bluuebunny/crossref_metadata_2025 huggingface dataset:
Comparison of the recovery and half‐life of a high‐purity factor IX concentrate with those of a factor IX complex concentrate. Factor IX Study Group
Authors: Poon M. ‐C. , Aledort L. M. , Anderle K. , Kunschak M. , Morfini M. , Group The Factor IX Study
Published: March 2003

BACKGROUND: Recovery and half‐life estimations were carried out to compare a high‐purity factor IX concentrate with an established factor IX complex concentrate. STUDY DESIGN AND METHODS: Two high‐purity factor IX concentrates, which are identical except for the presence or absence of heparin (Immuninehep‐plus and Immuninehep‐minus), were evaluated in two independent crossover studies using an intermediate‐ purity factor IX complex concentrate (Bebulin) as reference drug. RESULTS: In the Immuninehep‐plus crossover study (n = 27), Immuninehep‐ plus and Bebulin had, respectively, a recovery of 0.90 +/− 0.26 and 0.84 +/− 0.23 IU per dL per IU per kg, a compartmental half‐life of 17.11 +/− 6.18 and 15.94 +/− 4.69 hours, and an effective half‐life of 16.51 +/− 3.48 and 16.48 +/− 4.26 hours. In the Immuninehep‐minus crossover study (n = 26), Immuninehep‐minus and Bebulin had, respectively, a recovery of 0.92 +/− 0.31 and 1.02 +/− 0.36 IU per dL per IU per kg, a compartmental half‐life of 17.42 +/− 5.60 and 18.77 +/− 6.27 hours, and an effective half‐life of 16.39 +/− 4.44 and 16.48 +/− 4.28 hours. Equivalence tests indicated that the recovery and half‐life of Immunine, with or without heparin, are equivalent to those of Bebulin. CONCLUSION: The equivalence in pharmacokinetics and bioavailability indicates that the dosage schedule for Immunine should be the same as or very similar to that of Bebulin. The high specific activity of the former, however, allows administration at lower volumes.
Immune responsiveness in orthopedic surgery patients after transfusion of autologous or allogeneic blood
Authors: Tietze M. , Klüter H. , Troch M. , Kirchner H.
Published: March 2003

BACKGROUND: The proposed immunosuppressive effect of blood transfusion is not yet understood, and the clinical relevance is a controversial topic of discussion.

STUDY DESIGN AND METHODS: The effect of blood transfusions on the capacity of the host's immunocompetent cells to react to mitogenic stimulation was evaluated. Patients undergoing hip replacement surgery received either allogeneic (n = 13) or autologous (n = 14) buffy coat‐depleted red cells or plasma. Patients' blood samples taken before and on Days 1 and 5 after surgery were stimulated in a whole‐blood assay. The release of interleukin 2, soluble interleukin 2 receptor, interleukin 6, tumor necrosis factor alpha, interferon alpha 2, and interferon gamma was assessed by enzyme‐linked immunosorbent assay. In addition, the white cell counts and frequencies of the lymphocyte subsets CD4+, CD8+, and natural killer cells were analyzed.

RESULTS: For both groups, decreased levels of interleukin 2 and interferon‐gamma were detected postoperatively, whereas the values for soluble interleukin 2 receptor and tumor necrosis factor alpha showed no significant change. Interferon alpha 2 was decreased on Day 1, but returned to normal by Day 5. Interleukin 6 increased during the time of observation. There were no significant differences between the two groups in cytokine production and lymphocyte‐subset analysis that could be attributed to the transfusion of allogeneic blood.

CONCLUSION: The transfusion of buffy coat‐depleted red cells showed no immediate suppressive effect on the immune function of the host's peripheral blood cells.
The effect of donor red cell sedimentation rate on efficiency of granulocyte collection by centrifugal leukapheresis
Authors: Lee J.‐H. , Klein H. G.
Published: March 2003

BACKGROUND: Granulocyte collection relies on the use of a red cell‐ sedimenting agent and is influenced by poorly defined intrinsic donor characteristics. The donor's baseline red cell (erythrocyte) sedimentation rate (ESR), a readily measurable intrinsic donor variable, may influence the effectiveness of red cell‐sedimenting agents and affect the granulocyte yield.

STUDY DESIGN AND METHODS: The in vitro and in vivo effects of 6‐percent hydroxyethyl starch on the donor ESR were prospectively studied in 67 granulocytapheresis procedures with a blood cell separator, and the findings were correlated with granulocyte collection efficiency (GCE). A relationship that predicts the GCE on the basis of the donor ESR was then derived and tested.

RESULTS: The 3.7‐fold mean increase in the donor ESR measured after in vitro addition of hydroxyethyl starch approximated the 3.3‐fold increase measured when it was administered to the donors. Higher baseline ESR correlated with larger in vitro and in vivo hydroxyethyl starch‐induced increases in ESR and predicted more efficient cell collections and greater cell yields. Furthermore, both ESR and GCE, which varied significantly among donors, remained constant for a given donor undergoing repeat procedures. The results could be summarized by a simple predictive formula that relates the GCE (%) to the ESR (mm/hour): GCE = 1.3ESR + 45. The GCE and yield as predicted by the formula were accurate within 10 percent of the observed values in six subsequent procedures.

