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BC: Articoli scritti da S. Secchiero

La valutazione delle prestazioni analitiche dei laboratori mediante programmi di valutazione esterna di qualità: una analisi multifattoriale
The evaluation of laboratories’ analytical performance through external quality assessment programs: amultifaceted analysis
<p>The Italian accreditation body, Accredia, requires that clinical laboratories obtained positiveanalytical performances in the last four External Quality Assessment (EQA) surveys in order to undertake theaccreditation with flexible scope (document RT-26).<br />In addition to the choice of acceptability limits (AL), other factors contribute to define the analytical performance:nature and commutability of control materials, definition of target value (TV), homogeneous group classification, dataelaboration, procedures for outliers exclusion.<br />In this study, the creatinine performances of 106 participants, obtained in the last four surveys of the year 2017 ofthe Centre of Biomedical Research (CRB) EQA program, have been evaluated using two different AL and TV: the ALproposed by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and by the RegionalReference Centre of the Azienda Ospedaliera Universitaria &ldquo;Careggi&rdquo; of Firenze (Italy) (CRRVEQ); the TV assignedwith the reference method (RV) and as consensus value, i.e. median of the results obtained with the same method(AV).<br />The percentage of laboratories satisfying the RT-26 requisite was different on the basis of the AL and TV considered:with the EFLM-AL, 68.8 % laboratories complied the requisite if AV was used and 60.4% if RV was applied; with theCRRVEQ-AL, 50.0% and 48.1%, respectively.<br />These data demonstrate that harmonized criteria and procedures for evaluation of EQA results are needed to obtainhomogeneous classification of laboratories&rsquo; performance.<br />In order to support the laboratory professionals in accreditation processes and, above all, to guarantee theirperformance reliability, time has come that the Scientific Societies of Laboratory Medicine promote the merging of thedifferent Italian EQA schemes in a consolidated network of EQA providers.</p>
Biochimica Clinica ; 43(2) 168-172
Opinioni - Opinion
 
Verso l’armonizzazione dell’analisi delle urine con striscia reattiva: il ruolo di un programma di VEQ
Towards harmonization in dipstick urinalysis: the role of EQAS
<p>We reviewed the results of our 2013 to 2016 EQAS to evaluate the performance of the most used dipstick urinalysis methods in Italy. 67,450 results from 32 control samples were analyzed by using a normalized scale. For pH, the mean of the most frequent results was 72.1%&plusmn;15.6. For specific gravity, the mean for values &lt;1.020 Kg/L was 77.9%&plusmn;9.5. For glucose detection, in negative samples 97.4%&plusmn;3.1 of dipsticks provided correct results, while for samples with 300-500 mg/L, 10.8%&plusmn;6.2 provided negative results, mainly Siemens dipsticks. For proteins, in negative samples 99.7%&plusmn;0.2 of dipsticks supplied correct results, but for samples with 100-250 mg/L of proteins 25.6%&plusmn;10.7 still resulted negative. For hemoglobin, in negative samples 94.8%&plusmn;5.5 of dipsticks provided correct results; for samples with 0.1-0.3 mg/L 10.0%&plusmn;0.8 of dipsticks resulted negative. For ketones, in negative samples 99.8%&plusmn;0.2 of dipsticks provided correct results; however, Uropaper Alpha3-9L never revealed their presence in positive controls. For leucocyte esterase, in negative samples 97.6%&plusmn;0.9 of dipsticks provided correct results. For nitrites, results were consistent both with negative and positive controls (99.3%&plusmn;0.6). For protein/creatinine ratio, in samples with ~150 mg/g 14.3%&plusmn;5.3 of dipsticks provided a normal ratio. The study demonstrates the importance of an EQAS in providing to participants an evaluation of their performance and a reliable view of the degree of harmonization among results of different types of dipsticks.</p>
Biochimica Clinica ; 41(3) 248-257
Contributi scientifici - Scientific papers
 
Esame fisico, chimico e morfologico delle urine: proposta di linee guida per la fase analitica del Gruppo Intersocietario Analisi delle Urine (GIAU)
Physical, chemical and morphological urine examination: proposed guidelines for the analytical phase by the Intersociety Urinalysis Group
<p>With these guidelines, the Intersociety Urinalysis Group (GIAU) aims to stimulate the following aspects: a) improvement and standardization of the analytical approach to physical, chemical and morphological urine examination (ECMU); b) to emphasize the value added to ECMU by automated analyzers for the study of the morphology of the corpuscular fraction urine; c) improvement of the chemical analysis of urine with particular regard to the reconsideration of the diagnostic significance of parameters that are traditionally evaluated in dipstick analysis, together with an increasing awareness of the limits of sensitivity and specificity of this analytical method; d) to increase the awareness of the importance of professional skills in the field of urinary morphology and of the relationships with clinicians; e) implementation of a policy for the evaluation of the analytical quality by using, in addition to traditional IQC and EQA, a program for the evaluation of morphological competence; f) to stimulate the diagnostic industry to focus research efforts and development methodology and instrumental catering to the needs of clinical diagnosis. The hope is to revalue the enormous diagnostic potential of ECMU, by implementing an urinalysis based on personalized diagnostic needs.</p>
Biochimica Clinica ; 40(4) 353-382
Documenti SIBioC - SIBioC Documents
 
