Publications by authors named "Mario Plebani"

855 Publications

Antibody response to first and second dose of BNT162b2 in a cohort of characterized healthcare workers.

Clin Chim Acta 2021 Apr 20;519:60-63. Epub 2021 Apr 20.

Department of Medicine-DIMED, University of Padova, Italy; Department of Laboratory Medicine, University-Hospital of Padova, Italy. Electronic address:

Background: Vaccine-induced population immunity is a key global strategy to control coronavirus disease 2019 (COVID-19). The rapid implementation and availability of several COVID-19 vaccines is now a global health-care priority but more information about humoral responses to single- and double-dose vaccine is needed.

Methods: 163 health care workers (HCW) of the Padua University Hospitals, who underwent a complete vaccination campaign with BNT162b2 vaccine were asked to collect serum samples at 12 (t12) and 28 (t28) days after the first inoculum to allow the measurement of SARS-CoV-2 Antibodies (Ab) using chemiluminescent assays against the spike (S) protein and the Receptor Binding Domain (RBD) of the virus, respectively.

Results: Significant differences were found at t12 for infection-naïve and subjects with previous-natural infection who present higher values of specific antibodies, while no significant differences have been found between t12 and t28. No statistically significant difference was found between male and female, while lower Ab levels have been observed in subjects older than 60 years at t12 but not at t28.

Conclusions: Our study confirms observed differences in vaccine responses between infection-naïve and subjects with previous natural infection at t12 but not for a longer time. The influence of sex and age deserves further studies, even if the relationship with age seems particularly significant.
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http://dx.doi.org/10.1016/j.cca.2021.04.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8056941PMC
April 2021

Analytical and clinical performances of a SARS-CoV-2 S-RBD IgG assay: comparison with neutralization titers.

Clin Chem Lab Med 2021 Apr 13. Epub 2021 Apr 13.

Department of Medicine-DIMED, Medical School, University of Padova, Padova, Italy.

Objectives: SARS-CoV-2 serology presents an important role in several aspects of COVID-19 pandemic. Immunoassays performances have to be accurately evaluated and correlated with neutralizing antibodies. We investigated the analytical and clinical performances of a SARS-CoV-2 RBD IgG assay, automated on a high throughput platform, and the correlation of the antibodies (Ab) levels with the plaque reduction neutralization (PRNT) Ab titers.

Methods: A series of 546 samples were evaluated by SARS-CoV-2 RBD IgG assay (Snibe diagnostics), including 171 negative and 168 positive SARS-CoV-2 subjects and a further group of 207 subjects of the COVID-19 family clusters follow-up cohort.

Results: Assay imprecision ranged from 3.98 to 12.18% being satisfactory at low and medium levels; linearity was excellent in all the measurement range. Considering specimens collected after 14 days post symptoms onset, overall sensitivity and specificity were 99.0 and 92.5%, respectively. A total of 281 leftover samples results of the PRNT test were available. An elevated correlation was obtained between the SARS-CoV-2 RBD IgG assay and the PRNT titer at univariate (=0.689) and multivariate (=0.712) analyses.

Conclusions: SARS-CoV-2 S-RBD IgG assay shows satisfactory analytical and clinical performances, and a strong correlation with sera neutralizing activity.
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http://dx.doi.org/10.1515/cclm-2021-0313DOI Listing
April 2021

Serum miR-375 for Diagnostic and Prognostic Purposes in Medullary Thyroid Carcinoma.

Front Endocrinol (Lausanne) 2021 29;12:647369. Epub 2021 Mar 29.

Endocrinology Unit, Department of Medicine (DIMED), University of Padua, Padua, Italy.

Purpose: Having previously demonstrated that tissue miR-375 expression in medullary thyroid carcinoma (MTC) tissues is linked to prognosis, the aim of this study was to assess the diagnostic and prognostic value of circulating miR-375 levels in MTC patients.

Methods: A series of 68 patients with MTC was retrospectively retrieved and assessed in terms of their clinicopathological characteristics. MiR-375 levels were measured in all patients' presurgical blood samples. Both serum and tissue levels were tested prior to surgery in a subgroup of 57 patients. Serum miR-375 levels were also measured in serum from 49 patients with non-C-cell thyroid nodular diseases (non-CTN), 14 patients with pheochromocytoma, and 19 healthy controls.

