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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

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

Biomedia srl
Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

Editorial Secretary
Chiara Riva
Biomedia srl
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Tel. 0245498282


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

BC: Articoli scritti da R. Paleari

Glycated albumin stability in frozen plasma samples
R. Paleari  |  G. Santini  |  A. Mosca  | 
Biochimica Clinica ; 46(2) 180-181
Lettere all'Editore - Letters to the Editor
How to report HbA1c in presence of hemoglobin variants
How to report HbA1c in presence of hemoglobin variants
<p>Measurement of glycated hemoglobin (HbA1c) has a key-role in the management of diabetic patients. Clinicians need reliable and accurate measurements, with negligible pre-analytical and post-analytical errors. Among the preanalytical variables, the presence of hemoglobin variants is a challenge to the laboratorians, both on pre-analytical and analytical phase. The purpose of this document is to give some practical advices on how to report HbA1c values in presence of hemoglobin variants. This is an update of a previously reported document, published in 2011. The list of the most diffused method for measuring HbA1c has been updated, and the most recent enzymatic assays have been included. A new aspect concerns the post-analytical phase, in which we recommend to report the presence of the hemoglobin variant in the final laboratory report</p>
Biochimica Clinica ; 46(2) 176-179
Documenti SIBioC - SIBioC Documents
Performance evaluation of ARKRAY HA-8190V system for measuring glycated hemoglobin
Performance evaluation of ARKRAY HA-8190V system for measuring glycated hemoglobin
R. Paleari  |  F. Ceriotti  |  A. Mosca  | 
<p>Introduction: the new fully automated HPLC ion-exchange system ADAMS A1c HA-8190V analyzer, developed by ARKRAY Inc., running in two different modes (Variant and Fast) has been evaluated.<br />Methods: reproducibility was evaluated according to the EP-15A3 standard. Method comparison was performed on 122 fresh blood samples, according to the EP-9 standard. The system was compared to 3 other HPLC analyzers, based on ion-exchange (Tosoh G11 and Bio-Rad D-100) and boronate affinity chromatography (Trinity Biotech Premier Hb9210). Usability was evaluated by using to a score evaluation system.<br />Results: reproducibility proved to be very good at normal and high HbA1c concentration, with total CVs always &lt;0.7 %, when HbA1c was expressed in mmol/mol as well as in % units. The HA-8190V system was well correlated to the other HPLC analyzers, with a mean bias not clinically relevant. Finally, the usability of the system was evaluated and proved to be well acceptable.<br />Conclusions: the ARKRAY HA-8190 V system was found to be a reliable and suitable method for routine HbA1c measurement in clinical chemistry laboratories.</p>
Biochimica Clinica ; 46(1) 068-073
Contributi Scientifici - Scientific Papers
Malattia renale nel diabete: oltre la nefropatia diabetica
Kidney disease in diabetes: beyond diabetic nephropathy
<p>Chronic kidney disease is a major type of kidney disease where a gradual loss of kidney function over a period of months to years can be observed. Its early detection is critical in improving the clinical outcome. It may be associated to diabetes, the illness being cause of the nephropathy, and then the condition is known as diabetic kidney disease (DKD). However, it may be associated to diabetes, but the pathogenesis arising could be attributable to other reasons, and then the condition is known as non diabetic kidney disease (NDKD). In this review we will focus on these two conditions, and we will briefly outline the state of the art of some traditional biomarkers (the quantitative determination of albumin in urine, eGFR), the role and the interpretation of some established biomarkers for the evaluation of glycemic control (glycated hemoglobin and glycated albumin) and the potential use of other new biomarkers useful to predict the development of the nephropathy.</p>