CONCLUSION: In granulocyte harvests using a blood cell separator with hydroxyethyl starch as the sedimenting agent, 1) both ESR and GCE vary widely among donors yet may remain relatively constant for a given donor; 2) the baseline ESR correlates with hydroxyethyl starch‐modified ESR and with GCE; and 3) it may be possible to predict GCE and yield from the donor's baseline ESR.
A comprehensive transfusion medicine curriculum for medical students. Transfusion Medicine Academic Award Group
Authors: Cable Ritchard G. , Thal Sara E. , Fink Arlene , Calhoun Loni , Petz Lawrence D.
Published: March 2003

BACKGROUND: The Transfusion Medicine Academic Awards (TMAA) program, sponsored by the National Heart, Lung, and Blood Institute, has provided grants to medical schools to help them develop comprehensive curricula in transfusion medicine. In 1989, the TMAA Group published a set of comprehensive curricular goals for teaching transfusion medicine. The medical student portion of this curriculum has now been revised to reflect new developments in transfusion medicine and recent trends in medical school education. STUDY DESIGN AND METHODS: Two medical schools independently revised the 1989 curriculum for their students. Because significant similarities were noted between curricula of the two institutions, the two revisions were combined and submitted to all TMAA institutions for comment. As a result, a revised medical school curriculum was developed and approved by the TMAA Group. RESULTS: The revised curriculum consists of 28 objectives in six major areas of transfusion medicine. It is presented in its entirety in this article. CONCLUSION: The TMAA transfusion medicine curriculum should provide to medical schools a valuable resource for evaluating their teaching of transfusion medicine and should provide to medical school deans and curriculum committees an authoritative source of transfusion medicine expertise.
Comparison of two anti‐hepatitis C virus enzyme‐linked immunosorbent assays
Authors: Vrielink H. , Zaaijer H. L. , Lelie P. N. , van der Poel C. L.
Published: March 2003

BACKGROUND: Third‐generation anti‐hepatitis C virus (HCV) enzyme‐linked immunosorbent assays (ELISA) are now implemented in most laboratories in Europe, but have not yet been fully implemented in the United States.

STUDY DESIGN AND METHODS: Two ELISAs (Ortho 3.0 and Ortho 2.0, Ortho Diagnostics, Raritan, NJ) were compared by tests on various serum panels: A) blood donor samples (n = 530) that tested positive in first‐ or second‐generation anti‐HCV ELISA; B) samples from persons with chronic non‐A, non‐B hepatitis (n = 185); C) samples from multiply transfused patients (n = 79); D) samples from patients on hemodialysis (n = 473); and E) samples from Dutch random blood donors (n = 2153).

RESULTS: In panels A, B, and C, 247 (100%) of 247 polymerase chain reaction (PCR)‐positive and 278 (100%) of 278 second‐generation recombinant immunoblot assay (RIBA‐2)‐positive specimens were detected by Ortho 2.0 and 3.0 (sensitivity, 100%). In the sera of panel D, used to represent a group of patients with a high risk for HCV, no additional positives were found by Ortho 3.0. In panel E, of 2153 blood donor samples, 2 (0.1%) were positive in Ortho 2.0 and 8 (0.4%) in Ortho 3.0. Two samples that were positive in both Ortho 2.0 and 3.0 were also positive in RIBA‐2; one was positive on PCR. From the 6 remaining Ortho 3.0‐positive (Ortho 2.0‐negative) samples, 1 was positive in RIBA‐2 (isolated anti‐c100) and 3 were positive in third‐ generation RIBA (1/3 isolated anti‐c100, 2/3 isolated NS5). All 6 samples were PCR negative. In first‐time donors, no difference in specificity was found.

CONCLUSION: The sensitivity and specificity of the Ortho 3.0 ELISA are comparable to those of the Ortho 2.0 ELISA.
Analysis of apheresis content of progenitor cell collections from normal donors to whom granulocyte‐colony‐stimulating factor is administered
Authors: Weinthal J. A. , Nemunaitis J. J. , Aston S. , Magsamen M. J. , Rosenfeld C. S.
Published: March 2003

BACKGROUND: Allogeneic blood cell transplantation is a new alternative to bone marrow transplantation. Preliminary data suggest that granulocyte‐colony‐stimulating factor (G‐CSF)‐mobilized peripheral blood progenitor cells from normal donors can provide rapid hematopoietic engraftment without significant increases in transplant‐ related morbidity. Potential advantages to donors include the elimination of an operation under general anesthesia. STUDY DESIGN AND METHODS: Twenty‐one normal donors underwent high‐dose (16 pg/kg/day for 5 days) G‐CSF mobilization. Apheresis was performed on the fifth and sixth days of G‐CSF administration, and apheresis components were analyzed by flow cytometry. Donor characteristics in relationship to apheresis yields were also analyzed. RESULTS: Apheresis components were analyzed according to donor weight. The median total numbers of white cells per kg, CD34+ cells per kg, and CD3+ cells per kg were 10.8 × 10(6), 7.2 × 10(8), and 295 × 10(8), respectively. Day 5 collections had significantly higher nucleated cell content and median CD34+ percentages than did Day 6 collections (0.71% on Day 5 vs. 0.58% on Day 6, p < 0.01). CD34+ content and total white cells were not related to age or sex. No donors experienced toxic effects that required their removal from the study. CONCLUSION: Day 5 is the optimal day for the harvest of normal‐donor peripheral blood progenitor cells after mobilization with high‐dose G‐CSF. Older individuals are acceptable donors of allogeneic progenitor cells.
A novel strategy to limit blood donor exposure and blood waste in multiply transfused premature infants
Authors: Wang‐Rodriguez J. , Mannino F. L. , Liu E. , Lane T. A.
Published: March 2003

Background: Small, premature infants require frequent small‐volume transfusions. Traditional methods of transfusion expose these infants to multiple blood donors. It has recently been demonstrated that multiple donor exposures can be safely prevented in these infants by the assignment of fresh units to them and by the use of a sterile connecting device to remove blood for transfusion, as needed until the expiration of the unit. However, the program resulted in the wasting of approximately 60 percent of the blood in each unit.

