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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
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Giuseppe Agosta

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

BC: Articoli scritti da S. Secchiero

Stato dell’arte dei biomarcatori di malattia renale osservato mediante i Programmi di VEQ del Centro di Ricerca Biomedica
The quality of laboratory tests for the Chronic Kidney Disease in Italy through EQA programs
<p>Introduction: the diagnosis and classification of Chronic Kidney Disease (CKD) are based on laboratory tests. The aim of this paper is to verify their harmonization at national level, through the examination of participants&rsquo; results to EQA programs of the Centre of Biomedical Research.<br />Methods: we considered results of creatinine and eGFR of the last 8 EQA cycles (2013-2020) for a total of 80 lyophilized control samples and results of albumin and albumin/creatinine ratio (ACR) in urine of the last 3 EQA cycles (2018-2020) for a total of 24 lyophilized control materials.<br />Results: for creatinine measurement, enzymatic assays show the best accuracy, but only 40% of participants use them. For eGFR the 64% of participants use the equation derived by the CKD-Epidemiology Collaboration (CKD-EPI) study and this formula applied to enzymatic creatinine shows the best performances. For urine albumin, analytical variability (median CV%) is lower for all diagnostic systems at pathological concentrations than at concentrations below the cut-off. Important bias still exists between different methods and overall 12% of the albumin results provided by the participating laboratories did not reach the minimum quality level for the clinical use of the measure and for value &lt;30.0 mg/L the number of unacceptable performances increases to 24%. Similar results were found for ACR: overall 14% of the results were unacceptable and for value &lt;3.4 mg/mmol the number of unacceptable performances increases to 21%.<br />Conclusion: even if some improvements can be observed during the recent years, efforts for a better alignment to international recommendations are needed. A Reference system of higher order is needed to enable standardization of urine albumin measurement results. The participation in specific External Quality Programs is a valuable tool to assess the harmonization of laboratory tests for CKD diagnosis in our country.</p>
Biochimica Clinica ; 45(3) s076-s089
Contributi Scientifici - Scientific Papers
Modalità di refertazione del D-Dimero e prestazioni dei sistemi analitici: quali informazioni dal programma di Valutazione Esterna di Qualità del Centro di Ricerca Biomedica
Reporting of D-Dimer and performance of analytical systems: data from participants to the External Quality Assessment Scheme of the Biomedical Research Centre in Italy
<p>Introduction: D-Dimer assessment represents a cornerstone in the diagnostic approach to several thrombotic disorders. Recent literature has highlighted the role of D-Dimer also in the diagnostic pathway of coronavirus infection (COVID-19) and the importance of harmonized reporting [D-dimer unit (DDU) or fibrinogen equivalent unit (FEU); unit of measure; cut-off] in order to guarantee the correct interpretation of the results.<br />Methods: D-Dimer data from 100 EQA participants and the inter-laboratory variability (CV%) of the last 7 years for the most used analytical systems: Werfen, HemosIL HS; Werfen, HemosIL HS-500; Auto D-D, Sclavo; Innovance, Siemens; VIDAS, bioM&eacute;rieux and STA Liatest, Stago have been evaluated.<br />Results: concerning the results expression in DDU or FEU, we observed a prevalence of FEU (55.1%) over DDU (44.9%); the value was confirmed in the last 7 years (average FEU = 55.6%), differently from data obtained in the survey conducted in 2014 at a national level.<br />The units used are: ng/mL (67.8%), &mu;g/L (29.0%) and mg/L (3.2%) for D-Dimer DDU; ng/mL (57.9%), &mu;g/mL (21.0%), &mu;g/L (15.8%) and mg/L (5.3%) for D-Dimer FEU.<br />Inter-laboratory variability (mean CV%) calculated on a total of 72 controls is lower for all diagnostic systems at pathological levels than the one observed for concentrations below the cut-off.<br />Discussion: this study demonstrates that the reporting of D-Dimer results does not comply with the 2014 SIBioC consensus document which recommended the use of &mu;g/L FEU, and highlights 8 different types of information. Data reported in this study call for the harmonization of D-Dimer reporting in order to guarantee the correct interpretation of the information, both in the case of COVID-19 and in all the diseases already known where this analyte has a clinical relevance.</p>
Biochimica Clinica ; 45(2) 158-167
Contributi Scientifici - Scientific Papers
Esame fisico, chimico e morfologico delle urine: raccomandazioni per la fase postanalitica del Gruppo Interdisciplinare Laboratorio e Clinica Apparato Urinario (GIAU)
Physical, chemical and morphological urine examination: recommendations for the postanalytical phase from the Interdisciplinary Urinalysis Group (GIAU)
<p>This document of the Interdisciplinary Urinalysis Group (GIAU) is aimed to provide recommendations on how to improve and standardize the postanalytical approach to physical, chemical and morphological urine examination (ECMU). The main tool to emphasize the value of the ECMU is the development of a laboratory report suitable for the clinical needs. As a consequence, these recommendations are mainly related to the structure and content of the report. They include: the layout, the parameters to be included, the measurement units, the reference values, the inclusion of interpretative comments. Really, an important section of the report is dedicated to the interpretative comments: these are a real add-on value and are tailored on the type of laboratory performing the analysis (general or with a specific section dedicated to the urine examination). The different levels of the laboratory competence determine the category of possible comments. The basic one concerns comments that evaluate the non-conformity of the sample (i.e. presence of urethral, seminal, vaginal, faecal contamination; too concentrated/too diluted samples). The second level of comments is dedicated mainly to the reporting of the discrepancies between the biochemical analysis and the microscopy examination (i.e. presence of haemoglobin and no erythrocyte detection; presence of leucocyte esterase and no leucocyte detection). The third level requires a specific competence of the pathologist together with a strict collaboration with the clinic; these comments are elaborated on the basis of a specific clinical request. The detection of the &ldquo;decoy cells&rdquo; in immunosuppressed solid organ transplant recipients, that are typical of a poliomavirus infection, is a good example of the third level of interpretative comments. A final section of the document is dedicated to the opportunity to implement and adopt specific programs of external evaluation of the urinary sediment.<br />After the issuing of the recommendations dedicated to pre-analytical and analytical phases, this GIAU document gives suggestions for the standardisation and harmonisation of post-analytical phase in the attempt to emphasize the diagnostic importance of ECMU.</p>
Biochimica Clinica ; 44(1) 086-099
Documenti SIBioC - SIBioC Documents
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