Normative dataset for plasma cytokines in healthy human adults.

We determined normative data for plasma cytokines established from a cohort of 126 carefully screened healthy adults aged 18 to 64 years. Participants were enrolled to ensure an even age and sex distribution and to include at least 30% non-Caucasians. Plasma cytokines for 18 analytes were tested by multiplex immunoassay. The data are presented by age cohort (18-29 years, 30-39, 40-49, and 50-66), as well as by sex and racial background. This dataset complements published normative ranges of cellular subsets generated by comprehensive polychromatic flow cytometry analysis of the healthy human immune system [1]. These data are available to researchers and have value as a reference range for research involving peripheral cytokines.

Development and validation of donor adverse reaction severity grading tool: enhancing objective grade assignment to donor adverse events.

BACKGROUND: Uniform and consistent reporting and comparison of donor adverse events (DAEs) and severity are well-recognized challenges for donor hemovigilance (DHV). While the 2014 Standard for Surveillance of Complications Related to Blood Donation (SSCRBD), developed by hemovigilance experts from AABB, the International Society of Blood Transfusion, and International Hemovigilance Network, established the DAE definitions, no specific guidelines were provided to grade severity. A group of subject matter experts developed the Severity Grading Tool for Blood Donor Adverse Events (SGT) to enhance objective assignment of severity and conducted a study to validate the tool. STUDY DESIGN AND METHODS: Between January 8, 2019, and February 28, 2019, participants graded severity of 32 cases (34 DAEs) using the SGT. Comments boxes allowed participants to provide rationale for selecting a severity grade for each case. Agreement with expert grading among study participants was evaluated using percentage agreement. Inter-rater reliability was evaluated by Kendall's coefficient of concordance (W). The final SGT was revised based on validation study results and feedback received. RESULTS: The overall agreement was almost perfect with W = 0.84 (confidence interval [CI], 0.78-0.90). Of 34 DAEs, respondent agreement with expert grading of more than 90% was reached for 18 DAEs, 80% to 90% for six DAEs, 70% to 80% for six DAEs, and less than 70% for four DAEs. CONCLUSION: The development and validation of a uniform SGT with objective criteria for assigning severity of DAEs used together with standard reaction definitions will provide opportunities for comparison between blood centers and systems to enhance the field of DHV.

Establishment of normative ranges of the healthy human immune system with comprehensive polychromatic flow cytometry profiling.

Existing normative flow cytometry data have several limitations including small sample sizes, incompletely described study populations, variable flow cytometry methodology, and limited depth for defining lymphocyte subpopulations. To overcome these issues, we defined high-dimensional flow cytometry reference ranges for the healthy human immune system using Human Immunology Project Consortium methodologies after carefully screening 127 subjects deemed healthy through clinical and laboratory testing. We enrolled subjects in the following age cohorts: 18-29 years, 30-39, 40-49, and 50-66 and enrolled cohorts to ensure an even gender distribution and at least 30% non-Caucasians. From peripheral blood mononuclear cells, flow cytometry reference ranges were defined for >50 immune subsets including T-cell (activation, maturation, T follicular helper and regulatory T cell), B-cell, and innate cells. We also developed a web tool for visualization of the dataset and download of raw data. This dataset provides the immunology community with a resource to compare and extract data from rigorously characterized healthy subjects across age groups, gender and race.

Frequent source plasma donors are not at risk of iron depletion: the Ferritin Levels in Plasma Donor (FLIPD) study.

BACKGROUND: Whole blood and red blood cell (RBC) donors are at risk of iron deficiency. Since Source plasma (SP) donors have RBCs returned during apheresis, risk of iron depletion appears low. However, SP donors can donate frequently and assessment of frequent donor iron status is needed. STUDY DESIGN AND METHODS: A total of 1254 SP donors were enrolled in four frequency groups determined by donations in the prior 12 months: no donations and 1 to 24, 25 to 69, and 70 or more donations. Ferritin was determined for each donor. Donors with ferritin levels of less than 12 ng/mL were classified as having absent iron stores (AIS). RESULTS: Compared to new donors, ferritin for females was higher in each successive frequency group. For 70 or more donations, ferritin was 13 ng/mL higher than in new donors (p = 0.02). For males, 1 to 24 donations had the highest ferritin levels. Compared to new donors, highest-frequency donors had lower ferritin levels, 114 ng/mL versus 100 ng/mL (p = 0.14). Age for females and males increased with each successive frequency group. Age adjustment resulted in smaller ferritin differences for females and larger differences for males in the high-frequency groups; AIS for females was highest in new donors (7%) and lowest in the highest-frequency group (1%). In aggregate, AIS occurred in less than 1% of all male donors. Male new and highest-frequency donors had 1% AIS with none in the other groups. CONCLUSION: Few SP donors have iron depletion and it is not higher in frequent donors. Frequent SP donation does not adversely impact iron stores. Thus, monitoring donor iron status or iron supplementation is not necessary.