ISSN:0041-1132    

DOI:10.1046/j.1537-2995.1994.34294143959.x

出版商:Blackwell Science Ltd    

年代:1994

数据来源: WILEY

ISSN:0041-1132    

DOI:10.1046/j.1537-2995.1994.34294143960.x

出版商:Blackwell Science Ltd    

年代:1994

数据来源: WILEY

摘要:

Background:The safety of intravenous immunoglobulin (IGIV), manufactured from units testing negative for antibody to hepatitis C virus (anti‐HCV), was investigated.Study Design and Methods:A study involving five chimpanzees was performed to determine whether the safety of IGIV would be compromised if units of plasma that reacted for anti‐HCV were withheld from pools from which IGIV is manufactured. In the first phase of the experiment, two chimpanzees were infused with 25 mL per kg of unprocessed, pooled plasma from 2887 donors who did not react for anti‐HCV in single‐antigen (c100‐3) enzyme‐linked immunosorbent assays. In the second phase, each of three chimpanzees was infused with 1000 mg per kg of IGIV manufactured from the same plasma units. The immunoglobulin was made by seven United States‐ licensed manufacturers, each using its own approved method. Each chimpanzee received an equal dose of each manufacturer's IGIV.Results:The two chimpanzees that received anti‐c100‐3‐nonreactive, unprocessed pooled plasma became infected with HCV. The three chimpanzees infused with IGIV did not show any evidence of infection with HCV 15 months after inoculation. Two of these animals were challenged with human non‐ A,non‐B hepatitis‐infectious plasma, and both subsequently showed evidence of HCV infection.Conclusion:These studies demonstrate that, as determined by infectivity for chimpanzees, 1) the withholding of plasma units that react for anti‐c100‐3 from pools from which plasma products are manufactured does not render the source material noninfectious, and 2) the safety of IGIV manufactured from such plasma pools is not compromised by withholding the unit

ISSN:0041-1132    

DOI:10.1046/j.1537-2995.1994.34294143934.x

出版商:Blackwell Science Ltd    

年代:1994

数据来源: WILEY

摘要:

Background:This article describes standard operating procedures (SOPs) for a computer crossmatch to replace the immediate‐spin crossmatch for ABO incompatibility between patient blood samples submitted for pretransfusion testing and the blood component selected for transfusion. These SOPs were developed following recent changes to theStandards for Blood Banks and Transfusion Servicesof the American Association of Blood Banks (AABB).Study Design and Methods:SOPs were developed, utilizing currently available software, for pretransfusion testing. The SOP for donor unit processing entails bar code entry of the unit number, component name, and ABO/Rh type; computer entry and interpretation of serologic reactions; warning of discrepancies between bar code‐entered blood type and result interpretation; and quarantine of the donor unit in such instances. The SOP for patient sample testing requires bar code entry of specimen accession number, which accesses patient demographics; computer entry and interpretation of ABO/Rh tests; repeat blood typing at the time of crossmatch if only one patient blood type is on record; and warning if there are nonconcordant current and historical blood types. The computer crossmatch SOP requires bar code entry of specimen accession and donor unit numbers; release of group O red cells pending resolution of discrepancies; and immediate‐spin crossmatch during computer downtime. Tables validated on‐ site prompt warning messages and prevent both computer crossmatch and release if blood components of the wrong ABO type are selected.Results:These SOPs meet the requirements of the 15th edition of the AABB Standards. Projected annual time savings at this institution are>100,000 workload recording units. Further benefits include reduced patient sample volume requirements, less handling of biohazardous material, and elimination of unwanted positive or negative reactions associated with the immediate‐spin crossmatch. Release of incompatible blood components when the wrong patient blood type is on record is addressed by requiring the use of group O red cells in the absence of two concordant blood types, one of which must be from a current sample.Conclusion:A combination of existing computer programs and carefully developed SOPs can provide a safe and efficient means of detecting donor‐recipient incompatibility without performance of serologic

ISSN:0041-1132    

DOI:10.1046/j.1537-2995.1994.34294143935.x

出版商:Blackwell Science Ltd    

年代:1994

数据来源: WILEY

摘要:

Background:The purpose of this study was to evaluate the criteria for assessing the appropriateness of red cell transfusions. The data were obtained by a computer search of all English‐language literature from 1966 to October 1992.Study Design and Methods:Nine studies were selected, which dated from 1986 to 1989 and employed explicit criteria evaluating the appropriateness of red cell transfusion in adults. The following data were abstracted from all studies: study design, timing, location, criteria for evaluating appropriateness, and rate of appropriate or inappropriate transfusions.Results:Five studies evaluated transfusion appropriateness. Appropriateness rates ranged from 88 to 99 percent in three studies, and inappropriateness rates ranged from 0.3 to 57.3 percent in two studies. Four studies evaluated transfusion inappropriateness and reported inappropriateness rates of 18 to 55 percent. Substantial variation was found in the criteria for an appropriate or an inappropriate transfusion. Appropriateness rates did not depend upon characteristics of the study design, location, or timing of data collection. Restrictiveness in the criteria used to determine appropriateness and the use of additional implicit evaluation after an initial explicit review affected appropriateness rates.Conclusion:In the 1980s, high rates of inappropriate transfusion and low rates of appropriate transfusion were still reported. Appropriateness rates varied widely, in part because of marked variation in the criteria for an appropriate transfusion. Newly derived standards for an appropriate red cell transfusion, published in 1992, appear to provide a simple and objective means of evaluating the appropriateness of a transfusion. Appropriateness rates resulting from the application of these new standards have not yet been determine

ISSN:0041-1132    

DOI:10.1046/j.1537-2995.1994.34294143936.x

出版商:Blackwell Science Ltd    

年代:1994

数据来源: WILEY

摘要:

Background:Historically, paid blood donors were found to transmit hepatitis at higher rates than volunteers. In those older studies, paid donors frequently were recruited from prisons or slum areas–a finding consistent with the belief that monetary payment in itself did not necessarily lead to the high‐risk status of commercial blood. Instead, it was the population base from which the donors were recruited that was important.Study Design and Methods:Today, cytapheresis donors are in great demand. Because payment is one incentive that might entice donors to undertake the increased commitment of repeated cytapheresis donation, the results were studied of infectious disease history and laboratory testing performed concurrently in 917 volunteer whole‐blood donors and 1240 paid cytapheresis donors, who were enrolled in distinct programs at the DeGowin Blood Center from October 7, 1987, through November 30, 1990.Results:When first, repeat, and overall donations made by these donors were evaluated separately, paid cytapheresis donors were found to exhibit no increase in infectious disease history or test results beyond those of volunteer whole‐blood donors.Conclusion:Thus, paid cytapheresis donors, when managed within a formal program, should not necessarily be presumed to be more dangerous than volunteers, from an infectious disease aspect. However, definitive proof of safety (comparison of transfusion‐transmitted infection rates in two groups of patients receiving blood components exclusively from either paid cytapheresis or volunteer donors) was not pursued by long‐ term follow

ISSN:0041-1132    

DOI:10.1046/j.1537-2995.1994.34294143937.x

出版商:Blackwell Science Ltd    

年代:1994

数据来源: WILEY

摘要:

Background:In previous studies, 29 to 34 percent of potentially hemolytic red cell antibodies were not detected after short‐term follow‐ up.Study Design and Methods:To examine long‐term detection, records were reviewed for 44 consecutive patients who were tested more than 5 years after their potentially hemolytic red cell antibodies were first identified in this hospital.Results:After 5 to 10 years, 14 (39%) of 36 Rh, Kell, and Duffy system antibodies were not detected on at least one occasion. Twenty‐two other such antibodies were sought again after more than 10 years; 10 (45%) were not detected. When restimulation by pregnancy was excluded, these rates were 42 and 48 percent, respectively.Conclusion:Clinically significant red cell antibody formation is probably more common than previously realized, because nearly half of these antibodies are undetected after long‐term f

ISSN:0041-1132    

DOI:10.1046/j.1537-2995.1994.34294143938.x

出版商:Blackwell Science Ltd    

年代:1994

数据来源: WILEY

摘要:

Background:Despite the use of the anti‐c100‐3 assay for blood donor screening, posttransfusion non‐A,non‐B hepatitis still occurred. A more sensitive assay should be developed to prevent this.Study Design and Methods:Stored serum specimens from 2020 healthy blood donors who were negative for c100‐3 antibody to hepatitis C virus (HCV) were retrospectively screened for the presence of antibodies against a core protein of HCV using an enzyme‐linked immunosorbent assay and Western blot analysis as part of a study on posttransfusion non‐A,non‐B hepatitis.Results:Eight (0.4%) of the 2020 donors were positive for HCV core antibody. Posttransfusion non‐A,non‐B hepatitis occurred in 5 of five patients known to have received blood that was positive for HCV core antibody and 1 of 141 patients transfused with blood that was negative for HCV core antibody. The total incidence of posttransfusion non‐A,non‐B hepatitis was 4.1 percent (6/146). The nucleotide sequence of the nonstructural 5 region of the HCV genome obtained from two donors and corresponding recipients was also analyzed. The HCV genome sequences were identical for one donor‐recipient pair, and there was 99.4‐percent homology for a second pair.Conclusion:Anti‐core‐positive blood proved to be highly infectious for HCV, and this validated the use of the second‐generation anti‐