Study Design and Methods: To minimize blood waste without compromising the goal of limiting donor exposure, a model designed to predict each infant's transfusion requirements was investigated. The model assigned infants predicted to have high transfusion requirements to receive blood from a unit dedicated to their individual use. All other infants were assigned to receive blood from a unit that could be shared among as many as four similar infants. Infant donor exposure and blood unit wastage after institution of the infant assignment model were compared with the same measurements obtained before the use of the model, during which time infants were assigned to dedicated units at the discretion of the physician.

Results: The numbers of transfusions per infant (3.5 +/− 2.3) and of donor exposures per infant (1.5 +/− 0.7) under the assignment model were unaltered from those in controls (4.1 +/− 2.9 transfusions and 1.6 +/− 0.8 donor exposures); however, there was significantly less blood wastage in the group assigned to shared units (32 +/− 28%) than in the group assigned to dedicated units (62 +/− 17%; p < 0.05) or than was seen in an earlier study (60 +/− 23% wasted; p < 0.05).

Conclusion: Improved management of blood resources can be achieved within the context of a transfusion program designed to safely limit donor exposure in infants who require frequent transfusion.
Patients' attitudes regarding out‐of‐hospital blood transfusion
Authors: Benson K. , Balducci L. , Milo K. M. , Heckel L. , Lyman G. H.
Published: March 2003

BACKGROUND: While the administration of blood transfusions outside of the hospital has become more prevalent, little is known about patients' attitudes regarding this practice.

STUDY DESIGN and METHODS: Twenty‐ nine adult patients who regularly received blood transfusions in a hospital's outpatient clinic and had never received home transfusions were surveyed. Linear analogue and categorical monetary scales were used to evaluate their responses to a series of questions.

RESULTS: At the time of the survey, 27 study participants (93%) did not want home transfusions, and 21 (72%) thought home transfusions posed a greater risk than hospital based transfusion. More than half (56%) of the participants were unwilling to pay more for a home transfusion for themselves than for an outpatient hospital‐based transfusion. Participants were willing to pay more for a home blood transfusion for a hypothetical patient requesting transfusions at home. The lack of available transportation and poor patient health were identified as important factors in determining how much more they would be willing to pay for transfusions at home.

CONCLUSION: While blood transfusions at home may become more accessible, many patients may prefer to receive their transfusions in the hospital, probably because home transfusions are thought to pose a greater risk. A patient's health and the availability of transportation were determined to be important factors in decisions about how much more money to spend for transfusions at home than for those in an outpatient hospital setting.
Risk factors for Trypanosoma cruzi infection in California blood donors
Authors: Galel S.A. , Kirchhoff L.V.
Published: March 2003

Background: Trypanosoma cruzi, the protozoan parasite that causes Chagas'disease, is endemic in Central and South America and in Mexico. Risk of infection is related to exposure to insects harboring T. cruzi or to the transfusion of blood from an infected donor. Large numbers of immigrants from endemic areas reside in California, but the frequency with which persons at risk for T. cruzi contribute to the blood supply there is not known.

Study Design and Methods: A questionnaire was used to survey donors in 18 California donor centers for risk factors for T. cruzi infection.

Results: Otherwise eligible allogeneic blood donors (n = 17,521) completed questionnaires. Of this group, 427 (2.4%) had lived in endemic areas for more than 1 year, and 39 of these donors had lived in dwellings with mud walls or thatched roofs. Sixteen donors had received transfusions in endemic areas. Six donors gave a history of Chagas' disease. Fifty‐seven donors (0.33% of total) had at least one risk factor for T. cruzi infection. Donors at risk for T. cruzi were found in all 18 centers studied, at a median prevalence of 1 per 340 donors.

Conclusion: Donors at risk for T. cruzi are contributing to the blood supply throughout California. Further consideration should be given to donor screening for this transfusion‐transmissible infection.
Hemolytic anemia in chronic large granular lymphocytic leukemia of natural killer cells: Cytotoxicity of natural killer cells against autologous red cells is associated with hemolysis
Authors: GILSANZ F. , de la SERNA J. , MOLTó L. , ALVAREZ‐MON M.
Published: March 2003

BACKGROUND: It has ben suggested that natural killer cells are effectors in some hemolytic transfusion reactions, but a direct mechanism of the destruction of red cells has not been demonstrated.

CASE REPORT: Lytic activity of natural killer cells against autologous red cells was found in a patient with large granular lymphocytic leukemia of natural killer cells and hemolytic anemia, with no evidence of immune antibody or complement‐mediated hemolysis. Large granular lymphocytes in the blood showed a CD2+ CD3‐ CD16+ CD57+ phenotype, cytotoxic activity against natural killer cell‐sensitive K562 target cells, and no lytic activity against natural killer cell‐resistant JY target cells. Cytotoxicity directed against red cells was quantified by a 51Cr‐specific release assay with autologous and ABO‐identical red cells used as target cells and the patients purified natural killer cells used as effector cells in the presence and absence of autologous serum. The cytotoxic activity of natural killer cells was directed against autologous red cells but not against allogenic red cells, and it was not enhanced by the presence of autologous serum in the medium. Clinical remission was induced by the administration of cyclophosphamide, after which no evidence of cytotoxic activity against the red cells could be found. CONCLUSION: Hemolytic anemia in the presence of a negative direct antiglobulin test can be attributed to a direct cytotoxic mechanism mediated by natural killer cells.
Third‐generation recombinant immunoblot assay: comparison of reactivities according to hepatitis C virus genotype
Authors: Dow B. C. , Munro H. , Buchanan I. , Follett E. A.C. , Davidson F. , Yap P. L. , Simmonds P.
Published: March 2003

