Selection criteria to protect the blood donor in North America and Europe: past (dogma), present (evidence), and future (hemovigilance).

The safety of the blood supply depends on measures to protect not only the transfusion recipient but also the blood donor. Donor selection criteria have been voluntarily adopted or enforced through regulation in different countries, but review of practices in different blood centers reveals wide disparity in the current approaches. Such variability in practice suggests that the criteria for the protection of donor are often arbitrary or reflect deeply engrained precautionary practices and exposes the inherent uncertainty about the best way to minimize risk to the donor.

The impact of discontinuation of 7-day storage of apheresis platelets (PASSPORT) on recipient safety: an illustration of the need for proper risk assessments.

Background: Seven-day stored apheresis platelets (APs) were withdrawn from the US market after detection of two culture-positive units from 2571 tested at outdate in the PASSPORT surveillance study. The impact of this discontinuation on recipient safety was explored using mathematical modeling.

Study Design And Methods: Risk models for septic transfusion reactions (STRs) and transfusion-related acute lung injury (TRALI) were developed.

West Nile virus infections projected from blood donor screening data, United States, 2003.

National blood donor screening for West Nile virus (WNV) RNA using minipool nucleic acid amplification testing (MP-NAT) was implemented in the United States in July 2003. We compiled national NAT yield data and performed WNV immunoglobulin M (IgM) testing in 1 WNV-epidemic region (North Dakota). State-specific MP-NAT yield, antibody seroprevalence, and the average time RNA is detectable by MP-NAT were used to estimate incident infections in 2003.

Twelve years of the Brazilian External Quality Assessment Program in Immunohematology: benefits of the program.

The Brazilian External Quality Assessment Program in Immunohematology (BEQAPI) was introduced with the objective of evaluating the quality of diagnosis in immunohematology. From 1992 to 2003, proficiency tests for ABO grouping, Rh (D, C, c, E, e), K phenotyping, direct antiglobulin testing (DAT), antibody screening (AS), and antibody identification (AI) were performed. A total of 41 evaluations were carried out in 223 institutions.

Protecting the blood supply from emerging pathogens: the role of pathogen inactivation.

Although the risk of infection by blood transfusion is relatively low, breakthrough infections still occur, Transfusion-related fatalities caused by infections continue to be reported, and blood is not tested for many potentially dangerous pathogens. The current paradigm for increasing the safety of the blood supply is the development and implementation of laboratory screening methods and restrictive donor criteria. When considering the large number of known pathogens and the fact that pathogens continue to emerge, it is clear that the utility of new tests and donor restrictions will continue to be a challenge when considering the cost of developing and implementing new screening assays, the loss of potential donors, and the risk of testing errors.

The 2003 West Nile virus United States epidemic: the America's Blood Centers experience.

Background: A detailed assessment of West Nile virus (WNV) yield is needed to evaluate the effectiveness of the WNV nucleic acid amplification technology (NAT) screening implemented in 2003.

Study Design And Methods: WNV NAT screening and donation data were compiled from members of America's Blood Centers, which collect nearly 50 percent of the US blood supply. WNV RNA screening was performed with either the Gen-Probe/Chiron Procleix transcription-mediated amplification assay or the Roche TaqScreen polymerase chain reaction.

Technical considerations for the performance of Nucleic acid Amplification Technology (NAT). The NAT Task Force Group.

The complexity of Nucleic acid Amplification Technology (NAT(1)), comprising sample preparation, amplification and detection methods, requires specific design considerations for both the laboratory and the procedures utilized in such testing. The purpose of this paper is to establish technical considerations for the performance of NAT. These include the collection, handling and assay of specimens and the design of laboratories to routinely and reliably detect low levels of nucleic acid sequences.

Detection of human T-lymphotropic virus (HTLV) tax sequences in New York City blood donors seronegative for HTLV types 1 and 2.

A potential public health concern is the reported detection of the human T-lymphotropic virus (HTLV) tax gene in the lymphocytes of up to 11% of a low-risk group of New York City blood donors (NYBD). This study aimed to independently confirm the prevalence of HTLV tax sequences in 293 NYBD. All NYBD tested negative for antibodies to HTLV types 1 and 2 and HTLV Tax.

Pathological and virological assessment of acute HTLV-I-associated myelopathy complicated with encephalopathy and systemic inflammation.

HTLV-I-associated myelopathy, also known as tropical spastic paraparesis (HAM/TSP), is a chronic inflammatory disease of the spinal cord. Acute cases are uncommon. We report the case of a 41-year-old woman with acute HAM/TSP complicated with encephalitis, an intense inflammatory reaction of the nervous system and lymphocytic infiltration of skeletal muscles, liver, salivary, adrenal and pituitary glands.

Racial and ethnic composition of volunteer cord blood donors: comparison with volunteer unrelated marrow donors.

Background: Umbilical cord blood is an alternative peripheral blood progenitor cell source for patients who need transplantation. A presumed advantage of cord blood is the ability to increase minority recruitment.

Study Design And Methods: The racial composition of five member cord blood banks of the National Marrow Donor Program (NMDP) was compared, representing 9020 cord blood donors with NMDP marrow donors from comparable geographic areas, representing 417,676 donors.

The upward spiral of drug costs: a time series analysis of drugs used in the treatment of hemophilia.

Background: Hemophilia is an expensive disease because its treatment is heavily dependent on costly clotting factor drugs. Over the last nine years,a consortium of three Comprehensive Hemophilia Treatment Centers and other hospitals, which purchased clotting factors for their patients, has seen treatment costs escalate on average 17% annually. Currently, new, even more expensive drugs are entering the market.

DNA-based typing of blood groups for the management of multiply-transfused sickle cell disease patients.

Background: The usefulness of DNA genotyping for RBC antigens as a tool for the management of multiply-transfused patients with sickle cell disease (SCD) to overcome the limitations of hemagglutination assays was evaluated.

Study Design And Methods: Blood samples from 40 multiply-transfused SCD patients were studied by hemagglutination and by PCR-RFLP for antigens or genes in the Rh (D, C/c, E/e), Kell, Kidd, and Duffy systems.

Results: Discrepancies were found between hemaglutination and DNA typing test results in six patients: two were discrepant in Rh typing (one was D- by hemagglutination and RhD by DNA, and one was E+e- and RhEe by DNA), two were discrepant in Duffy typing [both were Fy(a+b-) and Fy(b)/Fy(b) by DNA], and four were discrepant in Kidd typing [Jk(a+b+) and Jk(b)/Jk(b) by DNA; two of these samples were also discrepant in Duffy].