22 results on '"Pruss, Axel"'
Search Results
2. Positive Long-Term Outcome of Kidney Allocation via Acceptable Mismatch Program in Highly Sensitized Patients.
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Strehler Y, Lachmann N, Niemann M, Halleck F, Budde K, and Pruß A
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Introduction: Eurotransplant established the acceptable mismatch (AM) program to facilitate timely kidney transplantations of highly sensitized patients, but long-term granular clinical and immunological outcomes regarding overall graft survival and de novo DSA (dnDSA) formation are still intensively researched. The right choice of induction therapy in patients with differing immunological risk is not conclusively determined, as well as the impact of human leukocyte antigen (HLA) epitope matching on dnDSA formation., Methods: This monocentric, retrospective study analyzed 94 patients transplanted within the AM program between 2000 and 2019 compared to case-control matched cohorts of non- (PRA 0-5%; PRA-0) and intermediately sensitized (PRA 6-84%; PRA-6/84) patients transplanted through Eurotransplant Kidney Allocation System., Results: Estimated 10-year overall graft survival between the PRA-0 and AM cohorts was similar, whereas PRA-6/84 was significantly disadvantageous compared to PRA-0. Estimated 10-year incidence of antibody-mediated rejection rates was significantly lower in the PRA-0 group compared to AM and PRA-6/84 groups. Compared to the AM group, estimated incidence of de novo donor-specific antibody (dnDSA) was significantly lower in PRA-0 patients, with no differences between the AM and PRA-6/84 cohorts. The PRA-6/84 cohort was the only subgroup in which interleukin-2 receptor antagonist (IL2RA) induction was associated with longer overall graft survival, patient survival, and graft survival compared to depleting induction (ATG or OKT3). Broad HLA-A, -B, -DR mismatches (mmABDR) and HLA epitope mismatches determined by Eplets and PIRCHE-II were predictive for dnDSA formation in the total cohort, and the AM subgroup., Discussion: The high efforts expended on AM patients are justified to allow timely organ transplantation with acceptable risk profile and non-inferior outcomes. IL2RA induction in intermediately sensitized patients is associated with superior overall graft survival, patient survival, and graft survival compared to ATG/OKT3 induction, without negative effects on rejection episodes or dnDSA formation. In silico epitope matching might further help reduce dnDSA formation, particularly in high-risk AM patients., Competing Interests: M. Niemann works for PIRCHE AG, which develops and operates the PIRCHE web service. The remaining authors have no conflicts of interest to declare., (© 2024 The Author(s). Published by S. Karger AG, Basel.)
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- 2024
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3. Safety Aspects in Tissue Banking - An Update.
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Pruß A and Schroeter J
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- 2021
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4. Validation of Microbiological Testing of Tissue Preparations with Different Incubation Temperatures.
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Herrlinger F, Schulz T, Pruß A, and Schulz E
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Introduction: The European Pharmacopoeia (Ph. Eur.) provides principles for microbiological testing of tissue preparations. According to the Ph. Eur., tests should be performed at different temperatures for detection of aerobic bacteria and fungi (20-25°C) vs. anaerobic bacteria (30-35°C). Semiautomated systems using blood culture bottles are already widely used and they are adequate for growth detection. Resin-containing bottles and the addition of penicillinase permit testing of culture media containing antibiotics., Materials and Methods: At 3 temperatures (21, 30, and 35°C) cornea culture media with and without dextran (CM II and CM I) and thermal disinfected femoral head medium (FH) were spiked with the 6 reference strains recommended by the Ph. Eur. (additionally: Enterococcus faecalis, Staphylococcus epidermidis, and Cutibacterium acnes ). Microbial growth was monitored with the BACTEC
TM FX unit or visually at 21°C., Results: Growth for all strains was detected with each medium at all 3 temperatures, except for C. acnes at 21°C (all media) and 30°C with FH. C. acnes had the highest times to detection, requiring test durations of 14 days. Microbial growth was faster at 30 and 35°C compared to 21°C., Conclusion: The requirements according to the Ph. Eur. for a successful method suitability test could be fulfilled for the semiautomated blood culture bottle system with the BACTECTM FX unit for the media and microorganisms used. In the presented validation study 35°C was shown to be the incubation temperature with the fastest growth, of the majority of the test strains used, and complete detection within 14 days., Competing Interests: The authors have no conflicts of interest to declare., (Copyright © 2020 by S. Karger AG, Basel.)- Published
- 2021
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5. Comparison of Total Immunoglobulin G in Ante- and Postmortem Blood Samples from Tissue Donors.