BACKGROUND: Recombinant immunoblot assay (RIBA) is widely used as a supplemental test in hepatitis C virus (HCV) confirmatory algorithms. As this assay is based on HCV type 1, its performance was examined with the common European HCV genotypes (1, 2, and 3). STUDY DESIGN AND METHODS: A study was performed to retest in third‐generation RIBA (RIBA‐ 3) all 146 second‐generation RIBA (RIBA‐2)‐positive polymerase chain reaction‐positive samples detected by second‐generation enzyme‐linked immunosorbent assays and having known HCV genotypes (74 HCV type 1, 21 type 2, 51 type 3). RIBA band intensities were examined according to HCV genotype. An additional 90 RIBA‐3‐confirmed PCR‐positive samples (47 HCV type 1, 5 type 2, 38 type 3) detected by third‐generation enzyme‐linked immunosorbent assays were also examined. RESULTS: In the first group of 146 samples, the RIBA‐3 NS4 (c100p) band showed a marked improvement in sensitivity for the detection of HCV types 2 and 3 over that of the c100 antigen of RIBA‐2, but the mean band intensities of HCV types 2 and 3 remained significantly lower than those of type 1. Improved sensitivity of the NS3 band of RIBA‐3 to HCV type 3 was also apparent, but, again, the mean band intensity measured was lower for type 3 than for either type 1 or type 2. The c22 band of RIBA‐2 and RIBA‐3 exhibited equal sensitivity for all HCV genotypes. These differences were also apparent when RIBA‐3 was used in conjunction with third‐generation enzyme‐linked immunosorbent assays. CONCLUSION: The current RIBA‐3 lacks sensitivity to the NS4 antibody for HCV types 2 and 3. The incorporation of type‐specific components to other genotypes for NS4 (and NS3) antigens should be considered by the manufacturers.
In‐service training with videotape is useful in teaching transfusion medicine principles
Authors: Brooks J. P. , Combest T. G.
Published: March 2003

BACKGROUND: Failure to follow the basics of patient identification caused the ABO‐incompatible transfusion and death of an anesthetized patient. An investigation found that the medical center's transfusion policy, while adequate, was not being disseminated uniformly to all personnel. STUDY DESIGN AND METHODS: With the help of the hospital's medical media department, a 23‐minute videotape was produced emphasizing the importance of patient identification during phlebotomy and blood administration. Each department involved in blood transfusion was separately trained for a total of 182 persons trained. To assess whether learning had occurred, a 10‐question quiz was administered both before and after the video was presented. A one‐tailed t test was performed, and p < 0.05 was considered significant. RESULTS: The overall pre‐video test mean was 8.0 and the post‐video test mean was 9.5. The difference was highly significant at p < 0.00005. Except for the Transfusion Medicine Service, which had a perfect score on the pre‐ video test, all departments improved their scores with p values ranging from less than 0.00005 to 0.014. CONCLUSION: This study demonstrates that learning did occur. Videotape is useful for in‐service training and can be used for teaching on a variety of topics in transfusion medicine.
Microbiologic contamination of peripheral blood progenitor cells collected for hematopoietic cell transplantation
Authors: Espinosa M.T.F. , Fox R. , Creger R.J. , Lazarus H.M.
Published: March 2003

Background: Peripheral blood progenitor cells (PBPCs) rather than bone marrow are used increasingly to provide hematologic reconstitution when transfused after marrow‐ablative chemotherapy. PBPCs often are collected via central venous catheters that have remained in place for long periods of time and that may become infected.

Study Design and Methods: The investigators reviewed their 5‐year experience in collecting PBPCs for the prevalence of bacterial contamination. Except for cotrimoxazole therapy given to prevent Pneumocystis cariini pneumonia, patients were not given antibiotic prophylaxis.

Results: Each patient underwent a median of 7 (range, 2–21) PBPC collections; 0.2 percent (3/1040 collections) were culture positive for bacteria (two collections contained coagulase‐negative staphylococci and one contained Serratia marcescens). All culture‐positive collections were discarded; no PBPCs were culture positive at the time of thawing and transfusion.

Conclusion: This contamination rate is below that previously reported for bone marrow harvests and platelet concentrate collections. Obtaining PBPCs through large‐bore central venous catheters has not added to the risk of infection in transplant patients. A program of screening in vitro cultures and strict adherence to sterility techniques can result in very low microbiologic contamination and thus obviates the need for prophylactic antimicrobials in the PBPCs and in the patient.
The effects of diaspirin‐crosslinked hemoglobin on the assessment of immunohematology profiles
Authors: Reppucci A.J. , Mattia‐Goldberg C. , Przybelski R.J. , Kuczerepa P.R. , Balma D.L.
Published: March 2003

BACKGROUND: Extensive studies have been conducted on the in vitro effects of diaspirin‐crosslinked hemoglobin (DCLHb) in biochemical, hematologic, hemostatic, and blood banking (immunohematologic) methods. The absence of red cell antigens or plasma and/or serum antibodies allows DCLHb to be used as “universal‐donor” material. This study evaluates the effects of DCLHb on the accurate assessment of the immunohematologic profile (ABO and Rh blood grouping, antibody screen, and crossmatching). STUDY DESIGN AND METHODS: DCLHb, 7.4 g per dL in an electrolyte solution, was mixed in vitro with human whole blood, representing the blood types A Rh‐positive. A Rh‐negative, B Rh‐ positive, B Rh‐negative, O Rh‐positive, O Rh‐negative, and AB Rh‐ positive. Two concentrations of DCLHb were tested: 10‐percent (0.74 g/dL) and 30‐percent (2.22 g/dL). Controls were prepared by adding a 5‐ percent albumin solution to aliquots of whole blood in volumes equivalent to those used in preparing the DCLHb dilutions. Serum and/or red cell suspensions from these admixed samples were analyzed for their ABO and Rh blood groups, the presence of unexpected antibodies (antibody screen), and compatibility in crossmatch testing. RESULTS: DCLHb added to whole blood in vitro had no effect on the accurate interpretation of the immunohematologic profile. CONCLUSION: DCLHb does not appear to inhibit the true response or crossreact in the analysis of blood grouping, antibody screening, or crossmatching. In addition, the red color of DCLHb (up to 2.22 g/dL) did not obscure the visual reading for agglutination.
Asymptomatic hepatitis G virus infection in blood donors
Authors: Prati D. , Capelli C. , Zanella A. , Bosoni P. , De Mattei C. , Mozzi F. , Donato M.F. , Colombo M. , Milani S. , Sirchia G.
Published: March 2003

