three (16%) of 19 plasmas were positive before and after freezing. At high inoculum levels, 16 (89%) of 18 whole-blood samples and RBCs were positive before filtration; 6 (33%) of 18 RBCs were positive after filtration (p = 0.0002); 8 (44%) of 18 platelets were positive before filtration; 3 (17%) of 18 were positive after filtration (difference not statistically significant), and 7 (37%) of 18 plasma samples were positive before and after freezing. CONCLUSION The growth characteristics of CNS in blood components vary with differences either in the subtype of bacteria or in the donor blood. Filtration reduces but does not eradicate contamination of RBCs and platelets by CNS. Plasma may act as a reservoir for CNS infection.
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Affiliation(s)
- F Holden
- Irish Blood Transfusion Service, Dublin, Ireland
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