bluuebunny/crossref_metadata_2025_split huggingface dataset:
Development and evaluation of a shipping system for platelet components
Authors: George V.M. , Pringle T.C. , Kline L. , Friedman L.I. 
Published: March 2003

Background: Platelet concentrates and apheresis platelets must be maintained at a temperature as close as possible to 20 to 24°C during transport. To improve temperature control, ensure component quality, and meet handling and freight carrier needs, a new insulated shipping container system was developed and evaluated.Study Design and Methods: Molded polyurethane‐insulated shipping containers were loaded with different payloads of simulated platelet components, with or without gel‐based temperature stabilizing packs (TSPs). The containers were subjected to constant ambient temperature of 37, 4 or ‐10°C. Payload temperatures were continuously monitored, in situ, for 24 hours.Results: Temperature data are reported as the mean number of hours needed for components to warm or cool by 1 degree C. The temperature of payloads exposed to a constant 37°C ambient temperature increased by 1 degree C in 2.5 to 3.8 hours when no TSPs were included in the shipment and in 6.1 to 6.9 hours when TSPs were used. Exposure to a constant 4°C ambient temperature resulted in a 1 degree C temperature decrease in 1.8 to 3.4 hours without TSPs and in 4.6 to 5.6 hours with TSPs. At a ‐10°C ambient temperature, there was a 1 degree C drop within 1.0 to 1.6 hours without TSPs and within 2.7 to 2.9 hours with TSPs.Conclusion: The container and packing methods described moderate the rate of change in the temperature of platelet components during their exposure to challenging ambient conditions. The use of TSPs substantially improves the performance of the system. In addition, the system meets freight carrier requirements and is easy to use, environmentally friendly, and durable.
Use of a directly conjugated monoclonal anti‐D (BRAD‐3) for quantification of fetomaternal hemorrhage by flow cytometry
Authors: Lloyd‐Evans P. , Kumpel B. M. , Bromelow I. , Austin E. , Taylor E. 
Published: March 2003

BACKGROUND: Determination of the volume of fetal D‐positive cells in the circulation of D‐negative women after delivery is carried out to determine whether additional prophylactic anti‐D should be given to the mother. Although the Kleihauer‐Betke test is still widely used to calculate the fetomaternal hemorrhage, increasing use is being made of flow cytometry.STUDY DESIGN AND METHODS: A conjugated monoclonal anti‐ D was prepared by labeling purified BRAD‐3 (IgG3) with fluorescein isothiocyanate (FITC‐BRAD‐3). This reagent was used to label D‐positive red cells by a one‐step procedure: 5 microL of washed cells were incubated with 50 microL of FITC‐BRAD‐3 (50 micrograms/mL) at 37 degrees C for 30 minutes; then the cells were washed and 500,000 events were analyzed by flow cytometry.RESULTS: The FITC‐BRAD‐3 reagent effectively labeled D‐positive cells. The percentage of D‐positive cells in mixtures containing more than 0.04 percent D‐positive cells in D‐negative cells was accurately determined by using this reagent and flow cytometry. Although the Kleihauer‐Betke test was more accurate than this one‐step flow cytometric method at quantifying fetomaternal hemorrhage of < 1 mL, the flow cytometric method was more accurate in the 1‐ to 7‐mL fetomaternal hemorrhage range of 1 to 7 mL (whole‐blood equivalents). Analysis of 175 clinical samples for fetomaternal hemorrhage gave consistent quantification results with the three methods used: the Kleihauer‐Betke test, flow cytometry with FITC‐BRAD‐ 3, and flow cytometry with polyclonal anti‐D followed by FITC‐anti‐IgG.CONCLUSION: Labeling of samples with FITC‐BRAD‐3 was simple and rapid. By flow cytometric analysis, good separation of D‐positive from D‐ negative cells was obtained, and fetomaternal hemorrhage of > 1 mL was quantified accurately.
Assessment of blood donor privacy during health history interviews
Authors: Kline L. , Friedman L. I. , Dempesy D. , Rabinowitz W. M. , Popovsky M. A. 
Published: March 2003

