Assessing the performance of LumiraDx™ SARS-CoV-2 Ag test in detecting Omicron lineages: 2022-2023 study.

Background: The introduction of rapid antigen tests revolutionized the approach to SARS-CoV-2 diagnosis, offering prompt and accurate results with high sensitivity and specificity. Although it is more cost- and time-saving than the gold standard, real-time polymerase chain reaction (RT-PCR), the efficacy in general population screening in both hospital- and community-based settings remains unknown. Moreover, rapid antigen testing is limited by qualitative results. This study aims to evaluate the diagnostic reliability of the LumiraDx™ rapid antigen test during the Omicron era and to investigate its quantitative (analogue-to-digital converter (ADC)) results in comparison with RT-PCR Ct values. Methods: This prospective study included all adult patients with mild-to-moderate SARS-CoV-2 symptoms who were not hospitalised and did not require oxygen supplementation, consented to participate, and attended the Infectious and Tropical Diseases Unit of Padua University Hospital from July 14th, 2022 to January 3rd, 2023. The patients underwent two different tests simultaneously: a nasal LumiraDx™ swab and a real-time RT-PCR assay performed on a nasopharyngeal swab. Sampling was repeated several times for a subset of subjects. Results: We enrolled 266 consecutive participants and collected 601 pairs of LumiraDx™ and RT-PCR samples. The most prevalent variant was BA.4/BA.5 Omicron (60.2 %). The sensitivity and specificity of LumiraDx™ test when compared to real-time RT-PCR results as the reference standard were 93.1 % and 79.75 %, respectively. No significant differences in diagnostic reliability were found based on the available characteristics, age, sex, symptom status, or COVID-19 variant, except for the days from symptom onset. According to the multilevel logistic regression analysis, the only independent variable significantly associated with test concordance was the Ct value (adjusted odds ratio (OR) = 0.56, p < 0.001). Significant differences in quantitative ADC values were found between false negative (FN) versus true negative (TN), and false positive (FP) and true positive (TP) tests. Conclusions: This study showed that LumiraDx™ test is reliable for SARS-CoV-2 diagnosis in patients with mild-to-moderate SARS-CoV-2 symptoms. This finding confirms the efficacy of rapid antigen tests in monitoring vulnerable individuals during the current post-vaccination era. When compared with the RT-PCR, LumiraDx™ test effectively quantitatively distinguishes between FN and TN cases, as well as FP and true TP tests, despite inaccuracies in qualitative results.

Intimate partner femicide (IPF): Medico-legal investigation at the Institutes of Legal Medicine of Freiburg (Germany) and Padova (Italy).

Violence against women is a significant public health concern, with femicide as its most extreme manifestation. This crime is often perpetrated by current or former intimate partners, thus taking the name of intimate partner femicide (IPF). Although international comparisons are essential for prevention policies, cross-country comparative studies are scarce in this context. The aim of this study was to evaluate and compare clinical, epidemiological and medico-legal characteristics of IPF autopsy cases investigated at the Institutes of Legal Medicine of two Western European cities, in order to identify a potential medico-legal pattern of IPF. Autopsy and police reports of IPF cases occurred in the judicial district of Freiburg (Germany) and Padova (Italy) from 2000 to 2022 were analyzed. Data relating to victims, perpetrators, relationship context, and circumstantial and pathological-forensic characteristics of the homicide were collected. Statistical analyses were performed to explore potential relationships between the data collected. Additionally, a review of the literature dealing with autopsy-based studies on IPF was performed. Overall, 82 cases of IPF were analyzed, 39 from Freiburg and 43 from Padova. A total of 6 papers fulfilled the review inclusion criteria. Our study identified a medico-legal pattern of IPF and demonstrated that it did not vary substantially between the two European Countries considered, suggesting that certain IPF characteristics are shared at the European level. However, a significant finding emerged regarding the higher prevalence of firearm-related IPFs in Italy compared to Germany. Forensic pathology research might contribute to developing targeted prevention policies to protect women from this lethal form of violence.

The Cost of Atrial Fibrillation: A Systematic Review.

