SARS-CoV-2 infection rebound among patients receiving antiviral agents, convalescent plasma, or no treatment: a systematic review with meta-analysis.

BACKGROUND: There is some evidence showing rebound of COVID-19 infections in patients treated with nirmatrelvir-ritonavir between 2 and 8 days following cessation of the antiviral treatment. COVID-19 rebound is not unique to patients treated with nirmatrelvir-ritonavir, but is also observed in molnupiravir recipients, in patients who did not receive any antiviral treatment and in patients who received convalescent plasma (CP). MATERIALS AND METHODS: This was a systematic review with meta-analysis of clinical trials evaluating rates of virologic and clinical rebound in COVID-19 patients receiving antiviral agents, CP or no treatment. Both randomized clinical trials and controlled cohort studies were considered. The methodological quality of trials was assessed using ROB-2 and ROBIN-1 checklists, and the GRADE approach. RESULTS: Data were available from 16 trials. The occurrence of virologic rebound was more commonly observed among nirmatrelvir recipients than among untreated patients (relative risk [RR]=2.12; 95% confidence interval [CI]: 1.38-3.28; p=0.0007). No differences were observed in the occurrence of virologic rebound between nirmatrelvir-ritonavir and molnupiravir recipients (RR=1.01; 95% CI: 0.71-1.43). Similar rates of virologic rebounds were observed in molnupiravir recipients and untreated patients (RR=1.14; 95% CI: 0.81-1.6). One study in the pre-omicron period compared rates of virologic rebound between patients receiving standard of care with or without CP: no differences were observed between groups (RR=1.04; 95% CI: 0.55-1.99). Rates of clinical rebound were reported in seven trials, five evaluating nirmatrelvir-ritonavir and untreated patients, and two evaluating nirmatrelvir-ritonavir and molnupiravir recipients. No statistically significant differences between groups were observed. For all these comparisons, the certainty of the available evidence was graded as low or moderate. DISCUSSION: Virologic rebound of COVID-19 infections appears to be mild and self-limited, and was observed more commonly in nirmatrelvir-ritonavir recipients than in untreated patients, but was also observed in patients treated with molnupiravir or CP.

Platelet rich plasma for facial rejuvenation: an overview of systematic reviews.

BACKGROUND: Platelet-rich plasma (PRP) as a non-surgical therapy for facial rejuvenation is increasingly adopted. This article aims to review the literature and critically appraise the available evidence regarding the efficacy and safety of PRP for facial rejuvenation. MATERIAL AND METHODS: An overview of systematic reviews (SRs) of PRP use for facial rejuvenation. The methodological quality of the SRs was assessed using the AMSTAR-2 checklist; quality of the evidence from the trials included in each SR was appraised following the GRADE approach. RESULTS: Thirteen SRs published between 2015 and 2023, reporting data from 114 overlapping reports, based on 28 individual primary studies (18 uncontrolled reports), were included in this umbrella review. Eight primary studies evaluated PRP in combination with other treatments (laser therapy, fat grafting, hyaluronic acid, basic fibroblast growth factor), and 20 PRP monotherapy. Most of the included primary studies were uncontrolled, and meta-analysis for outcomes related to facial rejuvenation was conducted in only 1 of the 13 SRs, showing that patients treated with PRP as an adjunct treatment have increased satisfaction over controls without PRP (mean difference, 0.63; 95% confidence intervals (CIs) 0.25/1; p=0-001; low certainty of evidence due to risk of bias (ROB) and inconsistency). No other quantitative data were available from the SRs, although 4 SRs concluded in a descriptive way reveal that PRP combined with laser therapy increased subject satisfaction and skin elasticity, and decreased the erythema index (very low certainty of evidence due to imprecision, unsystematic clinical observations, and ROB). The occurrence of adverse events was a predefined outcome in only 2 SRs (15%). Almost all the SRs demonstrated poor compliance with the AMSTAR 2 items, and the confidence in the results of SRs was graded as low or critically low in 12 of the 13 SRs. DISCUSSION: The available evidence is insufficient to suggest firm conclusions about the use of PRP, alone or in combination with other treatments, in promoting facial rejuvenation.