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Larscheid G, Schulz T, Herbst H, Trögel T, Eulert S, Pruß A, and Schroeter J
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Background: A serology testing for infectious diseases (HIV, hepatitis B and C, syphilis) is mandatory in tissue donors. In many donors postmortem blood is the only sample available. Even though serological tests and nucleic acid amplification tests (NAT) used are validated for postmortem blood, a characterization of those blood samples is not yet established. We therefore investigated the total immunoglobulin G (IgG) content in postmortem blood of tissue donors and compared it to a corresponding antemortem blood sample., Methods: Ante- and postmortem blood samples were obtained from 100 consecutive tissue donors. The total IgG of all samples was measured using an immune-turbidometric test on the AU 480 Chemistry Analyzer (Beckman Coulter)., Results: The mean total IgG concentration of antemortem blood samples from all 100 donors was 8.9 g/L ± 3.7 g/L (median 8.9 g/L, range 1.5 to 23.8 g/L). In 80 donors the IgG concentration in the antemortem blood sample was within the normal range with values ≥6 g/L (mean 10.0 g/L ± 3.3 g/L, median 9.3 g/L,). The total IgG concentration of the postmortem blood samples was lower with 7.2 g/L ± 3.2 g/L (median 6.7 g/L, range 0.6 to 18.2 g/L). The difference between the values of the antemortem and postmortem blood samples was 1.7 g/L ± 2.6 g/L (16.3%) (median 1.6 g/L, range -7.7 to 10.1 g/L). In 36 donors this difference was less than 10%, in 23 it was between 10 and 25%, in 33 between 26 and 50%, and in 8 over 50%. In 57 donors the total IgG in the postmortem blood sample was within the normal range with ≥6 g/L, in 53 of them also the value of the antemortem blood sample was within the normal range. No correlation for total IgG was found regarding the donor characteristics (age, sex, disease) and the sample characteristics (hemolysis, postmortem time)., Conclusion: Total IgG values in antemortem samples were below the lower limit of 6 g/L in 20% of the cases. Total IgG was significantly lower in the postmortem samples compared to the antemortem samples, while 57% were still above the lower limit. No correlation with the postmortem time could be found. This lowered IgG levels should be payed attention to when using postmortem blood for infectious serology testing. Additional NAT testing should be considered., Competing Interests: The authors have no conflicts of interest to declare., (Copyright © 2021 by S. Karger AG, Basel.)
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- 2021
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6. Algorithms for the Testing of Tissue Donors for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus.
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Pruß A, Chandrasekar A, Sánchez-Ibáñez J, Lucas-Samuel S, Kalus U, and Rabenau HF
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Background: Although transmission of pathogenic viruses through human tissue grafts is rare, it is still one of the most serious dreaded risks of transplantation. Therefore, in addition to the detailed medical and social history, a comprehensive serologic and molecular screening of the tissue donors for relevant viral markers for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) is necessary. In the case of reactive results in particular, clear decisions regarding follow-up testing and the criteria for tissue release must be made., Methods: Based on the clinical relevance of the specific virus markers, the sensitivity of the serological and molecular biological methods used and the application of inactivation methods, algorithms for tissue release are suggested., Results: Compliance with the preanalytical requirements and assessment of a possible hemodilution are mandatory requirements before testing the blood samples. While HIV testing follows defined algorithms, the procedures for HBV and HCV diagnostics are under discussion. Screening and decisions for HBV are often not as simple, e.g., due to cases of occult HBV infection, false-positive anti-HBc results, or early window period positive HBV NAT results. In the case of HCV diagnostics, modern therapies with direct-acting antivirals, which are often associated with successful treatment of the infection, should be included in the decision., Conclusion: In HBV and HCV testing, a high-sensitivity virus genome test should play a central role in diagnostics, especially in the case of equivocal serology, and it should be the basis for the decision to release the tissue. The proposed test algorithms and decisions are also based on current European recommendations and standards for safety and quality assurance in tissue and cell banking., Competing Interests: The authors have no conflict of interests to declare., (Copyright © 2020 by S. Karger AG, Basel.)
- Published
- 2021
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7. Evaluation of the New Lateral Flow Card MDmulticard® Basic Extended Phenotype in Routine Clinical Practice.
