The Role of the Patient Advocate During a Pandemic: The Case of Convalescent Plasma.

The onset of the COVID-19 pandemic confronted medicine with several difficulties, including a lack of specific therapeutic options, the absence of out-of-hospital testing facilities to diagnose the condition, and the sudden extraordinary need for intensive medical care that overwhelmed most hospitals. Early in the pandemic, many physicians recognized that using antibodies harvested from recovering patients was a treatment that had a proven track record for many diseases and that might be used to manage the disease at least as a stopgap until more specific medicines for COVID-19 were developed. But using convalescent plasma raised many additional complications, most especially the logistics that needed to be put in place to collect and distribute such plasma. Unlike drugs ordered from a pharmacy, plasma and other blood products are procured by a complex process that depends intensely on interaction with the public, the provider of all blood products that are directly provided to patients. Blood components such as convalescent plasma, intended to be used immediately without major processing, are entirely supplied by donations from the public. This form of treatment can therefore benefit from patient advocates, especially if they are experienced in solving problems of logistics and in the process of matching supply to demand that is more commonly encountered in the business world than in medicine. In this chapter, one patient advocate, Chaim Lebovits, describes the process of mobilizing the population, interacting with blood banks and hospitals, and successfully channeling thousands of units of plasma from volunteers recovering from COVID-19 to patients in hospitals. Starting in New York City in early 2020 and initially working with communities with which Mr. Lebovits was familiar, the efforts steadily spread across many parts of the US. The model described here, which uses patient advocates to serve as a link between patients, blood banks, and hospitals in the service of gathering and distributing high-titer convalescent plasma to patients is likely to be relevant to the next pandemic.

Using competition for plasma donor recruitment and retention: An Australian university case study.

BACKGROUND AND OBJECTIVES: Using evidence from one Australian university's participation in the Vampire Cup (an 8-week national inter-university blood donation competition), this study aimed to (1) understand important motivators and successful promotional strategies driving engagement in the competition, and (2) determine the impact of competition on the recruitment and retention of young adult plasma donors. MATERIALS AND METHODS: We used a sequential explanatory mixed-methods design involving a self-administered survey (Study 1, n = 64) and four focus groups (Study 2, n = 20) with plasma donors aged 18-29 years who participated in the 2021 Vampire Cup. Also, we used a 12-month prospective comparative cohort analysis (Study 3) of those who did (n = 224 'competition donors') and did not (n = 448 control group) present to donate for the Vampire Cup. RESULTS: Competition was a strong motivator, with 76% of survey participants donating to help their university win the Vampire Cup. The survey and focus groups suggested that successful engagement in the competition was due to peer-led recruitment, leveraging existing rivalries at both the inter- and intra-university level, and using prize draws to create an active online social community promoting blood donation. Competition donors donated plasma significantly more often during the competition but donated at similar rates after the competition, compared to the control group. CONCLUSION: Rivalry-based competition strategies, combined with enthusiastic team leaders and an active social media community, can help to recruit, and retain, young adult plasma donors, and motivate an intermittent boost to donation frequency over a short period each year.

Safety and protection of plasma donors: A scoping review and evidence gap map.

BACKGROUND AND OBJECTIVES: As part of a large-scale project to safely increase plasma collection in Europe, the current scoping review identifies the existing evidence (gaps) on adverse events (AEs) and other health effects in plasmapheresis donors, as well as factors that may be associated with such events/effects. MATERIALS AND METHODS: We searched six databases and three registries. Study characteristics (publication type, language, study design, population, outcomes, associated factors, time of assessment, duration of follow-up, number and frequency of donations, convalescent plasma [y/n], setting and location) were synthesized narratively and in an interactive evidence gap map (EGM). RESULTS: Ninety-four research articles and five registrations were identified. Around 90% were observational studies (57 controlled and 33 uncontrolled), and most of them were performed in Europe (55%) or the United States (20%). Factors studied in association with donor health included donor characteristics (e.g., sex, age) (n = 27), cumulative number of donations (n = 21), donation frequency (n = 11), plasma collection device or programme (n = 11), donor status (first time vs. repeat) (n = 10), donation volume per session (n = 8), time in donation programme (n = 3), preventive measures (n = 2) or other (n = 9). CONCLUSION: The current scoping review provides an accessible tool for researchers and policymakers to identify the available evidence (gaps) concerning plasmapheresis donation safety. Controlled prospective studies with long-term donor follow-up are scarce. Furthermore, additional experimental studies comparing the health effects of different donation frequencies are required to inform a safe upper limit for donation frequency.