A survey on the implementation of Patient Blood Management programs in Italy.

BACKGROUND: Since 2012, in line with the World Health Organization (WHO) resolution WHA63.12 of 05/21/2010, the Italian National Blood Center has been promoting patient blood management (PBM). In order to verify the level of PBM implementation nationwide, we submitted a survey to all healthcare providers. MATERIAL AND METHODS: In line with what was proposed in the international scientific literature in the field, a series of indicators were used derived from the four main blocks related to PBM strategies: the management of patient anemia; the optimization of hemostasis; blood conservation strategies; patient-centred decision-making. We also added two blocks containing important information on general PBM management and other PBM-related aspects. RESULTS: The survey showed good implementation of anemia screening programs in accordance with the timelines established by national and international guidelines, and the single unit policy is used in line with national guideline recommendations. However, the survey also revealed limited auditing of PBM programs and reduced monitoring and reporting of clinical outcomes and indicators. DISCUSSION: The first national survey on the level of PBM implementation in Italy shows widespread adoption of diagnostic-therapeutic care pathways aimed at the diagnosis and treatment of anemia in the perioperative setting.

Nirmatrelvir/ritonavir for COVID-19: an overview of systematic reviews.

OBJECTIVES: A reappraisal of the validity of the conclusions of systematic reviews (SRs) related to nirmatrelvir/ritonavir for the treatment of COVID-19. METHODS: An overview of SRs (umbrella review). The methodological quality of the SRs was assessed using the AMSTAR 2 checklist; quality of the evidence from the trials included in each SR was appraised following the GRADE approach. RESULTS: Sixteen SRs with meta-analysis published between 2020 and 2023 were included in this overview. The SRs reported data from 108 overlapping reports, based on 43 individual primary studies [3 randomized clinical trials (RCTs), 40 non-RCTs]. In outpatient settings the use of nirmatrelvir/ritonavir reduced overall mortality, hospital admission and progression of disease compared with controls (from moderate to low certainty of evidence); nirmatrelvir/ritonavir reduced mortality, hospital admission and progression of disease in both immunized and non-immunized patients. No differences in the occurrence of any adverse events between groups were observed in the large majority of SRs; serious adverse events, including adverse events requiring discontinuation of treatment, were reported with lower prevalence in nirmatrelvir recipients compared with controls (from low to moderate certainty of evidence). CONCLUSIONS: There is low to moderate certainty of evidence from SRs that nirmatrelvir/ritonavir reduces mortality, clinical progression and hospitalization rate in COVID-19 patients compared with controls, without increasing the occurrence of overall and serious adverse events. Based on the overall methodological assessment, on average we can have high confidence in the quality of results generated by the SRs.

The Italian registry of therapeutic apheresis in SISTRA: Year of activity 2022.

Therapeutic apheresis refers to a group of extracorporeal blood processing procedures used in the treatment of a variety of systemic diseases. These complex procedures are burdened by adverse reactions related to both procedures and underlying medical conditions. Given the importance of centralizing the collection and the analysis of information on therapeutic apheresis, the Italian National Blood Center (NBC), at the request of the Italian Scientific Society of Hemapheresis and Cell Manipulation (SIdEM), implemented the Italian Registry of Therapeutic Apheresis (IRTA) including it in the Information System of Transfusion Services (SISTRA), coordinated by the NBC. In 2022, a total of 34,702 therapeutic apheresis procedures was carried out in 8,781 patients, including paediatric patients, with an average of 3.9 procedures per patient. The 2022 IRTA data indicate that the patient with hematological and/or neurological disorders mainly turns to the apheresis centers. These results confirm the IRTA data from years 2020 and 2021. In the hematological field, the apheresis centers supply hematopoietic stem cells collection for autologous transplantation as well as mononuclear cell collection for extracorporeal photopheresis. With regard to the neurological field, myasthenia, chronic inflammatory demyelinating polyneuropathy and Guillain-Barré syndrome along with other neurological pathologies related to immune disorders are the most treated. In conclusion, this manuscript presents 2022 activity data of IRTA providing institutions and scientific societies with a wide range of information including type and number of therapeutic procedures, adverse events and patients' outcome.

