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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 A. Ripoli

Calcolo e valutazione dei valori di riferimento della troponina cardiaca I (cTnI) misurata in un gruppo di volontari sani italiani con metodi immunometrici ad alta sensibilità: uno studio multicentrico
Establishment and evaluation of cardiac troponin I reference values measured in a group of Italian healthy volunteers using high-sensitivity methods: a multi-center study.
<p>Introduction: this study compares the cardiac troponin I (cTnI) values measured with three high-sensitivity (hs) different methods in apparently healthy volunteers enrolled in a multicenter study.<br />Methods: heparinized plasma samples were collected from 1511 volunteers in 8 Italian clinical institutions (mean age 51.5 years, SD 14.2, range 18-86, female to male ratio 0.94). All volunteers denied chronic or acute diseases and had normal values of routine laboratory tests and ECG. The reference laboratory of the study (Laboratorio Fondazione CNR Regione Toscana G. Monasterio, Pisa, Italy) assayed all plasma samples with three hs-methods: Architect hs-cTnI, Access hs-cTnIand ADVIA Centaur XPT hs-cTnI. After the exclusion of outlier values, calculation of 99th percentile (Upper Reference Limit, URL) values was performed using both robust nonparametric and bias corrected and accelerated bootstrap methods.<br />Results: large between-method differences were found. ADVIA Centaur measured higher cTnI values (up to 2-fold) than the two other methods. cTnI values were significantly higher in men than in women, and progressively increased with age over 55 years. Moreover, 99th percentile URL values also depended on the statistical approach used for calculation (robust non-parametric versusbootstrap). All 99th percentile URL values calculated with non-parametric robust method were on average slightly lower than those suggested by manufacturers (mean difference 4.2 ng/L, standard error 1.7, p=0.0273).<br />Conclusion: clinicians should be advised that plasma samples from the same patient should be measured for hs-cTnI in the same laboratory. Specific clinical studies are needed to establish the most appropriate statistical approach to calculate 99th percentile URL values for hs-cTnI methods.</p>
Biochimica Clinica ; 44(2) S032-S047
Contributi Scientifici - Scientific Papers
 
Valutazione delle caratteristiche analitiche dei metodi di misura delle troponine cardiache I e T: dalla teoria alla pratica di laboratorio. Documento congiunto del Gruppo di Studio Biomarcatori Cardiovascolari di SIBioC-Medicina di Laboratorio ed Europea
Evaluation of analytical performance of immunoassay methods for cardiac troponin I and T: from theory to laboratory practice. Joint document of SIBioC and European Ligand Assay Society
<p>All the national and international guidelines recommend that cardiac troponins (cTnI and cTnT) should be considered the preferred biomarkers for the differential diagnosis of acute coronary syndrome (ACS), and also that the 99th upper reference population limit (URL) value for cardiac troponins should be measured with an imprecision &le;10 CV%. Indeed, the measurement of the 99th URL of cTnI and cTnT is a very hard analytical challenge due to low biomarker concentrations in healthy subjects. For this reason, only after the year 2006, some manufacturers set up the first new generation of cTnI and cTnT immunoassays with improved analytical sensitivity in accordance with the quality specifications indicated by international guidelines. The most recent international guidelines recommend that immunoassays for cTnI and cTnT measurement, able to completely satisfy these quality specifications, should be defined high-sensitivity methods. These methods should be preferred for early diagnosis of ACS syndrome and also for stratification of cardiovascular risk in both general population and cardiac patients. Therefore, understanding the analytical performance of immunoassay methods for cTnI and cTnT, especially at the low normal concentration range, is critically important for both laboratory professionals and clinicians. The aim of this document is to discuss some theoretical considerations related to the definition of analytical sensitivity, as well as some critical aspects concerning the experimental protocols commonly adopted for evaluation and comparison of analytical performances of cardiac troponin immunossays.</p>
Biochimica Clinica ; 42(2) 155-166
Documenti - Documents
 
Analytical and clinical evaluation of the chemiluminescent microparticle immunoassay for galectin-3 determination
<p>This study tested if the chemiluminescent microparticle immunoassay (CMIA) method on the Architect platform meets the analytical and clinical quality goals required for the galectin-3 (GAL-3) use in clinical practice. We evaluated results obtained from 121 apparently healthy adults and 382 patients with heart failure (HF). All healthy subjects and patients showed GAL-3 concentrations in plasma above the limit of detection (1.9 &mu;g/L) and the limit of quantitation (2.4 &mu;g/L). GAL-3 in healthy subjects ranged between 6.4 and 40.6 &mu;g/L (median, 13.0 &mu;g/L, interquartile range, 11.2-15.2 &mu;g/L, 97.5th percentile, 33.7 &mu;g/L). GAL-3 values were found significantly increased in patients with chronic HF (median, 15.1 &mu;g/L, interquartile range, 11.7-19.4 &mu;g/L) compared to healthy subjects (P &lt;0.0001). HF patients with cardiac fibrosis, confirmed by magnetic resonance, showed significantly higher GAL-3 values (median, 15.3 &mu;g/L, interquartile range, 11.2-21.9 &mu;g/L) than those without cardiac fibrosis (median, 12.9 &mu;g/L, interquartile range, 11.2-15.0 &mu;g/L) (P=0.03). ROC analysis showed that GAL-3 discriminates the presence of cardiac fibrosis with an area under the curve of 0.635 (0.526-0.744), with a specificity of 76.7% and a sensitivity of 54.1% at the cut-off of 14.6 &mu;g/L. Using multivariable models cardiac fibrosis was significantly associated with the logGAL-3.</p>
Biochimica Clinica ; 40(4) 307-315
Contributi scientifici - Scientific Papers