[The factors determining motivation of blood plasma donorship, including conditions of COVID-19 pandemic].

The article analyzes publications considering motivation of plasma donors by factors related to ethical and socio-economic aspects. Their detailed analysis and systematical consideration in the work contributes into more effective informing of new potential donors, improving recruitment and retention of donors. The detailed analysis established among causes of negative beliefs and negative experiences regarding donorship such factors as increased risk of infectious diseases, decreased vitality, vaso-vagal reactions and reduced iron content. It is demonstrated that experienced plasma donors try to maintain practice of donorship in conditions of intensive life activity, often applying flexible approach to frequency of plasma donation. Their knowledge about contribution that their donation makes is key factor in continuing donation. However, the COVID-19 pandemic developed additional obstacles to donorship due to state preventive measures and increased personal health risks. In order to develop donorship policy during pandemic in the future, it is important to study changes in motivation of donors during pandemic.

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. STUDY DESIGN AND METHODS: There were 5608 SP donors from 14 SP centers who enrolled in a longitudinal cohort study to assess self-reported functional health and well-being. Donors were assigned to one of four groups, according to the frequency of SP donation in the 12 months before enrollment. One thousand four hundred forty-eight SP donors who lapsed in donating during 6 months or greater during the study follow-up were asked to complete a survey. RESULTS: There were 545 lapsed SP donors who returned surveys (37.6%); 63% were female. Most responses given for stopping SP donation were categorized as convenience reasons (69.1%). Self-reported health concerns, including being deferred multiple times, which were categorized as possibly related or unable to determine a relationship to plasmapheresis, represented 45.5% of the responses. DISCUSSION: Primary reasons US SP donors report for a lapse in donation were categorized as convenience (e.g., schedule conflicts/lack of time). Donor responses categorized as health concerns which have a possible or uncertain relationship to plasmapheresis were less frequent but present in all frequency groups. This study adds to the body of evidence that SP donors cease donating for a variety of self-reported reasons with the majority not directly related to a perceived negative impact on their health.

Large-scale real-world data analysis of source plasma collections using a novel technology-enabled nomogram.

BACKGROUND: Source plasma collections are needed to satisfy the growing demand for plasma-derived medicinal products. The US plasma collection target volume has been guided by a standard weight-based FDA-issued nomogram (STAN) since 1992. In this research, large-scale US-based real-world data (RWD) were analyzed to confirm the safety and volume gains of a newly introduced personalized nomogram (PERS) that was previously studied in a premarket randomized controlled environment. STUDY DESIGN AND METHODS: A non-inferiority (NI) analysis was conducted to compare the novel nomogram's significant hypotensive adverse event (AE) incidence rate with large historical standard nomogram AE datasets. Additionally, the average target volumes and donor return rates were compared for collections following PERS and STAN. RESULTS: A total of 4,816,784 donations (PERS) by 414,957 donors resulted in a rate of 0.0998% (95% CI [0.0970, 0.1027]) significant hypotensive AEs. NI analysis suggested strong non-inferiority of the new technology (Δ = -0.0082%, 95% CI [-0.0113, -0.0050], prespecified NI margin = 0.1080). Average plasma collection target volumes increased by 66.39 mL (8.49%; p < .0001). Consecutive weekly donor return rates were consistent between the two nomograms (PERS: 73.6%, 95% CI [69.6%-76.7%]; STAN: 74.1%, 95% CI [66.1%-77.2%]). DISCUSSION: This analysis confirms in a large-scale real-world dataset the key safety parameter and collection benefit of a novel, technology-enabled nomogram. The nomogram may help meet the growing demand for plasma-derived therapies by providing approximately 8.5% more plasma per donation on average while maintaining donor safety and return rates.

