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  1. Article: Growth and Distribution of Bacteria in Contaminated Whole Blood and Derived Blood Components.

    Gravemann, Ute / Handke, Wiebke / Schulze, Torsten J / Seltsam, Axel

    Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie

    2024  Volume 51, Issue 2, Page(s) 76–83

    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 ... ...

    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 (
    Results: Bacterial growth in WB varied remarkably between donations and species. Streptococcus species produced the highest titers in WB, whereas
    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.
    Language English
    Publishing date 2024-02-21
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2100848-6
    ISSN 1660-3818 ; 1660-3796
    ISSN (online) 1660-3818
    ISSN 1660-3796
    DOI 10.1159/000536242
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Pathogen Inactivation of Cellular Blood Products-An Additional Safety Layer in Transfusion Medicine.

    Seltsam, Axel

    Frontiers in medicine

    2017  Volume 4, Page(s) 219

    Abstract: In line with current microbial risk reduction efforts, pathogen inactivation (PI) technologies for blood components promise to reduce the residual risk of known and emerging infectious agents. The implementation of PI of labile blood components is slowly ...

    Abstract In line with current microbial risk reduction efforts, pathogen inactivation (PI) technologies for blood components promise to reduce the residual risk of known and emerging infectious agents. The implementation of PI of labile blood components is slowly but steadily increasing. This review discusses the relevance of PI for the field of transfusion medicine and describes the available and emerging PI technologies that can be used to treat cellular blood products such as platelet and red blood cell units. In collaboration with the French medical device manufacturer Macopharma, the German Red Cross Blood Services developed a new UVC light-based PI method for platelet units, which is currently being investigated in clinical trials.
    Language English
    Publishing date 2017-12-04
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2775999-4
    ISSN 2296-858X
    ISSN 2296-858X
    DOI 10.3389/fmed.2017.00219
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  3. Book ; Thesis: Intraokuläre Silikonöltamponade

    Seltsam, Axel

    eine klinisch-pathologische Studie an 36 enukleierten Augen

    1997  

    Author's details vorgelegt von Axel Seltsam
    Language German
    Size 63 Bl. : Ill., graph. Darst.
    Edition [Mikrofiche-Ausg.]
    Document type Book ; Thesis
    Thesis / German Habilitation thesis Erlangen-Nürnberg, Univ., Diss., 1997
    Note Mikrofiche-Ausg.: 1 Mikrofiche : 24x
    HBZ-ID HT007677543
    Database Catalogue ZB MED Medicine, Health

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    Shelf markLoan statusLocation
    1997 MB 1225 order for loan Magazin

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  4. Article ; Online: New ultraviolet C light-based method for pathogen inactivation of red blood cell units.

    Handke, Wiebke / Gravemann, Ute / Müller, Thomas H / Wagner, Franz F / Schulze, Torsten J / Seltsam, Axel

    Transfusion

    2022  Volume 62, Issue 11, Page(s) 2314–2323

    Abstract: Background: Pathogen inactivation (PI) technologies for platelet concentrates and plasma are steadily becoming more established, but new PI treatment options for red blood cells (RBCs), the most commonly used blood component, still need to be developed. ...