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Mayer B, Müller J, Candela-García MJ, Manteau AC, Weinstock C, and Pruß A
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Background: Transfusion emergencies and critical situations require specifically designed devices to simplify and optimize the standard procedures. In addition, matching antigens over and above ABO-Rh-K would be beneficial., Methods: Routine blood samples were collected in four immunohematology centers and tested with the new MDmulticard Basic Extended Phenotype for the simultaneous detection of the Duffy, Kidd, and Ss antigens, according to the principle of the lateral flow. Results were compared with those obtained using routine serology methods. Discrepancies were analyzed by molecular techniques/genotyping., Results: 310 samples were tested (167 donors; 75 patients; 28 subjects with positive direct antiglobulin test (DAT); 15 newborns; 25 previously transfused patients). The 285 samples with non-mixed-field reaction yielded 1,710 antigen results with 8 discrepancies (0.47%) six of which in DAT-positive subjects: three false-positive (Fy
a ) for MDmulticard, and two false-positive (Fya ) plus three false-negative (Fyb ) for the reference methods (MDmulticard PPA for donors/patients/newborns: 99.82%; negative percent agreement: 100%; sensitivity: 100%; specificity: 99.39%, positive predictive value: 99.75%; negative predictive value: 100%). The MDmulticard detected mixed-field in 15 antigen reactions from 13 transfused patients, undetected by the comparative method, with the opposite result in 8 antigens (5 patients)., Conclusion: The MDmulticard Basic Extended Phenotype met the criteria prescribed for the testing of donor, patient, DAT-positive, and newborn samples in transfusion laboratory routine.- Published
- 2018
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8. Coding of Tissue and Cell Preparations Using Eurocode.
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Knels R, Stüpmann K, Pruß A, Klerke J, Kardoeus J, and Hiller J
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Traceability of products requires their unique identification. In Germany blood products have been encoded by Eurocode since 1998. EU Directives 2004/23/EC, 2006/86/EC and 2015/565/EC demanded unique identification and safe traceability procedure also for tissues and cells. Eurocode IBLS e.V. and the German Society of Transfusion Medicine and Immunohematology (DGTI) working parties '!' within the Single European Code (SEC). Several data elements of Eurocode can be used to create the complete SEC data structure, except the tissue establishment number. This can be found on the EU Coding Platform in the internet. Consequently, existing software and labeling solutions in Eurocode format could be easily upgraded with SEC.
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- 2017
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9. Implementation of the Single European Code in a Multi-Tissue Bank.
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Schroeter J, Schulz T, Schroeter B, Fleischhauer K, and Pruß A
- Abstract
Introduction: The traceability of tissue and cells transplants is important to ensure a high level of safety for the recipients. With the final introduction of the Single European Code (SEC) in April 2017 in the EU a consistent system among all member states became mandatory., Methods: The regulations for the SEC on EU and national level were evaluated. An overview on the different parts of the SEC with detailed explanations is given. Our own experiences with the implementation of the SEC in our multi-tissue bank are reported in addition., Results: The implementation of the SEC in our multi-tissue bank could be successfully realized. However, it revealed a number of difficulties, especially the sterile labeling of certain tissue transplants and the complex update of the existing database., Conclusion: The introduction of the SEC has made a contribution to the safety of recipients of tissue and cells transplants through a system of comprehensive and transparent traceability.
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- 2017
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10. Coding of Tissue and Cell Products.
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Pruß A
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- 2017
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11. Autoimmune Hemolytic Anemia - Fascinating from a Laboratory as well as from a Clinical Point of View.
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Heuft HG and Pruß A
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- 2015
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12. Validation of Serological Testing for Anti-Treponema pallidum from Postmortem Blood on the Siemens-BEP(®)-III Automatic System.
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Kalus U, Wilkemeyer I, Pruss A, and Caspari G
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Background: Infectious disease marker testing is obligatory for the release of human tissue for transplantation. Most CE-marked tests are not validated for postmortem blood. In a previous study we have validated the testing for anti-HIV-1/2, anti-HCV, HBsAg, and anti-HBc. Here, we present the validation of testing for antibodies against T. pallidum, which is the last marker obligatory for tissue release for transplantation., Methods: 17 samples of postmortem sera and 10 samples of both pre-und postmortem sera were obtained from cornea donors and tested for anti-T. pallidum on the Siemens-BEP-III-System. These sera were spiked with anti-T. pallidum-positive standard sera in concentrations which give low- and high-positive results at the respective dilution., Results: Two of the unspiked postmortem sera were false-positive most likely due to intense hemolysis (free hemoglobin > 50 mg/dl). Of the 25 negative postmortem sera, none of the spiked samples was false-negative after 0, 24 and 60 h., Conclusion: There is no indication that postmortem samples give false-negative or false-positive results with the test system and test kits used in cases of low hemolysis. The procedure described might serve as a model for validating other test kits on postmortem samples.
