Why do US source plasma donors stop donating?

Background: In the United States, source plasma (SP) donors can donate up to 104 times per year. Considering the global need for SP and plasma-derived medicinal products, it is critical to maintain the health of frequent donors. This study explores SP donors' self-reported reasons for a lapse in donating.

Prospective, open-label, multicenter clinical study to assess the performance of a new donation system for the collection of source plasma.

Background: Safe, efficient, and reliable innovations among donation systems are needed to meet the growing global demand for source plasma. This study assessed the ability of a new donation system to collect appropriate product weights based on the US Food and Drug Administration nomogram for source plasma collections. Procedure duration and safety endpoints were also collected.

Analysis of 52 240 source plasma donors of convalescent COVID-19 plasma: Sex, ethnicity, and age association with initial antibody levels and rate of dissipation.

Background: COVID-19 convalescent plasma (CCP) was approved under emergency authorization to treat critically ill patients with COVID-19 in the United States in 2020. We explored the demographics of donors contributing plasma for a hyperimmune, plasma-derived therapy to evaluate factors that may be associated with anti-SARS-CoV-2 antibody response variability and, subsequently, antibody titers.

Study Design: An electronic search of CCP donors was performed across 282 US plasma donation centers.

Source plasma deferral trends: A 3-year analysis of 255 centers in the United States.

Background: Plasma contains many important proteins of therapeutic interest including albumin, clotting factors, and antibodies. Source plasma (SP) is in great demand particularly due to a shortage of immunoglobulin. To better understand how to increase supply, we examined SP donor deferrals for the previous 3 years.

Determination of neutralising anti-SARS-CoV-2 antibody half-life in COVID-19 convalescent donors.

Despite the burgeoning field of coronavirus disease-19 (COVID-19) research, the persistence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralising antibodies remains unclear. This study validated two high-throughput immunological methods for use as surrogate live virus neutralisation assays and employed them to examine the half-life of SARS-CoV-2 neutralising antibodies in convalescent plasma donations made by 42 repeat donors between April and September 2020. SARS-CoV-2 neutralising antibody titres decreased over time but typically remained above the methods' diagnostic cut-offs.

Anti-A/B isoagglutinin reduction in an intravenous immunoglobulin product and risk of hemolytic anemia: a hospital-based cohort study.

Background: Intravenous immunoglobulins (IVIG) are derived from large human plasma pools. IVIG-associated hemolytic anemia (HA) is a known class effect, likely attributed to dose-dependent passive transfer of anti-A/B isoagglutinins. Two isoagglutinin reduction steps were implemented in the manufacturing process of Privigen (human 10% liquid IVIG): exclusion of high-anti-A-titer donors in 2013, replaced by specific immunoaffinity chromatography in 2015.

Manufacturing of plasma-derived C1-inhibitor concentrate for treatment of patients with hereditary angioedema.

Replacement therapy with plasma-derived C1-inhibitor (C1-INH) has been used for decades to treat patients with hereditary angioedema (HAE) with C1-INH deficiency. This article reviewed the rationale for using C1-INH replacement therapy in patients with HAE and the process of manufacturing plasma-derived C1-INH. The manufacture of C1-INH is an involved and carefully monitored process that includes screening and selection of prospective donors, the collection of source plasma, and purification with dedicated pathogen reduction steps.

Longitudinal changes in measles antibody titers in plasma donors and minimum antibody levels of immunoglobulin products for treatment of primary immunodeficiency.

Background: To ensure that immunoglobulin (Ig) products have adequate functional antibody, the US Food and Drug Administration (FDA) requires that Ig lots contain minimum levels of measles neutralizing antibody; the current minimum is 0.48 x US Reference Ig 176.

Study Design And Methods: In the first part of the study, measles antibody titers were measured in donor plasma samples collected in 2007, 2011, and 2017.

Sensitivity and specificity of a new automated system for the detection of hepatitis B virus, hepatitis C virus, and human immunodeficiency virus nucleic acid in blood and plasma donations.

Background: Use of nucleic acid testing (NAT) in donor infectious disease screening improves transfusion safety. Advances in NAT technology include improvements in assay sensitivity and system automation, and real-time viral target discrimination in multiplex assays. This article describes the sensitivity and specificity of cobas MPX, a multiplex assay for detection of human immunodeficiency virus (HIV)-1 Group M, HIV-2 and HIV-1 Group O RNA, HCV RNA, and HBV DNA, for use on the cobas 6800/8800 Systems.

Measles Virus Neutralizing Antibodies in Intravenous Immunoglobulins: Is an Increase by Revaccination of Plasma Donors Possible?

We report a screen of plasma donors confirming that widespread use of childhood measles vaccination since 1963 resulted in a decrease in average measles virus antibody titers among plasma donors, which is reflected in intravenous immunoglobulins (IVIGs). The measles virus antibody titer, however, is a potency requirement for IVIGs, as defined in a Food and Drug Administration regulation. To mitigate the decline in measles virus antibody titers in IVIGs and to ensure consistent product release, revaccination of plasma donors was investigated as a means to boost titers.