    Abstract Background: Pathogen inactivation (PI) technologies for platelet concentrates and plasma are steadily becoming more established, but new PI treatment options for red blood cells (RBCs), the most commonly used blood component, still need to be developed. We present a novel approach to inactivating pathogens in RBC units employing ultraviolet C (UVC) light.
    Methods: Whole blood-derived leukoreduced RBCs suspended in PAGGS-C, a third generation additive solution, served as test samples, and RBCs in PAGGS-C or SAG-M as controls. Vigorous agitation and hematocrit reduction by diluting the RBCs with additional additive solution during illumination ensured that UVC light penetrated and inactivated the nine bacteria and eight virus species tested. Bacterial and viral infectivity assays and in vitro analyses were performed to evaluate the system's PI capacity and to measure the RBC quality, metabolic, functional, and blood group serological parameters of UVC-treated versus untreated RBCs during 36-day storage.
    Results: UVC treatment of RBCs in the PAGGS-C additive solution did not alter RBC antigen expression, but significantly influenced some in vitro parameters. Compared to controls, hemolysis was higher in UVC-treated RBC units, but was still below 0.8% at 36 days of storage. Extracellular potassium increased early after PI treatment and reached ≤70 mmol/L by the end of storage. UVC-treated RBC units had higher glucose and 2,3-diphosphoglycerate levels than controls.
    Conclusion: As UVC irradiation efficiently reduces the infectivity of relevant bacteria and viruses while maintaining the quality of RBCs, the proposed method offers a new approach for PI of RBC concentrates.
    MeSH term(s) Humans ; Blood Preservation/methods ; Erythrocytes/metabolism ; Hemolysis ; Ultraviolet Rays ; Erythrocyte Count
    Language English
    Publishing date 2022-09-10
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 208417-x
    ISSN 1537-2995 ; 0041-1132
    ISSN (online) 1537-2995
    ISSN 0041-1132
    DOI 10.1111/trf.17098
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  5. Article ; Online: Intensity of endogenous thrombocytopenia after autologous stem cell transplantation in patients prophylactically transfused with platelets.

    Voß, Andreas / Doescher, Andrea / Kapels, Hans-Hermann / Seltsam, Axel / Greinacher, Andreas / Metzner, Bernd / Müller, Thomas H

    Vox sanguinis

    2023  Volume 118, Issue 7, Page(s) 559–566

    Abstract: Background and objectives: Large clinical trials have demonstrated that some patient groups with hypoproliferative thrombocytopenia benefit from prophylactic platelet transfusions, while in others, a therapeutic transfusion regimen might be sufficient. ... ...

    Abstract Background and objectives: Large clinical trials have demonstrated that some patient groups with hypoproliferative thrombocytopenia benefit from prophylactic platelet transfusions, while in others, a therapeutic transfusion regimen might be sufficient. The remaining capacity to generate endogenous platelets might be helpful to select the platelet transfusion regimen. We assessed whether the recently described method of digital droplet polymerase chain reaction (PCR) can be used to assess the endogenous platelet levels in two groups of patients undergoing high-dose chemotherapy with autologous stem cell transplantation (ASCT).
    Materials and methods: Multiple myeloma (n = 22) patients received high-dose melphalan alone (HDMA); lymphoma patients (n = 15) received BEAM or TEAM (B/TEAM) conditioning. Patients with a total platelet count <10 G/L received prophylactic apheresis platelet concentrates. Daily endogenous platelet counts were measured by digital droplet PCR for at least 10 days post-ASCT.
    Results: Post-transplantation B/TEAM patients received their first platelet transfusion on average 3 days earlier than HDMA patients (p < 0.001) and required about twofold more platelet concentrates (p < 0.001). The endogenous platelet count fell ≤5 G/L for a median of 115 h (91-159; 95% confidence interval) in B/TEAM-treated patients compared to 12.6 h (0-24) (p < 0.0001) in HDMA-treated patients. Multivariate analysis confirmed this profound effect of the high-dose regimen (p < 0.001). The CD-34
    Conclusion: Monitoring endogenous platelet counts detects the direct effects of myelosuppressive chemotherapies on platelet regeneration. This approach may help to develop a platelet transfusion regimen tailored to specific patient groups.
    MeSH term(s) Humans ; Hematopoietic Stem Cell Transplantation/adverse effects ; Blood Platelets ; Transplantation, Autologous ; Thrombocytopenia/etiology ; Thrombocytopenia/therapy ; Platelet Transfusion/adverse effects
    Chemical Substances N-hydroxysuccinimidyl digoxigenin-3-O-methylcarbonyl-epsilon-aminocaproate (129273-26-3)
    Language English
    Publishing date 2023-05-22
    Publishing country England
    Document type Journal Article
    ZDB-ID 80313-3
    ISSN 1423-0410 ; 0042-9007
    ISSN (online) 1423-0410
    ISSN 0042-9007
    DOI 10.1111/vox.13445
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  6. Article ; Online: West Nile and Usutu viruses are efficiently inactivated in platelet concentrates by UVC light using the THERAFLEX UV-Platelets system.

