bluuebunny/crossref_metadata_2025 huggingface dataset:
Psychological distress in blood donors notified of HTLV‐I/II infection. Retrovirus Epidemiology Donor Study
Authors: Guiltinan A.M. , Murphy E.L. , Horton J. A. , Nass C.C. , McEntire R.L. , Watanabe K.
Published: March 2003

BACKGROUND: Blood donations in the United States have been screened for antibody to human T‐cell lymphotropic virus types I and II (HTLV‐I/II) since November 1988. Although clinically diagnosed illness associated with HTLV‐I/II remains relatively uncommon, blood donors notified of HTLV infection frequently report negative psychological and social effects following notification. STUDY DESIGN AND METHODS: To assess psychological outcomes, the General Well‐Being Scale, a standardized 18‐ item questionnaire, was administered to 464 HTLV‐I/II‐positive donors and 91 sex partners at five blood centers in the United States following notification of HTLV‐I/II infection. The questionnaire was also given to 735 HTLV‐I/II‐negative donors. RESULTS: Scores for donors seropositive for HTLV‐I and HTLV‐II showed significantly more psychological distress than did scores for seronegative donors (p < 0.0005) or a large national sample (p < 0.05). Both HTLV‐I (p = 0.02) and HTLV‐II (p = 0.01) seropositivity remained significant predictors of lower overall well‐being scores after analysis controlling for race, age, gender, education, income, donation type, time since notification, self‐reported health status, and intravenous drug use. Variables that predicted higher overall scores were negative HTLV status, older age, higher income, better health, fewer sick days, and fewer work limitations due to health problems. CONCLUSION: Increased psychological distress may be related to notification of HTLV infection among blood donors in the United States.
Transfusion‐associated or nosocomial hepatitis G virus infection in patients undergoing surgery
Authors: Lunel F. , Frangeul L. , Chuteau C. , Fretz C. , Thiers V. , Azar N. , Bidet J.M. , Huraux J.‐M. , Bréchot C. , Valla D. , Opolon P.
Published: March 2003

BACKGROUND: Despite blood donor screening, there are still cases of transfusion‐associated hepatitis. From 1988 to 1992, a prospective study was conducted on the incidence of non‐A, non‐B posttransfusion hepatitis (PTH). STUDY DESIGN: The present investigation was designed to determine if transfusion recipients with PTH who are negative for hepatitis C virus (HCV) were positive for hepatitis G virus (HGV). Patients admitted for surgery who had normal liver tests and no transfusions during the previous 6 months were enrolled. Alanine amino transferase levels were determined monthly for 6 months after surgery and for 1 year in the case of PTH (defined as alanine aminotranferase twice the upper limit of normal in two consecutive assays). HGV RNA and E2 antibodies were tested for in samples from transfusion recipients with or without PTH and from nontransfused patients. RESULTS: Of the 308 blood recipients who were enrolled in the study, 21 (6.8%) had PTH. HGV RNA was detected at the onset of hepatitis in 3 patients with PTH (14%), 2 of whom were also anti‐HCV and HCV RNA positive. One patient developed E2 antibodies without detectable HGV RNA. Three (10.7%) of 28 recipients of an allogeneic transfusion without PTH developed HGV infection. HGV RNA was also found in two nontransfused patients, which suggests nosocomial transmission of HGV. CONCLUSION: Some cases of PTH are associated with HGV; most cases of postoperative HGV infection are not associated with liver abnormalities; and most PTH cases are not associated with known hepatotropic viruses.
ISO 9000 model ideally suited for quality plan at blood centers
Authors: Kalmin ND , Myers LK , Fisk MB
Published: March 2003

BACKGROUND: The development of a quality plan is essential for organizations involved in manufacturing, trade, and services. The International Organization for Standardization (ISO) has established a common set of manufacturing, trade, and communications standards that are applicable worldwide and that provide the basis of a quality plan for institutions such as blood centers. STUDY DESIGN AND METHODS: The ISO 9002 conformance model and a registrar were selected to guide a core management team in establishing a superior quality plan for a blood center. The initial phase required that an analysis of the existing quality and document systems be performed, utilizing a 20‐ element “status of readiness” ISO assessment audit (gap analysis). Weaknesses in the quality systems were targeted and progress was evaluated by the registrar and an outside facilitator. RESULTS: Full implementation of ISO principles was achieved within the established timeline. Standard operating procedures were reviewed, supplemented, and expanded in every department, thereby ensuring consistent quality throughout the organization. Improvements in management, training, inspections, and statistical reporting were soon apparent during regular departmental audits. CONCLUSION: The ISO 9000 model is ideally suited for use by blood centers to establish a quality plan as required by the American Association of Blood Banks.
Minimal number of circulating CD34+ cells to ensure successful leukapheresis and engraftment in autologous peripheral blood progenitor cell transplantation
Authors: Pérez‐Simón J. A. , Caballero M. D. , Corral M. , Nieto M. J. , Orfao A. , Vazquez L. , Amigo M. L. , Berges C. , González M. , Del Cañizo C. , Miguel J. F. San
Published: March 2003

BACKGROUND: The number of peripheral blood (PB) CD34+ cells has been widely used to monitor the timing of leukapheresis for autologous transplantation. However, no cutoff value for CD34+ cells in PB has been defined as a guideline for the identification of patients in whom the harvest would be effective and those in whom there was a high probability of failure.

STUDY DESIGN AND METHODS: The present study investigated the best threshold of CD34+ cells in PB for successful harvesting and engraftment, using 263 PB samples with their corresponding leukapheresis components. In addition, that measure has been compared to other commonly used criteria such as the white cell count, the number of mononuclear cells, and the number of colony‐ forming units‐granulocyte macrophage in PB.

