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Editor-in-chief
Maria Stella Graziani

Deputy Director
Martina Zaninotto

Associate Editors
Ferruccio Ceriotti
Davide Giavarina
Bruna Lo Sasso
Giampaolo Merlini
Martina Montagnana
Andrea Mosca
Paola Pezzati
Rossella Tomaiuolo
Matteo Vidali

EIC Assistant
Francesco Busardò

International Advisory Board Khosrow Adeli Canada
Sergio Bernardini Italy
Marcello Ciaccio Italy
Eleftherios Diamandis Canada
Philippe Gillery France
Kjell Grankvist Sweden
Hans Jacobs The Netherlands
Eric Kilpatrick UK
Magdalena Krintus Poland
Giuseppe Lippi Italy
Mario Plebani Italy
Sverre Sandberg Norway
Ana-Maria Simundic Croatia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada


Publisher
Biomedia srl
Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

Editorial Secretary
Chiara Riva
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282
email: biochimica.clinica@sibioc.it

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ISSN print: 0393 – 0564
ISSN digital: 0392- 7091



BC: Articoli scritti da MM. Mion

Sistema POCT per la determinazione su sangue intero della troponina cardiaca I ad alta sensibilità: quale valore nel territorio?
POCT system for the determination of high sensitivity cardiac troponin I: the value in the territory
<p>The Italian National Recovery and Resilience Plan (NRRP) provides resources for the activation for over a thousand Community Houses that will serve as permanent points of reference for the population with the aim to guarantee both the prevention activity and the&nbsp; care of patients. These structures need to be provided with Information Technology&nbsp; (essential for the implementation of telemedecine), an adequate multi-specialty instrumental equipment (radiology, clinical laboratory) and a multidisciplinary team of medical specialists, paediatricians, nurses and other health professionals. In this context, the clinical laboratory activity takes on a strategic role especially in the diagnosis of the acute miocardial damage (AMI) which is fundamentally based on the determination of Troponin I o T and no longer on instrumental investigations, such as ECG. High quality POCT devices are currently available on the market for the determination of Troponin I (and T) with high sensitivity methods characterized by adequate costs for the diagnostic efficacy they should guarantee. Recently, the POCT system QuidelTriage High Sensitivity Troponin I test has been evaluated&nbsp; using 75 whole blood samples from patients. Overall, the outcome of the trial was satisfactory and corresponded to the quality and performance specifications recommended by AACC and IFCC for a method that should assure&nbsp; an elevated level of diagnostic accuracy. The tested POCT device was effective in the management of patients with suspected AMI using either single cut-off value or 0/1 hour algorithm. This demonstrates the important contribution that POCT devices can offer for of early diagnosis and monitoring of chronic disease</p>
Biochimica Clinica ; 46(3) 241-246
Opinioni - Opinions
 
Metodo ad alta sensibilità per la misura della troponina I ed efficienza: risultati di un'esperienza
High-sensitive method to measure troponin I and efficiency: the results of an experience
AI. Leahu  |  MM. Mion  |  A. Padoan  |  M. Zaninotto  |  M. Plebani  | 
<p>Background: the development of improved methods for cardiac troponins measurement, characterized by higher analytical sensitivity, allows to adopt rapid rule-in and rule-out strategies by increasing diagnostic accuracy and optimizing the clinical and organizational pathways.<br />Methods: the efficiency achieved with the adoption of a high sensitive troponin I method, defined by its analytical characteristics a &ldquo;new generation&rdquo; method (STAT high sensitive troponin I, hs-TnI, Abbott Diagnostics), in place of a previous assay (LOCI CTNI, Siemens Health Care Diagnostics), has been evaluated. The results obtained in 1000 consecutive patients admitted to the Emergency Department (ED) with acute chest pain, in 2015 (before the new method) have been compared with those obtained in 1004 consecutive patients admitted in 2017 (after theintroduction of the hs-TnI method).<br />Results: in 2017 an increased number of troponin I baseline values higher than 99th percentile (10.7 versus8.3% in 2015, p = 0.089) has been observed. Furthermore, an improvement on the following clinical and organizational aspects has been detected in 2017: the adoption of an accelerated algorithm, being the median interval between two consecutive measurements 3 h and 18 min in 2017 and 4 h and 30 min in 2015 (p &lt;0.001); in the 75% of patients showing either positive or negative value at admission, the second measurement has been carried out within 180 min and 225 min (p = 0.024), respectively (in 2015 the timings were 239 e 337 min, p &lt;0.001, respectively). Finally, in 2017 a third troponin I measurement has been carried out in 0.4% of patients only (it was 3.5% in 2015, p = 0.044).<br />Conclusions: These data demonstrate a significant improvement in the patient management as well as an optimization of human and organizational resources with the adoption of a method with improved analytical performances to measure troponin I in ED.</p>
Biochimica Clinica ; 44(2) S054-S058
Contributi Scientifici - Scientific Papers
 