OBJECTIVES: Atrial fibrillation (AF) is the most common cardiac arrhythmia, with an increasing incidence and prevalence because of progressively aging populations. Costs related to AF are both direct and indirect. This systematic review aims to identify the main cost drivers of the illness, assess the potential economic impact resulting from changes in care strategies, and propose interventions where they are most needed. METHODS: A systematic literature search of the PubMed and Scopus databases was performed to identify analytical observational studies defining the cost of illness in cases of AF. The search strategy was based on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 recommendations. RESULTS: Of the 944 articles retrieved, 24 met the inclusion criteria. These studies were conducted in several countries. All studies calculated the direct medical costs, whereas 8 of 24 studies assessed indirect costs. The median annual direct medical cost per patient, considering all studies, was €9409 (13 333 US dollars in purchasing power parities), with a very large variability due to the heterogeneity of different analyses. Hospitalization costs are generally the main cost drivers. Comorbidities and complications, such as stroke, considerably increase the average annual direct medical cost of AF. CONCLUSIONS: In most of the analyzed studies, inpatient care cost represents the main component of the mean direct medical cost per patient. Stroke and heart failure are responsible for a large share of the total costs; therefore, implementing guidelines to manage comorbidities in AF is a necessary step to improve health and mitigate healthcare costs.

The impact of SARS-CoV-2 on healthcare workers of a large University Hospital in the Veneto Region: risk of infection and clinical presentation in relation to different pandemic phases and some relevant determinants.

Aim: The aim of this study is to evaluate the incidence of SARS-CoV-2 infection and the prevalence of COVID-19-related symptoms in relation to pandemic phases and some relevant variables in a cohort of 8,029 HCWs from one of the largest Italian University Hospitals. Methods: A single-center retrospective study was performed on data collected during SARS-CoV-2 infection surveillance of HCWs. Cox's multiple regression was performed to estimate hazard ratios of SARS-CoV-2 infection. Logistic multivariate regression was used to assess the risk of asymptomatic infections and the onset of the most frequent symptoms. All analyses were adjusted for sociodemographic and occupational factors, pandemic phases, vaccination status, and previous infections. Results: A total of 3,760 HCWs resulted positive (2.0%-18.6% across five study phases). The total incidence rate of SARS-CoV-2 infection was 7.31 cases per 10,000 person-days, significantly lower in phase 1 and higher in phases 4 and 5, compared to phase 3. Younger HCWs, healthcare personnel, and unvaccinated subjects showed a higher risk of infection. Overall, 24.5% were asymptomatic infections, with a higher probability for men, physicians, and HCWs tested for screening, fully vaccinated, and those with previous infection. The clinical presentation changed over the phases in relation to vaccination status and the emergence of new variants. Conclusion: The screening activities of HCWs allowed for the early detection of asymptomatic cases, limiting the epidemic clusters inside the hospital wards. SARS-CoV-2 vaccination reduced infections and symptomatic cases, demonstrating again its paramount value as a preventive tool for occupational and public health.

MAGLIO study: epideMiological Analysis on invasive meninGococcaL disease in Italy: fOcus on hospitalization from 2015 to 2019.

This study analyzed hospital admissions for invasive meningococcal disease (IMD) in epidemiological and economic terms in Italy from 2015 to 2019. The volume of acute admissions for meningococcal diagnosis was analyzed in the period from 2015 to 2019. IMD admissions were identified by ICD-9-CM diagnoses. Costs were assessed using current DRG tariffs. In 2019, a total of 237 admissions for meningococcal disease were recorded in Italy. The mean age of patients was 36.1 years. Lumbar puncture was reported in only 14% of hospital discharge forms. From 2015 to 2019, there was a mean annual reduction of - 1.2% nationally for IMD hospitalizations. For 2019, the total costs for acute inpatient admissions were €2,001,093. Considering annual incidence due to IMD, a significant decrease was noted in the age group from 0 to 1 year (p = 0.010) during 2015-2019. For all years, mortality associated with meningeal syndrome was lower compared to septic shock with or without meningitis. From 2015 to 2019, hospitalizations for IMD appear to be decreasing slightly in Italy, even if mortality remains high. Favorable trends in hospitalizations for IMD were seen in the 0-1-year age group, which may be attributable to increased vaccination. Costs of hospitalizations for IMD remain high.

Use of Information and Communication Technology Strategies to Increase Vaccination Coverage in Older Adults: A Systematic Review.