BACKGROUND: Given the personal nature of health history interviews, it is important to provide donors with both visual and auditory privacy. Privacy is affected by variables such as background noise, the use of visual screens, and the loudness of the donor's voice.STUDY DESIGN AND METHODS: In Phase I of this study, an interview station and waiting area were simulated. To measure auditory privacy, a speech intelligibility test was given to subjects with and without the use of a free‐standing privacy screen and masking noise device. Phase II was a field trial designed to evaluate screens and masking noise. Background noise was measured during each blood collection operation, and donors completed a survey.RESULTS: In Phase I, speech intelligibility test scores ranged from 78 to 5.1 percent, depending on the type of visual screen and the number of masking noise devices used. In Phase II, with the use of screens, 94 percent of donors rated visual privacy as “good to excellent,” compared with 74 percent who did so when no screens were used. At many blood drives, the background noise level exceeded the level of the masking noise.CONCLUSION: The use of visual screens increases donors' perception of visual privacy. The use of masking noise is effective only when the health history interview is conducted under conditions of low background noise levels.
Clinical toxicity and laboratory effects of granulocyte‐colony‐ stimulating factor (filgrastim) mobilization and blood stem cell apheresis from normal donors, and analysis of charges for the procedures
Authors: Anderlini P. , Przepiorka D. , Seong D. , Miller P. , Sundberg J. , Lichtiger B. , Norfleet F. , Chan K.‐W , Champlin R. , Korbling M. 
Published: March 2003

BACKGROUND: Apheresis of granulocyte‐colony‐stimulating factor (filgrastim)‐mobilized blood stem cells from normal donors is now being used in place of a marrow harvest in transplantation. How the adverse effects of and charges for this procedure compare with those of the standard marrow harvest is not known.STUDY DESIGN AND METHODS: Forty consecutive normal subjects who received filgrastim 96 micrograms/kg) subcutaneously twice daily for 4 to 6 days in preparation for apheresis were monitored prospectively by clinical and laboratory evaluation.RESULTS: Sixty‐two percent of the subjects required oral analgesics. None discontinued filgrastim prematurely. Bone pain (82%), headache (70%), fatigue (20%), and nausea (10%) were reported. Filgrastim caused a mean eightfold increase in neutrophil counts, a mean twofold increase in lymphocyte counts, a mean twofold rise in alkaline phosphatase and lactate dehydrogenase levels, and minor changes in serum potassium, magnesium, and uric acid. Adverse events and laboratory effects resolved within 7 days after apheresis. No apheresis stem cell donor required transfusion or hospitalization, and only one required an additional clinic visit after completion of apheresis. By comparison, a retrospective analysis of 33 normal marrow donors demonstrated that all received transfusion(s), 3 were hospitalized, 3 required additional clinic visits after the marrow harvest. The median total charges related to the two procedures were comparable (p = 0.43), although the charges were significantly lower for donors requiring only one apheresis procedure (p = 0.002).CONCLUSION: Filgrastim mobilization and apheresis of blood stem cells constitute a safe, well‐tolerated, and comparable or less expensive alternative to the traditional marrow harvest.
Cryopreservation of hematopoietic progenitor cells with 5‐percent dimethyl sulfoxide at −80° C without rate‐controlled freezing
Authors: Galmés A. , Besalduch J. , Bargay J. , Matamoros N. , Durán M.A. , Morey M. , Alvarez F. , Mascaró M. 
Published: March 2003

Background: Cryopreservation of hematopoietic cells with the rate‐controlled method is used in the majority of centers. In recent years, there has been a trend toward the simplification of the process. Study Design and Methods: A simplified method for cryopreservation was developed with 5‐percent dimethyl sulfoxide (DMSO) as the sole cryoprotectant without rate‐controlled freezing. Experiments were done with progressive concentrations of DMSO, ranging from 0 to 10 percent. With DMSO concentrations from 5‐ to 10‐percent, the best recovery and viability for hematopoietic progenitor cells were observed. Hematopoietic progenitor cells with plasma and 5‐percent DMSO were frozen and stored in a −80° C mechanical freezer. Ten patients with solid and hematologic malignancies underwent transplantation with autologous hematopoietic progenitor cells. Results: The median number of transfused mononuclear cells and CD34+ cells was 3.70 (3.1–8.2) × 108 per kg and 1.70 (0.8‐6.5) × 106 per kg, respectively. The median number of transfused colony‐forming units‐granulocyte‐macrophage was 12.45 (3.4–55.3) × 104 per kg. All patients showed rapid and sustained engraftment. The mean times to reach a neutrophil count of 0.5 × 109 per L and a platelet count of 50 × 109 per L were 11.50 ± 1.70 and 13.90 ± 3.98 days, respectively. All patients are alive and without transfusion requirements in complete remission 2 to 8 months after transplantation. Conclusion: This simplified cryopreservation technique will be useful for institutions without rate‐controlled freezing facilities. Moreover, this method diminishes the amount of DMSO infused to patients, as well as its toxicity.
Allele‐specific restriction analysis of human platelet antigen system 4
Authors: Matsuo K. , Reid D.M. 
Published: March 2003