Results: Circulating miR-375 levels were 101 times higher in the serum of patients with MTC than in all other patients and controls, with no overlap (P < 0.01). No correlation emerged between serum and tissue miR-375 levels. Serum miR-375 levels were higher in MTC patients with N0 than in those with N1 disease (P = 0.01), and also in patients who were biochemically cured than in those who were not (P = 0.02). In the whole series of patients and controls, calcitonin (CT) and serum miR-375 levels were correlated at diagnosis (R = 0.40, P < 0.01), but in a U-shaped manner: a positive correlation was found with low CT levels, then the correlation turns negative as CT rises (in MTC patients). A negative correlation was indeed found in MTC patients between serum miR-375 and CT (R = -0.10, P = 0.01). On ROC curve analysis, a cut-off of 2.1 for serum miR-375 proved capable of distinguishing between MTC patients and the other patients and controls with a 92.6% sensitivity and a 97.6% specificity (AUC: 0.978, P < 0.01).

Conclusions: Serum miR-375 levels can serve as a marker in the diagnosis of MTC, with a remarkable specificity. Serum miR-375 also proved a novel marker of prognosis in this disease. Further experiments to corroborate our results are currently underway.
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http://dx.doi.org/10.3389/fendo.2021.647369DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8039521PMC
March 2021

Laboratory medicine in the COVID-19 era: six lessons for the future.

Authors:
Mario Plebani

Clin Chem Lab Med 2021 Apr 7. Epub 2021 Apr 7.

Department of Medicine-DIMED, University of Padova, Padova, Italy.

The lockdown due to the coronavirus disease 2019 (COVID-19), a major healthcare challenge, is a worldwide threat to public health, social stability, and economic development. The pandemic has affected all aspects of society, dramatically changing our day-to-day lives and habits. It has also changed clinical practice, including practices of clinical laboratories. After one year, it is time to rethink what has happened, and is still happening, in order to learn lessons for the future of laboratory medicine and its professionals. While examining this issue, I was inspired by Italo Calvino's famous work, "Six memos for the next millennium".But I rearranged the Author's six memos into "Visibility, quickness, exactitude, multiplicity, lightness, consistency".
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http://dx.doi.org/10.1515/cclm-2021-0367DOI Listing
April 2021

The role of procalcitonin in reducing antibiotics across the surgical pathway.

World J Emerg Surg 2021 Mar 24;16(1):15. Epub 2021 Mar 24.

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Procalcitonin (PCT) is widely considered as a highly sensitive biomarker of bacterial infection, offering general and emergency surgeons a key tool in the management of surgical infections. A multidisciplinary task force of experts met in Bologna, Italy, on April 4, 2019, to clarify the key issues in the use of PCT across the surgical pathway. The panelists presented the statements developed for each of the main questions regarding the use of PCT across the surgical pathway. An agreement on the statements was reached by the Delphi method, and this document reports the executive summary of the final recommendations approved by the expert panel.
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http://dx.doi.org/10.1186/s13017-021-00357-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7988639PMC
March 2021

Monocyte distribution width (MDW) parameter as a sepsis indicator in intensive care units.

Clin Chem Lab Med 2021 Mar 5. Epub 2021 Mar 5.

Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy.

Objectives: Patients in Intensive Care Units (ICU) are a high-risk population for sepsis, recognized as a major cause of admission and death. The aim of the current study was to evaluate the diagnostic accuracy and prognostication of monocyte distribution width (MDW) in sepsis for patients admitted to ICU.

Methods: Between January and June 2020, we conducted a prospective observational study during the hospitalization of 506 adult patients admitted to the ICU. MDW was evaluated in 2,367 consecutive samples received for routine complete blood counts (CBC) performed once a day and every day during the study. Sepsis was diagnosed according to Sepsis-3 criteria and patients enrolled were classified in the following groups: no sepsis, sepsis and septic shock.

Results: MDW values were significantly higher in patients with sepsis or septic shock in comparison to those within the no sepsis group [median 26.23 (IQR: 23.48-29.83); 28.97 (IQR: 21.27-37.21); 21.99 (IQR: 19.86-24.36) respectively]. ROC analysis demonstrated that AUC is 0.785 with a sensitivity of 66.88% and specificity of 77.79% at a cut-off point of 24.63. In patients that developed an ICU-acquired sepsis MDW showed an increase from 21.33 [median (IQR: 19.47-21.72)] to 29.19 [median (IQR: 27.46-31.47)]. MDW increase is not affected by the aetiology of sepsis, even in patients with COVID-19. In sepsis survivors a decrease of MDW values were found from the first time to the end of their stay [median from 29.14 (IQR: 26.22-32.52) to 25.67 (IQR: 22.93-30.28)].

Conclusions: In ICU, MDW enhances the sepsis detection and is related to disease severity.
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http://dx.doi.org/10.1515/cclm-2021-0192DOI Listing
March 2021

Corrigendum to: Understanding and managing interferences in clinical laboratory assays: the role of laboratory professionals.

Clin Chem Lab Med 2021 Mar 1;59(5):1005. Epub 2021 Mar 1.

Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy.