RESULTS: Time to engraftment of both granulocytes and platelets was significantly influenced by the number of CD34+ cells transfused, but all patients receiving > or = 0.75 × 10(6) CD34+ cells per kg achieved engraftment within a reasonable number of days (> 0.5 × 10(9)/L granulocytes by Day 11 and > 20 × 10(9)/L platelets by Day 13). A clear correlation between the number of CD34+ cells per microL in PB and of CD34+ cells per kg collected was found at each apheresis (r = 0.9, p < 0.0001). Moreover, the number of CD34+ cells per microL measured in PB the day the first leukapheresis was initiated displayed an excellent correlation with the total amount of CD34+ cells per kg finally collected (r = 0.81, p < 0.0001). On the basis of the regression curve obtained and the clinical engraftment results, it was found that the presence of > 5 CD34+ cells per microL in PB ensured a good yield from the harvest in 95 percent of patients and would avoid an unsuccessful harvest in 81 percent of cases.

CONCLUSION: A dose of only 0.75 × 10(6) CD34+ cells per kg guarantees hematopoietic recovery within a reasonable number of days. To initiate a leukapheresis from which enough progenitor cells may confidently be obtained, a minimum of 5 CD34+ cells per microL in PB is required.
Measurement of the levels of reticulated platelets after plateletpheresis to monitor activity of thrombopoiesis
Authors: Stohlawetz P. , Stiegler G. , Jilma B. , Dettke M. , Hocker P. , Panzer S.
Published: March 2003

BACKGROUND: Little is known about the effects of long‐term plateletpheresis on the donors' health. The aim of this study was to examine the effect of plateletpheresis on the time course of reticulated platelet counts as an estimate for thrombopoiesis.

STUDY DESIGN AND METHODS: The effect of moderate platelet depletion on the thrombopoietic capacity was evaluated prospectively by the measurement of reticulated platelets before and after plateletpheresis and on the following 4 days. Donors undergoing plateletpheresis for the first time were compared to those donating platelets every other week for more than 18 months.

RESULTS: The median levels of reticulated platelets were significantly lower in frequent donors than in new donors. In new donors, there was a transient increase in the median levels of reticulated platelets on Day 3 after apheresis, and baseline values were reached again on Day 4. On the contrary, in repeat donors, there was a sustained rise in the percentage of reticulated platelets from Days 1 through 4. However, this increase in reticulated platelet counts was still less than that seen in new donors. There was no difference in the peripheral blood platelet counts in the two groups at any time point.

CONCLUSION: These findings suggest that repeat platelet donation might lead to a relative exhaustion of thrombopoiesis, as evidenced by the low levels of reticulated platelets exhibited by repeat donors. The reticulated platelet count can be used to monitor the thrombopoietic capacity of long‐term platelet donors.
A feasibility evaluation of an automated bloodcomponent collection system platelets and red cells
Authors: Rugg N. , Pitman C. , Menitove J.E. , Greenwalt T.J. , McAteer M.J.
Published: March 2003

BACKGROUND: The purpose of these studies was to evaluate the functional properties of blood components collected with an automated collection system.

STUDY DESIGN AND METHODS: Single‐donor platelets (n = 44) and packed red cell (RBC) units (n = 10) were collected. In vitro and in vivo assays were used to assess the function of single‐donor platelet components stored for 5 days and of packed RBC units after storage for 42 days at 4°C.

RESULTS: Adverse events observed in the 44 study subjects were minor. The mean 24‐hour recovery value for the packed RBC units stored for 42 days was 83.6 ± 5.4 percent, with a mean percentage of hemolysis on Day 42 at 0.46 ± 0.19 percent. The 25 patients receiving platelet components achieved a mean corrected count increment of 15.1 ± 10.4 × 103. All platelet concentrates had less than 1 × 106 total white cells.

CONCLUSION: Both in vitro and in vivo testing for the packed RBCs collected and stored for 42 days met the standards for both hemolysis and percentage of 51Cr 24‐hour RBC recovery. The in vitro results and transfusion data on white cell‐reduced platelet components transfused to thrombocytopenic patients were comparable to those on available platelet components.
A new apheresis procedure for the preparation of high‐quality red cells and plasma
Authors: Knutson F. , Rider J. , Franck V. , Joie M. , Högman C.F. , Pamphilon D.
Published: March 2003

BACKGROUND: Multicomponent apheresis is an alternative way of preparing blood components that avoids the delay between collection and separation seen with standard whole‐blood techniques.

STUDY DESIGN AND METHODS: An apheresis device has been modified to facilitate the combined collection of a unit (250 mL) of red cells (RBCs) and a high‐volume unit (475 mL) of plasma. The procedure, using 8‐percent ACD‐A, has been tested in two European blood centers. Each center performed 20 procedures for in vitro evaluation of collected RBCs and plasma and 10 procedures for evaluation of in vivo RBC recovery. All RBCs were white cell reduced by filtration. One‐half of the RBC units were stored in the additive solution Adsol and one‐half in another such solution (Erythro‐Sol).

RESULTS: The target volumes of RBCs and plasma were obtained in 27 minutes (range, 20‐44 min) by using three to six cycles in a single‐needle procedure. Saline (275 mL) was used to replace fluid volume withdrawn in excess of standard whole‐blood donation. No side effects occurred, with the exception of minor signs of hypocalcemia. RBC ATP was well maintained (>65% at Day 42) during storage; 2,3‐DPG was less well maintained, with virtually none remaining at Day 21 in either Adsol or Erythro‐Sol. The RBC in vivo recoveries, after 42 days of storage at 4 ± 2°C determined by the single‐label method, were 86.7 ± 7.2 percent (Erythro‐Sol) and 84.4 ± 8.1 percent (Adsol). Mean plasma factor VIII levels were >100 percent in all test groups.

