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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

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

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Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

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Andrea di Bello
Biomedia srl
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ISSN print: 0393 – 0564
ISSN digital: 0392- 7091

BC: Articoli scritti da E. Guerra

Importanza dell’utilizzo di Biological Variation Data Critical Appraisal Checklist nel disegno sperimentale di studi di variabilità biologica. Valutazione a confronto di due pubblicazioni sulla variabilità biologica della proteina S100βe dell’enolasi neu
The importance of the Biological Variation Data Critical Appraisal Checklist when designing experimental studies on biological variation. Comparison of two papers reporting biological variation results for S100-β and neuron-specific enolase proteins
<p>The Biological Variation Data Critical Appraisal Checklist (BIVAC) has been designed to evaluate biological variation (BV) studies and the reliability of the associated BV estimates. To illustrate its utility, two studies delivering within-subject BV (CVI) data for S100-&beta; protein and neuron-specific enolase (NSE), markers typically used for melanoma and neuroendocrine tumors, respectively, were appraised using BIVAC. Data from the European Biological Variation Study (EuBIVAS) and the recently published Johnson et al. study (ref n 11) were scored using the 14 BIVAC quality items (QI), with alternatives A, B, C and/or D to verify whether the elements required to obtain reliable BV data, were present and appropriately documented. Grade A indicates compliance with all the QIs and D indicates non compliance. The sizes of the confidence interval (CI) around the CVI estimates were also compared. Johnson&rsquo;s study received a BIVAC grade C, EuBIVAS a grade A. EuBIVAS is a large scale study, with&nbsp;1609 and 1728 results for NSE and S100-&beta;, respectively. In Johnson&rsquo;s study, only 40 results were available. The EuBIVAS CVI estimates [NSE, 10.9% (10.3-11.5); S100-&beta; , 10.2% (9.6-10.7)] were clearly lower than Johnson&rsquo;s CVIs [NSE, 22.1% (9.9-34.3); S100-&beta;, 18.9% (8.5-29.4)]. The overlapping CI between the two estimates are caused by Johnson&rsquo;s CI being about 20 times larger than the corresponding EuBIVAS CI. It is likely that studies that do not comply with all BIVAC QI deliver less reliable, and possibly too high, CVI estimates. Adherence to the BIVAC ensures safe clinical application of BV estimates.</p><p>&nbsp;</p>
Biochimica Clinica ; 43(1) 059-066
Contributi Scientifici - Scientific Paper
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
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