BACKGROUND: Hepatitis G virus (HGV) has been reported in patients with fulminant hepatitis and aplastic anemia, but HGV RNA has also been found in healthy individuals. The possible associations of HGV with liver function and hematologic abnormalities in asymptomatic blood donors were investigated. STUDY DESIGN AND METHODS: Serum HGV RNA was determined in 200 repeat donors (Group A), 44 subjects with elevated alanine aminotransferase (Group B), and 54 hepatitis C virus carriers (Group C). Liver histology was evaluated in Group C by using the histologic activity index. RESULTS: HGV RNA was detected in three subjects of Group A (1.5%; 95% CI: 0.3–4.3), two of Group B (4.5%; 95% CI: 0.6–15.5%), and six of Group C (11.1%; 95% CI: 4.2–22.6). The prevalence of leukopenia and elevated gamma‐glutamyl transpeptidase was higher in the 11 viremic donors than in 88 nonviremic subjects (36% vs. 2.3%, and 55% vs. 22%, respectively; p < 0.05), matched for clinical and demographic characteristics. The mean histologic activity index score +/− standard error was 4 +/− 0.7 in the HGV RNA‐positive donors and 3.4 +/− 0.3 in the HGV RNA‐negative donors. CONCLUSION: HGV is endemic in Italian blood donors, although it has a limited role in causing liver damage. Further studies are needed to clarify its role in inducing transfusion‐associated disease in myelosuppression.
Comparative performances of enzyme‐linked immunosorbent, western blot, and polymerase chain reaction assays for human T‐lymphotropic virus type II infection that is endemic among Indians of the Gran Chaco region of South America
Authors: Poiesz B.J. , Dube S. , Jones B. , Bryz‐Gornia V. , Dean M.T. , Spicer T. , Hengst J. , Sayre K. , Esteban E. , Ferrer J.F.
Published: March 2003

BACKGROUND: Human T‐cell lymphoma/leukemia viruses types I and II (HTLV‐ I and HTLV‐II) are related exogenous human retroviruses. The former is definitely pathogenic while disease association with the latter is unclear. There are two subtypes of HTLV‐II, A and B. Currently, enzyme‐ linked immunosorbent assays (ELISAs) based on HTLV‐I antigens are used to screen for the presence of HTLV‐I and ‐II antibodies. Confirmation and subtyping are accomplished by Western blot (WB) or ELISAs based on HTLV‐I whole viral antigens and/or HTLV‐I and HTLV‐IIA peptides. The sensitivity and specificity of these serologic assays were compared to those of HTLV‐I and‐II‐specific polymerase chain reaction (PCR) assays in tests on samples from Indians from South America in whom the HTLV‐ IIB subtype is endemic.

STUDY DESIGN AND METHODS: Sera from 246 Gran Chaco Indians were evaluated for HTLV antibodies with the use of four ELISAs (Retrotek HTLV‐I; Cambridge Biotech rgp21 enhanced HTLV‐I/II; Vironostika HTLV‐I/II; and Select HTLV‐I/II), and a WB assay. Peripheral blood leukocyte DNA from each Indian was analyzed for HTLV‐I or HTLV‐II pol DNA via PCR. Fifteen of the PCR‐positive samples were further subtyped via cloning and sequencing and/or oligomer restriction.

RESULTS: Ninety‐seven samples (39%) were positive for HTLV‐ II by serologic and/or PCR assays. All 15 positive DNA samples that were further analyzed were of the HTLV‐IIB subtype and were clustered as a highly conserved phylogenetic group. Comparative analyses indicate that the sensitivity and specificity of the various assays were: PCR, 97 and 100 percent; Retrotek, 70 and 91 percent; Cambridge Biotech, 74 and 96 percent; Vironostika, 73 and 99 percent; Select 72 and 98 percent; and WB, 70 and 100 percent.

CONCLUSION: The sensitivities of the tested HTLV serologic assays were comparable. However, the specificity of the Retrotek ELISA was significantly lower than that of the others. When positive, the subtyping assays were very specific. However, PCR assays would seem preferable or to be a necessary adjunct for the sensitive detection of HTLV‐IIB infection.
Removal of ABO‐incompatible red cells from lymphocytapheresis and granulocytapheresis components before transfusion
Authors: Wuest D.L. , Reich L.M.
Published: March 2003

BACKGROUND: The collection of allogeneic lymphocytapheresis and granulocytapheresis components containing significant volumes of ABO‐ incompatible red cells is sometimes necessary. STUDY DESIGN AND METHODS: Twenty‐nine ABO‐incompatible lymphocytapheresis components collected for transfusion to three patients and 11 ABO‐incompatible granulocytapheresis components collected for transfusion to five patients were depleted of red cells by gravity sedimentation aided by the addition of hetastarch solution. The efficacy of red cell depletion and white cell retention and the complications of transfusion were analyzed. RESULTS: Lymphocytapheresis components contained 82 +/− 13 percent of the original white cells and 5 +/− 3 mL of red cells after depletion; however, for those components containing < 70 mL of red cells before depletion (n = 12), white cell recovery was 92 +/− 5 percent. After depletion, granulocytapheresis components contained 96 +/− 3 percent of the original white cells and 6 +/− 2 mL of red cells. No clinical or laboratory evidence of hemolysis was observed after the transfusion of any leukapheresis component. CONCLUSION: Red cells can be effectively removed from leukacytapheresis components by a simple gravity sedimentation technique with added hetastarch. This allows safe transfusion of ABO‐incompatible components.
Lack of correlation between the incidence of bloodborne AIDS and overall AIDS incidence in Western Europe
Authors: Dal Maso L. , Franceschi S. , Lo Re A. , De Angelis V. , La Vecchia C.
Published: March 2003

