Diagnostic accuracy of an automated chemiluminescent immunoassay for anti-SARS-CoV-2 IgM and IgG antibodies: an Italian experience.

A pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been spreading throughout the world. Though molecular diagnostic tests are the gold standard for COVID-19, serological testing is emerging as a potential surveillance tool, in addition to its complementary role in COVID-19 diagnostics. Indubitably quantitative serological testing provides greater advantages than qualitative tests but today there is still little known about serological diagnostics and what the most appropriate role quantitative tests might play. Sixty-one COVID-19 patients and 64 patients from a control group were tested by iFlash1800 CLIA analyzer for anti-SARS CoV-2 antibodies IgM and IgG. All COVID-19 patients were hospitalized in San Giovanni di Dio Hospital (Florence, Italy) and had a positive oro/nasopharyngeal swab reverse-transcription polymerase chain reaction result. The highest sensitivity with a very good specificity performance was reached at a cutoff value of 10.0 AU/mL for IgM and of 7.1 for IgG antibodies, hence near to the manufacturer's cutoff values of 10 AU/mL for both isotypes. The receiver operating characteristic curves showed area under the curve values of 0.918 and 0.980 for anti-SARS CoV-2 antibodies IgM and IgG, respectively. iFlash1800 CLIA analyzer has shown highly accurate results for the anti-SARS-CoV-2 antibodies profile and can be considered an excellent tool for COVID-19 diagnostics.

Referral of newly diagnosed chronic hepatitis B and C patients in six EU countries: results of the HEPscreen Project.

BACKGROUND: Effective linkage to specialist care following screening is crucial for secondary prevention of chronic viral hepatitis-related consequences. METHODS: To explore the frequency of referral of patients to secondary care from the health services involved in screening and to gather information on the services responsible for the provision of post-test counselling and contact tracing, four online surveys were conducted among general practitioners (GP), and experts working in sexual health services (SHS), antenatal care (ANC) and specialist secondary care in Germany, Hungary, Italy, The Netherlands, Spain and the UK. RESULTS: Overall, 60% of GPs report referring all patients to specialist care. Although 67% of specialists commonly receive patients referred by GPs, specialists in Germany rarely or never receive patients from ANC or from centres testing injecting drug users; and specialists in the Netherlands, Hungary and Germany rarely receive patients from SHS. Gastroenterologists/hepatologists are the professionals mainly responsible for the provision of counselling following a positive diagnosis of viral hepatitis according to two-thirds of specialists, 14% of SHS providers and 11% of ANC providers. Almost half of ANC providers (45%) stated that gynaecologists are the professionals responsible for the provision of counselling to positive pregnant women; among SHS providers, only 14% identified SHS as the services responsible. CONCLUSION: Our findings suggest the existence of complex/ineffective referral practices or that opportunities to screen risk groups are missed. Recommendations clarifying the services responsible at each step of the referral pathway are needed in order to increase the success of screening programmes.

Cycling promotion and non-communicable disease prevention: health impact assessment and economic evaluation of cycling to work or school in Florence.

OBJECTIVE: To estimate the effects of cycling promotion on major non-communicable diseases (NCDs) and costs from the public healthcare payer's perspective. DESIGN: Health impact assessment and economic evaluation using a dynamic model over a ten-year period and according to two cycling promotion scenarios. SETTING: Cycling to work or school in Florence, Italy. POPULATION: All individuals aged 15 and older commuting to work or school in Florence. MAIN OUTCOME MEASURES: The primary outcome measures were changes in NCD incidence and healthcare direct costs for the Tuscany Regional Health Service (SST) due to increased cycling. The secondary outcome was change in road traffic accidents. RESULTS: Increasing cycling modal share in Florence from 7.5% to about 17% (Scenario 1) or 27% (Scenario 2) could decrease the incidence of type 2 diabetes by 1.2% or 2.5%, and the incidence of acute myocardial infarction (AMI) and stroke by 0.6% or 1.2%. Within 10 years, the number of cases that can be prevented is 280 or 549 for type 2 diabetes, 51 or 100 for AMI, and 51 or 99 for stroke in Scenario 1 or Scenario 2, respectively. Average annual discounted savings for the SST are estimated to amount to €400,804 or €771,201 in Scenario 1 or Scenario 2, respectively. In Florence, due to the high use of vulnerable motorized vehicles (such as scooters, mopeds, and motorcycles), road traffic accidents are expected to decline in both our scenarios. Sensitivity analyses showed that health benefits and savings for the SST are substantial, the most sensitive parameters being the relative risk estimates of NCDs and active commuting. CONCLUSIONS: Effective policies and programs to promote a modal shift towards cycling among students and workers in Florence will contribute to reducing the NCD burden and helping long-term economic sustainability of the SST.

