摘要:

AbstractThe small‐scale production of a severely heated factor VIII concentrate is described. As starting material for the production 48 units of fresh frozen plasma from whole‐blood donations or 24 units of plasma from apheresis are used. During a glycine and sodium chloride fractionation, contaminating proteins are removed from a pooled extract of single‐donor cryoprecipitates. The resulting factor VIII‐rich precipitate is redissolved in freeze‐drying buffer and this solution is desalted by diafiltration. After filtration, this solution is dispensed into 10 vials and frozen. The product is freeze dried, and heat treated at 80°C for 72 h. The mean yield of the heat‐treated product improved from 160 IU factor VIII per liter plasma at the start of the production to 215 IU per liter plasma after a modification of the purification process. The validation of the virus inactivation during freeze‐drying and 80°C heat treatment for 72 h showed a reduction of ≥7.6 log PFU/ml for Sindbis and a reduction of ≥6.4 log TCID50/ml for HIV‐1. The factor VIII concentrate was clinically tested in 6 patients. It possessed a normal half‐life, showed a high recovery and no side effects. A Dutch license was granted in June 1991 and since then this product has been routinely manufactured in

ISSN:0042-9007    

DOI:10.1111/j.1423-0410.1994.tb00288.x

出版商:Blackwell Publishing Ltd    

年代:1994

数据来源: WILEY

摘要:

AbstractDuring product development of a factor VIII concentrate (Dutch blood banks) the conversion from unsterilized to autoclaved freeze‐drying buffer caused impaired product characteristics after severe dry heat treatment (80°C for 72 h). Analysis of the freeze‐drying buffers showed the presence of fructose and glucose in heated buffers, resulting from hydrolysis of sucrose. The detrimental effect of glucose and fructose on solubility, yield of factor VIII and color of the heat‐treated product was confirmed by freeze‐drying and heating products spiked with increasing levels of these monosaccharides. The effect of the use of freeze‐drying buffers autoclaved with and without sucrose was examined in two other factor VIII concentrates, S(8) and Z8 (Protein Fractionation Centre, Edinburgh, UK). If sucrose was present during autoclaving of the buffer, a slightly lower yield over freeze‐drying and 80°C heat treatment was observed.Since glucose is present as a substrate in the medium for the host cells during cultivation of viruses, its potential effect on the 80°C heated product (Dutch blood banks) was examined during the validation study of the inactivation of HIV‐1 and Sindbis. The cultivation cycles for the virus inolcula were simulated and residual glucose levels measured. In the supernatant medium of the host cell culture used for the propagation of Sindbis no residual glucose was found. Glucose however was found in the supernatant medium of the host cell culture for propagation of HIV‐1, and therefore small molecular weight substances were removed from the actual HIV‐1 inoculum by ultrafiltration. The study of the inactivation of both viruses during freeze‐drying and 80°C heat treatment was subsequently carried ou

ISSN:0042-9007    

DOI:10.1111/j.1423-0410.1994.tb00289.x

出版商:Blackwell Publishing Ltd    

年代:1994

数据来源: WILEY

摘要:

AbstractHLA alloimmunization following blood transfusion results from recipient exposure to donor alloantigens. Numerous studies have documented that intact donor leukocytes are capable of provoking primary alloimmunization and that leukoreduction can decrease the incidence of primary HLA alloimmunization. HLA antigens also exist in soluble form and are present on leukocyte cell fragments. We measured the concentration of soluble HLA class I antigen in both standard and leukoreduced blood components during storage. Although the concentration of soluble class I HLA protein varied widely among different individuals, the concentration was stable during refrigerated storage of red cell concentrates and was not affected by leukocyte reduction by filtration. We also investigated whether or not HLA antigens present on leukocyte fragments were capable of stimulating either resting or in‐vitro‐primed lymphocytes in the mixed lymphocyte reaction (MLR). Leukocyte fragments prepared by repeated freeze‐thaw were found to express both class I and class II HLA antigens, but fragments were not able to stimulate in primary or secondary MLR even in cultures supplemented with recombinant interleukin‐2. These studies provide in vitro evidence to support the hypothesis that HLA antigens are not shed from intact cells to soluble forms during storage and that HLA alloantigens on cell fragments do not elicit a cellular immune r

