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Editor-in-chief
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
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada


Publisher
Biomedia srl
Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

Editorial Secretary
Chiara Riva
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282
email: biochimica.clinica@sibioc.it

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



BC: Articoli scritti da S. Buoro

Identificazione di positività al SARS-CoV-2 attraverso metodi di Machine Learning sui dati dell’esame emocromocitometrico: validazione esterna di modelli allo stato dell'arte
Identification of SARS-CoV-2 positivity using machine learning methods on blood count data: external validation of state-of-the-art models.
<p>Introduction: The aim of the paper is to present the results from the process of external validation of a number of machine learning (ML) models that had been previously developed to detect SARS-CoV-2 virus positivity on both symptomatic and asymptomatic patients on the basis of the complete blood count (CBC) test.<br />Methods: Briefly, models were trained using a dataset of 816 COVID-19 positive and 920 negative cases collected at the emergency departments of IRCCS Hospital San Raffaele and IRCCS Istituto Ortopedico Galeazzi. 21 parameters, including the results of the CBC analysis, age [60.9 (0.9) years], gender (57% males) and the presence of COVID-19 related symptoms were used. The validation regarded the evaluation of the error rate (through different metrics, including accuracy, sensitivity, specificity and the area under the curve (AUC)) of the models considered. This external validation was conducted on two well balanced datasets coming from two different hospitals in Northern Italy: Desio hospital and Bergamo Papa Giovanni XXIII hospital. 163 positive and 174 true negative patients from Desio, and 104 positive and 145 true negative from Bergamo were included in the validation.<br />Results: The performance of the predictive models is satisfactory as we can report an average AUC of 95% for both external datasets.<br />Conclusion: ML models have been applied to hematological parameters for a more rapid and cost-effective detection of the COVID-19 disease. We make the point that validated models may be useful in the management and early detection of potential COVID-19 patients.</p>
Biochimica Clinica ; 45(3) 281-289
Contributi Scientifici - Scientific Papers
 
Rischio clinico ed ematologia di Laboratorio: è possibile affidarsi al solo Volume Corpuscolare Medio per scoprire l’errata identificazione del paziente?
Clinical risk management in laboratory haematology: is Mean Corpuscular Volume a reliable marker to recognize identification errors?
M. Berardi  |  F. Balboni  |  S. Buoro  | 
<p>Identification errors in laboratory medicine are a major issue. Delta checks rules have a fundamental function to identify this type of errors. In the haematology section of the laboratory, the mean corpuscular volume (MCV) is one of the parameters which delta checks rely on. Unfortunately, this approach is sub-optimal since many patients show similar MCV. We present here a case illustrating the problem and the potential drawbacks for patient safety.</p>
Biochimica Clinica ; 45(1) e4-e6
Casi Clinici - Case Report
 
Indagine conoscitiva sulla qualità del referto dell’esame emocromocitometrico
A survey on the quality of the hematological reporting among the Italian laboratories
<p>Introduction: the Working Groups &ldquo;Hematology&rdquo; and &ldquo;Extra-Analytical Variability&rdquo; of the Italian Society of Clinical Biochemistry (SIBioC) promoted a survey investigating the quality of the complete blood count reporting among Italian Laboratories.<br />Methods: the survey included 36 questions and was sent to all the SIBioC members. 251 laboratories participated in the survey.<br />Results: there is a full concordance in reporting the traditional parameters (leukocytes, erythrocytes and platelet count, hemoglobin, hematocrit and the calculated indices, plus the leukocytes differential count), while other relatively new parameters, like the mean platelet volume (MPV) and the platelet distribution width (PDW) are reported by 70% of the laboratories. A low percentage of laboratories (20-30%) do not report the presence of abnormal cell populations, if detected (blasts, immature granulocytes, plasma cells, prolymphocytes and erythroblasts). 70% of laboratories do not report the erythrocyte and leukocyte related parameters available on the new analyzers. Specific reference intervals for gender and age are adopted by 68% of the laboratories, but only 50% have instrument-specific intervals. 83% of the laboratories include interpretative comments in the report, but only in less than half of them these are harmonized according to the recent available recommendations. 83% of the laboratories have a shared document to manage critical values, that are communicated to the requesting physician by 90% of the laboratories.<br />Discussion: activities promoted by the SIBioC Hematology working group to harmonize the hematological report have been effective on traditional parameters reporting with a substantial improvement compared to the 2014 survey. Two issues remain however unresolved: the inclusion of interpretative comments and of the recent available parameters in the report.</p>
Biochimica Clinica ; 44(2) 129-142
Contributi Scientifici - Scientific Papers
 
