Current status and prospect of global development of lung transplantation

During the novel coronavirus pneumonia (COVID-19) pandemic from 2020 to 2021, lung transplantation entered a new stage of development worldwide. Globally, more than 70 000 cases of lung transplantation have been reported to the International Society for Heart and Lung Transplantation (ISHLT). With the development of medical techniques over time, the characteristics of lung transplant donors and recipients and the indications of pediatric lung transplantation recipients have undergone significant changes. Application of lung transplantation in the treatment of COVID-19-related acute respiratory distress syndrome (ARDS) has also captivated worldwide attention. Along with persistent development of lung transplantation, it will be integrated with more novel techniques to make breakthroughs in the fields of artificial lung and xenotransplantation. In this article, research progresses on the characteristics of lung transplant donors and recipients around the world were reviewed and the development trend was predicted, enabling patients with end-stage lung disease to obtain more benefits from the development of lung transplantation technique.Copyright © 2022 Organ Transplantation. All rights reserved.

Factors Affecting the Need for a Second HPC(A) Collection in Unrelated Allogenic Transplants: Process Improvement Opportunity

Introduction: Matched unrelated donors (MUD) for hematopoietic progenitor cell (HPC) transplantation are facilitated through the National Marrow Donor Program. Most peripheral blood collections (HPC-A) are obtained in a single day apheresis collection. Extensive planning is required to coordinate the mobilization, collection, and shipment of the product with the conditioning and infusing at the transplant center. Typically, these products are infused fresh, although the COVID pandemic has necessitated cryopreservation in many instances. It was perceived that the number of two-day MUD collections was increasing at our institution. This study was performed to determine if this was true and to evaluate potential causes. Method(s): The project was considered a laboratory quality improvement project;IRB approval was not required per institutional guideline. Data was collected retrospectively for 120 HPC(A) MUD from August 2017-November 2020 including donor's age, weight, and sex, along with recipient to donor weight ratio. Each factor was analyzed against CD34 yield per day of collection. Result(s): Of the 120 donors, 5.6% collected over 2 days in 2017(n=1), 3.7 % (n=1, 2018), 3.6 % (n=1, 2019) with highest observation 17% (n=8) in 2020 (Image). Donor age, donor weight, donor sex, and recipient to donor weight ratio were compared to absolute CD34 yield. There was not a correlation seen between CD34 yield and donor age nor weight. However, donor sex along with recipient/donor weight ratio each showed a correlation in the number of collections required. Of those requiring a second day of collection, 73% were female while 27% were male. Two-day collections could be predicted with 83% accuracy in female with >1.09 recipient/donor weight ratio and male with > 1.49 recipient/donor weight ratio.(Figure Presented) Conclusion(s): The observed trend of increased 2-day NMDP collections coincided with an increase in frequency of female donors. Not surprisingly, higher recipient/donor weight was associated with a higher likelihood of 2-day collections. The size and scope of this study do not allow us to determine a definitive cause. However, it was noted these findings coincided with new donor selection guidelines prioritizing HLA-DP match potentially leading to an increase in female donors being selected. Unexpected two-day collection can have significant effects on transplantation. Developing a predictive algorithm with 83% accuracy allows for patient and staff preparation to anticipate the likelihood for additional collections. Having the product collected and received in advance, prior to patient conditioning improves logistics and removes some variability from scheduling. Larger, multicenter studies are required to determine if increased numbers of two-day collection of MUD are occurring at other centers and to the potential causesCopyright © 2023 American Society for Transplantation and Cellular Therapy

The positive impact of the COVID 19 pandemic on organ utilisation in liver transplantation

Background: As the world recovers from the aftermath of devastating waves of an outbreak, the ongoing Coronavirus disease 2019 pandemic has presented a unique perspective to the transplantation community of ''organ utilisation'' in liver transplantation, a poorly defined term and ongoing hurdle in this field. To this end, we report the key metrics of transplantation activity from a high-volume liver transplantation centre in the United Kingdom over the past two years. Method(s): Between March 2019 and February 2021, details of donor liver offers received by our centre from National Health Service Blood & Transplant, and of transplantation were reviewed. Differences in the activity before and after the outbreak of the pandemic, including short term post-transplant survival, have been reported. Result(s): The pandemic year at our centre witnessed a higher utilisation of Donation after Cardiac Death livers (80.4% vs. 58.3%, p = 0.016) with preserved United Kingdom donor liver indices and median donor age (2.12 vs. 2.02, p = 0.638;55 vs. 57 years, p = 0.541) when compared to the pre-pandemic year. The 1- year patient survival rates for recipients in both the periods were comparable. The pandemic year, that was associated with increased utilisation of Donation after Cardiac Death livers, had an ischaemic cholangiopathy rate of 6%. Conclusion(s): The pressures imposed by the pandemic led to increased utilisation of specific donor livers to meet patient needs and minimise the risk of death on the waiting list, with apparently preserved early post-transplant survival. Optimum organ utilisation is a balancing act between risk and benefit for the potential recipient, and technologies like machine perfusion may allow surgeons to increase utilisation without compromising patient outcomes.Copyright © 2022