BACKGROUND: The incidence of bloodborne AIDS and the total incidence of AIDS in various areas of the United States are strongly correlated. STUDY DESIGN AND METHODS: To determine whether the same held true for Western Europe, data for 1985 through 1993 from the World Health Organization's European Non‐Aggregate AIDS Data Set and for 1985 through 1992 from the Centers for Disease Control and Prevention's AIDS Public information Data Set were compared. Incidence rates per million population were adjusted for reporting delays in each country and age‐ standardized (world standard population). RESULTS: In Western Europe, there were no significant correlations between the annual incidence of transfusion‐associated (TA)‐AIDS (correlation coefficient, r = 0.38) and that of hemophilia‐associated AIDS (r = 0.24) and the corresponding incidence of all AIDS cases. Whereas similar age‐specific incidence rates for hemophilia‐associated AIDS emerged in all countries examined, those for TA‐AIDS varied and increased greatly with age in France and the United States. Male‐to‐female ratios of TA‐AIDS ranged between 0.5 in the United Kingdom and > or = 1.5 in Italy, Portugal, Spain, Sweden, and the United States. CONCLUSION: Lack of significant correlation between the incidence of bloodborne AIDS and that of all AIDS in Western Europe points to important, but little‐quantified sources of variation by country in the safety of blood and blood derivatives. Higher rates of TA‐AIDS in the elderly and in males in some countries suggest international differences in transfusion practices by age and sex.
Loss of high‐affinity thrombin receptors during platelet concentrate storage impairs the reactivity of platelets to thrombin
Authors: Lozano M. L. , Rivera J. , Gónzález‐Conejero R. , Moraleda J.M. , Vicente V.
Published: March 2003

BACKGROUND: The storage of platelet concentrates (PCs) induces a reduction in the platelet surface expression of glycoprotein (GP) Ib alpha. The location of the platelets' high‐affinity binding site for thrombin has been postulated as being located on GPIb alpha. This study attempts to determine whether loss or alteration of GPIb alpha during storage of PCs is related to impairment in the reactivity of platelets to thrombin. STUDY DESIGN AND METHODS: In this study, platelet surface expression of GPIb alpha was monitored by means of flow cytometry, throughout standard storage of PCs for up to 10 days. Two thrombin‐ induced platelet responses, the binding of radiolabeled fibrinogen and the platelet surface expression of P‐selectin, were evaluated. Thrombin‐ binding assays were also performed to assess the number of thrombin receptors in platelets. RESULTS: The surface expression of the GPIb/IX complex declines during storage of PCs. The thrombin‐induced maximal binding of fibrinogen in platelets stored for 3, 7, and 10 days was 77 +/− 7 percent, 60 +/− 20 percent, and 34 +/− 25 percent, respectively, of that found in fresh platelets. Moreover, the concentration of thrombin needed for 50 percent of platelets to express the CD62 antigen P‐selectin at the surface increased from 0.05 U per mL in fresh platelets to 0.11, 0.56, and 1.2 U per mL in platelets stored for 3, 7, and 10 days, respectively. Thrombin‐binding experiments demonstrated a significant reduction in the number of high‐affinity binding sites throughout storage of PCs (55 +/− 21 sites/platelet in 10‐day‐stored platelets vs. 73 +/− 25 in fresh platelets). A significant correlation was also observed between the number of high‐affinity thrombin‐binding sites and surface expression of GPIb alpha. Selective blockage of the thrombin‐binding site on GPIb alpha with monoclonal antibody LJ‐Ib10 also inhibited the response of fresh platelets to thrombin, up to a level equivalent to that found in 3‐day‐stored platelets. CONCLUSION: The loss of the GPIb alpha‐located high‐affinity thrombin‐binding site may impair the ability of platelets to become activated by thrombin as storage time increases.
Photochemical inactivation of viruses and bacteria in platelet concentrates by use of a novel psoralen and long‐wavelength ultraviolet light
Authors: Lin L. , Cook D. N. , Wiesehahn G. P. , Alfonso R. , Behrman B. , Cimino G. D. , Corten L. , Damonte P. B. , Dikeman R. , Dupuis K. , Fang Y. M. , Hanson C. V. , Hearst J. E. , Lin C. Y. , Londe H. F. , Metchette K. , Nerio A. T. , Pu J. T. , Reames A. A. , Rheinschmidt M. , Tessman J. , Isaacs S. T. , Wollowitz S. , Corash L.
Published: March 2003