CONCLUSION: A novel automated technique for the simultaneous collection and preparation of RBCs and plasma has been evaluated. The apheresis procedure was acceptable and well tolerated by donors, and it resulted in high‐quality blood components. Further optimization of the system should yield a practicable component suitable for routine use in blood banks.
Evaluation of RNA and E2 antibodies in prospectively followed recipients of hepatitis G virus‐infected blood
Authors: Sauleda S. , Esteban J.I. , Hernandez J.M. , Reesink H. , Castella D. , Quer J. , Hess G. , Esteban R. , Guardia J.
Published: March 2003

BACKGROUND: Hepatitis G virus (HGV) has recently been cloned and tests for HGV RNA and envelope antibodies (anti‐E2) have been developed. HGV infection is widespread among blood donors worldwide, but the clinical and serologic outcome of transfusion‐associated HGV infection has not been fully characterized.

STUDY DESIGN AND METHODS: Consecutive blood donors (n = 2210) were investigated for HGV markers (RNA and anti‐E2). The recipients of HGV RNA‐positive blood were followed for 1 year after transfusion.

RESULTS: Forty‐two blood donors (1.9%) were positive for HGV RNA. Eight recipients of HGV RNA‐positive blood were retrospectively identified within 2 weeks of transfusion and prospectively followed. In four patients, the presence of anti‐E2 before transfusion or an early antibody response protected them from reinfection or prevented HGV persistence, while, in the remaining four patients, transient or persistent viremia was detected shortly after exposure. None of the infected recipients had any evidence of liver disease.

CONCLUSION: These results do not support the screening of donors to prevent transfusion‐associated HGV infection.
Alloimmunization after blood transfusion in patients with hematologic and oncologic diseases
Authors: Schonewille H. , Haak H.L. , Van Zijl A.M.
Published: March 2003

BACKGROUND: Because of intensive marrow depression and improved survival, patients with hematologic and oncologic malignancies are dependent on transfusion for a longer period. It has been advocated that these patients should receive blood that is matched for blood group antigens other than ABO and D. A retrospective study was performed on the rate of alloimmunization against red cell antigens in 564 patients with malignant hematologic diseases over a period of 10 years.

STUDY DESIGN AND METHODS: Records of transfusion and immunohematologic studies of all patients (n = 1066) with malignant myeloproliferative and lymphoproliferative diseases diagnosed between 1987 and 1996 at one hospital were collected from the hospital computer blood bank files. Transfusions were correlated with antibody formation. Factors affecting this correlation were analyzed.

RESULTS: Seventy‐one antibodies were found in 51 patients. The overall immunization rate was 9.0 percent. Fifty percent of antibodies were formed after 13 units had been transfused. Once a patient had formed an antibody, the probability of additional antibodies increased 3.3‐fold. Anti‐c, anti‐E, and anti‐K composed the majority of antibodies found. Four patients formed Rh system antibodies after incompatible platelet transfusions. Patients who underwent intensive chemotherapy formed antibodies at a much lower rate than other patients. More than 40 percent of antibodies became undetectable after the first detection. No difficulty was encountered in finding compatible blood for these patients.

CONCLUSIONS: Antibody formation in hematologic malignancies is comparable to that in other diseases requiring multiple blood transfusions. Extensive antigen matching before transfusion of patients with hematologic and oncologic malignancies is not necessary and leads to increased costs.
The influence of automated plateletpheresis on systemic levels of hematopoietic growth factors
Authors: Weisbach V. , Friedlein H. , Glaser A. , Zingsem J. , Zimmermann R. , Eckstein R.
Published: March 2003

BACKGROUND: Megakaryocytopoiesis and platelet production are regulated by several hematopoietic growth factors. The present study focuses on the effects of automated plateletpheresis on systemic levels of different hematopoietic growth factors.

STUDY DESIGN AND METHODS: Platelet count, mean platelet volume, and serum levels of thrombopoietin, erythropoietin, interleukin‐1β, interleukin‐6, and stem cell factor in 21 healthy donors were measured before platelet collection, after the first half of the apheresis procedure, at the end of apheresis, and on Days 1, 2, and 7 thereafter.

RESULTS: Thrombopoietin levels (initial level: 49.5 ± 25.5 pg/mL) showed a significant increase between measurements taken at the end of apheresis and Day 1 (56.9 ± 26.7 pg/mL; p = 0.01). There was a highly significant decrease in stem cell factor levels during apheresis (p<0.0005), reaching preapheresis values (1679 ± 210 pg/mL) on Day 1. A highly significant increase in erythropoietin levels (initial level: 7.5 ± 4.0 U/L) was seen after apheresis (p<0.0005 on Days 1 and 2). The level remained significantly elevated until Day 7 (p = 0.004). Interleukin‐1β and interleukin‐6 levels (before donation: 1.4 ± 1.8 pg/mL and 1.1 ± 0.7 pg/mL, respectively) did not change during the observation period. Thrombopoietin levels correlated consistently and inversely with stem cell factor levels after apheresis (Day 1, r = ‐0.46, p = 0.035; Day 2, r = ‐0.50, p = 0.02; Day 7, r = ‐0.50, p = 0.02).