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- 2013
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13. Whither advanced therapy medicinal products?
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Smith MD, Brune JC, Wildemann B, and Pruss A
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- 2013
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14. Advanced therapy medicinal products - a multiple challenge.
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Pruss A and Garritsen H
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- 2013
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15. Virus NAT for HIV, HBV, and HCV in Post-Mortal Blood Specimens over 48 h after Death of Infected Patients - First Results.
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Meyer T, Polywka S, Wulff B, Edler C, Schröder AS, Wilkemeyer I, Kalus U, and Pruss A
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Objective: According to EU regulations (EU directive 2006/17/EC), blood specimens for virologic testing in the context of post-mortal tissue donation must be taken not later than 24 h post mortem., Methods: To verify validity of NAT in blood specimens collected later, viral nucleic acid concentrations were monitored in blood samples of deceased persons infected with HIV (n = 7), HBV (n = 5), and HCV (n = 17) taken upon admission and at 12 h, 24 h, 36 h and 48 h post mortem. HIV and HCV RNA were quantified using Cobas TaqMan (Roche), HBV DNA was measured by in-house PCR., Results: A more than 10-fold decrease of viral load in samples taken 36 h or 48 h post mortem was seen in one HIV-infected patient only. For all other patients tested the decrease of viral load in 36-hour or 48-hour post-mortal samples was less pronounced. Specimens of 3 HIV- and 2 HBV-infected patients taken 24 h post mortem or later were even found to have increased concentrations (>10-fold), possibly due to post-mortem liberation of virus from particular cells or tissues., Conclusion: Our preliminary data indicate that the time point of blood collection for HIV, HBV and HCV testing by PCR may be extended to 36 h or even 48 h post mortem and thus improve availability of tissue donations.
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- 2012
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16. Coding of tissue preparations with eurocode in Germany.
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Knels R, Hans-Joachim M, Wittmann G, von Versen R, and Pruss A
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Summary: A safe look back of products requires their unique identification. Blood products are encoded in Germany with Eurocode since 1987. EU Directives 2004/23/EC und 2006/86/EC demanded unique identification and safe look back procedure also for tissues and cells. Eurocode IBLS e.V. and the DGTI working parties 'Tissue Preparations' and 'Automation and Data Processing' supplemented the already available Eurocode nomenclature for blood products with further data structures for tissue preparations and deliberated the federal authorities during the EU hearings. In result all EU member states can administer the coding system oneself, but have to take care about the 'key code' structure as defined and the common part at the begin of the ID number of the preparations. Eurocode today offers an EU-conform coding system considering various aspects of blood, tissue and cell preparations in an ISO-standardized form.
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- 2012
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17. Comparison of in situ Corneoscleral Disc Excision versus Whole Globe Enucleation in Cornea Donors Regarding Microbial Contamination in Organ Culture Medium - a Prospective Monocentric Study over 9 Years.
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Schroeter J, Wilkemeyer I, Herrlinger F, and Pruss A
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Background: CORNEAS NEEDED FOR KERATOPLASTY CAN BE HARVESTED USING TWO TECHNIQUES: whole globe enucleation and in situ excision of the corneoscleral disc. This study evaluates the rate of microbial contamination of the donor cornea organ culture medium according to the method of retrieval., Methods: All donor corneas of our cornea bank received between January 1, 2001 and December 31, 2009 put into organ culture and microbio-logically tested were prospectively analyzed for microbial contamination of the organ culture medium., Results: 2,805 donor corneas could be included in this study in total. 975 of them were retrieved by whole globe enucleation (group 1) and 1,830 by in situ corneoscleral disc excision (group 2). 15 corneas of group 1 (1.5%) and 46 corneas of group 2 (2.5%) showed a contamination of the organ culture medium. The difference was shown not to be statistically significant (p = 0.082)., Conclusion: The rate of microbial contamination in organ-cultured donor corneas does not seem to be dependent on the method of their retrieval.
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- 2012
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18. Validation of the Microbiological Testing of Tissue Preparations Using the BACTEC™ Blood Culture System.
