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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

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

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Andrea di Bello
Biomedia srl
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Tel. 0245498282


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

BC: Articoli scritti da C. Ottomano

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
Variabilità biologica dei parametri dell’esame emocromocitometrico in soggetti sani
Biological variation estimates of complete blood count parameters in healthy subjects
<p>Background: the complete blood count (CBC) is the test more frequently requested in clinical practice. Therefore, estimating the biological variation (BV) of CBC parameters is essential for assessing the analytical performance of hematological analyzers and for enabling accurate data interpretation and appropriate clinical management. This study was aimed to define BV estimates and reference change value (RCV) of CBC parameters.<br />Methods: the study population consisted of 21 healthy volunteers, who had BV of CBC parameters assessed with Sysmex XN. The study protocol, the analytical measurements and the statistical analysis were carried out according to current recommendations of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM).<br />Results: Within-subject BV ranged between 0,3% for mean cell hemoglobin (MCH) and 19,7% for immature granulocytes (IG), whilst between-subjects BVs ranged between 0,9% for mean corpuscolar haemoglobin concentration (MCHC) and 66,6% for microcytic red blood cells (Micro-R). The RCV ranged between 2,3% for MCH and 73,5% for IG.<br />Conclusion: This study has allowed the estimation of BV of many CBC parameters, some of which have not been currently explored, thus leading the way to use RCV calculated according to time of monitoring and/or differentiated by sex.</p>
Biochimica Clinica ; 43(4) 384-393
Contributi Scientifici - Scientific Papers
Raccomandazioni FISMeLab per il trasporto del materiale biologico
C. Ottomano  | 
<p>Italian Federation of Laboratory Medicine Societies (FISMeLab) recommendations for biological samples transportation. In recent years the transport of biological samples has become a strategic issue and a frequent practice, due to the tendency of public laboratories to move towards consistent consolidations and of private laboratories to join other, bigger or more equipped ones (hub and spoke model), to process a substantial part of the analytical repertoire. Moreover, the sampling centers have become more numerous and more widespread to improve the service to the citizens. The time and the way of remote transport of biological samples is a source of potential corruption of the matrix that can generates preanalytical errors of various kinds and severity. The lack of unequivocal national indications in Italy has prompted the Italian Federation of Laboratory Medicine Societies (FISMeLab) to set up a working group that includes representatives from the scientific societies members of the Federation, with the aim of assembling a practical recommendation on transport requirements of biological samples. In order to enable the users to consult the document quickly and effectively, the recommendation lists the single measurands from different areas of laboratory medicine and reports for each of them the ideal transportation modalities. These are based on the time elapsed from the blood collection: less or more than three hours; it is however recommended that the time from the blood collection to the transport be as short as possible.</p>
Biochimica Clinica ; 43(2) 187-199
Documenti SIBioC - Italian Federation of Laboratory Medicine Societies (FISMeLab) recommendations for biological samples transportation
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
Valutazione analitica della misura di nuovi parametri emocitometrici su analizzatore Sysmex XN-9000
Assessment of the analytical performance of novel parameters of automated blood count on Sysmex XN-9000
<p>Recent technological advancements in laboratory hematology have promoted the introduction of many innovative parameters, which have the potential to enhance the clinical efficiency of this diagnostic area. This study aimed to&nbsp;assess the analytical performance of some of these new parameters available on Sysmex XN-9000 according to the&nbsp;International Council for Standardization in Haematology (ICSH) guidelines. Our evaluation included the assessment&nbsp;of imprecision (both intra- and inter-assay), carryover, sample stability and comparison with optical microscopy. The&nbsp;new red blood cell and platelet parameters displayed CV comprised between 0.7% and 34.6%. The new leukocyte&nbsp;parameters immature granulocyte (IG), hight fluorescence cell and cell population data (CPD) were characterized by&nbsp;CV ranging from 1% to 24%. Carryover was negligible for all parameters. Samples stability showed different trends&nbsp;for the different parameters, especially for CPD, depending on temperature and time of testing. The comparison of&nbsp;IG and nucleated red blood cell (NRBC) enumeration determined with Sysmex XN-9000 and optical microscopy&nbsp;yielded Pearson&rsquo;s correlation coefficients comprised between 0.82 and 0.99. The absolute bias was 0.83% and -0.06% for IG and NRBC, respectively. The results of this evaluation show that the innovative parameters available on&nbsp;Sysmex XN-9000 display, with some exceptions, acceptable performance, in line with data obtained with other&nbsp;analyzers. The results of sample stability studies are helpful to identify the best storage conditions for these&nbsp;parameters.</p>
Biochimica Clinica ; 40(3) 217-224
Contributi scientifici - Scientific Papers
Determinazione degli intervalli di riferimento dell’esame emocromocitometrico eseguito con analizzatore Sysmex XN 9000
Evaluation of reference intervals for complete blood count on Sysmex XN 9000