Results in kidney transplant recipients from cadaveric donors with SARS-CoV-2 infection: A case series in a transplant center in Colombia / Resultados en receptores de trasplante renal de donantes cadavéricos con infección por SARS-CoV-2: Una serie de casos en un centro de trasplante en Colombia

Introducción. La pandemia por COVID-19 ha causado la muerte de 6,5 millones de personas en el mundo y la donación de órganos se ha visto ampliamente afectada, reflejándose en una disminución importante en el número de trasplantes. Colombia no ha sido ajena a dicha problemática. Ante este desafío, el Instituto Nacional de Salud ha permitido tomar donantes cadavéricos con reacción en cadena de la polimerasa con transcripción reversa (RT-PCR) positiva para Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), sin enfermedad activa. El objetivo de este estudio fue describir una serie de pacientes trasplantados de riñón con donantes cadavéricos con RT-PCR SARS-CoV-2 positivo y sus principales desenlaces clínicos. Métodos. Serie de casos de pacientes que fueron llevados a trasplante renal con donante cadavérico con SARS-CoV-2 positivo, sin enfermedad activa, entre mayo y agosto de 2022. Se recolectaron las variables demográficas y clínicas y se evaluó la infección y la mortalidad asociada a SARS-CoV-2 en un mes de seguimiento. Resultados. Un total de 5 receptores de trasplante renal con 5 donantes cadavéricos SARS-CoV-2 positivos fueron evaluados. No se presentó mortalidad ni pérdida del injerto renal. Se registraron dos casos de función retardada del injerto y un caso de rechazo agudo. Ninguno de los pacientes presentó RT-PCR SARS-CoV-2 positiva en el seguimiento posterior al trasplante. Conclusión. Con nuestra serie de casos mostramos que el trasplante de riñón proveniente de donante cadavérico con prueba positiva para RT-PCR SARS-CoV-2, sin evidencia de enfermedad COVID-19 activa, es un procedimiento seguro y una estrategia eficaz para aumentar el número de donantes en pandemia

Introduction. Coronavirus Disease-2019 (COVID-19) pandemic have caused the death of 6.5 million of people worldwide. The organ donation was extremely affected reflecting in the number of transplants. Colombia has not been immune to this problem. Facing this challenge, the National Institute of Health (Instituto Nacional de Salud, INS) allowed to assign cadaveric donors with reverse transcription-polymerase chain reaction (RT-PCR) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive without COVID-19. We aim to describe a case series of kidney transplant patients with RT-PCR SARS-CoV-2 positive cadaveric donors, and their main clinical outcomes. Methods. A case series of five patients who underwent kidney transplantation of cadaveric donors with positive RT-PCR SARS-CoV-2 during the study period from May to august of 2022. Demographics and clinical characteristics were collected from the institutional medical records, and we evaluated the mortality and infection associated with SARS-CoV-2. Results. A total of five kidney transplant recipients and five cadaveric donors with positive RT-PCR SARS-CoV-2 were described in the present study. There were not mortality reported and none of the patients had graft loss. Two cases of delayed graft function and one case of acute kidney rejection were documented. None of the patients had positive RT-PCR SARS-CoV-2 in the follow-up. Conclusion. Our series demonstrated that the kidney transplant of cadaveric donors with positive RT-PCR SARS-CoV-2 without clinical evidence of active COVID-19 disease is a safe procedure and an efficient strategy to increase donors during a pandemic

The Stem Cell Unrelated Donor Search during Covid19

Background In Stem Cell Transplants approximately two thirds of donors are identified and used from unrelated donor registries. In January 2020, we considered the impact that Covid19 infections and restrictions would have on donor availability. We identified that we needed to change our practice to ensure we could continue the SCT procedures which are critical for patients. Methods In January 2020, the Joint United Kingdom Blood Transfusion and Transplantation Service Professional Advisory committee (JPAC) changed the Tissue and cell donor selection guidelines. The risk and restrictions of Covid19 caused significant challenges including logistical issues for product delivery. Donor deferrals at medical assessments increased from 14% to 29% and overall activity in the UK was 75% of usual provision. Best practice was established and agreed with the donor registries. As per NICE guidelines, cryopreservation of all stem cell products was recommended with fresh donations considered according to patient condition. Back up donors were identified where possible. All donors were tested for Covid 19 on day of medical and harvest to ensure effective screening. We carried out 58 stem cell procedures from unrelated donors in 2020 and 56 in 2021. This activity is comparable to previous years. We secured stem cell products from Germany, USA, Korea, Poland, Turkey, Greece, Switzerland, the Netherlands and the UK. We analysed our data to assess if any delays occurred. Ethical approval was not required for this service evaluation. Results SCT activity was maintained throughout Covid19 with only postponement of elective SCT's which was assessed to be in the patient's best interest. Discussion We were able to adapt our practice to the benefit of our patients in unique and challenging circumstances. Conclusion We implemented measures which enabled BMT activity to continue throughout the acute Covid19 period despite challenges with new variants and further restrictions.