    Gravemann, Ute / Boelke, Mathias / Könenkamp, Laura / Söder, Lars / Maurer, Maurice / Ziegler, Ute / Schulze, Torsten J / Seltsam, Axel / Becker, Stefanie C / Steffen, Imke

    Vox sanguinis

    2024  

    Abstract: Background and objectives: West Nile virus (WNV) and Usutu virus (USUV) are mosquito-borne flaviviruses (Flaviviridae) that originated in Africa, have expanded their geographical range during the last decades and caused documented infections in Europe ... ...

    Abstract Background and objectives: West Nile virus (WNV) and Usutu virus (USUV) are mosquito-borne flaviviruses (Flaviviridae) that originated in Africa, have expanded their geographical range during the last decades and caused documented infections in Europe in the last years. Acute WNV and USUV infections have been detected in asymptomatic blood donors by nucleic acid testing. Thus, inactivation of both viral pathogens before blood transfusion is necessary to ensure blood product safety. This study aimed to investigate the efficacy of the THERAFLEX UV-Platelets system to inactivate WNV and USUV in platelet concentrates (PCs).
    Materials and methods: Plasma-reduced PCs were spiked with the virus suspension. Spiked PC samples were taken after spiking (load and hold sample) and after UVC illumination on the Macotronic UV illumination machine with different light doses (0.05, 0.1, 0.15 and 0.2 (standard) J/cm
    Results: Infectivity assays showed that UVC illumination inactivated WNV and USUV in a dose-dependent manner. At a UVC dose of 0.2 J/cm
    Conclusions: Our results demonstrate that the THERAFLEX UV-Platelets procedure is an effective technology to inactivate WNV and USUV in contaminated PCs.
    Language English
    Publishing date 2024-05-03
    Publishing country England
    Document type Journal Article
    ZDB-ID 80313-3
    ISSN 1423-0410 ; 0042-9007
    ISSN (online) 1423-0410
    ISSN 0042-9007
    DOI 10.1111/vox.13648
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  7. Article ; Online: Proliferation of psychrotrophic bacteria in cold-stored platelet concentrates.

    Ramirez-Arcos, Sandra / Kumaran, Dilini / Cap, Andrew / Cardenas, Kristin Michelle / Cloutier, Marc / Ferdin, Justin / Gravemann, Ute / Ketter, Patrick / Landry, Patricia / Lu, Thea / Niekerk, Truscha / Parker, Joel / Renke, Claudia / Seltsam, Axel / Stafford, Bianca / Süssner, Susanne / Vollmer, Tanja / Zilkenat, Susann / McDonald, Carl

    Vox sanguinis

    2024  

    Abstract: Background and objectives: Platelet concentrates (PC) are stored at 20-24°C to maintain platelet functionality, which may promote growth of contaminant bacteria. Alternatively, cold storage of PC limits bacterial growth; however, data related to ... ...

    Abstract Background and objectives: Platelet concentrates (PC) are stored at 20-24°C to maintain platelet functionality, which may promote growth of contaminant bacteria. Alternatively, cold storage of PC limits bacterial growth; however, data related to proliferation of psychotrophic species in cold-stored PC (CSP) are scarce, which is addressed in this study.
    Materials and methods: Eight laboratories participated in this study with a pool/split approach. Two split PC units were spiked with ~25 colony forming units (CFU)/PC of Staphylococcus aureus, Klebsiella pneumoniae, Serratia liquefaciens, Pseudomonas fluorescens and Listeria monocytogenes. One unit was stored under agitation at 20-24°C/7 days while the second was stored at 1-6°C/no agitation for 21 days. PC were sampled periodically to determine bacterial loads. Five laboratories repeated the study with PC inoculated with lyophilized inocula (~30 CFU/mL) of S. aureus and K. pneumoniae.
    Results: All species proliferated in PC stored at 20-24°C, reaching concentrations of ≤10
    Conclusion: Psychrotrophic bacteria, which are relatively rare contaminants in PC, proliferated in CSP, with P. fluorescens reaching clinically significant levels (≥10
    Language English
    Publishing date 2024-04-17
    Publishing country England
    Document type Journal Article
    ZDB-ID 80313-3
    ISSN 1423-0410 ; 0042-9007
    ISSN (online) 1423-0410
    ISSN 0042-9007
    DOI 10.1111/vox.13640
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  8. Article ; Online: Digital droplet polymerase chain reaction to monitor ultraviolet C treatment of single-donor and buffy coat platelet units.