Platelet rich plasma use for treatment of acne scars: an overview of systematic reviews.

BACKGROUND: A reappraisal of the conclusions of systematic reviews (SRs) and meta-analyses validity related to Platelet-rich plasma (PRP), alone or in combination with other treatments, compared to regimens PRP-free for the treatment of acne scars. MATERIALS AND METHODS: An overview of SRs. The methodological quality of the reviews was assessed using AMSTAR-2 checklist; quality of the evidence of primary studies was appraised following the GRADE approach. RESULTS: Fifteen SRs were included in this overview. Data were from 124 overlapping reports, based on 34 individual primary studies (10 parallel arm randomized trials, 21 split-face studies, and 3 uncontrolled studies). Most of the studies evaluated combination of PRP with microneedling or with laser therapy compared to microneedling or laser therapy without PRP. Clinical improvement (reported as degree of improvement or improvement score) and patient's satisfaction rate were significantly higher in PRP recipients compared to controls. Crusting time and duration of erythema were significantly shorter in PRP recipients compared to controls. Most of the reviews considered in this overview can be considered of low methodological quality due to the fact that several critical methodological requirements of AMSTAR-2 checklist were unmet or partially met; only 6 of the 15 reviews incorporated study quality in their conclusions, and no GRADE assessment was performed for the reported outcomes in any of the SRs. With the GRADE approach, the quality of the evidence for the outcomes analysed ranged from very low to low due to risk of bias in the primary studies, inconsistency between the studies, and imprecision. DISCUSSION: The low or very low certainty of evidence does not support clear clinical decision about the PRP use in combination with microneedling or laser therapy for the treatment of acne scars. Further well-designed studies are required to improve the evidence base for PRP combination therapy for acne scars.

Hyperimmune Globulins for the Management of Infectious Diseases.

This review is focused on the use of hyperimmune globulin therapy to treat some infectious diseases of viral or bacterial origin. Despite the introduction of antibiotics and vaccines, plasma immunoglobulin therapy from whole blood donation can still play a key role. These treatments provide passive transfer of high-titer antibodies that either reduces the risk or the severity of the infection and offer immediate but short-term protection against specific diseases. Antibody preparations derived from immunized human donors are commonly used for the prophylaxis and treatment of rabies, hepatitis A and B viruses, varicella-zoster virus, and pneumonia caused by respiratory syncytial virus, Clostridium tetani, Clostridium botulinum. The use of hyperimmune globulin therapy is a promising challenge, especially for the treatment of emerging viral infections for which there are no specific therapies or licensed vaccines.

Platelet-rich plasma for the treatment of alopecia: a systematic review and meta-analysis.

BACKGROUND: The number of articles evaluating the efficacy of platelet-rich plasma (PRP) in androgenetic alopecia (AGA) and alopecia areata (AA) has increased exponentially during the last years. This systematic review and meta-analysis is aimed at evaluating the benefit of PRP in the treatment of alopecia. MATERIAL AND METHODS: We searched MEDLINE (through PUBMED), Embase, and CENTRAL for relevant data. Treatment effect was described by mean difference (MD) and risk difference with 95% confidence intervals (CI). The GRADE system was used to assess the certainty of the body of evidence. RESULTS: We found 27 controlled trials (1,117 subjects) that met our inclusion criteria: 18 trials (713 subjects) in patients with AGA, and 9 (404 subjects) in patients with AA. Eleven studies had a split head design. There was heterogeneity in types of PRP (e.g., activated and non-activated) and administration schedules. PRP was compared to saline injections (18 studies), local steroid injections (4 studies) and other comparators (5 studies). Most commonly reported outcomes were hair density and hair regrowth. It was not possible to pool all outcome data because of heterogeneity in reporting, and because reporting was often limited to a single study. Compared to saline injections, PRP injections increased hair density over a medium-term follow-up (MD, 25.6 hairs/cm2; 95 % CI: 2.62-48.57), but the evidence was rated as low quality due to inconsistency and risk of bias. In individuals with AA, it is unclear whether PRP injection compared with triamcinolone injection increase the rate of subjects with hair regrowth (very-low quality of evidence due to inconsistency, imprecision, and risk of bias). There were no serious adverse events related to PRP injection or control treatments. CONCLUSIONS: There is limited evidence showing benefit of PRP for treatment of alopecia, and most of this evidence is of low quality.