Utilization of COVID-19 positive donors for Heart transplantation and associated short-term outcomes.

BACKGROUND: The safety and efficacy of using COVID-19 positive donors in heart transplantation (HT) are increasingly relevant, but not well established. The present study evaluated the characteristics and utilization of such donors and associated post-HT outcomes. METHODS: All adult (≥18 years old) potential donors and HT recipients in the United States from April 21, 2020 to March 31, 2022 were included. Donor COVID-19 status was defined by the presence (or absence) of any positive test within 21 days of organ recovery. Donor and recipient characteristics and post-HT outcomes, including a primary composite of death, graft failure, and re-transplantation, were compared by donor COVID-19 status. RESULTS: Of 967 COVID-19(+) potential donors, 19.3% (n = 187) were used for HT compared to 26.7% (n = 6277) of COVID-19(-) donors (p < 0.001). Transplanted COVID-19(+) vs COVID-19(-) donors were younger, but otherwise were similar. Recipients of hearts from COVID-19+ vs COVID-19(-) donors less frequently received pre-HT inotropes (24.1% vs 31.7%, p = 0.023) and ventricular assist device therapy (29.7% vs 36.8%, p = 0.040). There were no significant differences in any post-HT outcome by donor COVID-19 status, including the primary composite outcome at 90 days (5.4% vs 5.6%, p = 0.91). Among COVID-19(+) donors, the presence of a subsequent negative test prior to transplant was not associated with posttransplant outcomes. CONCLUSIONS: Our results suggest that carefully selected COVID-19 positive donors may be used for HT with no difference in short-term post-transplant outcomes. Additional data regarding donor and recipient treatments and impact of vaccination should be collected to better inform our use of organs from COVID(+) donors.

Real-time transcription polymerase chain reaction cycle threshold values as criteria for utilization of incidental COVID-19 positive lung donors.

Shortage of organ donors is an ongoing limiting factor in lung transplantation (LT). Despite increasing prevalence of asymptomatic COVID-19 infection, positive COVID-19 testing from a potential donor remains a contraindication at many LT centers. In this report, we present the outcomes of LT utilizing an algorithm based on donor clinical presentation, and COVID-19 real-time reverse transcription polymerase chain reaction (RT-PCR) with cycle threshold (Ct) values evaluation. The Ct value threshold for organ acceptance was >35. A total of 8 COVID-positive donors were included. No donor-to-recipient transmissions of COVID-19 were observed. Short-term outcomes were comparable to those reported in pre-COVID literature. Survival-to-date is 100% with median POD of 161 days. Our findings support the safety and efficacy of utilizing our algorithm including Ct value threshold for selection of donors with incidental COVID-19 positive testing.

A Randomised Open-Label Trial of Early, Very High-Titre Convalescent Plasma Therapy in Clinically Vulnerable Individuals with Mild COVID-19 as model of early treatment in a pandemia with a new pathogen: Experience from collection of very high-titer plasma from superimmunized individuals

Background: COVID-19 convalescent plasma (CCP) remains a potential therapy of COVID-19, e.g. for new variants and for patients with impaired immune response. The trial COVIC-19 takes into account lessons learned from previous trials and combines it to a novel approach: * CCP with very high levels of SARS-CoV-2 antibodies from donors with previous SARS-CoV-2 infection (inf) and vaccination (vax) * Treatment early after symptom onset * Treatment of vulnerable persons (e.g. immunocompromised) * Study of immune escape Methods: We report the initial experience of collection of very high-titer plasma units (defined as >=4.000 BAU/ml in the QuantiVac ELISA) for this COVIC-19 trial. We recruited 348 potential donors (151 male, 197 female) who had passed initial eligibility check. S-Ab were measured by anti-SARS-CoV-2 QuantiVac ELISA (Euroimmun): mean 4229 BAU/ml (IQR 2.239-5.486 BAU/ml). High S-Ab in the QuantiVac assay correlated with high neutralizing capacity in the GenScript surrogat neutralization assay. S-Ab was >=4.000 BAU/ml in 25.1% of the individuals and did not significantly differ by gender or ABO type, but were higher among those who had received 3 vax (median 4.231 BAU/ml) or 2 vax (median 2.954 BAU/ml) or 1 vax (median 1.832 BAU/ml)(p<0.01). Result(s): We analyzed the association between the order of immunizing events and S-Ab. Highest S-Ab were observed among those with a breakthrough infection after 2 vax, followed by a booster (3rd dose post inf.) (median 5.840 BAU/ml;76.7% >=4.000 BAU/ml) or breakthrough inf after 3 vax (no further booster;median 3.841 BAU/ml;47.9% >=4.000 BAU/ml). S-Ab were lower in those with inf before vax followed by 1 vax (median 1.806 BAU/ml;18.1% >=4.000 BAU/ml) or >1 vax (median 2.586 BAU/ ml). S-Ab declined rapidly: 42% of donors with S-Ab >=4.000 BAU/ml had declined below this threshold in the short interval until 1st plasmapheresis and further 6% until 2nd apheresis. Further follow-up will be presented. Conclusion(s): Taking into account all eligibility criteria only 8.6% of individuals willing to donate could provide plasma units meeting the criteria of high-titer plasma for COVIC-19. Collection of very-high titer plasma from super-immunized individuals with previous infection and vaccination is feasible, but requires substantial donor selection and rapid screening and immediate start of apheresis to take advantage of the short period of very high mAb.