ISSN:0041-1132    

DOI:10.1046/j.1537-2995.1994.34294143939.x

出版商:Blackwell Science Ltd    

年代:1994

数据来源: WILEY

摘要:

Background:Approximately 25 percent of blood donor sera that are repeatably reactive for hepatitis C virus (HCV) on second‐generation enzyme immunoassay (EIA 2.0) are indeterminate on second‐generation recombinant immunoblot assay (RIBA 2.0), and over 76 percent of these results are due to single reactivity to the HCV recombinant antigen c22‐ 3.Study Design and Methods:Data are presented on 46 volunteer allogeneic blood donors who were reactive on EIA2.0 and c22‐3 indeterminate in RIBA 2.0. Index and follow‐up samples were evaluated by using a panel of five synthetic peptide EIAs, a prototype strip immunoblot assay that uses synthetic peptides in addition to recombinant protein (RIBA 3.0), and polymerase chain reaction (PCR) for HCV RNA.Results:All 46 donations had normal alanine aminotransferase values; only 2 (4.3%) reacted for antibody to hepatitis B core antigen. With a panel of 12 synthetic peptides spanning the entire sequence of the c22‐3 recombinant antigen, 33 plasmas (72%) reacted to one peptide or none, including 19 plasmas with reactivity restricted entirely to the N‐terminal peptide (1–15 amino acids) of c22‐3. With RIBA 3.0, 28 donations (61%) were nonreactive, including 25 that reacted with one peptide or none in EIA. Of these 25 plasmas, 18 reacted with the N‐ terminal sequence only. All 46 index donations were tested by PCR; the single PCR‐positive unit reacted with four HCV peptides, was positive by RIBA 3.0, and reacted for antibody to hepatitis B core antigen. Twenty‐six index donors were successfully recalled 3 to 7 months after their index donation. None seroconverted to positivity in RIBA 2.0, 1 was nonreactive, and 25 remained positive for c22‐3 only. The restricted epitope reactivity in peptide EIA and RIBA 3.0 was maintained over time in all cases. All 26 of the follow‐up samples tested negative by PCR.Conclusion:On the basis of the restricted peptide reactivity and PCR negativity of index and follow‐up samples, it is concluded that the majority of c22‐3 RIBA 2.0‐indeterminate results are due to nonspecific cross‐reactivity to restricted (principally, N‐

ISSN:0041-1132    

DOI:10.1046/j.1537-2995.1994.34294143940.x

出版商:Blackwell Science Ltd    

年代:1994

数据来源: WILEY

摘要:

Background:Few epidemiologic reports on the prevalence of hepatitis C in Saudi blood donors have been published.Study Design and Methods:Men (of several nationalities) donating blood at the King Khalid National Guard Hospital (Jeddah, Saudi Arabia) were randomly selected (n = 744) for this study examining the prevalence of hepatitis C virus (HCV) in the local donor population, the relationship of antibody to HCV (anti‐HCV) to the surrogate markers alanine aminotransferase (ALT) and antibody to hepatitis B core antigen (anti‐HBc), and the effect of the use of these markers on the discard rate.Results:The prevalence of anti‐HCV in the group examined was 3.2 percent (24/744), with a significantly high prevalence of 24.5 percent (12/49) in donors who were Egyptian (p65 U/L (p<0.0001). There was no significant relationship between anti‐HCV and anti‐HBc (p = 0.66). The prevalence of anti‐HCV in the Saudis studied was 1.7 percent (9/528). The prevalence of anti‐HCV in non‐Bedouin Saudis was significantly greater than that in Bedouin Saudis (7/165 [4.2%] vs. 2/363 [0.5%]; p90 U/L) and anti‐HBc as surrogate markers would increase the current discard rate (8.3%) by 2.8 and 23.8 percent, respectively.Conclusion:These findings demonstrate the practical difficulties of using anti‐HBc as a surrogate marker for hepatitis C in areas ende

ISSN:0041-1132    

DOI:10.1046/j.1537-2995.1994.34294143941.x

出版商:Blackwell Science Ltd    

年代:1994

数据来源: WILEY