Valutazione delle prestazioni analitiche dei conteggi cellulari in automazione su liquidi biologici mediante un programma di controllo di qualità dedicato
Evaluation of the analytical performances of the cell counting on biological fluids using a dedicated program of quality control
<p>Introduction: the development of new technologies in the era of information technology and digitization has certainly influenced the clinical laboratory and quality management system. The aim of this work is to verify the utility of a dedicated software (SNCS - Sysmex, Inc. Kobe, Japan) for the improvement of quality control management procedures of quantitative parameters obtained by the automated cell counting in biological liquids.<br />Methods: the measurements were performed on the XN &quot;Body Fluid Mode&quot; (XN-BF) analytical system (Sysmex, Inc. Kobe, Japan) according to the manufacturer&#39;s specifications. The parameters that can be included in the report using this mode are the total nucleated elements count, the leukocyte count, the differentiation of mononuclear from polymorphonuclear cells and the erythrocyte count.<br />Results: our study included: a comparative evaluation between the laboratory CVs and the CV of an international homogeneous group; a retroactive evaluation from the SNCS software using the standard deviation index and the precision index used as accuracy and precision measurements. Finally, a daily comparison was made between the Levi-Jennings cards of the instrument and the SNCS intra-day report, to improve the timely evaluation of the random error.<br />Conclusion: using the SNCS software, the performance of the analyzers can be precisely monitored and compared on an internaional basis. Its utility lies in the possibility of comparing internal performances with those of a group of laboratories using the same instruments and the same controls, allowing the quantification of the analytical bias.</p>
Biochimica Clinica ; 44(1) 028-035
Contributi Scientifici - Scientific Papers
 
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
 
Esame emocromocitometrico: telemedicina e competenze
S. Buoro  |  G. Da Rin  | 
Biochimica Clinica ; 43(3) 348-350
Lettere all'Editore - Letters to the Editor
 
Sicurezza del paziente e rischio clinico nel processo ematologico di laboratorio
Patient safety and clinical risk in the clinical laboratory haematological process
<p>&nbsp;Patient safety, defined as the prevention of harm to patients, is the ultimate goal for medical laboratories. Risk management principles should therefore be considered an integral part of laboratory processes, especially of those activities directly impacting on patient care. This work aims to identify the most critical phases of haematological process and the risk reduction actions that improve patient safety. Risk analysis of the laboratory haematological process was carried out through Failure Mode, Effects and Analysis Criticality methodology. A form including the phases of the process, error modes and their possible effects, errors occurrence, detectability and severity scores and risk index (RI), has been prepared and sent to eight Italian laboratories. A multidisciplinary team performed the analysis in each laboratory, then two team leaders of the project comprehensively analysed the collected data. The process was divided in 8 phases (medical prescription, request acceptance, sample collection, transportation, reception and processing, results reporting and validation), 25 activities (17 pre-analytical, 4 intra-analytical, 4 post-analytical) and 43 failure modes. RI, calculated for each activity, ranged from 11 to 33. The most critical topics (RI &gt;25) were: patient identification, peripheral blood smear review, interpretative comments and report validation. Staff training plays a central role in the entire laboratory haematological process and in the phases identified as critical. An effective management related to the attainment and maintenance of skills represents the best action in order to reduce risks of adverse events for patients. The promotion of procedures aimed to harmonize the interpretative comments and peripheral blood smear review is also pivotal</p><p>&nbsp;</p>
Biochimica Clinica ; 42(4) 300-312
Contributi Scientifici - Scientific Paper
 
Tre neonati con sindrome di Down ed alterazioni ematologiche
Three neonates with Down syndrome and hematological abnormalities
<p>Three neonates with Down syndrome and hematological abnormalities. We report three cases of neonates with Down syndrome. In the first newborn, the complete blood count (CBC) showed leukocytosis (30x109/L). The presence of rare blasts, with morphological characteristics attributable to megacaryocytic blasts, were appreciated at the review of peripheral blood. In the second case the patient was hospitalized for severe anemia and neutropenia. The visual inspection of the peripheral blood smear showed the presence of rare undifferentiated blasts. The third patient was a premature neonate, with fetal hydrops. The CBC showed 172x109/L leukocytes and anemia. The peripheral blood smear showed erythroblasts and dysplastic platelets, prevalence of blasts, some of them with cytoplasmic blebs. In the all cases the diagnosis was Transient Abnormal Myelopoiesis (TAM), rather frequent in patients with Down syndrome. It is a transient syndrome characterized by the presence of megacaryoblasts in peripheral blood and mutation of the GATA1 gene. The information obtained by the visual inspection of the peripheral smears, could be important for a correct diagnosis, especially when the CBC data are not particularly abnormal</p>
Biochimica Clinica ; 42(4) e47-e49
Casi Clinici - Case Report
 