The alloCELL program: Patient monitoring, donor selection and GMP-compliant manufacturing of virus-specific T cells from stem cell, family and third-party T-cell donors

Background: Intensive immunosuppression to prevent graft rejection and GvHD leads to impaired T-cell immunity in HSCT and SOT patients. These are at high risk for infection with and reactivation of opportunistic pathogens such as CMV, EBV, HHV6, ADV and BKV, which are associated with significant morbidity and mortality. The inadequacies of conventional therapies have increased interest in T-cell immunotherapy. Here, timely T-cell donor recruitment and rapid production of antiviral T cells are required. Method(s): To improve T-cell donor recruitment, the alloCELL registry was established (www.alloCELL.org), currently recording >3,500 HLAtyped donors with extensively characterized antiviral T-cell repertoire. The registry has been extended by convalescent COVID-19 donors. The alloCELL lab established protocols to consider clinical requirements of patients at high risk or with failed conventional therapy. The manufacturing license for clinical-grade virus-specific T-cell products using Cytokine Capture System and CliniMACS Prodigy was obtained. T-cell donors are considered eligible if >=0.01% specific Interferon-gamma+ T cells are detectable. A related haploidentical or >=5/10 HLA-matched alloCELL donor is recommended if the stem cell donor is not eligible. Result(s): As of April 2022, >410 multi-/monovirus-specific T-cell products were generated for clinical applications by using overlapping peptide pools that cover the complete sequence of a viral protein. For patients in need of an unrelated third-party donor, suitable donors were found and clinical grade T-cell products were provided within 1.5 weeks after request with an HLA compatibility >=5/10. The applied T cells were monitored to determine frequency, chimerism and TCR repertoire. Patients who received antiviral donor T cells did not show severe adverse effects and in 80% of the cases, antiviral T cells were detected in blood after T-cell transfer. Of note, there is evidence that adoptive T-cell transfer induces endogenous T-cell responses. Conclusion(s): Success of antiviral T-cell transfer benefits from (i) accurate monitoring of viral load and antiviral T-cell frequencies in patients, and (ii) early and fast selection of suitable T-cell donors. Our data support clinical safety and efficacy of third-party antiviral T cells.

Evolving Characteristics of Heart Transplantation Donors and Recipients: JACC Focus Seminar.

Although the burden of end-stage heart failure continues to increase, the number of available organs for heart transplantation (HT) remains inadequate. The HT community has been challenged to find ways to expand the number of donor hearts available. Recent advances include use of hearts from donors infected with hepatitis C virus as well as other previously underutilized donors, including those with left ventricular dysfunction, of older age, and with a history of cocaine use. Concurrently, emerging trends in HT surgery include donation after circulatory death, ex vivo normothermic heart perfusion, and controlled hypothermic preservation, which may enable procurement of organs from farther distances and prevent early allograft dysfunction. Contemporary HT recipients have also evolved in light of the 2018 revision to the U.S. heart allocation policy. This focus seminar discusses recent trends in donor and recipient phenotypes and management strategies for successful HT, as well as evolving areas and future directions.

