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BC: Articoli scritti da E. Frusciante

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
 
Verifica dell’accuratezza di tre glucometri “point-of-care” per l’utilizzo in ambito ospedaliero
Verification of accuracy of 3 glucose point-of-care testing (POCT) devices for their use in a hospital setting
<p>Inaccuracy in glucose POCT can lead to inappropriate therapeutic decisions. In this study, we evaluated the performance of 3 POCT glucometers by comparing results to those by an automated system traceable to higher-order references. Thirty-one heparinized venous blood samples were collected and assayed in duplicate for whole blood glucose concentrations with Roche Accu-Check Compact Plus, Nova Biomedical NovaPro and OK Biotech OKmeterDirect glucometers. All systems were calibrated to report plasma-equivalent results. Samples were then centrifuged and plasma glucose immediately determined by the hexokinase assay on Abbott Architect c16000 platform. The traceability of Abbott assay was checked by comparison with the hexokinase reference procedure performed on 3 samples. POCT performance was evaluated according to Cinical and Laboratory Standards Institute (CLSI) POCT12-A3 criteria [max. 5% of results &gt;&plusmn;12 mg/dL (for reference results &lt;100 mg/dL) or &gt;&plusmn;12.5% (for reference results &ge;100 mg/dL)] and consensus error grid (CEG) analysis. The Architect assay was perfectly standardized (mean bias, 0.2%). Sample glucose concentrations ranged from 62 to 326 mg/dL, with hematocrit spanning from 0.27 to 0.58 L/L. Average CV on duplicates was 3.5% for Roche, 3.6% for Nova and 5.9% for OK Biotech. All meters gave more than 5% of results (Roche 19.4%, Nova 16.1% and OK Biotech 22.6%) outside the CLSI criteria. However, all results, except two borderline values for OK Biotech, were within the low-risk zone according to CEG. In conclusion, by using CLSI acceptability criteria, the evaluated glucometers were not accurate enough for clinical use in a hospital setting. CEG analysis suggests, however, that this inaccuracy would not have any significant impact on patients&rsquo; outcome.</p>
Biochimica Clinica ; 41(1) 079-084
Contributi scientifici - Scientific papers
 
Valutazione dell’impatto del processo di standardizzazione sulla qualità della misura della creatininemia nei laboratori italiani
Evaluation of the impact of standardization process on the quality of serum creatinine determination in Italian laboratories
<p style="text-align: justify;">Evaluation of the impact of standardization process on the quality of serum creatinine determination in Italian laboratories. Creatinine determination in serum is a key indicator of kidney glomerular function. A reference measurement system for standardization of creatinine measurements is now available and virtually all IVD manufacturers have aligned their creatinine assays to this system. The aim of this work was to verify if and how these standardization efforts have improved the state of the art of creatinine determination in Italy through the analysis of Prolarit EQAS results using control materials with target values assigned by a traceable method (enzymatic assay calibrated against the NIST SRM 967). Results obtained during 2006, 2010, and 2011 schemes by participating laboratories showed a general good alignment at creatinine concentrations <span style="font-family: symbol;">&#61566;</span>2.00 mg/dL, with 2011 results &#8211; except for one method group &#8211; well inside the desirable bias (<span style="font-family: symbol;">&#61617;</span>4%). At higher concentrations, whereas the overall bias was small in 2010, for some groups using alkaline picrate (AP) methods it became significantly negative in 2011. The performance markedly worsens at creatinine physiologic concentrations, where a significant positive bias (up to <span style="font-family: symbol;">&#61566;</span>20%) is still present for most of the AP-based analytical systems. Unexpectedly, with few exceptions, no evident improvement in individual assay bias was noted from pre- (2006) to post-standardization (2011) periods. The enzymatic method groups were the only always presenting an acceptable bias for all concentration levels, in addition to showing the lowest between-laboratory variability. The number of laboratories using enzymatic methods, however, still remains only 7% of the total. In conclusion, our EQAS performance data indicate that most of the current "standardized" creatinine methods based on AP reaction do not perform well, mainly at the lower creatinine concentrations. This inaccuracy of creatinine measurements can adversely impact the estimation of glomerular filtration rate by equations and the evaluation of kidney function in pediatrics.</p>
Biochimica Clinica ; 36(6) 414-424
Contributi Scientifici - Scientific Papers
 
Stima dell'incertezza della misura della concentrazione di attività catalitica dell'alanina amminotransferasi (ALT) nel siero mediante il metodo di riferimento IFCC
Calculation of uncertainty of measurement of the catalytic activity concentration of alanine amminotransferase (ALT) in serum by the IFCC reference procedure.
Biochimica Clinica ; 35(1) 20
CONTRIBUTI SCIENTIFICI - CONTRIBUTI SCIENTIFICI