BACKGROUND: Coverage rates of routinely recommended vaccines in older adults still fall below the targets established by international and national advisory committees. As a result, related diseases still have a high incidence, morbidity, and mortality. Information and Communication Technologies (ICT) could provide useful tools to improve immunization rates by bringing information directly to the target user at a relatively low cost. The present research aims to systematically review recent literature on interventions applying ICT to improve the uptake of influenza, pneumococcal, COVID-19 and herpes zoster immunization rates among older adults. METHODS: Studies published in English between 1 January 2000 and 10 November 2022 were identified by searching electronic medical databases (PubMed, Scopus) and were independently reviewed by two different authors. A total of 22 studies were included in this review. FINDINGS: Interventions applied the following ICT tools: phone calls, text messages, messages sent via personal electronic medical records, automated phone calls, remote patient monitoring in a home telehealth program and emails. In terms of the vaccines promoted, 11 studies prompted the influenza vaccine, four prompted the influenza and pneumococcal vaccines, three the pneumococcal vaccine, two the herpes zoster vaccine, one the COVID-19 vaccine and one both the pneumococcal and herpes zoster vaccines. Overall, more than half of the studies (n = 12) found some level of effectiveness of these ICT strategies in increasing vaccination rates among older adults, while five studies were partially effective (for specific vaccines or population subgroups), and five reported no significant effect. CONCLUSIONS: Prevention programs using ICT tools could be effective in promoting immunizations among older adults.

Hospital readmissions and mortality following discharge against medical advice: a five-year retrospective, population-based cohort study in Veneto region, Northeast Italy.

OBJECTIVES: The aim of this study was to examine the odds of readmission and mortality after discharge against medical advice (DAMA) in the Veneto region of Northeast Italy, drawing on data from the regional archives of emergency department records and hospital discharge records. DESIGN: A retrospective cohort study. SETTING: Hospital discharges, Veneto region, Italy. PARTICIPANTS: All patients discharged after being admitted to a public or accredited private hospital between January 2016 and 31 January 2021 in the Veneto region were considered. A total of 3 574 124 index discharges were examined for inclusion in the analysis. PRIMARY AND SECONDARY OUTCOME MEASURES: Readmission and overall mortality at 30 days after the index discharge against admission. RESULTS: In our cohort, 7.6‰ of patients left hospital against their doctor's advice (n=19 272). These DAMA patients were more likely to be younger (mean age: 45.5 vs 55.0), foreign (22.1% vs 9.1%). The adjusted odds of readmission after DAMA was 2.76 (CI 95% 2.62-2.90) at 30 days (9.5% DAMA vs 4.6% not-DAMA), and the highest readmission rate was recorded in the first 24 hours after the index discharge. Mortality was higher for DAMA patients after adjusting for patient-level and hospital-level characteristics (with adjusted ORs of 1.40 for in-hospital mortality and 1.48 for overall mortality). CONCLUSIONS: The present study shows that DAMA patients are more likely to die and to need hospital readmission than patients discharged by their doctors. DAMA patients should be more committed to a proactive and diligent postdischarge care.

Improving the Quality of Healthcare Provision Regarding HPV Immunization for Women with CIN2+ Lesions: The Experience of the Veneto Region in Italy.

HPV is the most common cause of sexually-transmitted infections the world over. The aim of this study was to assess the impact of a healthcare quality improvement strategy designed to increase the rate of vaccination against HPV in women diagnosed with cervical lesions graded as CIN2 or higher (CIN2+) during routine screening. The Veneto Regional Health Service developed a 22-item questionnaire to measure the gap between ideal procedure and real practice regarding the offer of vaccination against HPV for women undergoing routine cervical screening. The questionnaire was administered to nine expert doctors, one at each of the region's Local Health Units (LHUs). An additional specific assessment concerned the quality of the related web pages available on the LHU websites. Strategies to close the gap between ideal procedure and real practice were decided collegially, and a checklist to support good practices was developed and shared with operators at the LHUs. Changes in practice were measured using data relating to women diagnosed with CIN2+ lesions extracted from the regional oncological screening database before and after the publication of a Regional Procedure on the topic. The LHUs differed considerably in how they managed each step, in terms of training for healthcare personnel, organization and assessment of the pathway from cervical screening to HPV vaccination, and in dedicated website communication. After implementing the quality improvement strategy, the proportion of women given a first dose of HPV vaccine within 3 months of being diagnosed with CIN2+ lesions at 1st-level screening rose to 50% (compared with 30.85% beforehand), and the median time elapsing between a diagnosis of CIN2+ lesion and a first dose of HPV vaccine dropped from 158 to 90 days. These findings underscore the importance of providing training to promote vaccination for general practitioners and other clinicians. The study also confirms the need for more efforts in communication to ensure that any citizen has the opportunity to access preventive healthcare.

