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Apheresis platelets (AP) may be contaminated by environmental bacteria via container defects acquired during processing, transport, storage, or transfusion, as highlighted by a recent series of septic reactions related to Acinetobacter spp. and other bacterial strains.The frequency and nature of acquired container defect reports to one manufacturer were evaluated from January 2019 to July 2020. The published incidence of contamination and sepsis due to environmental bacteria with culture screened AP in the United States was reviewed for the period of 2010-2019.Review of a manufacturers' records showed 23 US reports of leaks involving 24 containers attributed to postmanufacturing damage, at a rate of 44 per million distributed storage containers. Analysis of returned containers showed evidence of scratches, impressions, and/or piercings. Literature review of US hemovigilance data revealed that environmental bacteria comprised 7% of confirmed positive primary bacterial culture screens, were responsible for 14%-16% of reported septic, and 8 of 28 (29%) fatal reactions with bacterial-culture screened AP. Sepsis cases have been reported with culture screened, point-of-issue (POI) tested, or pathogen-reduced AP.Environmental contamination of AP is rare but can cause sepsis. Container damage provides a pathway for contamination after culture screening, POI bacteria testing, or pathogen reduction. Blood collectors and transfusion services should have procedures to ensure proper inspection, handling, storage, and transport of AP to avoid damage and should enhance efforts to detect defects prior to release and to eliminate bacteria from all contacting surfaces to minimize the risk of contamination.

Background Some countries impose an upper age limit on whole blood and double RBC donation while others do not. We evaluated the safety of blood donation in older individuals (≥71 years), and their contribution to the blood supply of five countries. Study design and methods Twelve blood center members of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative from four countries with no upper age limit for whole blood and double RBC donation (Canada, New Zealand, England, and the United States) or an upper age limit of 80 (Australia) provided 2016 data on donors and donations, deferral rates, and vasovagal reactions by donor age and sex. Donors under age 24 were included in the number of total donors and donations, but not in deferral and reaction rate comparisons. Results Older donors accounted for 1.0% (New Zealand) to 4.3% (United States) of donors, and 1.5% (New Zealand) to 5.6% (United States) of donations; most were between ages 71 and 76. The deferral rate was higher in older compared to 24- to 70-year-old males, but very similar between older and younger females. In contrast, vasovagal reaction rates were either lower (male donors) or similar (female donor for reactions with loss of consciousness) in older compared to 24- to 70-year-old donors. Conclusions Exclusion solely based on older age appears to be unwarranted based on safety concerns such as donor reactions. Healthy older individuals can continue to safely donate and make a significant contribution to the blood supply past arbitrary age limits.

Background Antibody response duration following severe acute respiratory syndrome coronavirus 2 infection tends to be variable and depends on severity of disease and method of detection. Study design and methods COVID‐19 convalescent plasma from 18 donors was collected longitudinally for a maximum of 63–129 days following resolution of symptoms. All the samples were initially screened by the Ortho total Ig test to confirm positivity and subsequently tested with seven additional direct sandwich or indirect binding assays (Ortho, Roche, Abbott, Broad Institute) directed against a variety of antigen targets (S1, receptor binding domain, and nucleocapsid [NC]), along with two neutralization assays (Broad Institute live virus PRNT and Vitalant Research Institute [VRI] Pseudovirus reporter viral particle neutralization [RVPN]). Results The direct detection assays (Ortho total Ig total and Roche total Ig) showed increasing levels of antibodies over the time period, in contrast to the indirect IgG assays that showed a decline. Neutralization assays also demonstrated declining responses; the VRI RVPN pseudovirus had a greater rate of decline than the Broad PRNT live virus assay. Discussion These data show that in addition to variable individual responses and associations with disease severity, the detection assay chosen contributes to the heterogeneous results in antibody stability over time. Depending on the scope of the research, one assay may be preferable over another. For serosurveillance studies, direct, double Ag‐sandwich assays appear to be the best choice due to their stability; in particular, algorithms that include both S1‐ and NC‐based assays can help reduce the rate of false‐positivity and discriminate between natural infection and vaccine‐derived seroreactivity.

Background COVID‐19 safety measures and possibly SARS‐CoV‐2 antibody testing may alter blood donor demography, which has the potential to alter blood safety. We characterized pre‐pandemic and pandemic rates of donor infectious disease marker (IDM) reactivity which reflect the residual risk of transfusion‐transmitted infections (TTIs) undetectable by current testing. Methods This cross‐sectional analysis of allogeneic blood donor presentations and successful donations in a large national US blood collector identifies changes in self‐reported behavioral risk factors and IDM reactivity. Data on allogeneic blood donor presentations and successful donations from March 1 through August 31, 2020 and the same period in 2019 were retrieved from the blood center's computer system. Donor demographics and deferrals for reported behavioral risk factors and confirmed‐positive IDMs were compared in pre‐pandemic and pandemic periods. Results With increasing mobile blood drive cancellations, pandemic donors were more likely than 2019 donors to be female, over age 30, non‐Hispanic Whites, and have a post‐secondary degree. First‐time donations (at highest risk for confirmed‐positive IDMs) did not substantially increase. Pandemic donors reported fewer behavioral risks and IDMs declined among these donors. Mid‐pandemic introduction of screening for SARS‐CoV‐2 antibodies did not affect IDM rates. Conclusions Unlike disasters, which tend to bring out more first‐time donors with increased IDM reactivity and TTI residual risk, COVID‐19 donors had lower IDM rates which were not affected by SARS‐CoV‐2 antibody testing. Already‐low TTI residual risk is likely to have declined as a result.