A survey on preoperative autologous blood donation policy in bone marrow stem cell donors in Italy.

BACKGROUND: The high safety of homologous blood components, together with the introduction of the Patient Blood Management strategy, has led to the progressive abandonment of preoperative autologous blood donation (PAD) in surgery. Furthermore, recent scientific publications provide evidence about the non-usefulness of PAD in the collection of hematopoietic stem cells (HSC) from bone marrow (BM), also in consideration of harvest procedure safety. Nevertheless, no conclusive studies have been published yet. MATERIALS AND METHODS: Blood Establishments (BE) and Bone Marrow Collection Centers (BMCC) participated in a specific qualitative survey proposed by Italian National Blood and Transplant centers with the support of the relevant Italian Scientific Societies. The survey aimed at evaluating the policy adopted for PAD in related and unrelated adult HSC donors in Italy during the period 2018-2020. RESULTS: Forty-one BE corresponding to 37 BMCC filled in the questionnaire. Of 830 BM donors, 661 (80%) underwent 1063 PAD (mean 1.6 PAD/donor). The remaining 169 donors (20%) underwent BM harvest without PAD. No serious adverse events were reported for either donor group. In the case of ineligibility of donors for the PAD program, due to low hemoglobin values, 7/10 centers shifted donors to peripheral blood stem cell collection and three centers chose a different donor. Remarkably, only 51% of the PAD units requested were eventually transfused during the BM harvest process. Finally, the iron support policy among centers was heterogeneous. DISCUSSION: The results of this survey show that PAD is heterogeneously applied in Italian BMCC, as in other countries. However, all BMCC except two are willing to adopt a Patient Blood Management strategy as an alternative approach to adult related and unrelated BM donor harvests.

Ultrasound-guided injection of platelet-rich plasma for tendinopathies: a systematic review and meta-analysis.

BACKGROUND: In this systematic review and meta-analysis, we evaluated ultrasound (US)-guided injections of platelet-rich plasma (PRP) as conservative treatment of tendinopathies. MATERIALS AND METHODS: We searched MEDLINE, EMBASE, SCOPUS, OVID, and the Cochrane Library to identify randomized controlled trials (RCT) on the use of US-guided PRP for tendinopathies. RESULTS: We found 33 RCT (2,025 subjects) that met our inclusion criteria: 8 in lateral epicondylitis, 5 in plantar fasciitis, 5 in Achilles tendinopathy, 7 in rotator cuff tendinopathy, 3 in patellar tendinopathy and 5 in carpal tunnel syndrome. PRP, given as a single injection (20 trials) or multiple injections (13 trials), was compared to US-guided injection of steroids, saline, autologous whole blood, local anesthetic, dry needling, prolotherapy, bone marrow mesenchymal stem cells, or with non-injective interventions. The outcomes more commonly reported included pain and functional measures, subgrouped as in the short-term (<3 months from the intervention), medium-term (3 to 6 months) or long-term (≥12 months). No clear between-group differences in these outcomes were observed in patients with lateral epicondylitis, plantar fasciitis, or Achilles, rotator cuff or patellar tendinopathy. In patients with carpal tunnel syndrome, visual analog scale scores for pain at 3 and 6 months and Boston Carpal Tunnel Questionnaire severity scores at 1, 3 and 6 months were significantly lower in PRP recipients than in controls. The certainty of evidence of all these comparisons was graded as low or very low due to risk of bias, imprecision and/or inconsistency. Pain at the injection site was more common among PRP recipients than among controls receiving other US-guided injections. DISCUSSION: In patients with tendinopathies, a trend towards pain reduction and functional improvement from baseline was observed after US-guided PRP injection, but in the majority of the comparisons, the effect size was comparable to that observed in control groups.