Background: Diagnosis, and occasionally treatment, of disorders involving platelet‐specific alloimmunization, including neonatal alloimmune thrombocytopenia and posttransfusion purpura, requires platelet allotyping. Allele‐specific restriction analyses for convenient genotyping are available for the major human platelet antigen (HPA) systems except HPA‐4. Study Design and Methods: An allele‐specific restriction analysis for HPA‐4 was developed by designing a polymerase chain reaction primer containing a single‐base substitution (A for T) at glycoprotein IIIa cDNA position 529. The resulting mismatch did not interfere with DNA amplification. Digestion of the polymerase chain reaction product with BsmI allowed differentiation of HPA‐4a and HPA‐4b alleles. Results: A 126‐bp polymerase chain reaction product was amplified with the novel primer. BsmI endonuclease cleaved product encoding HPA‐4a into 104‐ and 22‐bp fragments and left DNA encoding HPA‐4b intact. Conclusion: This rapid allele‐specific restriction analysis for genotyping the HPA‐4 system complements similar methods for other platelet alloantigenic determinants.
Cost‐effectiveness of expanded human immunodeficiency virus‐testing protocols for donated blood
Authors: AuBuchon J.P. , Birkmeyer J.D. , Busch M.P. 
Published: March 2003

BACKGROUND: This study was designed to estimate the cost‐effectiveness of expanding the human immunodeficiency virus (HIV)‐testing protocol for donated blood beyond screening for HIV antibodies to further reduce the risk of HIV transmission through transfusion.STUDY DESIGN AND METHODS: A Markov decision analysis model was developed to estimate the cost‐effectiveness of HIV antibody testing (at a cost of $5/unit) and of adding to that protocol a second HIV test, either plasma p24 antigen detection or RNA polymerase chain reaction (PCR) (at costs of $5/unit and $8/unit, respectively). Test efficacy was projected from anticipated window‐period reductions (6 days for p24 antigen, 11 days for RNA PCR), and donor seroconversion rates were derived from the Retrovirus Epidemiology Donor Study.RESULTS: On the basis of current estimates of HIV prevalence rates in blood donors (1/10,000) and 16 million annual transfusions in the United States HIV antibody testing prevents 1568 cases of transfusion‐acquired HIV infection each year at a cost of $3600 per quality‐adjusted year of life saved. The addition of p24 antigen testing would prevent 8 more cases at a net additional cost of $60 million annually ($2.3 million/quality‐adjusted life year); RNA PCR testing would prevent 16 more cases at a net additional cost of $96 million annually ($2.0 million/ quality‐adjusted life year).CONCLUSION: Although expanding the donor HIV screening protocol with p24 antigen or RNA PCR testing will prevent rare cases of transfusion‐associated HIV, the cost‐effectiveness of such an addition is predicted to be far below that of most medical interventions. Thus, HIV test protocol additions are unlikely to provide cost‐effective improvements to blood safety in the United States.
Indeterminate human immunodeficiency virus type 1 western blot may indicate an abortive infection in some low‐risk blood donors
Authors: Georgoulias V.A. , Malliaraki N. E. , Theodoropoulou M. , Spanakis E. , Fountouli P. , Tsatsaki D. , Kotsaki S. , Karvela‐Aggelaki A. , Malliaraki‐Pinetidou E. 
Published: March 2003