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http://dx.doi.org/10.1515/cclm-2021-0212DOI Listing
March 2021

Salivary SARS-CoV-2 antigen rapid detection: A prospective cohort study.

Clin Chim Acta 2021 Jun 21;517:54-59. Epub 2021 Feb 21.

Department of Medicine - DIMED, Laboratory Medicine, University Hospital of Padova, Padova, Italy.

Background And Aim: SARS-CoV-2 quick testing is relevant for the containment of new pandemic waves. Antigen testing in self-collected saliva might be useful. We compared salivary and naso-pharyngeal swab (NPS) SARS-CoV-2 antigen detection by a rapid chemiluminescent assay (CLEIA) and two different point-of-care (POC) immunochromatographic assays, with results of molecular testing.

Methods: 234 patients were prospectively enrolled. Paired self-collected saliva (Salivette) and NPS were obtained to perform rRT-PCR, chemiluminescent (Lumipulse G) and POC (NPS: Fujirebio and Abbott; saliva: Fujirebio) for SARS-CoV-2 antigen detection.

Results: The overall agreement between NPS and saliva rRT-PCR was 78.7%, reaching 91.7% at the first week from symptoms. SARS-CoV-2 CLEIA antigen was highly accurate in distinguishing positive and negative NPS (ROC-AUC = 0.939, 95%CI:0.903-0.977), with 81.6% sensitivity and 93.8% specificity. This assay on saliva reached the optimal value within 7 days from symptoms onset (Sensitivity: 72%; Specificity: 97%). Saliva POC antigen was limited in sensitivity (13%), performing better in NPS (Sensitivity: 48% and 66%; Specificity: 100% and 99% for Espline and Abbott respectively), depending on viral loads.

Conclusions: Self-collected saliva is a valid alternative to NPS for SARS-CoV-2 detection by molecular, but also by CLEIA antigen testing, which is therefore potentially useful for large scale screening.
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http://dx.doi.org/10.1016/j.cca.2021.02.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7897404PMC
June 2021

Machine learning-based analysis of alveolar and vascular injury in SARS-CoV-2 acute respiratory failure.

J Pathol 2021 Feb 24. Epub 2021 Feb 24.

Department of Cardiac, Thoracic, Vascular Sciences, and Public Health, University of Padua Medical School, Padua, Italy.

Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) pneumopathy is characterized by a complex clinical picture and heterogeneous pathological lesions, both involving alveolar and vascular components. The severity and distribution of morphological lesions associated with SARS-CoV-2 and how they relate to clinical, laboratory, and radiological data have not yet been studied systematically. The main goals of the present study were to objectively identify pathological phenotypes and factors that, in addition to SARS-CoV-2, may influence their occurrence. Lungs from 26 patients who died from SARS-CoV-2 acute respiratory failure were comprehensively analysed. Robust machine learning techniques were implemented to obtain a global pathological score to distinguish phenotypes with prevalent vascular or alveolar injury. The score was then analysed to assess its possible correlation with clinical, laboratory, radiological, and tissue viral data. Furthermore, an exploratory random forest algorithm was developed to identify the most discriminative clinical characteristics at hospital admission that might predict pathological phenotypes of SARS-CoV-2. Vascular injury phenotype was observed in most cases being consistently present as pure form or in combination with alveolar injury. Phenotypes with more severe alveolar injury showed significantly more frequent tracheal intubation; longer invasive mechanical ventilation, illness duration, intensive care unit or hospital ward stay; and lower tissue viral quantity (p < 0.001). Furthermore, in this phenotype, superimposed infections, tumours, and aspiration pneumonia were also more frequent (p < 0.001). Random forest algorithm identified some clinical features at admission (body mass index, white blood cells, D-dimer, lymphocyte and platelet counts, fever, respiratory rate, and PaCO ) to stratify patients into different clinical clusters and potential pathological phenotypes (a web-app for score assessment has also been developed; https://r-ubesp.dctv.unipd.it/shiny/AVI-Score/). In SARS-CoV-2 positive patients, alveolar injury is often associated with other factors in addition to viral infection. Identifying phenotypical patterns at admission may enable a better stratification of patients, ultimately favouring the most appropriate management. © 2021 The Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.
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http://dx.doi.org/10.1002/path.5653DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8014445PMC
February 2021

Persistent viral RNA shedding in COVID-19: Caution, not fear.

Authors:
Mario Plebani

EBioMedicine 2021 02 10;64:103234. Epub 2021 Feb 10.

Department of Medicine-Dimed, University of Padova and Department of Integrated Diagnostics, University-Hospital of Padova, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.ebiom.2021.103234DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7873611PMC
February 2021

Kinetics and biological characteristics of humoral response developing after SARS-CoV-2 infection: implications for vaccination.