Proper algorithm in donor-recipient selection, the key to success in convalescent plasma treatment of Covid 19 patients

Background: Convalescent plasma (CP) obtained from patients following recovery from COVID-19 is an option for treatment, since antibodies may have antiviral and anticoagulation effect. Aim(s): The goal of this review is to present the latest evidence in the use of CP for COVID-19, raise questions regarding donor selection, collection, testing of CP, timing and volume of CP, and offer recommendations for future research. Method(s): -Systematic review of all published available literature assessing the use of CP for COVID-19. -Simple scoring was structured (0 min-10max). Minimal score (O) gives maximal possibility of successfully treatment with CP in COVID-19 patients and the opposite. This scoring system was applied into chosen 54 published studies. Result(s): We analyzed data in 18 published Case reports, 31 Case series, 11 Observational studies, and 5 RTc. According to our score min.score 0 was not obtained in any type of study, either score 1 or 2. Only one observational study has score 3. In this group score vary from 3 to 9.5, but most studies had a high score (6 -9). In the group of case reports score was from 4 to 8 (the largest number had a score of 7). In case report studies the score vary from 4 (just one case) to 8. Higher scores were registered in the largest number of case reports also. In the case series that were the most numerous (31) available reports concerning research in CP treatment of COVID 9 patients, the minimum score was 5 (only one series), the max score was 10, and most series had a score of 6 to 9. The number of randomized studies was the lowest, only 5. In this group, the score ranged from 6.5 -9. Conclusion(s): Despite a number of performed studies there is not god enough pretreatment estimation for success of CP treatment in COVID.

Lung Transplantation for COVID Acute Respiratory Distress Syndrome: A Pediatric and Adult Case Series

Purpose: Lung transplantation (LTx) has been shown to be a viable treatment for irreversible lung disease caused by COVID-19. Given the limited data on the subject, our purpose was to examine the process and outcomes of LTx for COVID Acute Respiratory Distress Syndrome (ARDS) in a retrospective single center cohort study which includes one pediatric patient. Method(s): This case series is a retrospective review of our patients diagnosed with COVID ARDS who underwent LTx for that diagnosis. All LTx in this cohort occurred between September 9, 2020 and August 26, 2021. We report on candidate selection, pre-LTx patient care, intra-operative procedure, and post-transplant recovery. Result(s): A total of ten patients that underwent LTx for COVID ARDS were identified. The average age of the cohort was 44.9 years (range of 16-60 years) and the mean Lung Allocation Score (LAS) 85.4 +/- 9.65. LTx occurred on average 96.5 +/- 32.9 days following onset of COVID symptoms. Seven patients (70%) in the cohort were bridged to LTx on extracorporeal membrane oxygenation (ECMO) for an average of 72.1 +/- 25.9 days. Six patients (60%) required mechanical ventilation prior to LTx. Intra-operatively, seven patients received life support via ECMO, 2 via off-pump, and 1 via cardio-pulmonary bypass (CPB). Seven patients required intraoperative packed red blood cells (mean 5.4 +/- 2.5). Following transplant, 60% of patients received ECMO for a mean duration of 2.0 +/- 0.9 days;90% of the cohort received ventilatory support. At 72 hours following surgery, cohort graft viability surpassed in center averages for non COVID LTx recipients;50% of patients had no primary graft dysfunction (PGD) (grade 0) and 50% had PDG grade 1. Discharges occurred 29.0 +/- 11.7 days following LTx and no episodes of acute rejection were noted in this time frame. As of publication there is 100% patient and allograft survival. Conclusion(s): While substantial center resources and expertise are required, LTx for COVID ARDS can be safely performed with a high rate of success. Careful candidate selection, donor selection, and institutional support were all critical elements that contributed to the 100% success rate observed in this cohort, which includes the youngest reported patient to undergo LTx for COVID ARDS.

Immunotherapy: TIMING OF DONOR SELECTION ON CD45RA-MEMORY T CELLS AS ADOPTIVE CELL THERAPY FOR COVID-19

Background & Aim: The COVID-19 pandemic has resulted in significant morbidity and mortality worldwide. The vaccines had dramatically decreased infection rates, number of deaths, and hospitalizations, but they are not 100% effective and immunity is lost gradually over time. We have previously shown how we are able to detect, isolate and produce at clinical scale SARS-CoV-2-specific T cells within CD45RA-memory T cells from COVID-19 convalescent donors. In a phase I clinical trial we have proved that treatment with these cells of hospitalized patients with moderate/severe COVID-19 is safe and feasible. Understanding the durability and the level of cellular immunity within the CD45RA- memory T cells and how changes with immunization are critical for the development of a biobank of living drugs to treat future COVID-19 patients. We performed a longitudinal exploratory analysis of the SARS-CoV-2 specific humoral and cellular immunity within the memory CD45RA- T cells in naive and previously infected individuals at different time points after two doses of BNT162b2 BioNTech/Pfizer vaccine Methods, Results & Conclusion: We studied the cellular and humoral response of SARS-CoV-2 specific memory T cells from recovered patients and controls at different time points: 2 weeks after recovering from COVID-19, 9 months after the infection/just before mRNA immunization, 10 and 65 days after full immunization. Detection of SARSCoV- 2- Specific Memory T Cells was performed by IFNg assay after exposure of cells to the M, N, and S SARS-CoV-2 peptides. Our data shows that memory T cell responses within the CD45RA- memory T cell subpopulation and most of the subsets tend to be higher in recovered individuals at all time points. The cellular response produced by control individuals to the S peptide is like the one from recovered patients at the same time point. Humoral responses were higher in recovered individuals after full immunization. Antibodies titer was not boosted after the late vaccine time point. An exploratory analysis of non-parametric Spearman’s rho correlation of humoral and cellular responses shows a positive correlation after infection with the 3 peptides and 65 days after immunization. In conclusion: We have analyzed the SARS-COV-2 specific T cells within the CD45RA- memory T cell subpopulation and the different subsets at different time points after (Figure Presented) (Figure Presented) infection and fully vaccinated. We claim that the best donors would be immunized individuals recovered from COVID-19 ideally in a time frame not higher than 6 months.