BACKGROUND: The infectious status of persons with an indeterminate human immunodeficiency virus type 1 (HIV‐1) Western blot must be established.STUDY DESIGN AND METHODS: Evaluation of the CD4 and CD8 T‐ cell subsets and the expression of HIV‐1‐integrated sequences by Southern blot and polymerase chain reaction were studied in a group of low‐risk subjects with an indeterminate Western blot.RESULTS: From a total of 45,000 blood donors and 50 patients with chronic renal failure on hemodialysis who were tested during the period of 1985 through 1990, 50 sera (0.1%) had an indeterminate Western blot. A low CD4:CD8 ratio (0.7‐1.2) was detected in 14 of 24 tested subjects, whereas the unfractionated and adherence‐enriched cells of 7 (32%) and 5 (23%) of 22 patients, respectively, could be stained with a p24 monoclonal antibody. A transient positive culture was detected in 3 of 20 subjects, but these viral isolates could not be transmitted to CEM‐A310 cells. Ultracentrifuged culture supernatants hybridized under high‐ stringency conditions with genomic gag‐pol (4 cases), env (3 cases), and tat (1 case) cDNA fragments of the HXB2 HIV‐1 clone. In one case, DNA obtained from adherent but not unfractionated mononuclear cells contained 3.3‐ and 3.9‐kb env‐ and gag‐pol‐related HIV‐1 sequences, respectively; these sequences were heavier than expected. Polymerase chain reaction analysis for gag and pol but not env sequences was positive in 1 and 2 of 7 cases, respectively. A female patient with a positive viral culture and who was positive for pol in polymerase chain reaction demonstrated a full seroconversion 19 months later.CONCLUSION: The results strongly suggest that, rarely, some low‐risk subjects with indeterminate Western blot results might be infected with low‐level replicative strains or HIV‐related viruses; thus, an exhaustive immunologic and virologic workup is needed for the investigation of these subjects.
A multicenter evaluation of the routine use of a new white cell‐ reduction apheresis system for collection of platelets
Authors: Fournel J.‐J. , Zingsem J. , Riggert J. , Muylle L. , Müller N. , Köhler M. , Beaumont J.‐L. , Baeten M. , Eckstein R. , van Waeg G. 
Published: March 2003

BACKGROUND: Residual white cells (WBCs) cause serious side effects in platelet transfusion. An in‐line WBC‐reduction system based on fluidized particle bed technology was recently developed as a modification of an existing plateletpheresis system.STUDY DESIGN AND METHODS: In an investigational phase, three flow profiles were evaluated using prototype software in five centers, each using their standard conditions. In the confirmatory phase, the released software was tested in three centers. WBCs were counted in two full Nageotte grids (dilution 1‐in‐5).RESULTS: With the prototype software, WBC levels were always below 1 × 106 per procedure (median, 25,000/procedure; n = 314). One profile proved to be superior to the other two with respect to platelet yield and residual WBCs, and it was incorporated in the released WBC‐reduction system, together with a built‐in process control. Median residual WBCs in these WBC‐reduction system components not rejected by the process control were 19,000 per procedure (n = 211/225 total), with 99.5 percent of the platelet components having less than 1 × 106 WBCs.CONCLUSION: The protocol selected in the initial phase, now available as a WBC‐reduction system, results in platelet concentrates with very low residual WBC levels. This satisfies even the most stringent criteria for WBC reduction in platelets, without the platelet loss typically seen with conventional fiber filtration.
Screening blood donations for viral genomes: multicenter study of real‐ time simulation using pooled samples on the model of hepatitis C virus RNA detection
Authors: Lefrère J‐J. , Coste J. , Defer C. , Mercier B. , Férec C. , Loiseau P. , Portelette E. , Mariotti M. , Lerable J. , Rouger P. , Pawlotsky J.‐M. 
Published: March 2003

BACKGROUND: The systematic screening for several blood‐borne viral genomes in blood donations is a complementary safety measure planned or discussed by the national authorities of several countries.STUDY DESIGN AND METHODS: To appreciate the feasibility of such screening using pooled samples, a multicenter study of real‐time simulation has been performed on the model of hepatitis C virus (HCV) infection. Four blood transfusion center laboratories and two research and diagnosis laboratories simultaneously screened, by several HCV RNA polymerase chain reaction assays, a panel of plasma sample pools of different sizes (500, 100, and 10 samples), collected from HCV‐infected or HCV‐ uninfected blood donors. One viremic plasma was introduced in each pool. HCV RNA was detected by in‐house polymerase chain reaction procedures or by standardized manual or semi‐automated polymerase chain reaction assays.RESULTS: The results indicate the feasibility of sample pooling, which renders the screening for viral genomes by molecular biology techniques applicable in the short term and the importance of the experience of laboratory personnel in the use of molecular biology tools.CONCLUSION: The improvement of standardized assays needs to be continued, and training of laboratory staff members appears to be a crucial step before systematic screening of blood donations for viral genomes by molecular biology techniques can occur.
Hemagglutination inhibition of Cromer blood group antibodies with soluble recombinant decay‐accelerating factor
Authors: Daniels G. L. , Green C. A. , Powell R. M. , Ward T. 
Published: March 2003