Epidemiology of Treponema pallidum and HIV co-infections in the Italian blood donor population: 2009-2021.

BACKGROUND: In recent years, co-infection from HIV and Treponema pallidum has become more common. Early detection of the co-infection allows us to implement therapeutic strategies to control the evolution of the disease and to contain its transmission in the general population. The donor population is the target of choice for the detection of early-stage infections. This study aims to evaluate the trend of HIV/T. pallidum positivity in the Italian blood donor population, defining the type of donor most involved. MATERIALS AND METHODS: A retrospective analysis of consecutive blood donors' records, covering the period between January 2009 and December 2021, was conducted using the database of the National Blood Information System. The data extracted were the results of of confirmed positivity notifications for T. pallidum and sociodemographic variables of blood donors. The effect of age, female gender, donor category, year, and Italian origin on the probability of HIV/T. pallidum co-infection were estimated using a logistic regression model. RESULTS: In the period of observation, we found 79 subjects with HIV/T. pallidum dual co-infection, 3 with HIV/HCV/T. pallidum triple co-infections, and 2 with HIV/HBV/T. pallidum triple co-infections. Seventy-one out of 84 co-infections (89%) were among first-time tested donors, reporting sexual behaviors at risk. The results of the logistic regression show that age, female gender and regular donor status were not associated with HIV/T. pallidum co-infection. DISCUSSION: The transfusion network can provide a valid contribution to containing the spread of HIV and T. pallidum infections, raising the awareness of donors, and promptly referring the donor with confirmed positivity to the reference specialist.

Corticosteroids use for COVID-19: an overview of systematic reviews.

Purpose: A reappraisal of the validity of the conclusions of systematic reviews (SRs) and meta-analyses related to corticosteroids use for the treatment of COVID-19. Material and Methods: An overview of SRs (umbrella review). The methodological quality of the SRs was assessed using tha AMSTAR-2 checklist; quality of the evidence was appraised following the GRADE approach. Results: 35 SRs were included in this overview. Data were from 307 overlapping reports, based on 121 individual primary studies (25 randomized clinical trials (RCTs), 96 non-RCTs. In critically ill patients the use of steroids significantly reduced mortality compared to standard of care in 80% of the SRs, more often with moderate/high level of certainty; however, in patients not requiring oxygen supplementation the use of steroids increased the overall mortality in 2/3 of the comparisons. Clinical progression of diseases (need for mechanical ventilation, or for intensive care admission) was more commonly observed among controls compared to steroids recipients (in 9 out of 14 comparisons; certainty of evidence from very-low to moderate). The occurrence of adverse events was similar among steroids recipients and controls. Other outcomes (i.e., viral clearance, length of hospital stay) or issue related to optimal dose and type of steroids were addressed in a minority of SRs, with a high level of uncertainty, so that no definitive conclusions can be drawn. Conclusions: There is moderate certainty of evidence that corticosteroids reduce mortality and progression of disease in critically ill COVID-19 patients compared to standard of care, without increasing the occurrence of adverse events.

Chagas Disease and Transfusion Risk in Italy: The Results of a National Survey.

BACKGROUND: Universal serological screening in endemic areas is essential for preventing Chagas disease transmission by transfusions, while in non-endemic areas, screening is provided only to donors exposed to the infection risk. In this respect, in order to ensure high and uniform standards of quality and safety of blood components, the Italian National Blood Centre conducted a survey to detect information on management of donors at risk of Chagas disease and on the current transfusion risk. METHODS: The National Blood Centre conducted a survey on preventive measures for Chagas disease in the years 2020-2021. RESULTS: Survey results are broadly representative of the national situation; out of 24,269 tested donors, only 15 donors were confirmed positive (0.4 out of 100,000 donors). This rate is lower than the number of positive donors (72/100,000) for transfusion transmissible infections (HIV, HBV, HCV, and T. pallidum) in the same period. Furthermore, the number of T. cruzi positive blood donors is lower than the T. cruzi positive subjects in the general population. CONCLUSIONS: In Italy, T. cruzi infection transfusion risk may be considered still very low, and this is confirmed by the absence of documented transfusion transmission.