Is SARS-CoV-2 Vaccination of Subjects with a Prior History of Allergies Dangerous? Experiences in the Veneto Region of Italy.

Adverse events after SARS-CoV-2 vaccinations have caused alarm to some individuals with previously diagnosed allergies. The aim of this study was to investigate whether the risk of adverse reactions was actually higher in this subgroup. To this end, we carried out an observational descriptive analysis of vaccines administered in a "protected setting" in the Veneto region of Italy between December 2020 and December 2022. Reactions were classified using systemic organic classification (SOC), and their severity was assessed using the criteria of the Italian Drug Agency (AIFA). A total of 421 subjects were vaccinated with 1050 doses, 95.0% of which were administered without adverse events. In all, 53 subjects reported 87 SOC reactions (1.6 reactions/person), and 18.3% of these reactions were severe. One person was hospitalized, but all subjects enjoyed complete remission. Reporting rates were 9.0%, 3.1%, and 1.2% for first, second, and third doses, respectively. The most frequent reactions involved the respiratory system (2.3%), the cutaneous and subcutaneous systems (2.1%), and the nervous system (1.7%). Multivariate analyses (adjOR (95% CI)) revealed that the probability of experiencing at least one reaction significantly declined with increases in age [0.95 (0.94-0.97)] and in the number of doses received, i.e., 75% [0.25 (0.13-0.49)] for second doses and 88% [0.12 (0.04-0.39)] for third doses. These results indicated that vaccinations could be safely administered; few reactions were reported, and there were no permanent adverse outcomes.

Respiratory Syncytial Virus in Veneto Region: Analysis of Hospital Discharge Records from 2007 to 2021.

Respiratory Syncytial Virus (RSV) is a known cause of acute lower respiratory infections in infants and young children. The present study aims to analyze the temporal trends and characteristics of hospitalization related to RSV in the Veneto region (Italy) in the period between 2007 and 2021. The analysis is performed on all the hospital discharge records (HDRs) of public and accredited private hospitals corresponding to hospitalizations occurring in the Veneto region (Italy). HDRs are considered if they included at least one of the following ICD9-CM codes: 079.6-Respiratory Syncytial Virus (RSV); 466.11-acute bronchiolitis due to RSV; and 480.1-pneumonia due to RSV. Total annual cases, sex, and age-specific rates and trends are evaluated. Overall, an increasing trend in the number of hospitalizations due to RSV was observed between 2007 and 2019, with a slight drop in RSV seasons 2013-2014 and 2014-2015. From March 2020 to September 2021, almost no hospitalization was registered, but in the last quarter of 2021, the number of hospitalizations reached its highest value in the series. Our data confirm the preponderance of RSV hospitalizations in infants and young children, the seasonality of RSV hospitalizations, and acute bronchiolitis as the most frequent diagnosis. Interestingly, the data also show the existence of a significant burden of disease and a non-negligible number of deaths also in older adults. The present study confirms RSV is associated with high rates of hospitalization in infants and sheds light on the burden in the 70+ age group in which a considerable number of deaths was observed, as well as the parallelism with other countries, which is consistent with a wide underdiagnoses issue.

Organ procurement requiring the authorization of the judicial authority. An epidemiological investigation in the Veneto region (Italy).

BACKGROUND: When death occurs through a mechanism requiring a forensic investigation, consent for organ harvesting must be sought from the Judicial Authority (JA). AIM: To perform a retrospective study of potential organ donors in the Veneto region over a six-year period (2012-2017), analysing any differences between cases in which the JA approved or denied organ harvesting. MATERIAL AND METHODS: Both non-heart beating (NHB) and heart beating (HB) donors were included. For HB cases, personal and clinical data were collected. To evaluate the correlation between the JA response and the circumstantial and clinical data a logistic multivariate analysis was performed, estimating the adjusted odds ratios (adjORs). RESULTS: Between 2012 and 2017, 17,662 organ and/or tissue donors were included, of which 16,418 were NHB donors and 1,244 HB-donors. Among the 1,244 HB-donors, JA authorization was asked in 200 cases (16.1%), approved in 154 cases (77.0%), limited in 7 cases (3.5%) and denied in 39 cases (19.5%). The JA denied the authorization for organ harvesting in 53,3% of cases with hospitalizations of less than 1 day and in 9,4% of cases with hospitalization exceeding one week [adjOR(95%CI) = 10.67 (1.92-59.22)]. The performance of an autopsy was linked to a higher chance of denied outcome from the JA [adjOR(95%CI): 3.45 (1.42-8.39)]. CONCLUSIONS: Improvements in the communication between organ procurement organizations and the JA through efficient protocols furnishing detailed information on the cause of death might lead to a better procurement process with an increase in the number of transplanted organs.