Background Efficacy of COVID‐19 convalescent plasma (CCP) is hypothesized to be associated with the concentration of neutralizing antibodies (nAb) to SARS‐CoV‐2. High capacity serologic assays detecting binding antibodies (bAb) have been developed; nAb assays are not adaptable to high‐throughput testing. We sought to determine the effectiveness of using surrogate bAb signal‐to‐cutoff ratios (S/Co) in predicting nAb titers using a pseudovirus reporter viral particle neutralization (RVPN) assay. Methods CCP donor serum collected by three US blood collectors was tested with a bAb assay (Ortho Clinical Diagnostics VITROS Anti‐SARS‐CoV‐2 Total, CoV2T) and a nAb RVPN assay. Prediction effectiveness of various CoV2T S/Co criteria was evaluated for RVPN nAb NT50 titers using receiver operating characteristics. Results Seven hundred and fifty‐three CCPs were tested with median CoV2T S/Co and NT50 of 71.2 of 527.5. Proportions of donors with NT50 over target nAb titers were 86% ≥1:80, 76% ≥1:160, and 62% ≥1:320. Increasing CoV2T S/Co criterion reduced the sensitivity to predict NT50 titers, while specificity to identify those below increased. As target NT50 titers increase, the CoV2T assay becomes less accurate as a predictor with a decline in positive predictive value and rise in negative predictive value. Conclusion Selection of a clinically effective nAb titer will impact availability of CCP. Product release with CoV2T assay S/Co criterion must balance the risk of releasing products below target nAb titers with the cost of false negatives. A two‐step testing scheme may be optimal, with nAb testing on CoV2T samples with S/Cos below criterion.

Background Iron deficiency is observed in blood donors who meet hemoglobin requirements for donation. Frequent donation results in negative iron balance, and teenage donors may thus be at risk for adverse health consequences. Study design and methods Blood Systems implemented ferritin testing on all successful 16- to 18-year-old (teen) donations. Low ferritin (LF) was defined as less than 20 ng/mL in females and less than 30 ng/mL in males. Donors with LF were deferred from red blood cell (RBC) donations (12 months for females, and 6 for males) and counseled to take low-dose iron for 60 days. A ferritin value less than 26 ng/mL indicated iron-deficient erythropoiesis and less than 12 ng/mL absent iron stores. Results Over 16 months, 110,417 teen donations were tested and represented 10.5% of all successful donations. The rate of absent iron stores was 9.0% (1.9% male; 15.9% female) and of iron-deficient erythropoiesis, 31.9% (12.4% male; 50.6% female). The rate of LF deferrals was 26.9% (16.7% male; 36.6% female). The proportion of LF donors decreased with increasing predonation hemoglobin and rose with increasing RBC donations in the prior 24 months. Seasonality in LF deferrals and the RBC contribution from teen donors was observed. Conclusions Ferritin testing of teen donors identified individuals with LF who might benefit from risk mitigation. LF is more common in teenage female than male donors and those with RBC donations in the prior 24 months. An appreciable number of new/lapsed donors presented with LF, however. These data may be useful in guiding future risk mitigation efforts.

BACKGROUND The Food and Drug Administration's requirements for "Blood and Blood Components Intended for Transfusion or Further Manufacturing Use" (Final Rule) effective May 2016 changed eligibility criteria for blood donors. A multivariate analysis was performed to measure its impact on donor deferral rates. STUDY DESIGN AND METHODS Four blood centers submitted data for similar 6-month periods before and after implementation of the Final Rule. Data included presenting donors, units collected, deferrals, intended products from deferred donors, deferral reasons, presenting donor demographics, donor hemoglobin (Hgb), hematocrit (HCT), pulse, blood pressure (BP), temperature, and other reasons for deferral. Data were aggregated and periods compared. RESULTS After Final Rule implementation, successful donations decreased by 1.3% (83.1%-81.9%), despite a 0.2% increase in presenting donors. The rate of Hgb/HCT, pulse, and deferrals increased, while deferrals for other reasons decreased. Male Hgb/HCT deferral rates increased 1.2% (4213 total). Black male donors' Hgb/HCT deferral rate increased (2.7%-5.2%) but was counterbalanced by an overall 3.7% decrease in black female Hgb/HCT deferrals. While Hgb/HCT deferrals of black donors remained stable overall (17.0% vs. 16.2%), this trend was not observed by all centers. Deferrals for pulse increased (0.2%), as did BP deferrals (0.2%). CONCLUSION Although there was a small increase in presenting donors after implementation of the Final Rule, there was a decrease in successful donations. While it appeared that deferral in black donors was unchanged, this trend was not observed across all centers. Pulse and BP deferrals rose dissimilarly among centers, according to individual procedures.

Most purported benefits of blood donation have not been proven. While studies suggest individuals with type II diabetes have transiently improved postdonation glycemic control, the mechanism is unknown. Blood donors with nonanemic or mildly anemic iron deficiency can develop pica and undergo unnecessary diagnostic procedures. Lower infant birth weight has been documented in female blood donors. In other healthy populations, reversible fatigue and exercise capacity impairment occur with mild iron deficiency. The effects of donor iron depletion on cognition and neurocognitive outcomes after pregnancy continue to be studied. Blood collectors are beginning to implement enhanced educational and interventional measures to prevent iron depletion in at-risk donors.