Prevalence and risk factors for hepatitis E virus infection in blood donors: a nationwide survey in Italy, 2017 to 2019.

BackgroundIn high-income countries, hepatitis E virus (HEV) infection is mainly a zoonosis. However, it is also transfusion-transmissible and some countries, but not Italy, have introduced HEV screening for blood donations.AimWe assessed HEV infection prevalence and risk factors in a nationwide sample of Italian blood donors.MethodsWe selected 107 blood establishments (BE) distributed in the 20 Italian regions by a stratified two-stage design and invited them to participate in the study. Donors were tested for anti-HEV IgG and IgM and HEV RNA. Sociodemographic data and risk factors were collected through a questionnaire.ResultsOverall, 60 BE from 60 provinces in 19 Italian regions joined the study. We assessed HEV markers in 7,172 blood donors, of whom 6,235 completed the questionnaire. Overall crude and adjusted anti-HEV IgG prevalences were 8.3% and 5.5%, respectively. Overall anti-HEV IgM prevalence was 0.5%, while no blood donor was HEV RNA-positive. Anti-HEV IgG prevalence varied widely among regions (range: 1.3%-27.20%) and hyperendemic prevalences (> 40%) were detected in some provinces in two regions. Older age (AOR = 1.81; 95% CI: 1.36-2.41), foreign nationality (AOR = 2.77; 95% CI: 1.06-7.24), eating raw pork liver sausages (AOR = 2.23; 95% CI: 1.55-3.20) and raw homemade sausages (AOR = 3.63; 95% CI: 2.50-5.24) were independent infection predictors.ConclusionItalian blood donors showed a low to moderate HEV seroprevalence. High levels in some regions and/or provinces were mainly attributable to eating habits. Prevention should include avoiding consumption of raw or undercooked meat and safe production of commercial pork products.

Efficacy and Safety of Pathogen-Reduced Platelets Compared with Standard Apheresis Platelets: A Systematic Review of RCTs.

In this systematic review, we evaluate the efficacy and safety of blood components treated with pathogen reduction technologies (PRTs). We searched the Medline, Embase, Scopus, Ovid, and Cochrane Library to identify RCTs evaluating PRTs. Risk of bias assessment and the Mantel-Haenszel method for data synthesis were used. We included in this review 19 RCTs evaluating 4332 patients (mostly oncohematological patients) receiving blood components treated with three different PRTs. Compared with standard platelets (St-PLTs), the treatment with pathogen-reduced platelets (PR-PLTs) does not increase the occurrence of bleeding events, although a slight increase in the occurrence of severe bleeding events was observed in the overall comparison. No between-groups difference in the occurrence of serious adverse events was observed. PR-PLT recipients had a lower 1 and 24 h CI and CCI. The number of patients with platelet refractoriness and alloimmunization was significantly higher in PR-PLT recipients compared with St-PLT recipients. PR-PLT recipients had a higher number of platelet and RBC transfusions compared with St-PLT recipients, with a shorter transfusion time interval. The quality of evidence for these outcomes was from moderate to high. Blood components treated with PRTs are not implicated in serious adverse events, and PR-PLTs do not have a major effect on the increase in bleeding events. However, treatment with PRTs may require a greater number of transfusions in shorter time intervals and may be implicated in an increase in platelet refractoriness and alloimmunization.

Lack of Evidence of Chikungunya Virus Infection among Blood Donors during the Chikungunya Outbreak in Lazio Region, Italy, 2017.