Biochimica Clinica ; 45(3) s048-s059
Rassegne - Reviews
Il deficit di G6PD in Medicina di Laboratorio
G6PD deficiency in Laboratory Medicine
<p>Glucose 6-phosphate dehydrogenase has a key role in the production of the reducing power necessary to face oxidative stress and for providing ribose, which is a basic constituent of nucleic acids. It is therefore not surprising that the gene is present in all organisms, and that is also highly conserved during the evolution. The occurrence of G6PD mutants may have important consequences in carriers, depending on the class of the mutants, triggering events and various comorbidities. Acute and chronic hemolytic anemias are the most typical clinical hallmarks. The determination and characterization of G6PD can be achieved by qualitative tests, various quantitative catalytic activity determinations, and by molecular biology techniques. Sample collection and stability is not a critical problem, but some pre-analytical conditions in vivo(previous transfusions, recent blood losses) should be known by the laboratory before measuring G6PD. A number of quantitative methods is available and there is no consensus on the measuring temperature (30 or 37&deg;C) and on the reference ranges. The consequence is that the state-of-the-art of the various methods is variable, as clearly proven from recent EQAS analyses. Moreover, analytical goals have not been defined yet. In conclusion, we believe that this test needs better attention from laboratory professionals in order to offer an improved service to patients with G6PD deficiency anemias and related complications.</p>
Biochimica Clinica ; 44(3) 219-231
Rassegne - Reviews
Il progetto pilota SIBioC di VEQ della misura dell’emoglobina glicata
Pilot SIBioC EQAS project on glycated hemoglobin measurement
<p>Two fresh blood samples collected with EDTA&nbsp;were distributed by courier in December 2014 to 206 Italian laboratories asking for the determination of their HbA<sub>1c</sub> concentrations. Target HbA<sub>1c</sub> values were assigned by the IFCC reference measurement procedure based on HPLC capillary&nbsp;electrophoresis. The results, collected from 193 laboratories using analytical systems mainly from five&nbsp;manufacturers (Bio-Rad Laboratories, A. Menarini Diagnostics, Roche Diagnostics, Sebia and Tosoh), showed a&nbsp;global variability (in terms of CV) of 5.3% and 3.8% at HbA<sub>1c</sub> values of 37.4 mmol/mol (sample 1) and 62.0 mmol/mol&nbsp;(sample 2), respectively. Globally, 84% of the participants reported HbA<sub>1c</sub> results within the total allowable error (TE)&nbsp;of 8.6% (sample 1) and 93% for sample 2. These percentages decreased to 70% and 77%, respectively, when using&nbsp;a goal for the allowable TE of 6.0% as criterion. Inter-laboratory CVs, calculated per group of methods, were between&nbsp;3.3% and 5.0% and between 2.2% and 3.7% for sample 1 and 2, respectively. Tosoh users registered the smaller&nbsp;inter-laboratory CV in sample 1 and Sebia&rsquo;s in sample 2. With regard to trueness, all methods had a mean bias &le;2.8%&nbsp;respect to the target values, with the exception of Tosoh (bias of +6.1% and +5.8%, for samples 1 and 2, respectively).</p>
Biochimica Clinica ; 39(6) 568-574
Contributi scientifici - Scientific Papers
Valutazione del sistema Capillarys 2 Flex Piercing per la misura dell’emoglobina A1c
Evaluation of the Capillarys 2 Flex Piercing system for the determination of hemoglobin A1c (HbA1c)
R. Paleari  |  A. Mosca  | 