    Voglau, Uta / Müller, Thomas H / Seltsam, Axel / Gravemann, Ute / Handke, Wiebke / Doescher, Andrea

    Transfusion

    2020  Volume 60, Issue 8, Page(s) 1821–1827

    Abstract: Background: UVC illumination of agitated platelet concentrates (PCs) inactivates pathogens and white blood cells by modifications of their nucleic acids. Related effects on mitochondrial DNA (mtDNA) in platelets serve as a basis for an efficient ... ...

    Abstract Background: UVC illumination of agitated platelet concentrates (PCs) inactivates pathogens and white blood cells by modifications of their nucleic acids. Related effects on mitochondrial DNA (mtDNA) in platelets serve as a basis for an efficient monitoring suited for routine quality control (QC) of this purely physical pathogen reduction technology.
    Study design and methods: Samples from PCs (n = 530) were tested with an established LightCycler PCR (LC PCR) for QC of the UVC procedure. RNR2 and TRNK/ATP8 genes were sequenced in the PCs (n = 21) with out-of-specification results in the LC PCR. A digital droplet PCR (ddPCR) was developed to minimize the outliers and cross-validated by testing the 530 PCs. The ddPCR was further evaluated in a subgroup of 300 PCs without mtDNA extraction and in samples from systematic variations of UVC dose and agitation speed.
    Results: Apheresis PCs (n = 380) resulted in 5.3% outliers in LC PCR versus only 0.7% in buffy coat pool PCs (n = 150). Sequencing of these outliers revealed single-nucleotide polymorphisms in the primer- and probe-binding sites of LC PCR. The development of a ddPCR assay with modified probe sequences reduced the outliers to 0.4%. The ddPCR analysis of PCs both with and without mtDNA extraction demonstrated low intra- and interassay variabilities and congruent results also compared to LC PCR. Experiments varying the UVC dose and the agitation speed demonstrated that the ddPCR results closely reflect functional effects of the UVC treatment.
    Conclusion: The ddPCR assay offers a valid and reliable tool for QC of routine production of the UVC-treated PCs as well as for monitoring treatment conditions during optimization of the UVC procedure.
    MeSH term(s) Blood Buffy Coat ; Blood Platelets ; DNA, Mitochondrial/genetics ; Humans ; Mitochondrial Proteins/genetics ; Plateletpheresis ; Polymerase Chain Reaction ; Polymorphism, Single Nucleotide ; Quality Control ; Ultraviolet Rays
    Chemical Substances DNA, Mitochondrial ; Mitochondrial Proteins
    Language English
    Publishing date 2020-06-14
    Publishing country United States
    Document type Journal Article
    ZDB-ID 208417-x
    ISSN 1537-2995 ; 0041-1132
    ISSN (online) 1537-2995
    ISSN 0041-1132
    DOI 10.1111/trf.15904
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  9. Article ; Online: Inactivation of SARS-CoV-2 infectivity in platelet concentrates or plasma following treatment with ultraviolet C light or with methylene blue combined with visible light.

    Hobson-Peters, Jody / Amarilla, Alberto A / Rustanti, Lina / Marks, Denese C / Roulis, Eileen / Khromykh, Alexander A / Modhiran, Naphak / Watterson, Daniel / Reichenberg, Stefan / Tolksdorf, Frank / Sumian, Chryslain / Seltsam, Axel / Gravemann, Ute / Faddy, Helen M

    Transfusion

    2023  Volume 63, Issue 2, Page(s) 288–293

    Abstract: Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is unlikely to be a major transfusion-transmitted pathogen; however, convalescent plasma is a treatment option used in some regions. The risk of transfusion-transmitted infections ... ...

