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BC: Articoli scritti da R. Paleari

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
CONTRIBUTI SCIENTIFICI - CONTRIBUTI SCIENTIFICI
 
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
OPINIONI - OPINIONI