La diagnosi di malaria: ruolo dell’esame emocromocitometrico nello screening
The diagnosis of malaria: the role of the haematology analyzers as first level screening
R. Rolla  |  G. Da Rin  |  V. Granero  |  F. Dima  |  A. Fanelli  |  S. Francione  |  C. Ortolani  |  S. Pipitone  |  S. Buoro  | 
<p>The diagnosis of malaria: the role of the haematology analyzers as first level screening. Malaria is one of the three most common infectious diseases worldwide, and is caused mainly by four species of Plasmodium: P. falciparum, P. vivax, P. malariae and P. ovale. The disease is endemic in developing countries but it is also gradually involving Western Countries like Italy. Albeit in 1970 the World Health Organization has included Italy among the malaria-free countries, malaria has become the most frequently imported tropical disease.&nbsp; Microscopic examination of the peripheral blood smear is the gold standard for diagnosing malaria. Although this test is quick, cheap and readily applicable, it has also some drawbacks such as low sensitivity and the need of qualified personnel. Therefore, an effective screening test for detecting malaria in cases with low clinical suspicion or characterized by non-specific symptoms is increasingly necessary, especially in Countries where the disease is not endemic. A new generation of hematological analyzers, whose performance may be potentially useful for the screening of subjects with suspected malaria infection has made available. Many fully-automated hematological analyzers, using different techniques (optical-cytochemical, optical fluorescence, multiangle polarized dispersion and volume-conductance-scatter), can now identify the presence of the malarial parasites in peripheral blood, producing specific cell distributions. The blood count can hence be regarded as a new diagnostic opportunity in malaria infection, since it is one of the basic investigations performed in febrile patients, and is also a simple and fast test, that can be performed in virtually all clinical laboratories.</p>
Biochimica Clinica ; 42(3) 191-209
Rassegne - Reviews
 
Utilità della determinazione della frazione delle piastrine immature nella diagnostica delle trombocitopenie autoimmuni
Role of the determination of immature platelet fraction in the diagnosis of autoimmune thrombocytopenia
<p>A 34 years old woman presented progressive severe thrombocytopenia, without major bleeding. The diagnostic tests for systemic lupus erythematosus, HIV infection and HCV infection, were negative. The platelet count was 9x10<sup>9</sup>/L, with elevated immature platelet fraction (IPF). Bone marrow aspirate was normal; the final diagnosis was immune thrombocytopenia (ITP). ITP is an autoimmune disease characterized by low platelet count in the absence of other causes of thrombocytopenia. IPF is a parameter of Sysmex hematological analyzers that measures young platelets in peripheral blood. It is elevated in peripheral platelet destruction and it is low in hypoproliferative thrombocytopenias, making it useful in differential diagnosis. This case report demonstrates the utility of IPF in diagnosis, management and follow up of ITP.</p>
Biochimica Clinica ; 42(3) e40-e42
Casi clinici - Case report
 
Indagine conoscitiva congiunta SIBioC-Medicina di Laboratorio e Associazione Italiana Pneumologi Ospedalieri (AIPO) relativa alla gestione del processo diagnostico del liquido pleurico
Results of a survey produced by the Italian Society of Clinical Biochemestry (SIBioC) and the Italian Association of Hospital Pneumologists (AIPO) concerning pleural fluid analysis
<p>The aim of this paper is to present the preliminary results of a joint project by SIBioC-AIPO working group on &ldquo;Body cavities fluids&rdquo;. The main purpose of the working group is to achieve a harmonized and shared diagnostic pathway related to pleural fluid (PF) analysis. The multistep project begins with a state of the art analysis. A survey, sent to both laboratory medicine personnel and pneumologists, was conducted between October and December 2016. The questionnaire (21 questions) was made available through the web-based SurveyMonkey platform. Overall, 408 replies were collected, 40.4% from laboratory medicine specialists, 3.2% from laboratory technicians, 49.3% from pneumologists and 7.1% from professionals with non-specified qualification. Regarding the pre-analytical phase, the most critical issue resulted to be the clinical query, due to the lack of structured communication between clinicians and laboratory personnel. While over 76% of laboratory professionals stated that the working diagnosis was unavailable, 87% of pneumologists affirmed that the clinical question had been forwarded to the laboratory. An important issue was the widespread use of inappropriate containers for PF collection (60% of inappropriate tubes). Regarding the panel of tests, a satisfactory agreement was reached on the need to perform macroscopic analysis and cytometric evaluation, along with the assessment of pH, glucose, total proteins, lactate dehydrogenase and the respective ratios between PF and serum concentrations. As expected, the availability of verified or validated analytical methods, notably pH analysis, has emerged as a critical point. The layout of the laboratory report also needs improvements and better harmonization. Despite the many critical issues emerged from this survey, a positive feedback was reflected by a notable general interest on PF analysis, leading thus the way to produce a joint consensus document involving clinicians and laboratory personnel, as suggested by more than 30% of responders.</p>
Biochimica Clinica ; 42(2) 119-130
Contributi Scientifici - Scientific papers
 
