Maria Stella Graziani

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Articoli con TAG: valori di riferimento

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 ; 17(1)
Contributi Scientifici - Scientific Papers
Valutazione dell’esattezza della misura della fosfatasi alcalina sierica in un gruppo di laboratori italiani
Evaluation of the trueness of serum alkaline phosphatase (ALP) measurement in a group of Italian laboratories
<p>The reference measurement procedure for ALP published in 2011 by the IFCC allowed to define the metrological traceability chain for the standardization of ALP measurement. This paper reports the results of an EQA experiment conducted to evaluate the level of ALP standardization among different Italian laboratories enrolled for a scientific project with the final aim to derive ALP traceable reference intervals for pediatric population. Three frozen serum pools with a target value assigned by the IFCC reference procedure were distributed to 13 centers and analyzed in triplicates for 3 different days. Only 3 laboratories averagely fulfilled the desirable goal of bias (&le;&plusmn;5.5%) at all 3 concentrations (59.9 U/L, 186.9 U/L and 401.5 U/L), but only one provided data with a dispersion always within the uncertainty of the target result. The different ability to meet the goal clearly depended on the analytical system used. Focusing on the two most used analytical platforms, the Cobas systems (Roche Diagnostics) underestimated the ALP values, while the AU systems (Beckman Coulter) overestimated them. The regression parameters between the average values obtained by laboratories and the target values indicate that it would be possible to correct the results of all analytical systems and make them unbiased by a simple recalibration approach. The analysis of the commercial calibrator package inserts of the IVD companies involved in this study showed that, with the exception of Roche still aligned to the old Tietz method published in 1983, all companies offer at least two options, sometimes (e.g., Beckman AU) both not in line with the recommended standardization approach.</p>
Biochimica Clinica ; 41(1) 064-071
Contributi scientifici - Scientific papers
Intervalli di riferimento standardizzati della fosfatasi alcalina sierica in soggetti pediatrici
Traceable reference intervals for alkaline phosphatase in serum of pediatrics
<p>The definition of pediatric reference intervals for alkaline phosphatase (ALP) in serum represents a challenging task due to the high and variable concentrations of this enzyme in children compared to adults. Aim of this work was the establishment of ALP pediatric reference intervals in an Italian population using an indirect method and traceable assays for ALP measurements. A data mining approach involving 12 centers was applied. To verify the analytical quality of the participating centers, 3 pools with ALP target values established by the reference procedure were distributed and analyzed by the centers at the beginning and at regular intervals during the data collection period (May-September 2016). When needed (deviation from target &gt;2%), the results obtained on the 3 pools were used to recalculate ALP results of reference individuals, thus making them traceable to the reference procedure. Each center selected from its database the ALP results of outpatients, aged 0-20 years, excluding those from oncological or orthopedic clinics and the results from subjects that repeated the test more than once. Very high and very low ALP values were investigated for excluding liver, kidney or bone disease. The results were elaborated with a modification of the algorithm proposed by Concordet et al. 4824 ALP values were collected (2372 from females and 2452 from males, respectively). The lower reference limit was the same for boys and girls &lt;12 years old (140 U/L), reaching down the adult concentrations at 16 years for females and 18 years for males. The pubertal peak was at 9-11 years for females (430 U/L) and 12-14 years for males (465 U/L).</p>
Biochimica Clinica ; 41(2) 166-174
Contributi scientifici - Scientific papers
Variabilità biologica dei parametri dell’esame emocromocitometrico in soggetti sani
Biological variation estimates of complete blood count parameters in healthy subjects
<p>Background: the complete blood count (CBC) is the test more frequently requested in clinical practice. Therefore, estimating the biological variation (BV) of CBC parameters is essential for assessing the analytical performance of hematological analyzers and for enabling accurate data interpretation and appropriate clinical management. This study was aimed to define BV estimates and reference change value (RCV) of CBC parameters.<br />Methods: the study population consisted of 21 healthy volunteers, who had BV of CBC parameters assessed with Sysmex XN. The study protocol, the analytical measurements and the statistical analysis were carried out according to current recommendations of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM).<br />Results: Within-subject BV ranged between 0,3% for mean cell hemoglobin (MCH) and 19,7% for immature granulocytes (IG), whilst between-subjects BVs ranged between 0,9% for mean corpuscolar haemoglobin concentration (MCHC) and 66,6% for microcytic red blood cells (Micro-R). The RCV ranged between 2,3% for MCH and 73,5% for IG.<br />Conclusion: This study has allowed the estimation of BV of many CBC parameters, some of which have not been currently explored, thus leading the way to use RCV calculated according to time of monitoring and/or differentiated by sex.</p>
Biochimica Clinica ; 43(4) 384-393
Contributi Scientifici - Scientific Papers