Collection of COVID-19 convalescent plasma in institute for transfusion medicine of republic of North Macedonia and evaluation of anti-SARS-CoV-2 antibody concentration in different donors subgroups

Background: Plasma collected from patients that have recovered from an infectious disease has been transfused over many decades for prophylaxis and treatment of various infectious diseases. Taking into consideration the expansion of COVID-19 pandemics, we started the COVID-19 convalescent plasma (CCP) programme. Aims: The aim of our study is to show our experience with collecting the CCP and to evaluate the SARS-CoV-2 antibody concentration in different convalescent plasma donors' subgroups. Methods: This is a prospective study performed in the Institute for Transfusion Medicine of Republic of North Macedonia since 30 April 2020 till July 2021. Antibody testing was performed at the Institute for Immunobiology and Human Genetics in Skopje using CLIA method with Snibe Maglumi SARS-CoV-2 S-RBD IgG (quantitative) with IgG cut-off larger than 5 AU/ml. All potential donor were tested for: negative RTPCR for SARSCoV-2 before donation, anti-SARS-CoV-2 antibodies, anti- HLA antibodies (where applicable), blood count, blood group, TTI and biochemistry. Preferred method for plasma collection was plasmapheresis which was performed with Terumo BCT Trima Accel and donation of whole blood, depending on the donor preference and venous access. All donors signed inform consent for donation and inclusion in the study. Results: There were 1476 potential CCP donors, but only 700(47.9%) donors fulfilled all the criteria and we obtained 793 units of CCP;639 (80.6%) units from whole blood donors and 154 (19.4%) CCP units from 61 plasmapheresis donors, 485 (69.3%) males and 215 (30.7%) females. Mean age of the donors was 40 years (range 18-63). Mean value of SARS-CoV-2 S-RBD IgG concentration was 31.05 AU/ml, (range from 5.1 AU/ml to >100 AU/ml), mean value of SARS-CoV-2 S-RBD IgG in men was 37.6 AU/ml and 28.9 AU/ml in women (p < 0.05). Distribution of CCP donors according to the ABO blood group was: 301 blood group A (43%) with median value of SARS-CoV-2 S-RBD IgG = 27.15 AU/ml, 220 blood group O (31.4%) median value of SARS-CoV-2 S-RBD IgG = 32.1 AU/ml, 116 blood group B (16.6%) median value of SARS-CoV-2 S-RBD IgG = 35.9 AU/ml and 63 donors had blood group AB (9%) median value of SARS-CoV-2 S-RBD IgG = 26.45 AU/ml. There were 69 donors that were previously hospitalized with mean value of SARS-CoV-2 S-RBD IgG = 48.6 AU/ml, and 629 that were treated at home with mean value of SARS-CoV-2 SRBD IgG = 29.1 AU/ml (p < 0.05), of which 578 had symptoms with mean value of SARSCoV- 2 S-RBD IgG = 29.1 AU/ml and 51 were asymptomatic with mean value of SARS-CoV-2 S-RBD IgG = 29.3 AU/ml. The CCP donors had the following distribution according to the age: 125 donors in the 18-29 age group with median value of SARS-CoV-2 S-RBD IgG = 23.0 AU/ml, 200 donors in the 30-39 age group with mean value of SARSCoV-2 S-RBD IgG = 28.2 AU/ml, 217 donors in the 40-49 age group with mean value of SARS-CoV-2 SRBD IgG = 32.9 AU/ml and 156 donors in the 50-63 age group mean value of SARS-CoV-2 S-RBD IgG = 38.3 AU/ml (p < 0.05). Summary/Conclusions: The collection procedures are safe and effective and collected CCP units were with high concentration and quality. The concentration of SARS-CoV-2 S-RBD IgG in CCP obtained from previously hospitalized patients was significantly larger than in ones that were treated at home. The concentration of SARS-CoV-2 S-RBD IgG was higher in men, in advanced age group and in donors with blood group B. The further studies are needed to clarify the impact of different variables on antibodies concentration/ titre in donors.