Conteggio e contenuto di emoglobina reticolocitario in un caso di grave anemia
Reticulocyte count and hemoglobin content in a case of severe anemia
<p>A 4 years old child from Sry Lanka was admitted in our hospital after several blood transfusions for severe anemia in her country. Very low hemoglobin (65 g/L) and ferritin (&lt;1 ng/mL) concentrations were detected, consistent with iron deficiency anemia. The reticulocyte count and the hemoglobin content (Ret-He) were low (49,20x10<sup>9</sup>/L and 13.7 pg respectively). An important number of causes of iron deficiency anemia were excluded. The patient was treated with iron infusion for two weeks, with good recovery of hemoglobin levels iron stores, Ret-He and reticulocyte number. The patient was then treated with oral iron supplementation, but a considerable decrease of Ret-He and reticulocyte count was observed, so the infusive therapy was reintroduced. Diagnosis and treatment were optimized by the synergy between the clinical laboratory and pediatricians, utilizing these hematological parameters. The blood transfusions could thus be stopped and the bone marrow biopsy could be avoided. This case demonstrates the importance of the reticulocyte count and the Ret-He in the management of iron deficiency anemia.</p>
Biochimica Clinica ; 41(2) e09-e12
Casi clinici - Case report
 
Attività di SIBioC - Medicina di Laboratorio e soddisfazione dei soci: risultati di un questionario
Survey on the satisfaction of SIBioC members on the society’s activities
S. Buoro  |  M. Ciaccio  |  F. Ceriotti  | 
<p>This report presents the results of a survey performed on Oct-Nov 2015 on SIBioC member satisfaction. The survey addressed event attendance/received value, networking opportunities and overall benefit of SIBioC membership. An on-line questionnaire was sent to all SIBioC members through the web-based SurveyMonkey platform and the resulting database was statistically analyzed. The respondents (514 out of 2000 members) can be considered a representative sample of the associates, since different professional branches were represented proportionally. The large majority of respondents were familiar with SIBioC Newsletter and expressed a positive opinion on it. 71% of the respondents declared to access the official website from 1 to 5 times per month. Finally, 50,8% of respondents declared that they were aware of the existence of Lab Tests Online (LTO) website, with the majority of them (78.2%) being satisfied with it. Overall, the survey data showed a good level of satisfaction with SIBioC educational offer. The only aspect not completely positive was the limited knowledge of LTO, despite the large investment made on it by the society. Regarding the current scenario of reorganization of the laboratory network, many respondents addressed specific requests related to both enhancing the ad hoc education and improving the dialogue with institutions and other scientific societies. In these two fields, SIBioC is currently putting large efforts. Overall, the survey gave a positive feed-back stimulating the SIBioC management to further ameliorate the service to members, with the aim of contributing in continuously improving the quality of laboratory services and then the patient care.</p>
Biochimica Clinica ; 41(1) 096-101
Documenti - Documents
 