How to convert whole-blood donors to plasma donors: An investigation of the mechanisms of awareness of need for plasma and donors' perception of response efficacy.

BACKGROUND: Blood donation services need to increase plasma donations to match the rising demand. However, evidence on how to best recruit donors among whole-blood donors is limited. Therefore, this study evaluated the effectiveness of a conversion strategy based on two different mechanisms that drive donor behavior: (a) awareness of the need for plasma donation and (b) perception of response efficacy regarding plasma donation. STUDY DESIGN AND METHODS: An online experiment with 246 German Red Cross whole-blood donors (possibility of plasma donation, blood group AB) was conducted using a 2 × 2 factorial, between-subject setup, and a pre-post treatment measurement. The mechanisms varied and were addressed with experimental treatments and measured. Analyses of variance and hierarchical regression models were used to analyze the effects on intention and behavior. RESULTS: The intention to donate plasma was low, but increased with treatment (mean valueoverall of intentionbeforeTreatment = 2.63, SD = 1.73 vs. intentionafterTreatment = 3.28, SD = 1.92). Furthermore, 31% of participants expressed willingness to be forwarded to the appointment-scheduling system of the blood donation service for further information. Only the mechanism of response efficacy was significantly associated with the intention to donate plasma (ßEfficacy = .254, p = .001; ßAwareness of Need = .126, p = .070). DISCUSSION: A conversion strategy based on making donors aware of their response efficacy is a promising way to optimize donor panels by shifting them to where they have the greatest impact. However, this study also substantiates the difficulty of such an effort. Blood donation services should invest in persuasion efforts and build personalized integrated marketing communications.

Utilisation of immunoglobulin in New Zealand.

BACKGROUND: Immunoglobulin is an expensive and scarce resource and usage is increasing worldwide. Immunoglobulin is used to treat a variety of clinical conditions, particularly primary and acquired immunodeficiencies and immune-mediated neurological disorders. As immunoglobulin usage continues to increase, plasma collection must increase accordingly in order to sustain immunoglobulin production. The New Zealand Blood Service (NZBS) is the provider of immunoglobulin in New Zealand (NZ). Information regarding national immunoglobulin usage warrants analysis given the rise in usage. AIMS: To review immunoglobulin usage in NZ with a focus on the trend in the amount used, number of patients, clinical indications and compliance with international guidelines. A comparison with international immunoglobulin usage was performed. The impact on national plasma collection was reviewed. METHODS: Data on immunoglobulin usage, number of patients and plasma collection over the past decade were obtained from the NZBS Tableau database. Data from international literature were reviewed. RESULTS: Immunoglobulin usage in NZ has been increasing over the past decade, with an annual growth rate of 6.4%. The three main indications for immunoglobulin are primary immunodeficiency disorders, chronic inflammatory demyelinating polyneuropathy (CIDP) and acquired hypogammaglobulinaemia secondary to haematological malignancies. Prominent growth in usage is evident for CIDP and acquired hypogammaglobulinaemia. Immunoglobulin usage in NZ is low compared with other countries, such as Australia and the United States. There has been a marked increase in plasma donations in order to keep up with immunoglobulin demand. CONCLUSIONS: Immunoglobulin is a strategic resource and appropriate usage is critical to regulate demand.

SARS-CoV-2 variants inactivation of plasma units using a riboflavin and ultraviolet light-based photochemical treatment.

