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Maria Stella Graziani

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Martina Zaninotto

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Ferruccio Ceriotti
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Matteo Vidali

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Giuseppe Agosta

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

BC: Articoli scritti da R. Aloe

Valutazione di un metodo POCT ad elevata sensibilità per la troponina cardiaca: confronto con una strumentazione automatizzata di laboratorio
Evaluation of a high-sensitivity cardiac troponin point-of-care assay: a comparison with a laboratory platform
R. Aloe  |  P. Avanzini  |  R. Musa  |  P. Cerati  |  M. Di pietro  | 
<p>Introduction: until recently, high-sensitivity in cTn testing has been adequately performed exclusively by laboratory platforms, whereas point-of-care systems lack the required analytical performance. The Quidel TriageTrue High Sensitivity Troponin I Test (TriageTrue) is a novel point-of-care test that meets the IFCC definition of a high-sensitivity troponin assay. The aim of this study is to evaluate the performance of the TriageTrue assay versus the Beckman Coulter Access hsTnI assay, performed in a central laboratory analyzer.</p><p>Methods: the TriageTrue assay was carried out on Quidel Triage MeterPro; the Access Troponin I-hs assay was carried out on Beckman Coulter UniCel DxI 800. The two assays have been compared by a linearity study and by evaluating the agreement through a Passing-Bablok regression analysis and a Bland-Altman plot. In addition, the analytical performance of TriageTrue itself has been checked by performing an intra-assay precision study for two levels of troponin, including values at the 99th percentile.</p><p>Results: in comparing TriageTrue versus the Beckman Coulter Access hsTnI, a satisfactory linearity for the tested range (3.13-800 ng/L) has been observed; the precision study results demonstrate that the TriageTrue CV was less than 10% for all the three concentrations tested (21.5, 124.3 and 550 ng/L respectively).</p><p>Conclusions: the definition of a high linearity can be derived from the elevated Spearman&rsquo;s correlation coefficient of 1.000 (p &lt;0.001) which indicates that the values obtained by TriageTrue and by Beckman Coulter hsTnI are highly monotonically related, and thus have a high level of comparability.</p>
Biochimica Clinica ; 46(4) 309-316
Contributi Scientifici - Scientific Papers
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
Proteina S100B ed enolasi neurone-specifica nella valutazione iniziale del trauma cranico lieve nell’adulto: pronte per il debutto nel mondo reale?
Protein S100B and neuron-specific enolase (NSE) for the initial evaluation of mild head trauma in adults: ready for prime time?
<p>Computerized tomography (CT) remains the best option for diagnosis of head trauma,&nbsp;although it carries several drawbacks. Among a large number of putative biomarkers proposed for initial evaluation&nbsp;of mild head trauma, protein S100B and NSE exhibit the best diagnostic performance. We performed a prospective&nbsp;study, where these biomarkers were assessed in 68 patients consecutively admitted to the Emergency Department&nbsp;(ED) with mild head trauma. The CT scan revealed brain lesions in 11 patients (16%). Concentrations of both&nbsp;biomarkers in serum were found to be more elevated in patients with positive CT than in those with negative scans.&nbsp;The area under the ROC curve (AUC) of protein S100B (0.89, 95% confidence interval: 0.81-0.97) was, however,&nbsp;significantly greater than that of NSE (0.77, 95% confidence interval: 0.64-0.90) (P=0.044). It was estimated that&nbsp;determination of protein S100B in all patients presenting to the ED with mild head trauma could safely save up to 50%&nbsp;CT execution, reducing the overall healthcare expenditure by ~1/3.</p>
Biochimica Clinica ; 38(3) 227-233
Opinioni - Opinions