Clin Chem Lab Med 2021 Jan 21. Epub 2021 Jan 21.

Department of Laboratory Medicine, University Hospital of Padova, Padova, Italy.

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http://dx.doi.org/10.1515/cclm-2021-0038DOI Listing
January 2021

A challenging liver transplantation for decompensated alcoholic liver disease after recovery from SARS-CoV-2 infection.

Transpl Int 2021 04 27;34(4):756-757. Epub 2021 Feb 27.

Multivisceral Transplant Unit and Gastroenterology, Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy.

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http://dx.doi.org/10.1111/tri.13842DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8013652PMC
April 2021

Clinical relevance of biological variation of cardiac troponins.

Clin Chem Lab Med 2020 Nov 26. Epub 2020 Nov 26.

Dipartimento di Medicina di Laboratorio, Azienda Ospedaliera Universitaria di Padova, and Dipartimento di Medicina - Università di Padova, Padova, Italy.

The high-sensitivity immunoassays for cardiac troponin I (hs-cTnI) and cardiac troponin T (hs-cTnT) are recommended by all the most recent international guidelines as gold standard laboratory methods for the detection of myocardial injury and diagnosis of acute myocardial infarction (AMI). In this review article, the Authors aimed at discussing the relevant biochemical, physiological, and clinical issues related to biological variability of cTnI and cTnT. Cardiac troponins, measured with hs-cTn methods, show a better clinical profile than the other cardio-specific biomarkers (such as the natriuretic peptides, BNP and NT-proBNP). In particular, the hs-cTn methods are characterized by a low intra-individual index of variation (<0.6) and reduced analytical imprecision (about 5% CV) at the clinical cut-off value (i.e., the 99th percentile URL value). Moreover, recent studies have reported that differences between two hs-cTn measured values (RCV) >30% can be considered statistically significant. These favourable biological characteristics and analytical performance of hs-cTn methods significantly improved the accuracy in the diagnostic process of acute coronary syndromes (ACS) in patients admitted to emergence department. In addition, several studies have demonstrated the clinical usefulness of cardiovascular risk evaluation with hs-cTn methods in some groups of patients with clinical conditions at high cardiovascular risk (such as systemic hypertension, severe obesity, diabetes mellitus, renal insufficiency, and chronic obstructive pulmonary disease). However, screening programs in the general population with hs-cTn methods for cardiovascular risk stratification require further investigation to define the optimal target populations, timing of measurement, and preventive interventions.
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http://dx.doi.org/10.1515/cclm-2020-1433DOI Listing
November 2020

Cytokine "storm", cytokine "breeze", or both in COVID-19?

Clin Chem Lab Med 2020 Dec 3. Epub 2020 Dec 3.

Department of Laboratory Medicine, Clinical Chemistry and Laboratory Medicine, University Hospital of Padova, Padova, Italy.

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http://dx.doi.org/10.1515/cclm-2020-1761DOI Listing
December 2020

Automated Mindray CL-1200i chemiluminescent assays of renin and aldosterone for the diagnosis of primary aldosteronism.

Clin Chem Lab Med 2021 Apr 13;59(5):e215-e217. Epub 2021 Jan 13.

Department of Integrated Diagnostics, University-Hospital of Padova, Padova, Italy.

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http://dx.doi.org/10.1515/cclm-2020-1860DOI Listing
April 2021

The Italian External Quality Assessment (EQA) program on urinary sediment by microscopy examination: a 20 years journey.

Clin Chem Lab Med 2021 Apr 4;59(5):845-856. Epub 2020 Dec 4.

Centre of Biomedical Research for Quality in Laboratory Medicine, University-Hospital of Padova, Padova, Italy.

Objectives: In spite of the introduction of automated systems for urinary sediment analysis, microscopy examination remains the gold standard, and it is more than ever important to perform it with a good and reliable quality. External Quality Assessment (EQA) programs on urinary sediment are rare. The present paper provides an analysis of results from 2001 to date of the EQA Italian program which involves today 230 laboratories.

Methods: The program includes four surveys per year. Participants are asked the identification and clinical associations of urinary sediment particles, shown as phase contrast microscopy images in the website of the Center of Biomedical Research (CRB) (2 surveys), and the diagnosis of clinical cases presented by both images and a short clinical history (2 surveys). The results of each survey are then scored and commented. In 20 years, 298 images were presented: 90 cells (9 types), 23 lipids (5 types), 87 casts (21 types), 53 crystals (14 types), 22 microorganisms (5 types), and 23 contaminants (9 types). Moreover, 27 clinical cases, covering a wide spectrum of conditions with different degrees of complexity, were presented to participants.