BACKGROUND: Test the ability of Mirasol Pathogen Reduction Technology (PRT, Terumo BCT, Lakewood Co, USA) treatment with riboflavin and ultraviolet light (R + UV) in reducing SARS-CoV-2 infectivity while maintaining blood product quality. MATERIAL AND METHODS: SARS-CoV-2 strains were isolated and titrated to prepare cell free virus for plasma units infection. The units were then under treatment with Mirasol PRT. The infectious titers were determined before and after treatment with an in house microtitration assay on Vero E6 cells. Thirty-six plasma pool bags underwent PRT treatment. RESULTS: In all the experiments, the measured titer following riboflavin and UV treatment was below the limit of detection of microtitration assay for all the different SARS-CoV-2 strains. Despite the high copies number detected by RT-PCR for each viral strain after treatment, viruses were completely inactivated and not able to infect VERO E6 cells. CONCLUSION: Riboflavin and UV light treatment effectively reduced the virus titers of human plasma to the limit of detection in tissue culture, regardless of the strain. These data suggest that pathogen reduction in blood products highlight the safety of CP therapy procedures for critically ill COVID-19 patients, while maintaining blood product quality.

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. Donations were screened for nucleocapsid protein-binding-IgG using the Abbott SARS-CoV-2 IgG assay. RESULTS: Overall, 52 240 donors donated 418 046 units of CCP. Donors were of various ethnicities: 43% Caucasian, 34% Hispanic, 17% African American, 2% Native American, 1% Asian, and 3% other. Females had higher initial mean anti-SARS-CoV-2 antibody titers but an overall faster rate of decline (P < .0001). Initial antibody titers increased with age: individuals aged 55 to 66 years had elevated anti-SARS-CoV-2 titers for longer periods compared with other ages (P = .0004). African American donors had the lowest initial antibody titers but a slower rate of decline (P < .0001), while Caucasian (P = .0088) and Hispanic (P = .0193) groups had the fastest rates of decline. Most donor antibody levels decreased below the inclusion criteria (≥1.50) within 30 to 100 days of first donation, but donation frequency did not appear to be associated with rate of decline. CONCLUSION: Several factors may be associated with anti-SARS-CoV-2 antibody response including donor age and sex. Evaluating these factors during development of future hyperimmune globulin products may help generation of therapies with optimal efficacy.

Repeat donation and deferral rates in US source plasma donors: Exploratory analysis from the IMPACT trial.

BACKGROUND: The IMPACT trial demonstrated the safety of a new personalized nomogram for plasma donation and provided an opportunity to explore short- to mid-term impact on repeat donation and deferral rates, and factors affecting these. STUDY DESIGN AND METHODS: In the IMPACT trial, participants were randomized to donate plasma using an established weight-based nomogram (control) versus a new personalized nomogram incorporating height, weight, and hematocrit (experimental). In this exploratory analysis, repeat donations (per donor, by study arm) were analyzed using negative binomial generalized linear regression models and descriptive statistics. The mean number of donor deferral events was compared between the two arms using logistic regression and count data modeling approaches and were analyzed by lead cause. RESULTS: The predicted mean number of repeat donations was similar between the control and experimental arms (6.82 vs. 6.62, respectively; p = .22). Overall, the predicted mean number of repeat donations was significantly higher in males compared with females (p < .0001). Naïve donors had on average 2.8/2.7 (control/experimental) fewer repeat donations compared with experienced donors. In 23, 137 donations from 3443 donors, 798 donors (376 control, 422 experimental, p = .80) had at least one deferral (for any cause). The predicted mean number of deferrals in all categories of interest was not statistically different between the study arms. CONCLUSION: Similar repeat donation and deferral rates between arms suggest that the new nomogram did not result in disruptions to subsequent donation. Further longitudinal research on mid- to long-term effects is warranted.

Convalescent plasma for COVID-19: male gender, older age and hospitalisation associated with high neutralising antibody levels, England, 22 April to 12 May 2020.

We analysed factors associated with neutralising antibody levels in 330 convalescent plasma donors. Women and younger donors were more likely not to have measurable neutralising antibodies, while higher antibody levels were observed in men, in older donors and in those who had been hospitalised. These data will be of value in the timely recruitment of convalescent plasma donors most likely to have high levels of neutralising antibodies for ongoing studies investigating its effectiveness.

HIV-related stigma among people living with HIV/AIDS in rural Central China.