BACKGROUND: The latest European Chikungunya virus (CHIKV) outbreak occurred in Italy in 2017, in the municipalities of Anzio and Rome (Lazio Region), with a secondary outbreak in the Calabrian Region. Most CHIKV infections are symptomatic but about 15% of people who acquire the infection may be asymptomatic. A retrospective study was conducted with the aim of assessing the prevalence of recent/ongoing CHIKV infections on the blood donor population in the Lazio Region, during the 2017 outbreak (including in the period before it was detected). METHODS: The study was conducted on 4595 plasma samples from donors who donated in 14 different Blood Establishments in the Lazio Region, in the period June-November 2017. A total of 389 of these samples were collected in provinces not affected by the outbreak and were used as negative controls. All samples were tested for IgM detection by the use of an ELISA test, and positive samples were tested for confirmation through the use of a PRNT. Molecular tests were performed on sera that were found to be IgM-positive or borderline. RESULTS: A total of 41 (0.89%) blood donors tested positive for IgM. None of these positive IgM ELISA results was confirmed either by PRNT or by molecular tests. CONCLUSIONS: Our study has shown no evidence of recent/ongoing CHIKV infection in blood donors of the affected area.

Detection of antibodies against SARS-CoV-2 both in plasma pools for fractionation and in commercial intravenous immunoglobulins produced from plasma collected in Italy during the pandemic.

BACKGROUND: We investigated the presence of anti-SARS-CoV-2 antibodies in Italian plasma pools and intravenous immunoglobulins sent to our Institute (Italian National Institute of Health - Istituto Superiore di Sanità) in the context of the Official Control Authority Batch Release. The plasma pools were made up from donations collected in several different Italian regions from May 2017 to October 2020, i.e. in the pre-pandemic and pandemic periods. MATERIALS AND METHODS: All plasma pools were initially tested for the qualitative detection of anti-SARS-CoV-2 antibodies against the nucleocapsid protein using the Roche Elecsys® Anti-SARS-CoV-2 test kit. Plasma pools positive for these antibodies were further tested using the Roche Elecsys® Anti-SARS-CoV-2 S test kit for the quantitative detection of antibodies against SARS-CoV-2 spike receptor binding domain. All plasma pools showing reactivity to these antibodies were tested undiluted for the presence of SARS-CoV-2 RNA using the Grifols Procleix SARS-CoV-2 transcription-mediated amplification assay. Intravenous immunoglobulins were tested using both test kits to determine the presence of anti-SARS-CoV-2 antibodies. RESULTS: All plasma pools made up from donations collected in the pre-pandemic period were negative for anti-SARS-CoV-2 antibodies against the nucleocapsid protein. Of the plasma pools made up from donations collected from December 2018 to March 2020, only 1 pool out of 68 (1.4%), that was made up from donations from the Lombardy region, was reactive for these antibodies. Interestingly, 105 out of 174 (60.3%) of the plasma pools made up from donations collected from November 2018 to October 2020 showed the presence of these antibodies. All plasma pools positive for these antibodies were tested for antibodies against SARS-CoV-2 spike receptor binding domain and were confirmed positive. DISCUSSION: None of these plasma pools tested were reactive for SARS-CoV-2 RNA. In the case of intravenous immunoglobulins, 20 out of 25 (80%) batches showed the presence of both anti-SARS-CoV-2 antibodies, reflecting the concentration in the plasma pools used for their production.

The Italian registry of therapeutic apheresis enters the information system of transfusion services - SISTRA.

The National Blood Centre (NBC) at the request of the Italian Scientific Society of Haemapheresis and Cell Manipulation (SIdEM) has funded and developed a software dedicated to the collection of data related to therapeutic apheresis procedures, known as the Italian Registry of Therapeutic Apheresis (IRTA). Although on a voluntary basis, participation in the registry was widespread. The data collected includes type and number of procedures, patients treated and their outcomes, and reported adverse events to the procedures. For the years 2019 and 2020, the therapeutic apheresis procedure was widely used in the field of haematology, transplantation and rheumatology and was mainly associated with mild adverse events, thus showing a high level of safety. In addition to allowing the competent institution to monitor an important activity in the transfusion medicine field, the Registry is a new starting point for collaboration between transfusion centres distributed throughout the national territory and could encourage the design of major clinical trials.