CONCLUSION: The data show a coordinated response of the hematopoietic system to platelet loss. It is suggested that the decrease in serum stem cell factor levels during apheresis reflects the consumption of stem cell factor by early hematopoietic progenitors that expand to initiate early megakaryocytopoiesis. The temporary increase in thrombopoietin is the result of platelet loss and serves as a stimulus for subsequent thrombopoiesis. The pronounced elevation of erythropoietin after apheresis suggests a role for this primarily erythropoietic cytokine in thrombopoiesis, too.
Absence of human T‐lymphotropic virus type I tax sequences in a population of normal blood donors in the Baltimore, MD/Washington, DC, area: results from a multicenter study
Authors: Cowan E.P. , Nemo G.J. , Williams A.E. , Alexander R.K. , Vallejo A. , Hewlett I.K. , Lal R.B. , Dezzutti C.S. , Gallahan D. , George K. , Pancake B.A. , Zucker‐Franklin D. , McCurdy P.R. , Tabor E.
Published: March 2003

BACKGROUND: It was reported recently that sequences corresponding to the human T‐lymphotropic virus type I (HTLV‐I) tax gene were detected in peripheral blood mononuclear cells from 8 to 11 percent of healthy blood donors without detectable antibodies to HTLV‐I. A multicenter blind study was conducted to determine if these results could be independently confirmed.

STUDY DESIGN AND METHODS: Specimens were collected from 100 anti‐HTLV‐I‐negative healthy blood donors and from 11 anti‐HTLV‐I‐ or anti‐HTLV‐II‐positive individuals. All samples were coded and distributed to each of four independent testing laboratories for polymerase chain reaction analysis to detect sequences of the HTLV‐I or HTLV‐II tax gene, using detailed procedures specified by the laboratory reporting the original observation. Each laboratory also tested a dilution panel of a plasmid containing HTLV‐I tax to determine the analytical sensitivity of the procedure.

RESULTS: The analytical sensitivity of the screening methods permitted detection of as few as 1 to 10 copies of the tax gene. However, HTLV‐I tax sequences could not be detected in any of the anti‐HTLV‐I‐negative blood donors at more than one test site.

CONCLUSION: HTLV‐I tax sequences appear not to be present in this population of 100 blood donors negative for anti‐HTLV‐I.
Erythropoietin and preoperative autologous blood donation in the prevention of hepatitis C infection:necessity or luxury?
Authors: Woronoff‐Lemsi M.‐C. , Arveux P. , Limat S. , Morel P. , Le Pen C. , Cahn J.‐Y.
Published: March 2003

BACKGROUND: Prevention of exposure to allogeneic blood transfusion during surgery is an important financial issue when recombinant human erythropoietin (rHuEPO) is used in addition to preoperative blood donation.

STUDY DESIGN AND METHODS: The aim of this study was to carry out a cost‐effectiveness analysis of the use of rHuEPO in preoperative blood donation in orthopedic surgery. The study, based on a decision tree analysis of the use of rHuEPO, was conducted from the perspective of the French health care system. The efficacy criterion was the number of hepatitis C infections prevented. The decision tree analysis was constructed as follows: the residual risk of hepatitis C infection was 8.26 per million units transfused, and the chance node was defined according to the number of units transfused.

RESULTS: With the use of rHuEPO in preoperative blood donation, 0.30562 cases of hepatitis C infection per 100,000 patients were prevented. The incremental cost of one prevented hepatitis C infection amounted to $888,000,000 (US).

CONCLUSION: Despite the limitations of our model, the cost‐effectiveness ratio was so large that variations only slightly modified the size of the result. From the societal perspective, it was not cost‐effective to add rHuEPO to preoperative blood donation.
Anomaly of the des‐Arg9‐bradykinin metabolism associated with severe hypotensive reactions during blood transfusions: a preliminary study
Authors: Cyr M. , Hume H.A. , Champagne M. , Sweeney J.D. , Blais C. , Gervais N. , Adam A.
Published: March 2003

BACKGROUND: Severe hypotensive reactions have been described after the transfusion of platelets or red cells through negatively‐charged bedside white cellreduction filters. The possibility of a role for bradykinin (BK) in the genesis of these reactions has been raised.

STUDY DESIGN AND METHODS: To understand if an anomaly of BK metabolism is associated with these reactions, the metabolism of BK and des‐Arg9‐BK was studied in the sera of four patients who presented with a severe hypotensive transfusion reaction. Tests were performed in the absence and the presence of complete in vitro inhibition of angiotensin‐converting enzyme (ACE) activity by enalaprilat.

RESULTS: In the presence of ACE inhibition (enalaprilat), the half‐life (t½) of BK measured in the sera of patients who presented with a severe hypotensive transfusion reaction (361 ± 90 sec) was not significantly different from that measured in the sera of normal controls (249 ± 16 sec). In the presence of ACE inhibition (enalaprilat), the t½ of des‐Arg9‐BK was significantly greater in patients who presented with a severe hypotensive transfusion reaction (1549 ± 319 sec) than in normal controls (661 ± 38 sec) (p<0.001).

CONCLUSION: A metabolic anomaly mainly affecting the degradation of des‐Arg9‐BK could be responsible for its accumulation in vivo. Des‐Arg9‐BK could be responsible, at least in part, for severe hypotensive transfusion reactions.
Measurement of red cell survival using biotin‐labeled red cells: validation against51Cr‐labeled red cells
Authors: Mock Donald M. , Lankford Gary L. , Widness John A. , Burmeister Leon F. , Kahn Daniel , Strauss Ronald G.
Published: March 2003

BACKGROUND:Anemia is a serious problem in the fetus and preterm infant. To investigate the physiology and pathophysiology of anemia and to assess responses to blood transfusions and erythropoietin therapy, measurement of circulating red cell survival would be useful.