BACKGROUND: HIV-related stigma among people living with HIV/AIDS (PLWHA) has been associated with many negative consequences, including poor adherence to therapy and undue psychological stress. However, the relative influence of specific demographic and situational factors contributing to HIV-related stigma among rural PLWHA in central China remains unknown. The aim of this study was to explore the level of HIV-related stigma among rural PLWHA across specific demographic and situational factors in central China. METHODS: A cross-sectional study was conducted among PLWHA receiving care through the Chinese Centers for Disease Control of Zhenping county in Henan Province, China. Participants completed a 55-item questionnaire which included demographic and disease-related factors, HIV-related stigma was measured utilizing the validated Berger HIV Stigma Scale which has good psychometric characteristics in Chinese PLWHA. RESULTS: A total of 239 PLWHA completed the survey. The mean total HIV-related stigma score was 105.92 (SD = 12.35, 95% CI: 104.34, 107.49). Multivariable linear regression analysis revealed a higher level of HIV-related stigma in younger PLWHA (ß = - 0.57, 95% CI = - 0.78,-0.35, p<0.001) and those who self-reported opportunistic infections (ß = 6.26, 95% CI = 1.26, 11.26, p < 0.05). CONCLUSIONS: The findings in the current study suggest that rural PLWHA in central China suffer from the burden of HIV-related stigma at a moderate to high level. Younger PLWHA and PLWHA that have opportunistic infections tend to perceive a higher level of HIV stigma.

The effect of plasmapheresis on blood pressure in voluntary plasma donors.

BACKGROUND AND OBJECTIVES: Donor plasmapheresis involves the removal of a weight-adjusted volume of plasma and the return of cellular components to the donor. Although plasma volume generally returns to normal, some residual effect on vital signs may be possible. This analysis was performed to determine the possible effects of plasmapheresis on blood pressure. MATERIALS AND METHODS: A 16-week study was conducted to evaluate the effects of plasma donations on cholesterol levels in healthy donors. From this study, the vital signs obtained prior to donation were analysed using statistical and dynamic analytical predictive models. RESULTS: Preliminary analyses revealed a change in systolic and diastolic blood pressure from the corresponding baseline values (Pearson Coefficient -0.44 and -0.47, respectively). Statistical models predicted a marked decrease in systolic and diastolic blood pressure following multiple donations in donors with baseline pressure in the Stage 2 hypertension range with less pronounced decreases predicted in Stage 1 donors. Little or no change in blood pressure was predicted in donors with baseline normal blood pressure or prehypertension. Dynamic models including time between donations supported these results and predicted a recovery period of about 14 days without donation in donors with Stage 2 baseline levels. CONCLUSIONS: Results suggest that systolic and diastolic blood pressure may be decreased following plasmapheresis used for plasma donations at intervals of <14 days in donors with high baseline blood pressure levels.

Prospective multicentre study of the effect of voluntary plasmapheresis on plasma cholesterol levels in donors.

BACKGROUND AND OBJECTIVES: LDL apheresis is used to treat patients with familial hypercholesterolaemia, and low-volume plasmapheresis for plasma donation may similarly lower cholesterol levels in some donors. This study was designed to assess the effect of plasmapheresis on total, LDL and HDL cholesterol levels in a plasma donor population. MATERIALS AND METHODS: This was a prospective, unblinded longitudinal cohort study in which a blood sample was obtained for analysis before each donation. Data from 663 donors were analysed using a multivariable repeated measures regression model with a general estimating equations approach with changes in cholesterol as the primary outcome measure. RESULTS: The model predicted a significant decrease in total and LDL cholesterol for both genders and all baseline cholesterol levels (P < 0.01). The greatest total cholesterol decreases (women, -46.8 mg/dL; men, -32.2 mg/dL) were associated with high baseline levels and 2-4 days between donations. Small but statistically significant increases (P ≤ 0.01) in HDL cholesterol were predicted for donors with low baseline levels. CONCLUSIONS: These results suggest that, in donors with elevated baseline cholesterol levels, total and LDL cholesterol levels may decrease during routine voluntary plasmapheresis.