ISSN:0042-9007    

DOI:10.1111/j.1423-0410.1994.tb00290.x

出版商:Blackwell Publishing Ltd    

年代:1994

数据来源: WILEY

摘要:

AbstractA simple technique for red blood cell (RBC) removal in major ABO‐incompatible bone marrow transplantation is reported requiring two centrifugation steps, special blood bags and a mechanical device to separate the buffy coat from RBCs within the bag. In 42 transplantations an average of 84% of nucleated cells was recovered with an average contamination of 7.5 ml packed RBCs. The preparations were well tolerated in all patients whose isoagglutinin titers had not been reduced. Bone marrow engraftment was not significantly different from control group

ISSN:0042-9007    

DOI:10.1111/j.1423-0410.1994.tb00291.x

出版商:Blackwell Publishing Ltd    

年代:1994

数据来源: WILEY

摘要:

AbstractThe true incidence of bedside transfusion errors, i.e. those happening when blood products have left the blood bank, is underestimated because published figures rely on reporting of clinically relevant events or on indirect methods. The SAnGUIS project assessing blood practice in a prospective and randomized fashion for 6 elective surgical procedures gave the opportunity to trace all transfused units and to identify steps at risk during blood delivery in surgery. We considered transfusion of a wrong unit as a major error and poor execution or documentation as a recording error.Over 15 months, 808 patients out of 1,448 were transfused with 3,485 units. A total of 165 errors were foundafterblood products had left the blood banks. Seven were misidentifications (0.74% of patients, 0.2% of units). Eight other major errors occurred in 4 (0.5%) patients. Major errors occurred during nonemergency situations, in wards or intensive care units. The remaining (‘recording’) 150 errors consisted of misrecordings (61), mislabellings (6), or failures to document transfusions in the medical records (83).All errors were uneventful except one misidentification which induced a transient, yet unreported, reaction.The ‘descending’ inquiry method used for this study showed that most errors pass unnoticed and are therefore not reported. Measurement of error rates may constitute an important quality indicator.Retrospective information of this survey to the concerned staff people provided an impetus to take adequate measures to reduce these bedside

ISSN:0042-9007    

DOI:10.1111/j.1423-0410.1994.tb00292.x

出版商:Blackwell Publishing Ltd    

年代:1994

数据来源: WILEY

摘要:

AbstractA third‐generation (gen.) screening and immunoblot assay (Ortho EIA‐3.0; Chiron RIBA‐3 prototype), using antigens derived from the capsid and different nonstructural regions (NS3, NS4 and NS5) of the hepatitis C virus viral genome, were evaluated in comparison with the corresponding second‐gen. assays (Ortho EIA‐2.0; revised Ortho EIA‐2.5; Chiron RIBA‐2). In 203 depository sera of blood donors, positive in EIA‐2.0, specificity of the screening assays was improved as shown by an increase in positive predictive value for viral carrier state from 0.23 (EIA‐2.0) to 0.37 (EIA‐2.5) and 0.52 (EIA‐3.0). Comparing the confirmation patterns on RIBA‐2 and RIBA‐3, this amelioration was mainly due to the specific elimination of false‐positive c22‐3 and c100‐3 reactions. Antibody response to the newly added NS5 antigen was not as prevalent as to the other antigens and had only a minor influence in sample allocation. In contrast, screening of 1,560 volunteer blood donors and 47 hemodialysis patients revealed 3 additional positive sera, only reacting with the NS5 antigen. However none of these isolated NS5 reactions could be confirmed on synthetic peptides [INNO‐LIA: NS5(p)] and none was PCR positive. A documented seroconversion, detected earlier with EIA‐3.0, was related to a better immunological response to the NS3 antigen and not to the additional NS5. From this pilot study third‐gen. assays appeared extremely useful in the reevaluation of HCV‐seropositive depository sera. However the additional value of the NS5 antigen in blood donor screening is still hypothetical and remains to be