Results: Identification: among urinary particle categories, the correct identification rate (obtained for each particle from the sum of correct + partially correct answers) was very high for micro-organisms (mean ± SD: 96.2 ± 3.5%), high for lipids (88.0 ± 11.8%) and crystals (87.0 ± 16.5%) followed, in decreasing order, by cells (82.1 ± 15.9%), casts (81.8 ± 14.8%), and contaminants (76.7 ± 22.1%). Clinical associations (n=67): the rate of correct answers was 93.5 ± 5.7% ranging from 75.0 to 100% for all but one clinical association (i.e., acute glomerulonephritis: 55.4%). Clinical cases: throughout surveys, due to the overall rate of particle misidentification, only 59.8 ± 17.1%, (range 32.5-88.7%) of participants achieved access to clinical diagnosis. Of these, 88.7 ± 10.6% (range 59.9-99.3%) were able to indicate the correct diagnosis.

Conclusions: Our program can be used as a tool to improve the identification of urine particles and the knowledge of their clinical meaning and to encourage specialists of laboratory medicine to correlate urinary findings with other laboratory data and the clinical history, an aspect that improves the value of the day by day work.
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http://dx.doi.org/10.1515/cclm-2020-1656DOI Listing
April 2021

Home pregnancy tests: quality first.

Authors:
Mario Plebani

Clin Chem Lab Med 2020 Dec 15;59(5):795-796. Epub 2020 Dec 15.

Laboratory Medicine, University-Hospital of Padova, Via Giustiniani 2, 35100Padova, Italy.

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http://dx.doi.org/10.1515/cclm-2020-1797DOI Listing
December 2020

Chest pain management and biomarkers: the lack of trust in cardiac troponins measurement.

Diagnosis (Berl) 2020 Dec 21. Epub 2020 Dec 21.

Department of Laboratory Medicine, University Hospital, Padova, Italy.

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http://dx.doi.org/10.1515/dx-2020-0156DOI Listing
December 2020

Using high sensitivity cardiac troponin values in patients with SARS-CoV-2 infection (COVID-19): The Padova experience.

Clin Biochem 2021 Apr 30;90:8-14. Epub 2021 Jan 30.

Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, USA; Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA. Electronic address:

Background: The spectrum of Coronavirus Disease 2019 (COVID-19) is broad and thus early appropriate risk stratification can be helpful. Our objectives were to define the frequency of myocardial injury using high-sensitivity cardiac troponin I (hs-cTnI) and to understand how to use its prognostic abilities.

Methods: Retrospective study of patients with COVID-19 presenting to an Emergency Department (ED) in Italy in 2020. Hs-cTnI was sampled based on clinical judgment. Myocardial injury was defined as values above the sex-specific 99th percentile upper reference limits (URLs). Most data is from the initial hospital value.

Results: 426 unique patients were included. Hs-cTnI was measured in 313 (73.5%) patients; 85 (27.2%) had myocardial injury at baseline. Patients with myocardial injury had higher mortality during hospitalization (hazard ratio = 9 [95% confidence interval (CI) 4.55-17.79], p < 0.0001). Multivariable analysis including clinical and laboratory variables demonstrated an AUC of 0.942 with modest additional value of hs-cTnI. Myocardial injury was associated with mortality in patients with low APACHE II scores (<13) [OR (95% CI): 4.15 (1.40, 14.22), p = 0.014] but not in those with scores > 13 [OR (95% CI): 0.48 (0.08, 2.65), p = 0.40]. Initial hs-cTnI < 5 ng/L identified 33% of patients that were at low risk with 97.8% sensitivity (95% CI 88.7, 99.6) and 99.2% negative predictive value. Type 1 myocardial infarction (MI) and type 2 MI were infrequent.

Conclusions: hs-cTnI at baseline is a significant predictor of mortality in COVID-19 patients. A value < 5 ng/L identified patients at low risk.
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http://dx.doi.org/10.1016/j.clinbiochem.2021.01.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7847286PMC
April 2021

Distance from the outbreak of infection, ozone pollution and public health consequences of SARS-CoV-2 epidemic: the HOPE method.

Eur J Public Health 2021 02;31(1):7-12

Institute of Clinical Physiology of the National Research Council (CNR), Pisa, Italy.

Background: Italy was the second country in the world, after China, to be hit by SARS-CoV-2 pandemic. Italy's experience teaches that steps to limit people's movement by imposing 'red zones' need to be put in place early by carefully identifying the cities to be included within these areas of quarantine. The assessment of the relationship between the distance from an established outbreak of SARS-CoV-2 infection with transmission-linked cases and mortality observed in other sites could provide useful information to identify the optimal radius of red zones.