STUDY DESIGN AND METHODS:Because the standard51Cr method exposes the patient or subject to radiation, a practical, accurate method for measuring red cell survival was developed on the basis of determining the number of biotin‐labeled red cells that persist in the circulation by using fluorescein‐labeled avidin and flow cytometry. In addition, disappearance of total biotin label was measured by using125I‐streptavidin. Results of each detection method were compared to red cell survival measured by the standard51Cr method.

RESULTS:Biotinylated cells persisted in circulation with life spans approaching normal. Despite near‐normal persistence in circulation of the biotin‐labeled cells, about one‐half of the biotin label left the circulation over the first few weeks, causing early curvilinear disappearance. This observation is consistent with the hypothesis that about one‐half of the biotin label leaves the red cells. However, about one‐half of the biotin was permanently attached, which produced linear disappearance and approximately normal life span estimates for the linear survival curve appearing after the first few weeks.

CONCLUSION:Red cell survival can be measured accurately in humans using enumeration of biotinylated red cells. The method is practical and does not expose the patient to radiation.
Male fetuses are particularly affected by maternal alloimmunization to D antigen
Authors: Ulm Barbara , Svolba Gerhard , Ulm Martin R. , Bernaschek Gerhard , Panzer Simon
Published: March 2003

BACKGROUND: It is hypothesized that male fetuses are more severely affected by fetomaternal alloimmunization to D antigen than female fetuses.

STUDY DESIGN AND METHODS: One hundred four consecutive pregnancies with single D+ fetuses (51 males, 53 females) and maternal anti‐D titers >16 were analyzed retrospectively.

RESULT: Sixty fetuses (58%) received intrauterine transfusions. Male fetuses required more transfusions than females (5.0 vs. 2.0, p = 0.0001). At the initial transfusion, male fetuses had a lower gestational age (24.5 vs. 31.0 weeks, p = 0.0007), cord blood hemoglobin content (6.45 vs. 8.75 g/dL, p = 0.01), and hematocrit (19.8 vs. 26.8%, p = 0.004) than female fetuses. After adjustment for maternal gravidity, parity, and history of affected offspring, the odds ratio for development of hydrops by male fetuses was 13.1 (95% Cl 2.69–63.6, p = 0.001). Perinatal mortality was higher in male (18%) fetuses than in female (6%) (adjusted odds ratio for males 3.38; 95% Cl 0.59–19.46, p = 0.17).

CONCLUSION: Male fetuses are particularly affected by maternal alloimmunization to D and require more intense antepartum surveillance than female fetuses.
A case‐controlled multicenter study of vasovagal reactions in blood donors: influence of sex, age, donation status, weight, blood pressure, and pulse
Authors: Trouern‐Trend Jonathan J. , Cable Ritchard G. , Badon Stanley J. , Newman Bruce H. , Popovsky Mark A.
Published: March 2003

BACKGROUND: Vasovagal reactions occur in a small, but significant number of blood donors. These reactions may decrease return donation and disrupt blood collection activities. The purpose of this study was to define the contributory role of sex, age, weight, blood pressure, and pulse in vasovagal reactions with syncope in blood donors.

STUDY DESIGN AND METHODS: A retrospective case‐control study involved 1890 blood donors with syncope from three large United States blood centers during 1994 and 1995. Case controls and random population controls were used in a logistic regression analysis to determine the significance of individual variables to syncopal reactions.

RESULTS: Female donors, young donors, first‐time donors, low‐weight donors, and donors with low predonation blood pressure had higher absolute donation reaction rates than other donors. When each variable was adjusted for other variables by regression analysis, age, weight, and donation status (first‐time or repeat donor) were significant (p<0.0001), and sex, predonation blood pressure, and predonation pulse were not. The most important variables, in descending order, were age, weight, and donation status (first‐time or repeat donor).

CONCLUSIONS: Donation‐related vasovagal syncopal reactions are a multifactorial process determined largely by age, weight, and first‐time donor status.
Viral safety of solvent/detergent‐treated plasma
Authors: Solheim B.G. , Rollag H. , Svennevig J.L. , Arafa O. , Fosse E. , Bergerud U.
Published: March 2003

BACKGROUND: Pooling of plasma donations increases the risk for blood‐borne infections. In solvent/detergent (SD)‐treated plasma, lipid‐enveloped viruses are efficiently inactivated. This method, however, does not affect non‐lipid‐enveloped viruses. The current study investigated the viral safety of SD‐treated plasma (Octaplas) and paid particular attention to the transmission of non‐lipid‐enveloped viruses.

STUDY DESIGN AND METHODS: The study comprised 343 adults undergoing cardiac surgery. Follow‐up was performed 6 to 12 months and 2 years after operation. The sera were tested for hepatitis B surface antigen and specific antibodies against hepatitis A, B, and C; cyto‐megalovirus; HIV, human T‐lymphotropic virus types I and II; and human parvovirus B19 (B19). A total of 25 batches of SD‐treated plasma prepared from Norwegian plasma were used. All batches were tested for hepatitis A virus and B19 by nucleic acid amplification testing and investigated for neutralizing antibodies directed against these viruses.

RESULTS: In patients who received SD‐treated plasma, B19 seroconversion occurred at a rate similar to that in nontransfused patients. No other seroconversions could be ascribed to the transfusion of SD‐treated plasma. All 25 SD‐treated plasma batches contained neutralizing antibodies against hepatitis A virus and B19. In nucleic amplification testing, all SD‐treated plasma batches tested positive for B19, while five demonstrated borderline reactions for hepatitis A virus.