BACKGROUND: A photochemical treatment process has been developed for the inactivation of viruses and bacteria in platelet concentrates. This process is based on the photochemical reaction of a novel psoralen, S‐ 59, with nucleic acids upon illumination with long‐wavelength ultraviolet light (UVA, 320–400 nm). STUDY DESIGN AND METHODS: High levels of pathogens were added to single‐donor platelet concentrates containing 3 to 5 × 10(11) platelets in 300 mL of 35‐percent autologous plasma and 65‐percent platelet additive solution. After treatment with S‐59 (150 microM) and UVA (0–3 J/cm2), the infectivity of each pathogen was measured with established biologic assays. In vitro platelet function after photochemical treatment was evaluated during 7 days of storage by using a panel of 14 assays. The in vivo recovery and life span of photochemically treated platelets were evaluated after 24 hours of storage in a primate transfusion model. RESULTS: The following levels of pathogen inactivation were achieved:>10(6.7) plaque‐forming units (PFU) per mL of cell‐free human immunodeficiency virus (HIV),>10(6.6) PFU per mL of cell‐associated HIV,>10(6.8) infectious dose (ID50) per mL of duck hepatitis B virus (a model for hepatitis B virus),>10(6.5) PFU per mL of bovine viral diarrhea virus (a model for hepatitis C virus),>10(6.6) colony‐forming units of Staphylococcus epidermidis, and>10(5.6) colony‐forming units of Klebsiella pneumoniae. Expression of integrated HIV was inhibited by 0.1 microM S‐ 59 and 1 J per cm2 of UVA. In vitro and in vivo platelet function were adequately maintained after antiviral and antibacterial treatment. CONCLUSION: Photochemical treatment of platelet concentrates offers the potential for reducing transfusion‐related viral and bacterial diseases.
Automated blood component collection with the MCS 3p cell separator: evaluation of three protocols for buffy coat‐poor and white cell‐ reduced packed red cells and plasma
Authors: Zeiler Thomas A. , Kretschmer Volker
Published: March 2003

BACKGROUND: Automated collection of blood components with a cell separator (MCS 3p, Haemonetics), was performed according to three protocols. STUDY DESIGN AND METHODS: The first protocol provided 2 units of fresh‐frozen plasma (FFP); and one buffy coat‐poor red cell (RBC) concentrate in additive solution. The second protocol included an additional in‐line filtration of the RBC in a closed system after storage at 4 degrees C for 24 hours. In the third protocol, an additional platelet concentrate (PC) was recovered from the buffy coat. Cell counts and biochemical characterization of the RBCs (n=20 each) were determined on Days 0, 1, 14, 28, and 49. RESULTS: The RBC volume was 336 +/− 9 mL (first protocol), 337 +/− 7 mL (second protocol) and 293 +/− 12 mL (third protocol) with a hematocrit of 59 +/− 2, 53 +/− 3, and 61 +/− 5, percent respectively. On Day 49, hemolysis was 0.24 +/− 0.1 percent (first protocol), 0.33 +/− 0.32 percent (second protocol), and 0.38 +/− 0.1 percent (third protocol). The filtered RBC concentrate met the international standards for white cell‐reduced RBCs. Filtration resulted in a clinically irrelevant increase of hemolysis. The in vitro RBC values (lactate dehydrogenase, 2‐hydroxybutyrate dehydrogenase, hemolysis, potassium, 2,3 DPG, ATP) were at least equal to those in RBCs collected by conventional whole‐blood donation. There is a trend toward extended preservation of 2,3 DPG in RBCs collected by apheresis. Two units of FFP could be collected with each donation (first protocol: 420 +/− 55 mL, 5.4 +/− 7 WBCs/microL, 6.5 +/− 5 × 10(3) platelets/microL; second protocol: 440 +/− 33 mL, 3 +/− 5.2 WBCs/microL, 32 +/− 12 × 10(3) platelets/microL; third protocol: 398 +/− 32 mL, 5 +/− 12 WBCs/microL; 3.4 +/− 3.5 × 10(3) platelets/microL). PCs prepared from the buffy coat collected by the third protocol contained 90 +/− 30 × 10(9) platelets in 88 +/− 14 mL of plasma. In vitro test results in these PCs were superior to those in PCs collected by conventional whole‐blood donation. The procedure was well tolerated by all donors. No adverse reactions appeared. CONCLUSION: Erythroplasmapheresis with the MCS 3p cell separator is a useful alternative to conventional whole‐blood donation and separation.
Performance of three generations of anti‐hepatitis C virus enzyme‐ linked immunosorbent assays in donors and patients
Authors: Vrielink Hans , Reesink Henk W. , van den Burg Peter J.M. , Zaaijer Hans L. , Cuypers H. Theo M. , Lelie P. Nico , van der Poel Cees L.
Published: March 2003

BACKGROUND: Prevention of posttransfusion non‐A,non‐B hepatitis in recipients of blood components improved considerably with the introduction of the second‐generation of hepatitis C virus (HCV) antibody tests. In 1993, third‐generation HCV antibody assays were introduced in Europe. STUDY DESIGN AND METHODS: The performance of three generations of anti‐HCV enzyme‐linked immunosorbent assay (ELISA) (ELISA‐1, −2, −3) was compared in routine blood donor screening (99,394 donations were tested with ELISA‐1, 167,999 donations with ELISA‐2, and 262,090 donations with ELISA‐3) and in serial samples from nine patients with documented acute posttransfusion HCV infection. RESULTS: Eight (0.01%) repeat donors, previously negative in ELISA‐1, were found positive in ELISA‐2 and were confirmed as positive in second‐generation recombinant immunoblot assay and/or cDNA polymerase chain reaction. In the donor population, no difference in the sensitivity of ELISA‐2 and ‐ 3 was observed. The specificity of the three generations of ELISAs was comparable (99.8, 99.7, and 99.7%). In seroconversion samples, ELISA‐2 and −3 detected HCV antibodies at the same time in seven patients, but in two patients, ELISA‐3 found HCV antibodies, respectively, 63 and 77 days earlier than ELISA‐2 did. In the seroconversion samples, ELISA‐2 and −3 were significantly more sensitive than second‐ and third‐ generation recombinant immunoblot assays. CONCLUSION: ELISA‐3 did not detect more HCV‐infected individuals in a donor population that previously tested negative in ELISA‐2, but it did detect HCV antibodies earlier in some patients with acute HCV infection. ELISA‐2 and −3 were significantly more sensitive than second‐ and third‐generation recombinant immunoblot assays.
Use of human immunodeficiency virus (HIV) type 1 and 2 recombinant strip immunoblot assay to resolve enzyme immunoassay anti‐HIV‐2‐ repeatably reactive samples after anti‐HIV‐1/2 combination enzyme immunoassay screening
Authors: Tobler L.H. , Kaufman E. , Gefter N. , Schable C. , Busch M. P.
Published: March 2003

