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1.
Blood Transfus ; 2024 May 27.
Article in English | MEDLINE | ID: mdl-38814880

ABSTRACT

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.

2.
Blood Transfus ; 2024 Feb 21.
Article in English | MEDLINE | ID: mdl-38557322

ABSTRACT

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.

3.
J Antimicrob Chemother ; 79(3): 477-497, 2024 Mar 01.
Article in English | MEDLINE | ID: mdl-38084876

ABSTRACT

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.


Subject(s)
COVID-19 , Humans , COVID-19 Drug Treatment , Ritonavir/therapeutic use , Systematic Reviews as Topic
5.
Blood Transfus ; 2023 Sep 06.
Article in English | MEDLINE | ID: mdl-37677095

ABSTRACT

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.

6.
Viruses ; 15(7)2023 07 13.
Article in English | MEDLINE | ID: mdl-37515229

ABSTRACT

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.


Subject(s)
Communicable Diseases , Globulins , Vaccines , Humans , Immunoglobulins/therapeutic use , Immunization, Passive , Communicable Diseases/therapy , Antibodies, Viral
7.
Blood Transfus ; 21(1): 24-36, 2023 01.
Article in English | MEDLINE | ID: mdl-34967722

ABSTRACT

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.


Subject(s)
Alopecia Areata , Platelet-Rich Plasma , Humans , Alopecia Areata/therapy , Clinical Protocols , Treatment Outcome
8.
Blood Transfus ; 21(2): 119-136, 2023 03.
Article in English | MEDLINE | ID: mdl-36346880

ABSTRACT

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.


Subject(s)
Carpal Tunnel Syndrome , Fasciitis, Plantar , Platelet-Rich Plasma , Tendinopathy , Tennis Elbow , Humans , Tennis Elbow/diagnostic imaging , Tennis Elbow/therapy , Tendinopathy/diagnostic imaging , Tendinopathy/therapy , Ultrasonography, Interventional , Pain , Treatment Outcome
9.
Blood Transfus ; 21(3): 251-256, 2023 05.
Article in English | MEDLINE | ID: mdl-36346888

ABSTRACT

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.


Subject(s)
Coinfection , HIV Infections , Syphilis , Humans , Female , Treponema pallidum , Blood Donors , Syphilis/epidemiology , Coinfection/epidemiology , Retrospective Studies , Seroepidemiologic Studies , Prevalence , HIV Infections/epidemiology
10.
Infez Med ; 30(4): 469-479, 2022.
Article in English | MEDLINE | ID: mdl-36482954

ABSTRACT

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.

11.
Pathogens ; 11(11)2022 Oct 25.
Article in English | MEDLINE | ID: mdl-36364982

ABSTRACT

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.

12.
Diagnostics (Basel) ; 12(11)2022 Oct 25.
Article in English | MEDLINE | ID: mdl-36359430

ABSTRACT

Background: Eligibility criteria for blood donation require hemoglobin levels of ≥12.5 g/dL for women and ≥13.5 g/dL for men, and a platelet count of ≥180 × 109/L. Screening methods before donation should ensure high accuracy, precision, and ease in operation. We assessed the performance, precision, and repeatability of the Horiba Micros ES 60 (Horiba) compared to the Beckman Coulter DXH 800. Methods: Performance was compared by testing samples for each of the 11 devices across 6 sites in the Transfusion Service of Friuli Venezia Giulia Region, Italy. We measured precision by calculating the coefficient of variation (CV), concordance with ρ-Pearson's correlation coefficient, and accuracy with F-tests. The intra-assay agreement was examined in the 11 devices, and repeatability was performed by using CV and the Kruskal−Wallis test. Results: The precision of Horiba was acceptable. Overall, ρ-Pearson's coefficients indicated a strong correlation and positive relationship between all variables. The Bland−Altman plots showed that most of the differences lay within the limits of agreement. All CV were below the reference threshold for all the parameters. Finally, the Kruskal−Wallis test reported non-significant statistical differences for all parameters, except platelet count (p < 0.000). Conclusions: Horiba is adequate for routine pre-donation screening. The intra-assay agreement further demonstrates the accuracy of the device.