CONCLUSION: Transfusion of SD‐treated plasma was found to be safe with regard to lipid‐enveloped viruses. Immune antibodies neutralize viral particles in plasma and are of importance in avoiding clinical disease with the non‐lipid‐enveloped hepatitis A virus and B19.
Analysis of factors affecting quantification of fetomaternal hemorrhage by flow cytometry
Authors: Kumpel Belinda M.
Published: March 2003

BACKGROUND: An analysis was carried out to determine the sources and extent of errors encountered in the quantitation of the volume of fetomaternal hemorrhage (FMH) by flow cytometry. Different assay conditions were compared, to define the simplest, most accurate protocol.

STUDY DESIGN AND METHODS: D–, D+, and artificial FMH (mixtures of D+ and D– RBCs) were stained either by a direct method (using FITC‐conjugated IgG3 D MoAb [BRAD‐3]), with or without dual labeling with PE‐conjugated anti‐GPA, or by indirect methods (using polyclonal anti‐D followed by FITC‐ or biotin‐conjugated anti‐IgG reagents). Cells were selected for flow cytometric analysis on the basis of either forward or side scatter (log FSC/log SSC) characteristics or of GPA+ labeling or were unselected. The numbers of events labeled with anti‐D were determined from histograms. For some samples, 10 replicates of 500,000 events each were analyzed.

RESULTS: Background fluorescent events in 10 directly labeled gated D– samples ranged from 0.007 to 0.023 percent, equivalent to 0.15‐ to 0.51‐mL FMH. Both the use of a gate on log FSC/SSC or the selection of GPA+ events only resulted in a reduction in FMH of 0.3 mL or less. The intra‐assay variation in FMH, or sampling error, was found to be approximately 10 percent at low artificial FMH (<10 mL) but greater (≤50% with a CV of 15%) with D– samples. Direct staining was quicker and produced a lower background than indirect staining.

CONCLUSION: The inherent sampling error that is due to the random distribution of rare events throughout the blood sample contributed greatly to the variation in the volume of FMH calculated by flow cytometry. The FMH should not be underestimated. For a routine assay, a simplified protocol and calculation will be sufficiently accurate to determine the dose of prophylactic anti‐D that should be given to the patient.
Expression of C antigen in transduced K562 cells
Authors: Smythe Jonathan S. , Anstee David J.
Published: March 2003

BACKGROUND: The Rh blood group system is involved in HDN and transfusion reactions. A retrovirus‐expression system was previously used to show that polypeptides carrying the Rh blood group antigens are encoded by the RHD and RHCE genes. This study investigated the structure of the C antigen.

STUDY DESIGN AND METHODS: K562 cells were transduced with full‐length cDNA encoding Ce and CE antigens, and the expression of C, e, and E antigens was examined by flow cytometry using MoAbs. The importance of Cys16 in C antigen expression was examined by utilizing site‐directed mutagenesis to convert Cys16 to Trp in cDNA encoding Ce and CE before expression in K562 cells.

RESULTS: When K562 cells were transduced with cDNA that was predicted to encode Ce antigens, clear reactivity with anti‐e and anti‐C was obtained. In contrast, K562 cells transduced with cDNA that was predicted to encode CE antigens gave strong reactivity with anti‐E but failed to react with two examples of anti‐C. A third example of anti‐C gave weak reactivity. When cDNA encoding Ce antigens was mutated to encode Trp16, one example of anti‐C had the same reactivity with the mutated polypeptide as with the wild‐type molecule, but reactivity with two other anti‐C examples was reduced by 50 percent.

CONCLUSIONS: The nature of polymorphic residue 226 (proline when E is expressed, alanine when e is expressed) has a marked effect on the epitopes recognized by the three C MoAbs studied. The presence of Cys16 in Ce polypeptides influences the presentation of the C epitope recognized by two of the three MoAbs. These experiments provide the first direct demonstration that C and E/e antigens can be expressed on the same polypeptide.
PBPC mobilization with chemotherapy and G–CSF in patients with chronic myeloid leukemia: quantification of bcr/abl‐positive cells by interphase fluorescence in situ hybridization and competitive PCR
Authors: Keil Felix , Mitterbauer Gerlinde , Chen Xiao , Haas Oskar A. , Kalhs Peter , Lechner Klaus , Mannhalter Christine , Moser Karin , Worel Nina , Pirc‐Danoewinata Hendrate , Louda Norbert , Loidolt Heidrun , Rabitsch Werner , Greinix Hildegard T.
Published: March 2003

BACKGROUND: Autografting of normal stem cells mobilized after chemotherapy is increasingly used in chronic myeloid leukemia (CML). Thus, quantification of possible contamination of progenitor cell apheresis with breakpoint cluster region (bcr)/Abelson murine leukemia (abl)‐positive cells is of great clinical interest.

STUDY DESIGN AND METHODS: Two molecular methods were compared to quantify bcr/abl positivity in leukapheresis components obtained after mobilizing chemotherapy in six patients with CML. To document the efficacy of in vivo purging, the leukapheresis procedures were monitored with interphase fluorescence in situ hybridization (FISH) and quantitative competitive PCR (QC‐PCR) as a ratio of bcr/abl:abl.

RESULTS: From the first to the last leukapheresis, bcr/abl positivity in FISH increased from a median of 11 percent to 33 percent. For bcr/abl transcripts, a simultaneous increase in consecutive leukapheresis procedures was seen. The median percentage of bcr cells in a bcr/abl:abl ratio was 3.1 percent in the first apheresis. In the last apheresis after the mobilization with mRNA, the QC‐PCR showed a median of 19.5 percent. FISH and QC‐PCR showed a statistical significant increase of bcr/abl positivity from the first to the last apheresis.