A retrospective analysis of hospital discharge records for S. pneumoniae diseases in the elderly population of Florence, Italy, 2010-2012.

Invasive pneumococcal diseases (IPD) and community acquired pneumonia (CAP) represent two of the major causes of out-patient visits, hospital admissions and deaths in the elderly. In Tuscany (Italy), in the Local Health Unit of Florence, a project aimed at implementing an active surveillance of pneumococcal diseases in the hospitalized elderly population started in 2013. The aim of this study is to show the results of the retrospective analysis (2010-2012) on hospital discharge records (HDRs) related to diseases potentially due to S. pneumoniae, using a selection of ICD9-CM codes. All ordinary hospitalizations (primary and secondary diagnoses) of the elderly population were included (11 245 HDRs). Among a population of about 200 000 inhabitants ≥65 y, the hospitalization rate (HR) increased with increasing age and was higher in males in all age groups. Almost all hospitalizations (95%) were due to CAP, only 5% were invasive diseases. Only few cases of CAP were specified as related to S. pneumoniae, the percentage was higher in case of meningitis (100%) or septicemia (22%). In-hospital deaths over the three-year period were 1703 (case fatality rate: 15%). The risk of dying, being hospitalized for a disease potentially attributable to pneumococcus (as primary diagnosis) increased significantly with age (P < 0.001), the odds ratio (OR) per increasing age year was 1.06 (95% CI 1.05-1.07) and was higher in patients with co-existing medical conditions with respect to patients without comorbidities. Currently, an active surveillance system on S. pneumoniae diseases with the inclusion of bio-molecular tests (RT-PCR), is a key step to assess the effectiveness of the PCV13 vaccine (13-valent pneumococcal conjugate vaccine) in the elderly population after implementation of vaccination policies. The results of this study will provide the comparator baseline data for the evaluation of a possible immunization programme involving one or more cohorts of the elderly in Tuscany.

Antimicrobial resistance among non-fermentative Gram-negative bacilli isolated from the respiratory tracts of Italian inpatients: a 3-year surveillance study by the Italian Epidemiological Survey.

The Italian Epidemiological Survey evaluated antibiotic susceptibility of non-fermentative Gram-negative bacilli isolated from inpatient respiratory-tract specimens collected throughout Italy during 1997-1999. The minimal inhibitory concentrations of 14 antibiotics for 1474 Pseudomonas aeruginosa strains, 307 Stenotrophomonas maltophilia strains and 114 Acinetobacter baumannii strains were determined in 57 clinical microbiology laboratories by means of a standardised micro-dilution method. The most active drugs against P. aeruginosa isolates were meropenem (81% susceptible) and amikacin (80% susceptible). Imipenem and meropenem proved to be the only agents active against A. baumannii isolates, although 13 and 16%, respectively, of strains were resistant to these drugs. Trimethoprim-sulphamethoxazole (TMP-SMZ) showed activity only against S. maltophilia isolates (83% susceptible). A total of 185 multidrug-resistant P. aeruginosa isolates (resistant to piperacillin, ceftazidime, gentamicin, and imipenem) were found. Resistance rates and trends showed consistent regional variations, including sharp increases from 1997 to 1999 in imipenem resistance among P. aeruginosa isolates from central and southern Italy.

Attitude toward immunization and risk perception of measles, rubella, mumps, varicella, and pertussis in health care workers working in 6 hospitals of Florence, Italy 2011.