Mycobacterium chimaera Infections in a Unit of Cardio Surgery: Study at a General Hospital in Padua, Italy.

Mycobacterium chimaera is a slow-growing non-tuberculous mycobacterium already known for being able to colonize cardio surgery heater-cooler units (HCUs). This study aims to describe the real magnitude of the phenomenon, providing a methodological protocol and the results of a longitudinal survey. In the period 1 January 2017-23 May 2022, over 1191 samples were collected on 35 HCUs of two different manufacturers. Among them, we identified 118 (10.3%) positive results for M. chimaera. We propose our 4-year biosurveillance experience as a practical model to minimize microbiological patients' risk, suggesting the need for new procedures and interventions for a safer and more ecological cardio surgery.

Widening Disparities in Teen HPV Vaccinations during COVID-19 Pandemic: A Case Study from Veneto Region (Italy).

INTRODUCTION: In Local Health Unit 7, human papilloma virus (HPV) vaccination campaigns for 12-year-olds have long been implemented by the vaccination services of the Department of Prevention. Due to the pressure of the COVID-19 pandemic on these services, an emergency vaccination campaign was directly managed by primary care pediatricians (PCPs). An initial evaluation of this experience was conducted. MATERIALS AND METHODS: Data on 12-year-olds assisted by PCPs belonging to the 2006 (pre-pandemic) and 2008 (pandemic) birth cohorts were extracted, along with HPV vaccination data. Health district, gender, citizenship, socioeconomic status, and PCPs were evaluated as possible influencing factors in a two-level logistic regression (second level: single PCP). RESULTS: The HPV vaccination gap between males and females increased significantly for the 2008 birth cohort compared to the 2006 birth cohort (11 vs. 4 percentage points). As for PCPs, the vaccination uptake range was 4-71% for the 2008 birth cohort vs. 32-85% for the 2006 cohort. The proportion of variance explained at the second level was overall equal to 9.7% for the 2008 cohort vs. 3.6% for the 2006 cohort. CONCLUSIONS: The vaccination campaign carried out during the peak of the COVID-19 pandemic increased the HPV vaccination gaps among Health Districts, genders, and individual PCPs, probably due to a lack of homogeneity in professional practices and attitudes toward HPV vaccination. Catch-up interventions are required in the immediate term, while an equity-lens approach should be taken for reprogramming the vaccination campaign. Greater involvement of schools and families could ensure a more equitable approach and a better uptake.

COVID-19 Vaccine Effectiveness against Omicron Variant among Underage Subjects: The Veneto Region's Experience.

Even if most of the complications due to COVID-19 are observed in the elderly, in Italy the impact of COVID-19 among young people has not been negligible. Furthermore, their contribution to SARS-CoV-2 circulation is still unclear. These reasons have driven policy makers to involve subjects aged 5 to 17 years in the COVID-19 vaccination campaign. However, the trade-off of vaccinating this age-group should be further investigated, especially in view of the rise of new immunologically evasive variants of concern (VOCs). We used regional databases to retrospectively estimate vaccine effectiveness over time of each approved vaccination schedule among children (5-11) and adolescents (12-17). Our findings suggest that COVID-19 vaccines were highly effective and their protection levels lasted longer during a period of Delta variant predominance, whereas they offered just mild to moderate levels of protection-apparently affected by a rapid waning effect-in a period of Omicron variant predominance. Considering these results, it is plausible to evaluate a reformulation of possible future COVID-19 vaccination campaigns among underage subjects. However, effectiveness against serious complications due to COVID-19, as well as indirect benefits of underage vaccinations, should first be addressed. Furthermore, vaccine effectiveness should be kept monitored, as new VOCs may arise, but also new adapted vaccines may start being administered.

Differences in Immunological Evasion of the Delta (B.1.617.2) and Omicron (B.1.1.529) SARS-CoV-2 Variants: A Retrospective Study on the Veneto Region's Population.