Hundred-fold increase in SARS-CoV-2 spike antibody levels over three years in a hospital clinical laboratory.

IMPORTANCE: Despite the evolution of SARS-CoV-2 variants of concern and ongoing transmission, COVID-19 hospitalization and mortality rates continue to decline. Both the percent seropositive and antibody levels have risen over the past 3 years. Here, we observe more than 90% seropositivity as well as more than a hundred-fold increase in spike IgG levels in a tertiary hospital clinical immunology laboratory setting. Antibody effector functions (such as neutralization, opsonization, and complement activation) and cell-mediated immunity all contribute to protection from COVID-19 progression to hospitalization, and all correlate to the total SARS-CoV-2 antibody levels. We recommend therapeutic COVID-19 convalescent plasma be restricted to the top 20% of potential donors to maintain activity against ongoing SARS-CoV-2 variant evolution.

Analysis of influencing factors of serum total protein and serum calcium content in plasma donors.

Background and objectives: The adverse effects of plasma donation on the body has lowered the odds of donation. The aim of this study was to investigate the prevalence of abnormal serum calcium and total serum protein related to plasma donation, identify the influencing factors, and come up with suggestions to make plasma donation safer. Methods: Donors from 10 plasmapheresis centers in five provinces of China participated in this study. Serum samples were collected before donation. Serum calcium was measured by arsenazo III colorimetry, and the biuret method was used for total serum protein assay. An automatic biochemical analyzer was used to conduct serum calcium and total serum protein tests. Results: The mean serum calcium was 2.3 ± 0.15 mmol/L and total serum protein was 67.75 ± 6.02 g/L. The proportions of plasma donors whose serum calcium and total serum protein were lower than normal were 20.55% (815/3,966) and 27.99% (1,111/3,969), respectively. There were significant differences in mean serum calcium and total serum protein of plasma donors with different plasma donation frequencies, gender, age, regions, and body mass index (BMI), (all p < 0.05). Logistic regression analysis revealed that donation frequencies, age, BMI and regions were significantly associated with a higher risk of low serum calcium level, and donation frequencies, gender, age and regions were significant determinants factors of odds of abnormal total serum protein. Conclusions: Donation frequencies, gender, age, regions, and BMI showed different effects on serum calcium and total serum protein. More attention should be paid to the age, donation frequency and region of plasma donors to reduce the probability of low serum calcium and low total serum protein.

Seroprevalence of SARS-CoV-2 among potential convalescent plasma donors and analysis of their deferral pattern: Experience from tertiary care hospital in western India.

BACKGROUND AND OBJECTIVES: Seroprevalence estimation of COVID-19 is quite necessary for controlling the transmission of SARS-CoV-2 infection. Seroprevalence rate in recovered COVID-19 patients help us to identify individual with anti-SARS-CoV-2 antibodies and its protective nature. The objective of present study was to evaluate seroprevalence of SARS-CoV-2 among potential convalescent plasma donors and analysis of their deferral reasons. MATERIALS AND METHODS: A total 400 potential convalescent plasma donors were enrolled over five-month period for this prospective study. Inclusion criteria were lab confirmed COVID-19 recovered patients and 14 days of symptoms free period. All prospective plasmapheresis donors were tested for IgG SARS-CoV-2 antibody through chemiluminescent microparticle immunoassay, CBC, serum protein, blood grouping along with other required test for normal blood donation as per Drugs & Cosmetics Act. After pre donation testing and medical examination if donor was found to be ineligible for plasmapheresis was deferred. Seroprevalence rate was calculated by positive IgG antibody test results among the potential plasma donors. RESULTS: Seroprevalence rate was 87% for IgG SARS-CoV-2 antibodies in prospective convalescent plasma donors (recovered COVID-19 patients). There was no significant difference in seroprevalence rate between different sub-groups with respect to gender, age, blood groups, Rh factor, mode of treatment, day of Ab testing and repeat plasma donation. Most common reason for their deferral was absent IgG SARS-CoV-2 antibodies (13%) followed by absenteeism of eligible screen donors (6.7%), low Hb (1.7%) and poor veins for plasmapheresis (1.7%). Till five-month study period none of the plasmapheresis develop symptoms of reinfection with COVID-19. CONCLUSION: In all, 13% recovered patients did not develop IgG antibodies after SARS-CoV-2 infection. SARS-CoV-2 IgG antibodies persist for quite some time and are protective against reinfection. More long-term serology studies are needed to understand better antibody response kinetics and duration of persistence of IgG antibodies.