CONCLUSIONS: Both FISH and QC‐PCR were reliable methods of quantifying bcr/abl positivity, and they allowed selection of the optimal apheresis component for autologous transplantation. In both methods, a significant increase in bcr/abl positivity was seen from the first to the last leukapheresis. With FISH, results can be obtained within 24 hours. This method may prevent additional contaminated leukapheresis in case of increasing percentages of bcr/abl‐positive cells.
Diethylenetriaminopentaacetic acid is unsuitable for long‐term preservation of RBCs
Authors: Liu Tsan Zon , Chiu Daniel Tsun Y. , Stern Arnold
Published: March 2003

BACKGROUND : The addition of an appropriate metal chelator, such as diethylenetriaminopentaacetic acid (DTPA) to stored blood has been shown to be effective in a short‐term (0‐12 days) prevention of lipid peroxida‐tion of stored RBCs. However, its long‐term effectiveness has not been carefully evaluated.

STUDY DESIGN AND METHODS : Blood was preserved in simulated blood bank conditions with or without the addition of DTPA for 4 weeks. Aliquots of stored blood were taken weekly from the storage bag and the deformability profile was determined using a custom‐built laser viscodiffractometer. Malondialdehyde (MDA), an index of lipid peroxidation, and the extent of vesiculation of the stored blood were quantified concurrently.

RESULTS : It was found that MDA values for DTPA‐supplemented blood at the end of a 28‐day storage period were significantly elevated compared with the DTPA‐free counterpart (23.50 ± 3.2 vs. 16.10 ± 2.5 μM; p<0.05). In addition, DTPA‐supplemented blood was more susceptible to vesiculation than its DTPA‐free counterpart (31.26 ± 4.1 vs. 10.26 ± 1.5% of acetyl cholinesterase release, p<0.001). These data are also in accordance with the finding of the deformability profile result, indicating that DTPA‐supplemented blood exhibits not only a decrease in deformability index, but also a tendency to shift the profile to a lower osmolality compared with that of controls (a dehydration phenomenon).

CONCLUSION : Long‐term (0‐28 days) preservation of human RBCs with DTPA caused a gradual increase in MDA production, a progressive enhancement of the severity of vesiculation, and an alteration in the deformability profile. Free‐radical‐mediated oxidative damage is likely to be the culprit for this observed phenomenon. In addition, the direct effect of DTPA on RBC structural integrity must be considered.
Methicillin‐resistant Staphylococcus aureus sepsis associated with the transfusion of contaminated platelets: a case report
Authors: Sapatnekar Suneeti , Wood Erica M. , Miller John P. , Jacobs Michael R. , Arduino Matthew J. , McAllister Sigrid K. , Kellum Molly E. , Roth Virginia , Yomtovian Roslyn
Published: March 2003

BACKGROUND: Platelet transfusion‐associated sepsis is usually due to donor skin flora introduced into the unit during phlebotomy. An unusual case of a platelet component contaminated with methicillin‐resistant Staphylococcus aureus (MRSA) is reported.

CASE REPORT: A 54‐year‐old man, terminally ill with progressive non‐Hodgkin's lymphoma, developed fever and hypotension during a platelet transfusion. He was receiving multiple antibiotics, including vancomycin. Blood cultures taken soon after transfusion were negative. An aliquot taken from the platelet pool grew MRSA at a count of 1.6 × 108 CFUs per mL. One of the individual bags constituting the pool showed MRSA at a count of 5.1 × 108 CFUs per mL. The patient died soon after the platelet transfusion. This case was reported to the FDA and submitted to the BaCon Study. The identity of the isolate and its methicillin resistance were confirmed by the CDC as part of the BaCon Study protocol. The source of contamination of the implicated unit could not be established with certainty.

CONCLUSION: The emergence of antimicrobial‐resistant organisms poses additional challenges for the diagnosis and treatment of transfusion‐associated sepsis. Measures to prevent or intercept the transfusion of contaminated platelets should be developed.
A novelcis ABallele derived from aBallele through a single point mutation
Authors: Roubinet Francis , Janvier Daniel , Blancher Antoine
Published: March 2003

BACKGROUND:The very rare cis AB phenotype, first described in 1964, corresponds to a specialABOallele encoding a glycosyltransferase that is capable of synthesizing both A and B substances. Until now, gene sequences of only twocis ABalleles were partially characterized. One involved theA1*02allele with a single nonsynonymous substitution at codon 268, whereas the second arose from a single nonsynonymous substitution at codon 266 in exon 7 of aB1*01allele.

STUDY DESIGN AND METHODS:A cis AB phenotype was identified in a French family. The serologic characteristics of this phenotype were determined. Thecis ABallele was characterized from exon 6 to exon 7 by cloning and sequencing.

RESULTS:Thecis AB.tlse*01allele is identical toB1*01except for a single point mutation at nucleotide position 700, where a T replaces a C, implying a change of amino acid 234 (theB1*01proline being replaced by a serine).

CONCLUSION:Thecis AB.tlse*01allele clearly differs from all previously reportedABO,including the two previouscis ABdescribed.
Prestorage WBC filtration of RBC units with soft‐shell filters: filtration performance and impact on RBCs during storage for 42 days
Authors: Müller‐Steinhardt Michael , Hennig Holger , Kirchner Holger , Schlenke Peter
Published: March 2003

BACKGROUND: The introduction of universal WBC filtration of RBCs prior to storage is currently under consideration in many countries, as it is thought to minimize the incidence of transfusion‐associated adverse effects. Centrifugation of blood containers with newly developed soft‐shell WBC filters is more convenient, and so of great interest.