Methods: We investigated the relationship between SARS-CoV-2 cases and the distance of each Italian province from the first outbreak of SARS-CoV-2 epidemic in Italy (the city of Lodi placed in the Lombardia region). In 38 provinces of Lombardia and neighboring regions, we performed a breakpoint analysis to identify the radius of the red zone around Lodi minimizing epidemic spread and mortality in neighboring cities.

Results: In all Italian provinces, a non-linear relationship was found between SARS-CoV-2 cases and distance from Lodi. In an analysis including the provinces of Lombardia and neighboring regions, SARS-CoV-2 cases and mortality increased when the distance from Lodi reduced below 92 and 140 km, respectively, and such relationships were amplified by ozone (O3) pollution.

Conclusions: The breakpoint analysis identifies the radius around the outbreak of Lodi minimizing the public health consequences of SARS-CoV-2 in neighboring cities. Such an approach can be useful to identify the red zones in future epidemics due to highly infective pathogens similar to SARS-CoV-2.
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http://dx.doi.org/10.1093/eurpub/ckaa221DOI Listing
February 2021

Presepsin as a biomarker of inflammation and prognosis in decompensated liver disease.

J Hepatol 2021 Jan 21. Epub 2021 Jan 21.

Multivisceral Transplant Unit, Gastroenterology, Padova University Hospital, Padova, Italy.

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http://dx.doi.org/10.1016/j.jhep.2021.01.016DOI Listing
January 2021

Effectiveness of In-Hospital Cholecalciferol Use on Clinical Outcomes in Comorbid COVID-19 Patients: A Hypothesis-Generating Study.

Nutrients 2021 Jan 14;13(1). Epub 2021 Jan 14.

Internal Medicine, Department of Medicine, University Hospital AOUI, 37134 Verona, Italy.

Little information is available on the beneficial effects of cholecalciferol treatment in comorbid patients hospitalized for COVID-19. The aim of this study was to retrospectively examine the clinical outcome of patients receiving in-hospital high-dose bolus cholecalciferol. Patients with a positive diagnosis of SARS-CoV-2 and overt COVID-19, hospitalized from 15 March to 20 April 2020, were considered. Based on clinical characteristics, they were supplemented (or not) with 400,000 IU bolus oral cholecalciferol (200,000 IU administered in two consecutive days) and the composite outcome (transfer to intensive care unit; ICU and/or death) was recorded. Ninety-one patients (aged 74 ± 13 years) with COVID-19 were included in this retrospective study. Fifty (54.9%) patients presented with two or more comorbid diseases. Based on the decision of the referring physician, 36 (39.6%) patients were treated with vitamin D. Receiver operating characteristic curve analysis revealed a significant predictive power of the four variables: (a) low (<50 nmol/L) 25(OH) vitamin D levels, (b) current cigarette smoking, (c) elevated D-dimer levels (d) and the presence of comorbid diseases, to explain the decision to administer vitamin D (area under the curve = 0.77, 95% CI: 0.67-0.87, < 0.0001). Over the follow-up period (14 ± 10 days), 27 (29.7%) patients were transferred to the ICU and 22 (24.2%) died (16 prior to ICU and six in ICU). Overall, 43 (47.3%) patients experienced the combined endpoint of transfer to ICU and/or death. Logistic regression analyses revealed that the comorbidity burden significantly modified the effect of vitamin D treatment on the study outcome, both in crude ( = 0.033) and propensity score-adjusted analyses ( = 0.039), so the positive effect of high-dose cholecalciferol on the combined endpoint was significantly amplified with increasing comorbidity burden. This hypothesis-generating study warrants the formal evaluation (i.e., clinical trial) of the potential benefit that cholecalciferol can offer in these comorbid COVID-19 patients.
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http://dx.doi.org/10.3390/nu13010219DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7828675PMC
January 2021

Reducing salt intake by urine chloride self-measurement in non-compliant patients with chronic kidney disease followed in nephrology clinics: a randomized trial.

Nephrol Dial Transplant 2020 Dec 8. Epub 2020 Dec 8.

Institute of Clinical Physiology (IFC), Clinical Epidemiology of Renal Diseases and Hypertension Unit, Reggio Calabria, Italy.

Background: Adherence to low salt diets and control of hypertension remain unmet clinical needs in chronic kidney disease (CKD) patients.

Methods: We performed a 6-month multicentre randomized trial in non-compliant patients with CKD followed in nephrology clinics testing the effect of self-measurement of urinary chloride (69 patients) as compared with standard care (69 patients) on two primary outcome measures, adherence to a low sodium (Na) diet (<100 mmol/day) as measured by 24-h urine Na (UNa) excretion and 24-h ambulatory blood pressure (ABPM) monitoring.