Psychological assessment and lived experiences of recovered COVID-19 patients who presented for convalescent plasma donation.

BACKGROUND: Increasingly, it has been seen that patients recovering from COVID-19 may face a second battle of coping with its mental health ramifications. These psychological issues can even be experienced by patients who were asymptomatic or had mild to moderate symptoms, potentially impacting their quality of life. METHODOLOGY: This was a prospective observational study to analyse the psychological impact of COVID-19 in recovered patients who presented as prospective convalescent plasma (CP) donors. An interview for the psychological assessment of the prospective donors was carried out. Depression and anxiety in the participants were assessed by HAM-A, and HAM-D scores and Quality of Life were assessed using the WHOQOL-BREF scale. RESULTS: A total of 51 prospective donors were assessed, with a mean age of 34.37 (±9.08) years, with the majority being males (46). No clinically significant depression and anxiety were found on the basis of HAM-D and HAM-A scores. The worst affected quality of life parameter, based on the WHOQOL-BREF scale, was physical quality of life followed by environmental, psychological, and social relationships. Moreover, due to infection, social stigma was experienced by 49.02% of the donors, while 21.97% had anxiety related to convalescent plasma donation as a common livid experience. CONCLUSION: Poor quality of life and social stigma during the recovery phase is prevalent in COVID-19 recovered patients, for which formulation of holistic support strategies are the need of the hour.

Isoagglutinin Reduction in Human Immunoglobulin Products by Donor Screening.

INTRODUCTION: Hemolysis is considered a class effect and a rare adverse event that can occur following therapy with human normal immunoglobulin for intravenous administration [i.e., intravenous immunoglobulin (IVIG)]. Anti-A/B isoagglutinins (also referred to as isohemagglutinins) originating from donor plasma are present in polyvalent immunoglobulin G (IgG) products and are considered a probable risk factor for hemolysis. We hypothesized that, by excluding plasma from donors with high isoagglutinin titers, the final IVIG product would have a meaningful reduction in anti-A/B isoagglutinin titers. METHODS: A method for screening donor plasma for anti-A isoagglutinins using an automated indirect agglutination test (IAT) was developed. A cut-off for donor plasma exclusion was defined. Industry-scale donor plasma pools and final IVIG product were prepared according to the manufacturing process of Privigen(®) (CSL Behring, Berne, Switzerland; human 10% liquid IVIG). Anti-A/B isoagglutinin content in pooled plasma and final IVIG product was measured by IAT, direct agglutination test, and a flow cytometry-based assay [fluorescence-activated cell sorting (FACS) anti-A]. RESULTS: Screening of plasma from 705 donors identified 48 (6.8%) donors with high anti-A isoagglutinin titers in plasma (IAT agglutination score ≥2+ in a 1:200 pre-dilution). Exclusion of plasma from these donors resulted in a one-titer-step reduction of anti-A isoagglutinin in pooled plasma, confirmed by a twofold anti-A isoagglutinin concentration reduction measured by FACS anti-A (1,352 vs. 2,467 µg/g IgG). When the same screening and exclusion were applied to industrial-scale plasma pools (resulting in the exclusion of plasma from 5% of donors), anti-A isoagglutinins were reduced by one titer step in the final IVIG product. Anti-B isoagglutinins were also reduced by one titer step, as many donors with high anti-A isoagglutinins also have high anti-B. CONCLUSION: Reduction of anti-A/B isoagglutinin titers in IVIG products on an industrial scale is feasible through implementation of anti-A donor screening, which may reduce the risk of hemolysis following IVIG therapy.