<p>We aimed to define reference&nbsp;intervals for complete blood count in 240 apparently healthy Italian adults (120 males and 120 females) using Sysmex&nbsp;XN 9000 platform, as recommended by international standards. The recruitment criteria for reference individuals were&nbsp;based on negative anamnesis and physiological serum concentrations of glucose, creatinine, transaminases, ferritin&nbsp;and C-reactive protein. The results were comparable to those previously generated on different European&nbsp;populations. Interesting results were found for some research parameters, for which limited information was available&nbsp;in Italian populations so far. With regard to reticulocyte-related parameters, a significant gender difference was found&nbsp;for reticulocyte hemoglobin, highly fluorescent reticulocyte fraction and delta-He, which represents the difference in&nbsp;hemoglobin content between reticulocytes and erythrocytes. The results also support the reference interval of&nbsp;immature platelet fraction observed in previous studies, except for the absolute value for which larger range and&nbsp;higher values were found. For leukocyte morphological and functional parameters, we were able to define reference&nbsp;intervals in the whole study population as well as in male and female subgroups, since gender-related differences&nbsp;were observed for some parameters.</p>
Biochimica Clinica ; 39(4) 256-263
Contributi scientifici - Scientific Papers
La stima dell'incertezza delle misure nel laboratorio clinico
Measurement uncertainty calculation in clinical laboratories
<p>The result of a measurement is only an estimate of&nbsp;the value of the measurand and it is complete only when accompanied by a statement of the measurement uncertainty.&nbsp;The ISO 15189 standard requires that &ldquo;the laboratory shall determine measurement uncertainty for each measurement&nbsp;procedure&rdquo;. The approach to calculate the measurement uncertainty proposed by the &ldquo;Guide to the expression of&nbsp;uncertainty in measurement&rdquo; (GUM) requires the quantification of every source of variability to sum them up for the&nbsp;final calculation (&ldquo;bottom-up&rdquo; approach). To overcome inherent difficulties in the systematic application of this approach&nbsp;in a clinical laboratory, a &quot;top-down&quot; approach is proposed, through the calculation of measurement uncertainty from&nbsp;already existing data of IQC. The proposed approach is checked by applying it to the IQC data for serum glucose and&nbsp;creatinine measurements collected from 19 clinical laboratories. Different approaches to cope with the issue of the&nbsp;estimate of systematic error (bias) are proposed, based either on value-assigned trueness control/reference materials,&nbsp;on the mean value of the employed material defined by the laboratory at the start of the IQC program or on the peer&nbsp;group mean of an interlaboratory program material. The availability of a standardized way to estimate the measurement&nbsp;uncertainty provides a tool to evaluate the analytical quality of results and it allows comparison of the quality of results&nbsp;made available by different laboratories.</p>
Biochimica Clinica ; 39(2) 108-115
Contributi scientifici - Scientific Papers
Automated screening of bacterial meningitis by cytofluorimetric analysis of cerebrospinal fluid: preliminary results
<p>This study was planned to assess the diagnostic performance of the automated urine particle analyzer Sysmex UF-1000i for the rapid screening of cerebrospinal fluid (CSF) in patients with suspected meningitis. Cytometric analyses&nbsp;with either optical microscopy (OM) or UF-1000i, along with assessment of glucose and protein in CSF, were performed&nbsp;on 101 consecutive CSF of patients with suspected meningitis. In 50 out of 101 samples, cultural analysis was also&nbsp;performed with different culture media. Four different diagnostic combination were developed, with different mix of the&nbsp;tested parameters. A high correlation was found between OM and UF-1000i (r=0.99; mean bias, -4.9/&mu;L). The&nbsp;diagnostic agreement was 0.90 in adults and 0.97 in children. The diagnostic agreement between CSF culture and&nbsp;bacterial count by UF-1000i was 0.98, with 1.00 sensitivity and 0.98 specificity. Results showed that the diagnostic&nbsp;combination based on CSF glucose and total proteins, cytometric analysis (leukocyte count &plusmn; neutrophilia) and&nbsp;bacterial count on UF1000i exhibited the best performance when compared with microbiological examination (area&nbsp;under ROC curve, 1.00). In conclusion, the results of this study show that the combination of two rapid clinical&nbsp;chemistry tests such as glucose and total proteins with UF-1000i analysis could represent a valid approach for&nbsp;supporting more complex analyses or even for replacing OM and CSF culture during stat examination and to achieve&nbsp;a quick detection of central nervous system infections.</p>
Biochimica Clinica ; 38(3) 208-212
Contributi scientifici - Scientific Papers
Evaluation of Sysmex XE-2100 for enumeration and differentiation of cellular elements in peritoneal and pleural fluids
<p>The aim of this study was to evaluate the performance of Sysmex XE-2100 for automated flow cytometric analysis of<br />biological fluids. The results of 106 consecutive peritoneal samples and 20 pleural samples were compared with&#160;optical microscopy. A good agreement was found in total nucleated cells (TNC) count between Sysmex XE-2100 and&#160;manual microscopy (y=0.98x+3.2, r=0.99; mean bias, -9.5 TNC/&#956;L). The percentage of cells with high fluorescence&#160;in XE-2100 correlated with that of macrophages and mesothelial cells at microscopy (r=0.67; P &lt;0.001). The CV of&#160;TNC determination on XE-2100 ranged between 1.6% and 11.7%. At the 20% CV, the analytical sensitivity of XE-2100 was 29/&#956;L for TNC, 50/&#956;L for polymorphonuclear leukocytes (PMN) and 66/&#956;L for mononuclear elements. The&#160;linearity between 30 and 944 TNC/&#956;L was excellent (r=0.998, P &lt;0.001), whereas the carry-over was &lt;1%. At&#160;thresholds of &#8805;250 PMN/&#956;L in peritoneal fluid and &#8805;50% PMN or &#8805;50% lymphocytes in pleural fluid, the diagnostic&#160;accuracy of XE-2100 was 96.8%, with Cohen's kappa of 0.90 (P &lt;0.001). We conclude that automated flow&#160;cytometric analysis on Sysmex XE-2100 may be a viable options for screening of peritoneal and pleural fluids.</p>
Biochimica Clinica ; 37(4) 275-278
Contributi Scientifici - Scientific Papers