Results: In the whole sample (N = 138), baseline UNa and 24-h ABPM were143 ± 64 mmol/24 h and 131 ± 18/72 ± 10 mmHg, respectively, and did not differ between the two study arms. Patients in the active arm of the trial used >80% of the chloride strips provided to them at the baseline visit and at follow-up visits. At the third month, UNa was 35 mmol/24 h (95% CI 10.8-58.8 mmol/24 h; P = 0.005) lower in the active arm than the control arm, whereas at 6 months the between-arms difference in UNa decreased and was no longer significant [23 mmol/24 h (95% CI -5.6-50.7); P = 0.11]. The 24-h ABPM changes as well as daytime and night-time BP changes at 3 and 6 months were similar in the two study arms (Month 3, P = 0.69-0.99; Month 6, P = 0.73-0.91). Office BP, the use of antihypertensive drugs, estimated Glomerular Filtration Rate (eGFR) and proteinuria remained unchanged across the trial.

Conclusions: The application of self-measurement of urinary chloride to guide adherence to a low salt diet had a modest effect on 24-h UNa and no significant effect on 24-h ABPM.
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http://dx.doi.org/10.1093/ndt/gfaa262DOI Listing
December 2020

Toward a Unified View of Cognitive and Biochemical Activity: Meditation and Linguistic Self-Reconstructing May Lead to Inflammation and Oxidative Stress Improvement.

Entropy (Basel) 2020 Jul 27;22(8). Epub 2020 Jul 27.

Department of Physics "E.R. Caianiello", Salerno University, Via Giovanni Paolo II, 132, 84084 Fisciano (Salerno), Italy.

Stress appears to be the basis of many diseases, especially myocardial infarction. Events are not objectively "stressful" but what is central is how the individual structures the experience he is facing: the thoughts he produces about an event put him under stress. This cognitive process could be revealed by language (words and structure). We followed 90 patients with ischemic heart disease and 30 healthy volunteers, after having taught them the Relaxation Response (RR) as part of a 4-day Rational-Emotional-Education intervention. We analyzed with the Linguistic Inquiry and Word Count software the words that the subjects used across the study following the progression of blood galectin-3 (inflammation marker) and malondialdehyde (oxidative stress marker). During the follow-up, we confirmed an acute and chronic decrease in the markers of inflammation and oxidative stress already highlighted in our previous studies together with a significant change in the use of language by the subjects of the RR groups. Our results and the precise design of our study would seem to suggest the existence of an intimate relationship and regulatory action by cognitive processes (recognizable by the type of language used) on some molecular processes in the human body.
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http://dx.doi.org/10.3390/e22080818DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7517388PMC
July 2020

Validation of a composed COVID-19 chest radiography score: the CARE project.

ERJ Open Res 2020 Oct 26;6(4). Epub 2020 Oct 26.

Institute of Radiology, Dept of Medicine DIMED, University of Padova, Padua, Italy.

Objectives: The aim of this study was to validate a composed coronavirus disease 2019 (COVID-19) chest radiography score (CARE) based on the extension of ground-glass opacity (GG) and consolidations (Co), separately assessed, and to investigate its prognostic performance.

Methods: COVID-19-positive patients referring to our tertiary centre during the first month of the outbreak in our area and with a known outcome were retrospectively evaluated. Each lung was subdivided into three areas and a three-grade score assessing the extension of GG and Co was used. The CARE was derived from the sum of the subscores. A mixed-model ANOVA with Bonferroni correction was used to evaluate whether differences related to the referring unit (emergency room, COVID-19 wards and intensive care unit (ICU)) occurred. Logistic regression analyses were used to investigate the impact of CARE, patients' age and sex on the outcome. To evaluate the prognostic performance of CARE, receiver operating characteristic curves were computed for the entire stay and at admission only.

Results: A total of 1203 chest radiographs of 175 patients (120 males; mean age 67.81±15.5 years old) were examined. On average, each patient underwent 6.8±10.3 radiographs. Patients in ICU as well as deceased patients showed higher CARE scores (p<0.05, each). Age, Co and CARE significantly influenced the outcome (p<0.05 each). The CARE demonstrated good accuracy (area under the curve (AUC)=0.736) using longitudinal data as well as at admission only (AUC=0.740). A CARE score of 17.5 during hospitalisation showed 75% sensitivity and 69.9% specificity.

Conclusions: The CARE was demonstrated to be a reliable tool to assess the severity of pulmonary involvement at chest radiography with a good prognostic performance.
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http://dx.doi.org/10.1183/23120541.00359-2020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7682711PMC
October 2020

Vitamin K and Osteoporosis.

Nutrients 2020 Nov 25;12(12). Epub 2020 Nov 25.

Department of Medicine, University Health Network, University of Toronto, 200 Elizabeth Street, Eaton North 7-221, Toronto, ON M5G 2C4, Canada.