Donor selection and retention in the age of epidemics and pandemics

Blood transfusion is an essential part of health care service and securing a safe and adequate blood supply relies on a chain of complex activities: voluntary donation, collection, testing, processing and distribution to hospitals. Past pandemics, such as the 2002-2004 severe acute respiratory syndrome (SARS) outbreak or the 2009 H1N1 pandemic, have taught us that all these crucial steps in the blood supply chain can be disrupted. Therefore, it was no surprise that the COVID-19 pandemic had a profound impact on blood collection from the very beginning. Social distancing and lockdown policies, people's reluctance to attend collection venues for fear of getting infected, misconception about safety of blood donation were major reasons for the significant decrease in donor turnout at fixed donation sites. Blood drives were cancelled because of closure of schools and universities. Organizations were reluctant to host donation drives that requires gathering of large groups of people, all compounding the blood shortage. Strategies to mitigate the risk of virus transmission in the donation setting included measuring donor temperature, hand sanitization, wearing masks, physical distancing and encouraging appointments for donation to limit the number of people in donation rooms. Additional donor deferral criteria were put in place based on respiratory symptoms and fever, contact with individuals suspected or confirmed to be infected with SARS-CoV-2 and travel history. In the midst of the COVID-19 pandemic, it was of utmost importance that blood services addressed misinformation and misconception about blood donation. Using various channels such as TV, radio, newspapers and social media platforms, information regarding measures taken to ensure donor safety were communicated to maintain donor confidence in the safety of the blood donation environment and also raise awareness on the need and importance of regular blood donation. Blood services also needed to maintain close communication with the national authorities and hospitals to respond to changing situations of the pandemic and the blood supply situation in a timely and proportional manner. Entering the third year of the COVID-19 pandemic, the emergence of a new variant leading to a resurgence of COVID-19 cases not only impacted donor population but also caused staff shortages to an extend that blood services were not able to operate at full capacity. The continuous disruption of the blood supply chain lead to relaxation of donor deferral criteria in some countries not to compromise availability. Blood services all around the world have to deal with a blood crisis that was never experienced before and all stakeholders involved should take care not to impair the blood supply because of concerns about a theoretical possibility of transfusion transmission.

Impact of COVID-19 on blood donor deferral patterns during the COVID-19 pandemic: A retrospective analysis.

BACKGROUND AND OBJECTIVES: Blood donor deferral is an essential tool for blood safety. The ongoing COVID-19 pandemic has adversely affected blood transfusion services all over the world. But its impact on donor deferral rate and the pattern is unclear in light of the new donor deferral policy due to the COVID-19 pandemic. MATERIALS AND METHODS: This retrospective study was divided into pre-COVID and COVID (15 March 2019-14 March 2021). All the deferred donors were divided into six different categories: (1) medical causes, (2) surgical causes, (3) drugs and vaccination, (4) risk of transfusion-transmitted diseases, (5) miscellaneous causes and (6) flu-like symptoms. In addition, COVID-related deferrals were also incorporated. All these above categories along with the donor demography were analysed by SPSS software version 25. RESULTS: The donor deferral rate was 17.03% and 12.74% during the pre-COVID and COVID periods, respectively. During the pre-COVID period, Category 3 deferrals and during COVID period, Category 6 deferrals were significantly higher. A reversal in pattern with increased blood pressure (40.2% vs. 24.04%) over-riding low haemoglobin (34.77% vs. 55.5%) was noted in the Category 1 deferral during the COVID period. Category 1 deferral was more in middle-aged adults as compared to young and old adults (p < 0.05). Among middle-aged adults, deferral due to flu-like symptoms was also significantly more during the COVID period (p < 0.05). CONCLUSION: COVID-19 significantly affected the donor pool and changed the pattern of donor deferral. Understanding donor deferral patterns may help in identifying targeted donor populations and planning donor recruitment strategies in future pandemic crises.

Completing the Donor History Questionnaire before the Donation Visit Can Improve Blood Safety