ISSN:0042-9007    

DOI:10.1111/j.1423-0410.1994.tb00293.x

出版商:Blackwell Publishing Ltd    

年代:1994

数据来源: WILEY

摘要:

AbstractSince 1956 when Cartwright (Yt) was recognized as a new erythrocyte antigenic system, numerous studies about anti‐Ytaand anti‐Ytbantibodies have been published. A number of these studies described the laboratory techniques utilized in antibody identification, while others investigated the clinical importance of anti‐Yta, giving variable results. However, most authors agreed upon the homogeneity of expression in this antigenic system. In our study we have described a case regarding 1 Yt(a+) patient with anti‐Ytaantibody. Family studies indicated inheritance of a variant/variant expression of the Ytaantigen from the

ISSN:0042-9007    

DOI:10.1111/j.1423-0410.1994.tb00294.x

出版商:Blackwell Publishing Ltd    

年代:1994

数据来源: WILEY

摘要:

AbstractClassification of subjects with a partial D antigen is traditionally performed with immune anti‐D sera. The development of monoclonal antibodies enables a fine analysis to be made of the specificity of the epitopes that are present or missing in these cases. A systematic search in a Caucasian donor population of 17,500 revealed 8 unrelated male individuals (frequency 0.05%) with a red cell phenotype characteristic of partial D category VI, but without anti‐D in their serum. The relation to the ‘classic’ partial D category VI was investigated and is discussed, as is the observed serological heterogeneity of the partial D category VI group. Clinical consequences for the prevention of immunization of these subjects are me

ISSN:0042-9007    

DOI:10.1111/j.1423-0410.1994.tb00295.x

出版商:Blackwell Publishing Ltd    

年代:1994

数据来源: WILEY

摘要:

AbstractLewis phenotyping of 487 blood samples from Chinese newborn infants and young children, revealed that 50% of cord cells were Le(a–b+) and 50% Le(a–b–). The weak Lebantigen of Le(a–b+) cord cells is most likely produced by the newborn infant rather than of maternal origin and it appears that these infants eventually develop by way of an intermediate Le(a+b+) stage into the adult Le(a–b+) phenotype. Most infants with Le(a–b–) cord cells, but not all, appear to develop through a transitional Le(a+b–) stage, into Le (a+b+) by about 1 month of age, most likely continuing as such into adulthood. This development of Le(a–b–) cord cells into the adult Le(a+b+) phenotype is postulated to be the result of the weak secretor geneSeω. Those infants with Le(a–b–) cord cells that do not convert to Le(a+b+) during the first month of life, most likely remain as such into adulthood. The blood of 120 adult voluntary blood donors, used as controls, reconfirmed adult Chinese phenotypic frequencies of approximately 70% Le(a–b+), 22

ISSN:0042-9007    

DOI:10.1111/j.1423-0410.1994.tb00296.x

出版商:Blackwell Publishing Ltd    

年代:1994

数据来源: WILEY

摘要:

AbstractA series of 213 neutropenic patients were tested for the presence of granulocyte antibodies using the granulocyte chemiluminescence test (GCLT) and the granulocyte immunofluorescence test (GIFT). Sera containing lymphocyte (HLA) antibodies were excluded from the study. A direct GIFT was performed on granulocytes from 56 patients. Samples were obtained from patients with a range of clinical conditions including primary adult autoimmune neutropenia, autoimmune neutropenia of infancy, autoimmune neutropenia secondary to Felty's syndrome, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, proliferative disorders, bone marrow transplantation and patients with documented febrile or pulmonary transfusion reactions. Overall, granulocyte antibodies were detected in 52.1% of patient sera. Results for the GCLT and GIFT (IgG) were strongly correlated (plt;0.001) for both primary and secondary immune neutropenias. The results confirm the applicability of the GCLT in the granulocyte serology laboratory.

ISSN:0042-9007    

DOI:10.1111/j.1423-0410.1994.tb00297.x

出版商:Blackwell Publishing Ltd    

年代:1994

数据来源: WILEY