Vitamin K acts as a coenzyme of carboxylase, catalyzing the carboxylation of several vitamin K dependent proteins. Beyond its well-known effects on blood coagulation, it also exerts relevant effects on bone and the vascular system. In this review, we point out the relevance of an adequate vitamin K intake to obtain sufficient levels of carboxylated (active form) vitamin K dependent proteins (such as Osteocalcin and matrix Gla protein) to prevent bone health. Another bone-related action of Vitamin K is being a ligand of the nuclear steroid and xenobiotic receptor (SXR). We also discuss the recommended intake, deficiency, and assessment of vitamin K. Furthermore, we review the few available studies that have as pre-specified outcome bone fractures, indicating that we need more clinical studies to confirm that vitamin K is a potential therapeutic agent for bone fractures.
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http://dx.doi.org/10.3390/nu12123625DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7760385PMC
November 2020

Distance from the outbreak of infection, ozone pollution and public health consequences of SARS-CoV-2 epidemic.

Eur J Public Health 2020 Nov 24. Epub 2020 Nov 24.

Institute of Clinical Physiology of the National Research Council (CNR), Pisa, Italy and Department of Medicine, University of Padua, Padova, Italy.

Background: Italy was the second country in the world, after China, to be hit by SARS-CoV-2 pandemic. The Italy's experience teaches that steps to limit people's movement by imposing "red zones" need to be put in place early by carefully identifying the cities to be included within these areas of quarantine. The assessment of the relationship between the distance from an established outbreak of SARS-CoV-2 infection with transmission-linked cases and mortality observed in other sites could provide useful information to identify the optimal radius of red zones.

Methods: We investigated the relationship between SARS-CoV-2 cases and the distance of each Italian province from the first outbreak of SARS-CoV-2 epidemic in Italy (the city of Lodi placed in the Lombardia region). In 38 provinces of Lombardia and neighboring regions, we performed a breakpoint analysis to identify the radius of the red zone around Lodi minimizing epidemic spread and mortality in neighboring cities.

Results: In all Italian provinces a non-linear relationship was found between SARS-CoV-2 cases and distance from Lodi. In an analysis including the provinces of Lombardia and neighboring regions, SARS-CoV-2 cases and mortality increased when the distance from Lodi reduced below 92 km and 140 km, respectively, and such relationships were amplified by ozone (O3) pollution.

Conclusions: The breakpoint analysis identifies the radius around the outbreak of Lodi minimizing the public health consequences of SARS-CoV-2 in neighboring cities. Such an approach can be useful to identify the red zones in future epidemics due to highly infective pathogens similar to SARS-CoV-2.
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http://dx.doi.org/10.1093/eurpub/ckaa221DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717309PMC
November 2020

Performance of the COVID19SEROSpeed IgM/IgG Rapid Test, an Immunochromatographic Assay for the Diagnosis of SARS-CoV-2 Infection: a Multicenter European Study.

J Clin Microbiol 2021 01 21;59(2). Epub 2021 Jan 21.

Department of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, Milan, Italy.

This study assessed the diagnostic performance of the new COVID19SEROSpeed IgM/IgG rapid test (BioSpeedia, a spinoff of the Pasteur Institute of Paris) for the detection of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in comparison to other commercial antibody assays through a large cross-European investigation. The clinical specificity was assessed on 215 prepandemic sera (including some from patients with viral infections or autoimmune disorders). The clinical sensitivity was evaluated on 710 sera from 564 patients whose SARS-CoV-2 infection was confirmed by quantitative reverse transcription-PCR (qRT-PCR) and whose antibody response was compared to that measured by five other commercial tests. The kinetics of the antibody response were also analyzed in seven symptomatic patients. The specificity of the test (BioS) on prepandemic specimens was 98.1% (95% confidence interval [CI], 96.2% to 99.4%). When tested on the 710 pandemic specimens, BioS showed an overall clinical sensitivity of 86.0% (95% CI, 0.83 to 0.89), with good concordance with the Euroimmun assay (overall concordance of 0.91; Cohen's kappa coefficient of 0.62). Due in part to simultaneous detection of IgM and IgG for both S1 and N proteins, BioS exhibited the highest positive percent agreement at ≥11 days post-symptom onset (PSO). In conclusion, the BioS IgM/IgG rapid test was highly specific and demonstrated a higher positive percentage of agreement than all the enzyme-linked immunosorbent assay/chemiluminescence immunoassay (ELISA/CLIA) commercial tests considered in this study. Moreover, by detecting the presence of antibodies prior to 11 days PSO in 78.2% of the patients, the BioS test increased the efficiency of the diagnosis of SARS-CoV-2 infection in the early stages of the disease.
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http://dx.doi.org/10.1128/JCM.02240-20DOI Listing
January 2021