Background and Objectives: In Germany, the donor history questionnaire (DHQ) is traditionally filled in at the donation center to avoid any influence of others. Since March 2020, it has been suggested to donors to answer the DHQ already at home and to call if they have any concerns to reduce the number of ineligible donors on-site during the COVID-19 pandemic. Materials and Methods: We evaluated the rate of ineligible donors before and after March 2020. Additionally, an anonymous online survey asking for the donors' attitude towards the DHQ was performed. It included questions on whether and for what reason the DHQ had been answered incorrectly in the past. Results: The rate of ineligible donors decreased by 27% (from 7.1% to 5.2%). In total, 5,556 of 10,252 invited donors completed the survey (54.2%). 88.6% reported either going through the DHQ at home or knowing all questions from their previous donations. 444 donors (8.0%) had at least once postponed a donation after reading the DHQ at home. 68 donors (1.2%) admitted having intentionally provided false answers in the past (9 at home, 43 on-site, 14 both, 2 unknown). Not wanting to be rejected once arriving at the donation center was an important motivation for 42% of donors answering incorrectly on-site. Details on 46 incorrect answers were provided: only 17 had no influence on donor eligibility or product quality. In 5 cases, some blood products might have had impaired quality. Truthful answers to 17 questions would have led to deferral, mostly due to increased risk for unrecognized viral infections transmitted by sexual contacts. For a further 7 questions, there was insufficient information available to determine possible consequences. Asked about their general opinion, 753 (13.6%) of all donors estimated the risk of incorrect answers being greater on-site, while 239 (4.3%) presumed an increased risk at home. Conclusion: Answering the DHQ prior to a donation visit prevented ineligible donors from visiting the donation center. Furthermore, it might improve honesty, as the discomfort of being deferred after arriving at the donation center was an important reason to answer incorrectly. Overall, there was no increased risk of donor or product safety, and potentially even a benefit. © 2022 The Author(s). Published by S. Karger AG, Basel.

Validating potential organ and tissue donors in the middle of the COVID-19 pandemic: Scoping review and recommendations construction.

OBJECTIVE: To identify the available information to support registered nurses' clinical decisions in assessing and validating potential organ and tissue donors during the COVID-19 pandemic. METHOD: This is a scoping review developed in six stages. The sixth stage was developed with registered nurses who work in the Brazil Organ Donation System. To consolidate the information and prepare all assumptions, the legislation in force in Brazil was followed. RESULTS: Recommendations from 19 articles identified in the literature were analyzed; additionally, 52 professionals who work at Brazil Organ Donation System participated in the research. Four care assumptions were formed: investigation of community transmission, investigation of clinical situations, screening for COVID-19 signs and symptoms, and investigation of alterations presented in the physical examination. Such assumptions are formed by 34 care guidelines. DISCUSSION: Care assumptions were prepared to guide and support registered nurses during assessment and validation of potential organ and tissue donors. From this perspective, assumptions certainly promote safety, effectiveness and quality in the service offered during the organ and tissue donation process in the midst of the COVID-19 pandemic, in addition to empowering registered nurses in this scenario. Quality and bio-surveillance through the donation stages have been discussed extensively in recent times, to improve donation and transplantations by valuing care, safety, and quality of life of recipients. CONCLUSION: The care assumptions presented in this study support and subsidize the daily practice of registered nurses who work in assessing and validating potential organ and tissue donors, enabling these professionals to make decisions based on secure information.

COVID-19 Convalescent Plasma Donor Deferral Experience in a Tertiary Care Hospital: A Retrospective Study

Introduction: Corona virus disease also named as severe respiratorycorona virus 2 (SARS-COV 2) has emerged as global pandemic with3,40,00,500 cases in India till date and 23,82,72,207 cases worldwide.Lack of evidence of effective treatment modalities for covid 19 anddelay in vaccination led to experimenting with classical and historicalinterventions as treatment options. In past convalescent plasma hasbeen proven effectiveness against various viral diseases.Aims &Objectives:1. Analyzing the reason for convalescent plasma donor deferral.2. Assessment of IgG COVID 19 antibody levels for convalescentplasma donor3. Enumerating donation frequency and stage of deferral.Materials &Methods: Donor were recruited as per ICMR protocolversion 1.6 PLACID trial and ICMR bulletin released thereafter. Apre set convalescent plasma donor selection criteria &screeninginvestigation were designed according to national guideline. All thepotential donor were screened telephonically and in person by medical expert from blood center. The retrospective analysis of CCPdonor deferral record from May 2020 to April 2021 was done. Frequency of donation was noted. Stage of deferral were defined as (1)Pre donation, (2) Screening, (3) Medical examination, (4) Phlebotomy. Brief physical examination and COVID 19 Ig G antibodywork up was done on fully automated Vitros Electro Chemiluminescence system.Result: Total number of donors screened were 992, out of which 544were deferred. Most common deferral was due to low antibody titre(50.55%), Unclear vein (8.63%), Anaemia (7.4%) High Blood Pressure (5.51%), Low Blood Pressure (2.20%), and others reasons33.08%. Average IgG antibody levels against COVID 19 in our set upwas 4.6 AU (Absorbance Unit/ml9). However the benchmark set byICMR advisory was 13 AU. Most deferrals were observed at Medicalexamination Stage. 11% of the donors deferred were repeat donors.Conclusions: The deferral rate in Convalescent plasma donors (55%)was much higher as compared to deferral rates observed in wholeblood donors (10-15%).Higher rates were mostly due to stricter donorselection criteria and low antibody levels prevailing in Indian population post COVID.