13.
Euro Surveill ; 27(36)2022 09.
Article in English | MEDLINE | ID: mdl-36082685

ABSTRACT

As in 2018, when a large West Nile virus (WNV) epidemic occurred, the 2022 vector season in Italy was marked by an early onset of WNV circulation in mosquitoes and birds. Human infections were limited until early July, when we observed a rapid increase in the number of cases. We describe the epidemiology of human infections and animal and vector surveillance for WNV and compare the more consolidated data of June and July 2022 with the same period in 2018.


Subject(s)
Culicidae , West Nile Fever , West Nile virus , Animals , Birds , Humans , Italy/epidemiology , Mosquito Vectors , West Nile Fever/epidemiology , West Nile Fever/veterinary
15.
Euro Surveill ; 27(22)2022 06.
Article in English | MEDLINE | ID: mdl-35656832

ABSTRACT

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.


Subject(s)
Hepatitis E virus , Hepatitis E , Blood Donors , Hepatitis Antibodies , Hepatitis E/epidemiology , Humans , Immunoglobulin G , Immunoglobulin M , Prevalence , Risk Factors , Seroepidemiologic Studies , Surveys and Questionnaires
16.
Pathogens ; 11(6)2022 Jun 01.
Article in English | MEDLINE | ID: mdl-35745493

ABSTRACT

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.

17.
Viruses ; 14(3)2022 03 16.
Article in English | MEDLINE | ID: mdl-35337026

ABSTRACT

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.


Subject(s)
Chikungunya Fever , Antibodies, Viral , Blood Donors , Disease Outbreaks , Humans , Immunoglobulin M , Retrospective Studies
18.
Blood Transfus ; 20(3): 198-205, 2022 05.
Article in English | MEDLINE | ID: mdl-34059195

ABSTRACT

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.


Subject(s)
COVID-19 , SARS-CoV-2 , Antibodies, Viral , COVID-19/diagnosis , COVID-19/epidemiology , Humans , Immunoglobulins, Intravenous , Nucleocapsid Proteins , Pandemics , RNA, Viral
19.
Blood Transfus ; 20(4): 281-291, 2022 07.
Article in English | MEDLINE | ID: mdl-34694220

ABSTRACT

BACKGROUND: Acute and delayed vasovagal reactions (VVR) are the most frequent adverse reactions (AR) associated with donations. The aim of this study was to provide the data of the Italian donor haemovigilance system and contextualise the VVR data within the international framework, as well as evaluating, among first-time donors, the association of gender and age and the prevalence of VVR compared to other AR. MATERIALS AND METHODS: The prevalence analysis was performed on VVR and other AR notified to the Italian haemovigilance system from 2016 to 2019. The analysis on the association of gender and age group and VVR prevalence was performed on first-time donations. The definitions and severity of AR were as set out in the 2014 ISBT/IHN international standards. RESULTS: From 2016 to 2019, 34,519 AR were notified, of which 87.1% were VVR. The overall VVR prevalence was 25.0/10,000 donations and the overall prevalence of other AR was 3.7/10,000 donations. All the estimated prevalences of AR were higher for first-time donations than for regular donations and lower for whole blood than for apheresis donations. No difference was noted between whole blood and apheresis donations for VVR with complications or injuries. The prevalence of AR among first-time donors was higher in females than in males. The prevalence of VVR decreased as donor age increased. DISCUSSION: The prevalence of VVR related to blood donation was very low and similar to those calculated by other haemovigilance systems. Among first-time donors, the prevalence of AR was higher in females than in males. The higher prevalence of VVR in young donors and a significant decreasing trend by age group confirmed the results reported in the literature. Finally, no trend by age group in first-time donors was observed for other AR to donations.


Subject(s)
Blood Component Removal , Syncope, Vasovagal , Blood Donors , Cross-Sectional Studies , Female , Humans , Male , Prevalence , Syncope, Vasovagal/epidemiology , Syncope, Vasovagal/etiology
20.
Diagnostics (Basel) ; 11(12)2021 Dec 14.
Article in English | MEDLINE | ID: mdl-34943641

ABSTRACT

The correct affiliation 1 should be "Italian National Blood Centre, National Institute of Health, 00162 Rome, Italy" [...].

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