BACKGROUND: With the implementation of combination human immunodeficiency virus types 1 and 2 (HIV‐1/2) antibody enzyme immunoassay (EIA) in donor screening in 1992, the supplemental testing algorithm changed to require the use of a Food and Drug Administration (FDA)‐licensed HIV‐1 Western blot (WB) or immunofluorescence assay, as well as an FDA‐licensed HIV‐2 EIA. When HIV‐2 EIA‐reactive specimens are identified, further testing to confirm HIV‐2 infection is recommended. Currently, a licensed HIV‐2 supplemental assay is not available. STUDY DESIGN AND METHODS: The sensitivity of an HIV‐1/2 recombinant strip immunoblot assay (SIA) for HIV‐2 was determined on the basis of the analysis of 65 HIV‐2‐positive samples identified by the Centers for Disease Control and Prevention (CDC). Anti‐HIV‐1/2 combination EIA‐repeatably reactive (RR) specimens from seven blood centers and their affiliated hospitals were tested in parallel by HIV‐1 WB and HIV‐2 EIA. Anti‐HIV‐2 EIA‐RR specimens were further tested by HIV‐1/2 SIA. Specimens interpreted as positive for HIV‐2 or HIV‐1/2 were referred to the CDC for final resolution of antibody status. RESULTS: Ninety‐seven percent (63/65) of known HIV‐2‐positive samples tested positive for HIV‐2 only or HIV‐1/2 on the HIV‐1/2 SIA. A total of 1048 anti‐HIV‐1/2 combination‐EIA‐RR specimens were evaluated. Sixty‐ nine percent (75/109) of the WB‐positive specimens were HIV‐2 EIA‐RR, while only 9 percent (84/939) of WB‐indeterminate or WB‐negative specimens tested HIV‐2 EIA‐RR. The HIV‐1/2 SIA resolved 91 percent of HIV‐2 EIA‐RR samples as negative. Four HIV‐2 EIA‐RR specimens (all HIV‐ 1 WB‐positive) were classified as positive for HIV‐1 and HIV‐2 in the HIV‐1/2 SIA. Final interpretation of these specimens by CDC was that they were reactive for HIV‐1 with cross‐reactivity to HIV‐2. CONCLUSION: No confirmed HIV‐2‐positive specimens were detected. The HIV‐1/2 SIA is currently useful for resolving HIV‐2 EIA‐RR specimens.
Analysis of human plasma products: polymerase chain reaction does not discriminate between live and inactivated viruses
Authors: Hilfenhaus J. , Gröner A. , Nowak T. , Weimer T.
Published: March 2003

BACKGROUND: The viral safety of human plasma products is based on the careful selection of donors and donations and the removal and inactivation of human pathogenic viruses that could potentially contaminate human plasma. For the analysis of the final products for potential virus contamination, the use of polymerase chain reaction (PCR) has been proposed. To test whether this method can discriminate between infectious and inactivated viruses, the following studies were performed. STUDY DESIGN AND METHODS: Infectious and virus‐inactivated preparations were titrated with specific PCR, using viruses such as hepatitis B virus (HBV), hepatitis C virus, bovine viral diarrhea virus, and poliovirus. The inactivation method employed was pasteurization (10 hours, 60 degrees C) or solvent/detergent (SD) treatment; in the case of HBV, there was consecutive treatment by both methods. RESULTS: Pasteurization of HBV and hepatitis C virus as well as SD treatment of HBV or pasteurization of HBV followed by SD treatment did not affect the detectability of these viruses by PCR, whereas an infectivity study in chimpanzees demonstrated that infectious hepatitis C virus was inactivated by pasteurization. Pasteurization also had no effect on the PCR titers of stabilized bovine viral diarrhea virus or poliovirus preparations, but it destroyed the infectivity of these viruses completely after only 4 hours' heat treatment. CONCLUSION: Pasteurization or SD treatment destroys the infectivity of the viruses tested, but neither significantly affects their detectability by specific PCR. Therefore PCR is not a suitable measure for testing the viral safety of finished plasma products that have been subjected to virus inactivation.
The use of polymerase chain reaction in plasma pools for the concomitant detection of hepatitis C virus and HIV type 1 RNA
Authors: Yerly S. , Pedrocchi M. , Perrin L.
Published: March 2003

BACKGROUND: Detection of viral nucleic acids might increase blood transfusion safety through the detection of recently infected blood donors during the preseroconversion window period. Individual screening is difficult to apply, because of technical and financial constraints.

STUDY DESIGN AND METHODS: A polymerase chain reaction (PCR)‐based assay including a polyethylene glycol precipitation step was developed for the concomitant detection of hepatitis C virus (HCV) and HIV type 1 (HIV‐1) RNA in plasma pools corresponding to 50 blood donations by the use of commercial assays.

RESULTS: The assay had a sensitivity of less than 33 copies per mL for HCV RNA and 1000 copies per mL for HIV‐1 RNA for each individual sample included in the pool. The eight preseroconversion samples with HCV RNA between 1,250 and 762,000 copies per mL were all detected when 100‐μL aliquots from the samples were introduced into 5‐mL pools of 50 blood donations.

CONCLUSIONS: A PCR‐ based pooling assay associating a prepurification step with polyethylene glycol allows for the screening of blood donations for HCV and HIV‐1 RNA without marked loss of sensitivity from that seen with commercially available assays. This procedure might increase blood safety through systematic screening of blood donations at relatively low cost.