Troponina cardiaca ad alta sensibilità: risultati preliminari di un confronto tra un nuovo strumento “point-of-care” e i più comuni analizzatori impiegati nei laboratori clinici
High sensitivity cardiac troponin: preliminary results of a new point-of-care analyzer compared with the analyzers routinely used in clinical laboratories
<p>Introduction: cardiac troponin concentration measured using a point-of-care testing (POCT) analyzer could accelerate the management of patients awaiting assessment for suspected acute coronary syndrome without persistent ST-segment elevation in the emergency department (ED).<br />Methods: we evaluated a new high sensitivity cardiac troponin I (hs-cTnI) assay applied to the POCT PATHFAST&trade; (Gepa, Italia). The study of imprecision was carried out using commercial control materials and lithium-heparin plasma pools. The percentages of detectable hs-cTnI values between the Limit of Detection (LoD) and the 99th percentile as declared by the manufacturer were studied in a population of reference donors. The clinical diagnostic performance was evaluated in a population of patients presenting to the ED with chest pain (lithium-heparin plasma samples were collected at admission and 3 hours later), in comparison to the most common methods that measure hs-cTnI in clinical laboratories: Architect PLUS i2000SR, Dimension Vista, Advia Centaur XPT, UniCel DXI 800. Using the gender-specific 99thpercentile as declared from each manufacturer, the percentages of agreement and disagreement for the classification of hs-cTnI results were calculated as well as the Cohen&rsquo;s Kappa values.<br />Results: imprecision: concentration range (CV% range)=14.6-12227.3 ng/L (2.8-9.8%); % of hs-cTnI &gt;LoD and &lt;99th percentile in males and females were 30.0% and 18.5% respectively. The percentage ranges of agreement versus disagreement observed in the clinical study were 76.8-96.3% versus3.7-23.2% respectively, and the corresponding Cohen&rsquo;s Kappa values ranged from 0.532 to 0.864. The prevalence of discordant results was obtained on admission sample (range=59.1-83.3%).<br />Discussion: the observed analytical imprecision was satisfactory while the percentages of subjects with hs-cTnI&gt;LoD and &lt;99thpercentile were lower than those declared by the manufacturer because a limited number of subjects has been evaluated. The clinical performance has shown an overall satisfactory agreement with all the analytical platforms used.</p>
Biochimica Clinica ; 44(2) S059-S066
Contributi Scientifici - Scientific Papers
 
Determinazione della presepsina: non solo diagnosi di sepsi
Presepsin measurement: beyond sepsis diagnosis
G. Bragato  |  MM. Mion  |  A. Padoan  |  M. Zaninotto  |  M. Plebani  | 
<p>As sepsis is the leading cause of death among critically ill patients, early diagnosis is essential for the subsequent treatment to improve the outcome. Several diagnostic pathways have been proposed considering multiparametric approaches that combine clinical and biochemical evaluations. Among the several biomarkers proposed, procalcitonin measurement has been obtained significant consensus particularly in the evaluation of the efficacy of the therapeutic treatment. However, the need to define the prognosis and the outcome and to identify the patients at major risk of events during the hospitalization or at a short time later, seems to be an additional clinical value. The soluble cluster of differentiation 14 (S-CD14-ST or presepsin) is a free fragment of a glycoprotein expressed on monocytes and macrophages; several studies have demonstrated the significative prognostic value of the biomarker blood concentrations (at admission in particular) while the diagnostic performance of presepsin remains unclear. In a study carried out in a population of old patients (67-102 years) suffering from suspected pneumonia (n=50) the results of presepsin at admission in association with a Muldimensional Prognostic Index (MPI) score allow to identify the patients at major risk of adverse events (mortality) within 30 days. The prognostic efficiency of presepsin has been evaluated in different studies confirming, in different patient populations, the additional clinical value of this biomarker. Therefore, presepsin and prolacitonin measurements may provide complementary information that, in addition to clinical score and blood culture or molecular biology, can improve the management of patients with suspected sepsis.</p>
Biochimica Clinica ; 44(1) 068-072
Opinioni - Opinions