STUDY DESIGN AND METHODS: Two different quadruple blood pack systems with integrated soft‐shell WBC filters were compared (Sepacell OptiPure RC, Baxter Biotech, vs. LCR 5, Maco Pharma). Buffy coat‐depleted RBC units were investigated from whole‐blood donations that were held for 2 to 3 hours before centrifugation and subsequent filtration at 22°C (Group 1, OptiPure RC, 450 mL; Group 2, LCR 5, 450 mL; Group 3, OptiPure RC, 500 mL; Group 4, LCR 5, 500, mL, n = 12 per group). Filtration performance was analyzed, and the impact of WBC filtration on hemolysis rate, Hb content, pH, supernatant potassium, ATP, and 2,3 DPG was investigated weekly during storage for 42 days.

RESULTS: Filtration reduced the WBC count by 4.4 to 5.1 log. Mean ± SD Hb content was 44.7 ± 3.0, 41.2 ± 3.3, 53.1 ± 5.0, and 51.5 ± 6.3 g per unit, respectively, with a corresponding mean RBC recovery after filtration of 71.0 ± 3.0, 68.3 ± 3.3, 76.6 ± 1.7, and 68.9 ± 4.5 percent. WBC filtration resulted in a significant reduction of Hct (0.10‐0.14) in all four groups. Investigation of all RBC storage variables revealed acceptable values throughout the storage for 42 days.

CONCLUSION: WBC filtration with two newly developed soft‐shell filters showed acceptable WBC‐reduction efficacy without any difference between filter types in buffy coat‐depleted RBCs from 450‐ and 500‐mL whole‐blood donations. However, the application of both filters resulted in an unacceptably low RBC recovery after filtration, which was particularly evident with the LCR5 filter. Our findings raise concern that WBC reduction with these filters may result in the production of RBCs with an inappropriately low Hb concentration.
Sensitivity of HCV RNA and HIV RNA blood screening assays
Authors: Lelie P. Nico , Van Drimmelen Harry A.J. , Cuypers H. Theo M. , Best Susan J. , Stramer Susan L. , Hyland Catherine , Allain Jean‐Pierre , Moncharmont Pierre , Defer Christine , Nübling Micha , Glauser Andreas , Da Silva Cardoso Marcia , Viret Jean‐François , Lankinen Mervi H. , Grillner Lena , Wirthmüller Urs , Coste Joliette , Schottstedt Volkmar , Masecar Barbara , Dax Elizabeth M.
Published: March 2003

BACKGROUND: The FDA requirement for sensitivity of viral NAT methods used in blood screening is a 95‐percent detection limit of 100 copies per mL, whereas the NAT screening system should have a sensitivity of at least 5000 copies per mL per individual donation. According to the Common Technical Specifications of the European Directive 98/79/EC for in vitro diagnostics, viral standard dilutions (calibrated against the WHO standard) should be tested at least 24 times for a statistically valid assessment of the 95‐percent detection limit.

STUDY DESIGN AND METHODS: Viral standard dilution panels (PeliCheck, VQC‐CLB) were prepared for HCV RNA genotypes 1 and 3 and for HIV RNA genotypes B and E. In a multicenter study, 23 laboratories tested the panels all together in 8 to 91 test runs per NAT method.

RESULTS: The following 95‐percent detection limits (and 95% CIs) were found on the HCV RNA genotype 1 reference panels (shown as geq/mL): Gen‐Probe TMA, 85 (64‐118); AmpliScreen, 126 (83‐225); AmpliScreen with NucliSens Extractor, 21 (13‐44); Amplicor with NucliSens Extractor, 69 (50‐102), and Amplicor with Qiagen extraction technology, 144 (74‐102). On HIV RNA genotype B dilution panels, the following 95‐percent detection limits were found (shown as geq/mL): Gen‐Probe TMA, 31 (20‐52); AmpliScreen, 126 (67‐311); AmpliScreen with NucliSens Extractor, 37 (23‐69), and NucliSens QL assay, 123 (51‐566). HIV RNA genotype E panels were detected with equal sensitivity as HIV RNA genotype B panels. In the Gen‐Probe TMA assay, the 50‐percent detection limits on HIV RNA type B and type E were 3.6 (2.6‐5.0) and 3.9 (2.4‐5.8) geq per mL, respectively. The HCV RNA genotype 1 and 3 standards were detected with equal sensitivity.

CONCLUSION: The differences in sensitivity between NAT assays can be explained by the input of isolated viral nucleic acid in the amplification reactions. The FDA requirements for sensitivity of NAT blood screening assays can be met by the Gen‐probe TMA, as well as by the AmpliScreen assays, particularly when combined with the NucliSens Extractor.
Quantification of HCV RNA levels and detection of core antigen in donations before seroconversion
Authors: Grant P.R. , Sims C.M. , Tedder R.S.
Published: March 2003

BACKGROUND: Detection of HCV during the window phase of infection before seroconversion is important in blood screening. HCV RNA levels were measured before seroconversion and compared with HCV core antigen and anti‐HCV detection.

STUDY DESIGN AND METHODS: A total of 41 plasma samples from 17 US plasmapheresis donors and one English National Blood Service donor in the window phase before seroconversion of HCV infection were tested for the presence of anti‐HCV, HCV RNA, and HCV core antigen.

RESULTS: HCV RNA levels between 5.4 × 102and 3.4 × 107IU per mL were measured. HCV core antigen was detected in 11 of 18 donors at the same time point as RNA was detected.

CONCLUSIONS: A wide range of HCV RNA levels can be detected during the seronegative window phase of HCV infection. HCV core antigen can be used to detect HCV infection during the window phase of infection.