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Schroeter J, Wilkemeyer I, Schiller RA, and Pruss A
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Background: Since blood culture bottles are validated by the manufacturer for blood only, an additional validation for the use with fluids of tissue preparations is necessary., Methods: Two 10-ml samples of cornea culture medium, histidine-tryptophan-ketoglutarate (HTK) solution, or Ringer solution at the end of femur head thermo-disinfection were given into blood culture bottles (BD BACTEC™ Plus Aerobic/F, Anaerobic/F for cornea culture medium and BD BACTEC™ Standard Aerobic/Anaerobic for HTK and Ringer solution) and subsequently spiked with 10-100 colony forming units (CFU) of bacteria or fungi (aerobic bacteria: Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa; anaerobic bacteria: Clostridium sporogenes; fungi: Candida albicans, Aspergillus brasiliensis) according to the European Pharmacopoeia Chapter 2.6.1., Results: All tested bacteria and fungi could be detected in all solutions. All positive and negative controls were tested correctly. Compared to the positive controls, the microbial growth was delayed in the antibiotic-containing cornea culture medium, and negative in two cases of B. subtilis spiking., Conclusion: The use of BACTEC™ blood culture bottles seems to be a suitable method for microbiological testing of HTK solution, Ringer solution, and, with limitations, also for testing of the antibiotic-containing cornea culture medium.
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- 2012
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19. Current trends in tissue banking.
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Pruss A and Kalus U
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- 2012
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20. Inactivation Effect of Standard and Fractionated Electron Beam Irradiation on Enveloped and Non-Enveloped Viruses in a Tendon Transplant Model.
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Schmidt T, Hoburg AT, Gohs U, Schumann W, Sim-Brandenburg JW, Nitsche A, Scheffler S, and Pruss A
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BACKGROUND: For increasing allograft tendon safety in reconstructive surgery, an effective sterilization method achieving sterility assurance including viruses without impairing the grafts properties is needed. Fractionated Electron Beam (Ebeam) has shown promising in vitro results. The proof of sufficient virus inactivation is a central part of the process validation. METHODS: The Ebeam irradiation of the investigated viruses was performed in an optimized manner (oxygen content < 0.1%, -78 °C). Using principles of a tendon model the virus inactivation kinetics for HIV-2, HAV, pseudorabies virus (PRV) and porcine parvovirus (PPV) were calculated as TCID(50)/ml and D(10) value (kGy) for the fractionated (10 × 3.4 kGy) and the standard (1 × 34 kGy) Ebeam irradiation. RESULTS: All viruses showed comparable D(10) values for both Ebeam treatments. For sufficient virus titer reduction of 4 log(10) TCID(50)/ml, a dose of 34 kGy of the fractionated Ebeam irradiation was necessary in case of HIV-2, which was the most resistant virus investigated in this study. CONCLUSION: The fractionated and the standard Ebeam irradiation procedure revealed comparable and sufficient virus inactivation capacities. In combination with the known good biomechanical properties of fractionated Ebeam irradiated tendons, this method could be a safe and effective option for the terminal sterilization of soft tissue allografts.
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- 2012
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21. Tissue Banking and Transfusion Medicine - a Suitable Cooperation Model.
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Pruß A
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- 2011
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22. Validation of the Serological Testing for Anti-HIV-1/2, Anti-HCV, HBsAg, and Anti-HBc from Post-mortem Blood on the Siemens-BEP-III Automatic System.
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Kalus U, Wilkemeyer I, Caspari G, Schroeter J, and Pruss A
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BACKGROUND: Some properties of blood are modified post mortem. These modifications might give false-negative or false-positive results in infectious disease testing. Most CE-marked test equipment for infectious serology testing is not validated for testing post-mortal blood. Validation, however, is obligatory, if the results are used for the release of tissues for transplantation. MATHODS: Samples of pre- and post-mortem sera were obtained from 20 cornea donors, and the results were compared for anti-HIV-1/2, anti-HCV, HBsAg, and anti-HBc on the Siemens-BEP-III Automatic System. Negative post-mortem sera were spiked with standard sera (PEI anti-HCV IgG, PEI HBsAg ad 1000 standard, anti-HBc IgG (WHO) NIBSC 95/522, PEI anti-HIV-IV) in concentrations which give low- and high-positive results for the respective marker. RESULTS: All pre-mortem sera were negative for all markers. None of the post-mortem samples was false-positive. None of the spiked postmortem samples was false-negative. Technical errors occurred during the validation process but could be detected and eliminated. Serum samples should be centrifuged immediately after collection, and it must be taken into account that post-mortem serum could rarely lead to blockage of pipetting systems due to clotting phenomena. CONCLUSION: There is no indication that post-mortem samples give false-negative or false-positve results with the test system and test kits used. The procedure described might serve as a model for validating other test kits on post-mortem samples.
- Published
- 2011
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