Low hepatitis E virus RNA prevalence in a large-scale survey of United States source plasma donors.

Background: Hepatitis E virus (HEV) is a small, nonenveloped, single-stranded, RNA virus of emerging concern in industrialized countries. HEV transmission through transfusion of blood components has been reported, but not via plasma-derived medicinal products (PDMPs) manufactured with virus inactivation and/or removal steps. This study aimed to determine the prevalence of HEV among US source plasma donors.

Pathogen inactivation and removal methods for plasma-derived clotting factor concentrates.

Pathogen safety is crucial for plasma-derived clotting factor concentrates used in the treatment of bleeding disorders. Plasma, the starting material for these products, is collected by plasmapheresis (source plasma) or derived from whole blood donations (recovered plasma). The primary measures regarding pathogen safety are selection of healthy donors donating in centers with appropriate epidemiologic data for the main blood-transmissible viruses, screening donations for the absence of relevant infectious blood-borne viruses, and release of plasma pools for further processing only if they are nonreactive for serologic markers and nucleic acids for these viruses.

Laboratory variables for assessing iron deficiency in REDS-II Iron Status Evaluation (RISE) blood donors.

Background: Iron deficiency is common in regular blood donors. We evaluated the diagnostic sensitivity and specificity of red blood cell (RBC) hematology analyzer indices to assess iron status as a part of donor management.

Study Design And Methods: A total of 1659 male and female donors from the Retrovirus Epidemiology Donor Study-II (REDS-II) Donor Iron Status Evaluation (RISE) study who were either first-time/reactivated (FT/RA; no donations for 2 years) or frequent donors were recruited into a longitudinal study of regular donation of RBCs.

Population-based screening for anemia using first-time blood donors.

Anemia is an important public health concern. Data from population-based surveys such as the National Health and Nutrition Examination Survey (NHANES) are the gold standard, but are obtained infrequently and include only small samples from certain minority groups. We assessed whether readily available databases of blood donor hemoglobin values could be used as a surrogate for population hemoglobin values from NHANES.

Iron deficiency in blood donors: the REDS-II Donor Iron Status Evaluation (RISE) study.

Background: Blood donors are at risk of iron deficiency. We evaluated the effects of blood donation intensity on iron and hemoglobin (Hb) in a prospective study.

Study Design And Methods: Four cohorts of frequent and first-time or reactivated (FT/RA) blood donors (no donation in 2 years), female and male, totaling 2425, were characterized and followed as they donated blood frequently.

Demographics of successful, unsuccessful and deferral visits at six blood centers over a 4-year period.

Background: Descriptions of donor demographics are of value in formulating recruitment and retention strategies. The demographics of successful (SV), unsuccessful (UV; meaning a nonuseable unit), and deferred (DV) donor visits over a 4-year period were investigated using Retrovirus Epidemiology Donor Study (REDS)-II databases.

Study Design And Methods: Fourteen deferral categories were created that included low hematocrit (Hct) or hemoglobin (Hb), feeling unwell, malaria travel, malaria other, couldn't wait, blood pressure or pulse, medical diagnosis, medication, test results, higher-risk behavior, variant Creutzfeldt-Jakob disease (CJD), CJD, needle exposure or tattoo, and other.

Donation return time at fixed and mobile donation sites.

Background: This study investigated the effect of blood donation environment, fixed or mobile with differing sponsor types, on donation return time.

Study Design And Methods: Data from 2006 through 2009 at six US blood centers participating in the Retrovirus Epidemiology Donor Study-II (REDS-II) were used for analysis. Descriptive statistics stratified by whole blood (WB), plateletpheresis (PP), and double red blood cell (R2) donations were obtained for fixed and mobile locations, including median number of donations and median interdonation interval.

Donor return after temporary deferral.

Background: The consequences of temporary predonation deferral are unsatisfactorily understood. Studies have found that deferral negatively impacts future donor return. However, the applicability of these findings across centers has not been established.

Iron deficiency in blood donors: analysis of enrollment data from the REDS-II Donor Iron Status Evaluation (RISE) study.

Background: Regular blood donors are at risk of iron deficiency, but characteristics that predispose to this condition are poorly defined.

Study Design And Methods: A total of 2425 red blood cell donors, either first-time (FT) or reactivated donors (no donations for 2 years) or frequent donors, were recruited for follow-up. At enrollment, ferritin, soluble transferrin receptor (sTfR), and hemoglobin were determined.

Demographic correlates of low hemoglobin deferral among prospective whole blood donors.

Background: Approximately 10% of attempted blood donations are not allowed because of low hemoglobin (Hb) deferral.

Study Design And Methods: Low Hb deferrals were tracked in more 715,000 whole blood donors at six blood centers across the United States. A multivariable logistic regression model was developed to comprehensively assess demographic correlates for low Hb deferral.