Armonizzazione della diagnostica ematologica: lo stato della valutazione dei reticolociti
Harmonization in hematology: the status of reticulocyte count
E. Piva  |  S. Secchiero  |  F. Spolaore  |  F. Tosato  |  M. Plebani  | 
<p>Harmonization is a crucial step in laboratory&nbsp;medicine to provide reliable information. The reticulocyte count and even more maturity parameters and indices seem&nbsp;to be still highly variable, despite their proven clinical usefulness. Three hematology analyzers (Siemens Advia 2120,&nbsp;Sysmex XN-1000, Mindray BC-6800) were used to assess reticulocyte count (percentage and absolute count),&nbsp;parameters and indices of blood samples from 82 adult patients. Results from 92 participant laboratories to the last&nbsp;3 cycles (2012-2015) of EQA program of the Center of Biomedical Research were also evaluated. Statistical&nbsp;comparisons demonstrated an excellent correlation among the 3 instruments for reticulocyte count, both in&nbsp;percentage and absolute values. A systematic, not proportional difference in immature reticulocyte fraction results&nbsp;was observed between Advia 2120 and the other two analyzers, which conversely showed an excellent correlation&nbsp;between them. For the measurement of reticulocyte hemoglobin content, we found a systematic proportional&nbsp;difference between Advia 2120 and XN-1000, an excellent concordance between Advia 2120 and BC 6800 and a&nbsp;systematic not proportional difference between XN-1000 and BC 6800. Comparison between reticulocyte mean&nbsp;volume results obtained with Advia 2120 and BC 6800 showed a good correlation, even if systematic differences&nbsp;between the two methods were observed. For the reticulocyte counts the interlaboratory variability showed a CV&nbsp;Z10%, except for Advia 2120. EQA demonstrated the need of harmonization of reference intervals, which should go&nbsp;together with the harmonization of analytical methods for a correct clinical interpretation.</p>
Biochimica Clinica ; 40(3) 208-216
Contributi scientifici - Scientific Papers
 
La diagnostica di laboratorio della malattia renale cronica in Italia: armonizzare è d’obbligo
The laboratory role in chronic kidney disease (CKD) in Italy: need of harmonization
<p>The diagnosis and&nbsp;classification of CKD are based on laboratory tests. Aim of this paper is to examine different aspects of the laboratory&nbsp;contribution to verify their harmonization at national level. We review relationships between laboratory and clinical&nbsp;organizations, the role of 2012 Kidney Disease Improving Global Outcomes (KDIGO) guidelines, the quality of&nbsp;creatinine and urine albumin measurements, the status of estimated glomerular filtration rate (eGFR) reporting, the use&nbsp;of cystatin C and testing plans. Questionnaires examining different aspects of the CKD diagnostics were sent out and&nbsp;EQAS for creatinine and urine albumin measurements were carried out. For creatinine measurement, enzymatic&nbsp;assays show the best performance, while for urine albumin a bias still exists between different methods. The eGFR is&nbsp;routinely reported by 75% of surveyed laboratories, but only 15% of them use the equation derived by the CKDEpidemiology&nbsp;Collaboration (CKD-EPI) study. For urine albumin, the recommended first morning void sample is used&nbsp;by ~60% of laboratories, but the wrong terminology of &ldquo;microalbuminuria&rdquo; is still used by &gt;40% of them. Cystatin C is&nbsp;offered by a minority of laboratories. In conclusion, even if an improvement can be observed during the recent years,&nbsp;efforts for a better alignment to international recommendations are needed. Often they just require cultural and&nbsp;organizational changes, without the availability of additional economic resources.</p>
Biochimica Clinica ; 39(6) 617-626
Opinioni - Opinions
 
Linee guida per la gestione dei programmi di Valutazione Esterna di Qualità
Guidelines for External Quality Assessment Scheme organization
Biochimica Clinica ; 35(2) 107
DOCUMENTI SIBioC - SIBioC Documents