In December 2021-January 2022 the Veneto region in Italy faced an unprecedented wave of SARS-CoV-2 infections, even though both the vaccine coverage and the number of previously infected individuals keep increasing. In this study we address the protection against the SARS-CoV-2 infection offered by natural immunity and a three-dose regimen through a retrospective study based on Veneto's regional databases. In particular, we compared these protection levels during two distinct periods respectively representative of the Delta (B.1.617.2) and the Omicron (B.1.1.529) variants, in order to investigate and quantify the immunological evasion, especially of the Omicron. For each period we compared the incidence rate of infection among the population with various immunological protections against SARS-CoV-2 and performed a multivariable proportional hazard Cox binomial regression to assess the effectiveness afforded by both forms of active immunization. We found out that a previous SARS-CoV-2 infection (irrespective of its timing) offers 85% (83-87%) and 36% (33-39%) protection against being reinfected by Delta and Omicron, respectively. In addition, we estimated the third dose to be more effective in both periods and to have a minor proportional loss of effectiveness due to the rise of the Omicron variant, with an afforded effectiveness against SARS-CoV-2 Delta and Omicron infection of 97% (96-97%) and 47% (45-48%), respectively. Our findings suggest that viral variant factors may affect any form of active immunization but that receiving a booster vaccination cycle is more effective and less variable than natural immunity in terms of afforded protection against SARS-CoV-2 infections.

Stress in Medical Students: PRIMES, an Italian, Multicenter Cross-Sectional Study.

Medical students (MSs) are healthcare workers and must also cope with education-related stressors. This study aims to assess factors associated with perceived stress in Italian MSs. A cross-sectional study was conducted in 12 Italian medical schools (MSCs) in November 2018. A questionnaire assessed socio-demographic characteristics, habits, opinions about MSC, and concerns about the future. Stress was assessed with the PSS-10. Descriptive and univariable tests were performed. A linear model was fitted to find associations of the PSS-10 score with characteristics. There were 2513 collected questionnaires. Median PSS-10 score was 18 (IQR 11). Median age was 22 (IQR 4) and 61% of the sample was female. Female gender, being part of a sexual minority, poor financial situation, competitive atmosphere, having hobbies, resting, and sleeping hindered by MSC were characteristics associated with higher PSS-10 scores. Current relationship, good family relationship, and no concerns about the future were protective factors. Being part of sexual minorities had greater effects in students not living away from home, while in the other group it was not having satisfying friendships. Medical students suffer higher levels of stress than the general population, and many MSC stressors are associated. Living away from home modifies risk and protective factors, offering the possibility to tailor group-specific interventions.

Rapid Antigen Test LumiraDxTM vs. Real Time Polymerase Chain Reaction for the Diagnosis of SARS-CoV-2 Infection: A Retrospective Cohort Study.

Background: Real time reverse transcription polymerase chain reaction (real time RT-PCR) testing is the gold standard for the diagnosis of SARS-CoV-2 infections. However, to expand the testing capacity, new SARS-CoV-2 rapid antigen tests (Ag-RDTs) have been implemented. Ag-RDTs are more rapid, but less reliable in terms of sensitivity, and real-life data on their performance in comparison with the real time RT-PCR test are lacking. Methods: We aimed at assessing the diagnostic performance of the third-generation antigenic swab LumiraDx™ compared with real time RT-PCR in a retrospective cohort study at the Infectious Diseases Unit of Padua. All of the patients who were consecutively tested for SARS-CoV-2 in our centre (by both real time RT-PCR and Ag-RTD LumiraDxTM) from 19 January to 30 May 2021, were included. Cycle-threshold (Ct) values of positive real time RT-PCR were recorded as well as the number of days from symptoms' onset to testing. Results: Among the 282 patients included, 80.9% (N = 228) tested positive to real time RT-PCR, and among these, 174 tested positive also to LumiraDx™. Compared with real time RT-PCR, which is considered as the gold standard for the assessment of the presence/absence of SARS-CoV-2 infection, LumiraDx™ showed an overall sensitivity of 76.3% and specificity of 94.4%. Sensitivity increased to 91% when testing was performed <10 days from symptoms' onset, and to 95% when considering Ct < 25. Multivariable binomial logistic regression showed that false negative LumiraDx™ results were significantly associated with high Ct values, and with further testing from symptoms' onset. Conclusions: The results of our study suggested that the LumiraDx™ SARS-CoV-2 antigen assay may be appropriate for the detection of SARS-CoV-2 infection, especially in its early phase when the test largely meets the performance requirements of the European Centre for Disease Prevention and Control (ECDC).