BACKGROUND: Health care workers (HCWs) are at risk of infection and transmission of vaccine-preventable infectious diseases. In recent years cases of measles or varicella in health care workers were observed with increasing frequency. The aim of our study was to investigate attitude toward immunization and risk perception of measles, rubella, mumps, varicella, and pertussis in HCWs working in 6 hospitals of Florence (Italy). METHODS: A cross-sectional survey among the physicians, nurses, midwives, and nursing assistants working in selected departments was performed trough a self-administered, anonymous questionnaire. Overall, 600 questionnaires were sent and 436 HCWs' completed forms were included into the study (Participation rate: 72.7%). Data were analyzed with STATA 11.0® and odds ratio (OR) were calculated in a multivariate analysis. RESULTS: Among all respondents 74.9% were females. The average age was nearly 43-years-old (42.9-SD 8.95). The majority of participants (58.6%) were nurses, 21.3% physicians, 12.9% nursing assistants, and 7.2% were midwives. Among those HCWs reporting no history of disease, 52.8% (95% CI: 42.0-63.3%) declared to have been immunized for measles, 46.9% for rubella (95% CI: 39.0-54.9%), 21.6% for mumps (95% CI: 15.1-29.4%), 14.9% for varicella (95% CI: 7.4-25.7%), and 14.5% for pertussis (95% CI: 10.0-20.0%). When considering potentially susceptible HCWs (without history of disease or vaccination and without serological confirmation), less than a half of them feel at risk for the concerned diseases and only less than 30% would undergo immunization. One of the main reasons of the relatively low coverage was indeed lack of active offer of vaccines. CONCLUSION: Attitudes toward immunization observed in this study are generally positive for preventing some infectious diseases (i.e., measles and rubella), but relatively poor for others (i.e., varicella). More information should be made available to HCWs on the benefits of vaccination and efforts to encourage vaccination uptake should be performed. Educational program on the risk of being infected working in a hospital should be implemented in order to increase the risk perception toward infectious diseases among HCWs.

Economic analysis of the first 20 years of universal hepatitis B vaccination program in Italy: an a posteriori evaluation and forecast of future benefits.

Italy was one of the first countries in the world to introduce a routine vaccination program against HBV for newborns and 12-y-old children. From a clinical point of view, such strategy was clearly successful. The objective of our study was to verify whether, at 20 y from its implementation, hepatitis B universal vaccination had positive effects also from an economic point of view. An a posteriori analysis evaluated the impact that the hepatitis B immunization program had up to the present day. The implementation of vaccination brought an extensive reduction of the burden of hepatitis B-related diseases in the Italian population. As a consequence, the past and future savings due to clinical costs avoided are particularly high. We obtained a return on investment nearly equal to 1 from the National Health Service perspective, and a benefit-to-cost ratio slightly less than 1 for the Societal perspective, considering only the first 20 y from the start of the program. In the longer-time horizon, ROI and BCR values were positive (2.78 and 2.46, respectively). The break-even point was already achieved few years ago for the NHS and for the Society, and since then more and more money is progressively saved. The implementation of universal hepatitis B vaccination was very favorable during the first 20 y of adoption, and further benefits will be increasingly evident in the future. The hepatitis B vaccination program in Italy is a clear example of the great impact that universal immunization is able to provide in the medium-long-term when health care authorities are so wise as to invest in prevention.

Economic evaluation of Varicella vaccination: results of a systematic review.

INTRODUCTION: The aim of the present study is to review the economic burden of varicella disease and the benefit of universal varicella vaccination in different settings pending its implementation in all Italian regions. MATERIALS AND METHODS: Research was conducted using PubMed, Scopus and ISI databases. Score quality and data extraction were performed for all included studies. RESULTS: Twenty-three articles met the criteria: 15 cost-effectiveness, 8 cost-benefit and one cost-utility analysis. Varicella vaccination could save the society from €637,762 (infant strategy) to 53 million annually (combined infant and adolescent strategy). The median and the mean quality scores resulted in 91.8% and 85.4% respectively; 11 studies were considered of high quality and 12 of low quality. DISCUSSION: The studies are favorable to the introduction of universal varicella vaccination in Italy, being cost saving and having a positive impact on morbidity. The quality score of the studies varied greatly: recent analyses were of comparable quality to older studies.