BACKGROUND: Cromer blood group antigens are located on decay‐ accelerating factor (DAF, CD55), which contains four short consensus repeats (SCRs). Cromer system antibodies may be of clinical significance in blood transfusion.STUDY DESIGN AND METHODS: Soluble recombinant DAF (srDAF) constructs, consisting of all four SCRs or of only two SCRs, were expressed in the yeast Pichia pastoris. They are used in hemagglutination‐inhibition tests with Cromer system antibodies and with DAF‐specific monoclonal antibodies.RESULTS: The srDAF inhibited hemagglutination by all Cromer system alloantibodies in undiluted serum. Antibodies to antigens of other blood group systems were not inhibited by the srDAF. Hemagglutination‐inhibition tests with domain‐deleted srDAF showed that UMC is on SCR‐4 and confirmed that Tca, TcaTcb, and WESb are on SCR‐1; Dra is on SCR‐3; and Cra is on SCR‐ 4.CONCLUSIONS: Hemagglutination inhibition with srDAF is useful in the recognition of antibodies that belong to the Cromer blood group system and facilitates pretransfusion testing. This use of domain‐deleted srDAF provides an easy method of determining epitope location on DAF and is an aid to more precise identification of Cromer system antibodies.
An Israeli family with six cisAB members: serologic and enzymatic studies
Authors: Bennett M. , Levene C. , Greenwell P. 
Published: March 2003

BACKGROUND: The cisAB blood type is a rare phenomenon in which both the A and B blood types are inherited from a single parent. Several forms of this phenotype have been characterized that differ with respect to serologic reactions and the activities of the gene‐encoded blood group A and B transferases.STUDY DESIGN AND METHODS: The cisAB blood type was suspected when a baby typed as blood group O was born to a mother whose blood group was AB. Family studies revealed four generations in whom the pattern of inheritance could be explained only by the inheritance of the cisAB genotype. Blood and saliva samples from the family were tested serologically and assayed for the relevant glycosyltransferases. Samples suitable for DNA analysis were not available.RESULTS: Six family members were shown serologically to be of the cisAB type. The A and B transferases in the sera of these individuals were 20 to 35 and 25 to 50 percent of those obtained for A and B individuals, respectively. The enzymic characteristics of the A and B transferases were determined. The A transferase in the sera of the cisAB persons did not bind to agarose beads.CONCLUSION: The family described carries the cisAB gene, which encodes production of A and B transferases that differ from those of “normal” A, AB, and B controls. This variant has properties that are distinctly different from those described in other reports.
Improved progenitor assay standardization using peripheral blood progenitor cells from a donor treated with granulocyte–colony‐stimulating factor
Authors: Burger S.R. , Kadidlo D. , McCullough J. 
Published: March 2003

BACKGROUND: Progenitor assays are the principal method for evaluating hematopoietic cell function. The magnitude of assay variability and the assay steps contributing to variability were determined, and modifications intended to increase assay consistency were evaluated.STUDY DESIGN AND METHODS: Assays were performed using a serum‐free progenitor assay medium with cells plated at 5.0 × 104 and 1.0 × 105 cells per plate. A peripheral blood progenitor cell component collected from a normal donor after administration of granulocyte–colony‐stimulating factor was divided into identical aliquots. Each experiment involved at least 5 technologists, each performing assays in duplicate on five aliquots, with each person scoring all assay plates. Three sample preparation methods were tested: 1) ficoll mononuclear cell enrichment and sample dilution, 2) sample dilution without ficoll separation, and 3) sample dilution without ficoll separation, with cell counts performed before and after each dilution step, dilution volumes calculated on the basis of each cell count, automated electronic pipettors used in dilution steps, and colony frequency calculated on the basis of cell counts from the final specimen.RESULTS: Global variability for colony‐forming units–granulocyte‐macrophage, represented by the percentage of CV for all specimens and all technologists, was 89.6 percent at 5.0 × 104 cells per plate and 81.3 percent at 1.0 × 105, when ficoll separation was used. Subjective differences in scoring plates did not account for most of the variability observed, as results for any individual plate read by multiple technologists had a mean CV of 15.6 percent and 19.7 percent at the two plating concentrations. Method 3 resulted in the greatest improvement, reducing CV to 24.4 percent at 5.0 × 104 cells per plate and to 24.2 percent at 1.0 × 105 cells per plate. Similar results were obtained for erythroid–burst‐forming units.CONCLUSIONS: Baseline assay results were extremely inconsistent. Interindividual differences in colony interpretation did not contribute significantly to assay variability, although sample preparation and plating did. Improved control over cell concentration decreased assay variability by 70 to 73 percent.