Health and healthcare variables associated with Italy's excess mortality during the first wave of the COVID-19 pandemic: An ecological study.

BACKGROUND: Healthcare factors have strongly influenced the propagation of COVID-19. This study aims to examine whether excess mortality during the first phase of the COVID-19 outbreak in Italy was associated with health, healthcare, demographic, and socioeconomic, provincial-level indicators. METHODS: This ecological study concerns the raw number of deaths reported from February 1 to April 30, 2020 and the mean number of deaths occurred during the same months from 2015 to 2019, per province. Information on socioeconomic factors and healthcare settings was extracted from updated databases on the Italian National Institute of Statistics (ISTAT) website. A multivariate model and four multilevel models were constructed to test the association between excess mortality and the analysed indicators across 107 Italian provinces. RESULTS: The hospitalization rate in long-term care wards and the cardiovascular disease mortality rate correlate positively with excess mortality (p <0.05), while higher densities of licensed physicians and of general practitioners are associated with lower excess mortality (p <0.05). After controlling for the COVID-19 cumulative incidence in each province, only the density of licensed physicians remains negatively associated with excess mortality (p <0.01). CONCLUSION: Some health and healthcare variables (in particular, the density of physicians) are strongly associated with excess mortality during the first wave of the COVID-19 pandemic in Italy and should be targeted to increase the resilience of health systems.

"Would You Get Vaccinated against COVID-19?" The Picture Emerging from a Study on the Prevalence of SARS-CoV-2 Infection in the General Population of the Veneto Region.

COVID-19 disease, caused by the SARS-CoV-2 virus, continues to cause high hospitalization and death rates. Vaccination campaigns have been key to controlling the pandemic, but vaccine hesitancy is on the rise. This study investigated the general population's attitude to vaccination in Veneto (northeast Italy) in January 2021 as part of a study on the prevalence of SARS-CoV-2 infection. An ad hoc questionnaire collected 4467 respondents' sociodemographic data and propensity to be vaccinated, and findings were analyzed using logistic multivariable regression. The 48.9% of respondents were male, and the mean age was 46.8 ± 16.0 years. Asked whether they would get vaccinated against COVID-19, 84.3% said yes, 5.0% were uncertain, and 10.7% said no. Vaccine acceptance was higher in males than in females (85.8% vs. 82.8%), in people 70+ years old (92.3%), and among people with more than 14 years of schooling (89.6%). Multivariable analysis with adjOR (95% CI) showed a significantly greater vaccine reluctance in females (0.68 (0.57−0.81)), people 30−49 or 50−69 years old (0.69 (0.54−0.87)), and (0.76 (0.58−0.99)); and those with <9 or 9−13 years of schooling (0.62 (0.46−0.82)), and (0.72 (0.57−0.91)). As people refusing vaccination undeniably hinder efforts to control the pandemic, specific strategies are needed to overcome their doubts.

The Effectiveness of a Diverse COVID-19 Vaccine Portfolio and Its Impact on the Persistence of Positivity and Length of Hospital Stays: The Veneto Region's Experience.

The vaccination campaign for the Veneto region (northeastern Italy) started on 27 December 2020. As of early December 2021, 75.1% of the whole Veneto population has been fully vaccinated. Vaccine efficacy has been demonstrated in many clinical trials, but reports on real-world contexts are still necessary. We conducted a retrospective cohort study on 2,233,399 residents in the Veneto region to assess the reduction in the COVID-19 burden, taking different outcomes into consideration. First, we adopted a non-brand-specific approach borrowed from survival analysis to estimate the effectiveness of vaccination against SARS-CoV-2 in preventing infections, hospitalizations, and deaths. We used t-tests and multivariate regressions to examine vaccine impact on breakthrough infections, in terms of the persistence of positivity and the length of hospital stays. Evidence emerging from this study suggests that unvaccinated individuals are significantly more likely to become infected, need hospitalization, and are at a higher risk of death from COVID-19 than those given at least one dose of vaccine. Cox models indicate that the effectiveness of full vaccination is 88% against infection, 94% against hospitalization, and 95% against death. Multivariate regressions suggest that vaccination is significantly correlated with a shorter period of positivity and shorter hospital stays, with each step toward completion of the vaccination cycle coinciding with a reduction of 3.3 days in the persistence of positivity and 2.3 days in the length of hospital stay.