<p>The&nbsp;Capillarys HbA<sub>1c</sub> kit implemented on the Capillarys 2 Flex Piercing platform uses capillary electrophoresis to separate&nbsp;and quantify HbA<sub>1c</sub> in human blood. We performed an evaluation of this system by checking imprecision, relative bias&nbsp;and robustness respect to the analysis of samples with variable total hemoglobin concentrations. Intra-assay CVs were&nbsp;between 1.1% and 2.8% for HbA<sub>1c</sub> values between 35.8 mmol/mol and 96.4 mmol/mol. Inter-assay CVs, evaluated on&nbsp;control materials, were 2.0% and 2.4 % for high (68.6 mmol/mol) and low (36.8 mmol/mol) control levels, respectively.&nbsp;Results in three blood samples with various concentrations of HbA<sub>1c</sub> (36, 60 and 87 mmol/mol) were not affected by&nbsp;variation in total hemoglobin concentrations (between 40 to 180 g/L). Only at very low total hemoglobin concentration,&nbsp;the imprecision was slightly higher (CV 3.1%). The results obtained by capillary electrophoresis (y-method) were well&nbsp;correlated with those obtained by the HPLC Tosoh G8 (x-method) (y = 0.73 + 0.978x, r=0.998, n=100).</p>
Biochimica Clinica ; 38(2) 110-114
Contributi scientifici - Scientific papers
Valutazione multicentrica dell’analizzatore Tosoh G8 per la misura dell’emoglobina A2 e dell’emoglobina F
Multicenter evaluation of the Tosoh G8 analyzer for determination of hemoglobin (Hb) A2 and F
<p>The analytical performance of the new Tosoh automated analyzer HLC-723 G8 (-thalassemia analysis mode) to determine hemoglobin variants and to measure HbA2 and HbF in human blood was evaluated in three Italian centres. The within- and between-run imprecision for HbA2 were good, with CV between 0.2% and 1.8% and between 0.9% and 5.4%, respectively. The CV for HbF was between 0.4% and 9.8% (within-run) and beetwen 0.8% and 13.1% (between-run). The comparability of HbA2 measurements between different centres was excellent (r=0.99), but a significant bias in comparison with the previous version of the instrument was noted. Experiments to test the HbA2 stability in blood confirmed that blood samples stored at -80 &deg;C were stable for at least 4 months and that storage at -20 &deg;C is not recommended. In conclusion, the Tosoh G8 analyser was found reliable and robust and, therefore, suitable for the measurement of HbA2 and HbF in human blood.</p>
Biochimica Clinica ; 37(1) 30-35
Contributi Scientifici - Scientific Papers
Determinazione della variabilità biologica dell'emoglobina A2
Determination of biological variation of hemoglobin A2.
R. Paleari  |  M. Montagnana  |  E. Danese  |  M. Tozzi  |  G.C. Guidi  |  A. Mosca  | 
<p><strong>Determination of biological variation of hemoglobin A2.</strong> We present an experimental report aimed to evaluate the biological variation of hemoglobin A2 (HbA2), a minor hemoglobin component in post-natal life, accounting for 2.5%-3.5% of the total hemoglobin in red cells, which is very relevant for the laboratory diagnosis of thalassemic syndromes. We took five blood specimens from 17 apparently healthy subjects (9 men and 8 women, ages 26-52 years) on the same day, every two weeks for two months. Samples were stored at -80 &#176;C until analysis and assayed in duplicate by Bio-Rad Variant II analyzer. Data were analyzed by the ANOVA. There were no differences in HbA2 values between men and women. HbA2 exhibited marked individuality: within- (CVI) and between-subject (CVG) biological variation were 0.7% and 7.7%, respectively. Desirable analytical goals derived from biological variation for imprecision (0.5 CVI), bias [0.25 (CVI2 + CVG2)1/2] and total error [1.65 (0.5 CVI) + 0.25 (CVI2 + CVG2)1/2]were 0.4%, 1.9%, and 3.1%, respectively. In conclusion, this is the first evidence that HbA2, as well as total hemoglobin, is under a strict homeostatic control. Our data also show that stringent analytical goals are needed for the clinical application of HbA2 measurements.</p>
Biochimica Clinica ; 35(6) 458-460
Il "Joint Committee for Traceability in Laboratory Medicine" (JCTLM): una cooperazione internazionale per promuovere la standardizzazione dei risultati in Medicina di Laboratorio
The Joint Committee for Traceability in Laboratory Medicine (JCTLM): a global cooperation to promote the standardisation of test results in Laboratory Medicine
Biochimica Clinica ; 35(5) 377