    Abstract Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is unlikely to be a major transfusion-transmitted pathogen; however, convalescent plasma is a treatment option used in some regions. The risk of transfusion-transmitted infections can be minimized by implementing Pathogen Inactivation (PI), such as THERAFLEX MB-plasma and THERAFLEX UV-Platelets systems. Here we examined the capability of these PI systems to inactivate SARS-CoV-2.
    Study design and methods: SARS-CoV-2 spiked plasma units were treated using the THERAFLEX MB-Plasma system in the presence of methylene blue (~0.8 μmol/L; visible light doses: 20, 40, 60, and 120 [standard] J/cm
    Results: Treatment of spiked plasma with the THERAFLEX MB-Plasma system resulted in an average ≥5.03 log
    Conclusions: SARS-CoV-2 infectivity was reduced in plasma and platelets following treatment with the THERAFLEX MB-Plasma and THERAFLEX UV-Platelets systems, to the limit of detection, respectively. These PI technologies could therefore be an effective option to reduce the risk of transfusion-transmitted emerging pathogens.
    MeSH term(s) Humans ; Methylene Blue/pharmacology ; SARS-CoV-2 ; COVID-19/therapy ; COVID-19 Serotherapy ; Light ; Ultraviolet Rays ; Blood Platelets ; Virus Inactivation
    Chemical Substances Methylene Blue (T42P99266K)
    Language English
    Publishing date 2023-01-08
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 208417-x
    ISSN 1537-2995 ; 0041-1132
    ISSN (online) 1537-2995
    ISSN 0041-1132
    DOI 10.1111/trf.17238
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  10. Article ; Online: Bacterial inactivation of platelet concentrates with the THERAFLEX UV-Platelets pathogen inactivation system.

    Gravemann, Ute / Handke, Wiebke / Müller, Thomas H / Seltsam, Axel

    Transfusion

    2018  Volume 59, Issue 4, Page(s) 1324–1332

    Abstract: Background: The THERAFLEX UV-Platelets system (Maco Pharma) uses ultraviolet C (UVC) light for pathogen inactivation (PI) of platelet concentrates (PCs) without any additional photoactive compound. The aim of the study was to systematically investigate ... ...

    Abstract Background: The THERAFLEX UV-Platelets system (Maco Pharma) uses ultraviolet C (UVC) light for pathogen inactivation (PI) of platelet concentrates (PCs) without any additional photoactive compound. The aim of the study was to systematically investigate bacterial inactivation with this system under conditions of intended use.
    Study design and methods: The robustness of the system was evaluated by assessing its capacity to inactivate high concentrations of different bacterial species in accordance with World Health Organization guidelines. The optimal use of the PI system was explored in time-to-treatment experiments by testing its ability to sterilize PCs contaminated with low levels of bacteria on the day of manufacture (target concentration, 100 colony-forming units/unit). The bacteria panel used for spiking experiments in this study included the World Health Organization International Repository Platelet Transfusion Relevant Reference Strains (n = 14), commercially available strains (n = 13), and in-house clinical isolates (n = 2).
    Results: Mean log reduction factors after UVC treatment ranged from 3.1 to 7.5 and varied between different strains of the same species. All PCs (n = 12/species) spiked with up to 200 colony-forming units/bag remained sterile until the end of storage when UVC treated 6 hours after spiking. UVC treatment 8 hours after spiking resulted in single breakthrough contaminations with the fast-growing species Escherichia coli and Streptococcus pyogenes.
    Conclusion: The UVC-based THERAFLEX UV-Platelets system efficiently inactivates transfusion-relevant bacterial species in PCs. The comprehensive data from this study may provide a valuable basis for the optimal use of this UVC-based PI system.
    MeSH term(s) Bacteria/radiation effects ; Blood Platelets/microbiology ; Humans ; Platelet Transfusion/methods ; Sterilization/methods ; Ultraviolet Rays
    Language English
    Publishing date 2018-12-26
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 208417-x
    ISSN 1537-2995 ; 0041-1132
    ISSN (online) 1537-2995
    ISSN 0041-1132
    DOI 10.1111/trf.15119
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