Confronto tra l’applicazione “body fluid” di due analizzatori ematologici e il metodo in microscopia ottica per l’analisi cellulare del liquido cefalorachidiano
Comparison between “body fluid” mode of two hematology analyzers and the microscopy method for cellular analysis of the cerebrospinal fluid
M. Seghezzi  |  T. Mecca  |  P. Dominoni  |  E. Lochis  |  C. Saleri  |  B. Manenti  |  A. Crippa  |  S. Buoro  | 
<p>In the cerebrospinal fluid (CSF), the white blood cell count (WBC) and cell differentiation in mononuclear (MN) and polymorphonuclear (PMN) cells are useful tools in the diagnosis of central nervous system disease. We evaluated the analytical performance of the &ldquo;body fluid&rdquo; module of the hematology analyzers Mindray BC-6800 and Sysmex XN-9000 in the cytometric analysis of the CSF. 110 CSF samples were collected and analyzed with BC-6800, XN-9000 and evaluated by optical microscopy (OM). The diagnostic concordance between each analyzer and OM, as well as between the two analyzers were evaluated.The comparison between each analyzer and OM showed correlation coefficients ranging from 0.65 to 0.99 and bias ranging from 0.06x10<sup>6</sup> cell/L to 19.9x10<sup>6</sup> cell/L. The comparison between BC-6800 and XN-9000 showed a good correlation for total cell counts, WBC, MN and PMN (both in absolute and percentage values) with a correlation coefficient ranging from 0.83 to 0.98 and bias ranging from -0.2 to -43.8x10<sup>6</sup> cell/L. The introduction of automated methods for CSF analysis could be very useful in the routine work of a laboratory analysis.</p>
Biochimica Clinica ; 40(4) 322-327
Contributi scientifici - Scientific Papers
 
I commenti interpretativi nel referto ematologico di laboratorio
Interpretative comments in the laboratory hematology report
<p>Interpretative comments in the laboratory reports&nbsp;can improve the quality of diagnostic information. The complete blood count with differential (CBC-diff) is one of the&nbsp;hematology laboratory tests with demonstrated clinical usefulness. CBC-diff may include a peripheral blood smear if&nbsp;numerical or morphological review criteria are fulfilled. As such, hematologists need specific skill for interpreting and&nbsp;conveying the diagnostic information to clinicians by using adequate communication approaches. A survey carried&nbsp;out by the SIBioC Diagnostic Hematology Study Group (GdS-DE) showed a heterogeneous situation about the use&nbsp;of the hematological interpretative comments. In each laboratory, different descriptions were used even for the same&nbsp;cell abnormalities. Moreover, some laboratories omit to report relevant morphological abnormalities, such as&nbsp;activated or atypical lymphocytes as well as immature granulocytes, which are often necessary for the diagnosis.&nbsp;Therefore, the GdS-DE has decided to select appropriate comments and to propose a standardized reporting system.&nbsp;First, 423 comments from 13 laboratories were analyzed. These comments were revised with the purpose of: a)&nbsp;reducing the number, b) standardizing the language, c) providing an information in a format that could be easily&nbsp;understood by patients and clinicians, and d) increasing the quality of clinical information. The GdS-DE decided to&nbsp;provide written information for both physicians and patients or for physician&rsquo;s use only. The former is represented by&nbsp;59 comments using a simple and not frightening language, whereas the latter is a letter for the physician in which&nbsp;more specific information is provided.</p>
Biochimica Clinica ; 40(3) 255-269
Documenti SIBioC - SIBioC Documents
 
La diagnostica ematologica nel laboratorio clinico tra evoluzione tecnologica, analisi morfologica e tecniche innovative
The laboratory in hematology diagnostics between new technologies, morphological analysis and innovation
A. Marini  |  S. Buoro  |  M. Panteghini  | 
Biochimica Clinica ; 40(3) 177-179
Editoriale - Editorial
 
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
 
Valutazione multicentrica dei conteggi cellulari ottenuti con 8 analizzatori ematologici automatici
Multicenter evaluation of blood cell counts on 8 automated hematology analyzers
<p>The cellular analysis&nbsp;performed on hematology analyzers is based on the interaction of cells with electrical or optical signals. The&nbsp;heterogeneity of adopted methods and technologies by different analyzers can translate in a lack of homogeneity in&nbsp;analytical performance. This study compares 8 hematological analyzers vs. optical microscopy (OM) and, where&nbsp;possible, also compares the analyzers among each other. Correlations were assessed by Pearson&#39;s coefficient of&nbsp;correlation, Passing and Bablock regression and Bland-Altman bias plot analysis. The comparison among analyzers&nbsp;regarding leukocyte differential counts showed a good level of agreement, except for the basophil cell count. For this&nbsp;&ldquo;critical population&rdquo;, the bias ranged from -5,8% (Cell-Dyn Sapphire vs. XN-9000) to 30,6% (Advia 2120i vs. XE-2100). The comparison between automated differential leukocyte counts and OM showed also a good level of&nbsp;agreement, with a bias ranging from -0,9% to 8.9%. The bias for basophil cell count was however very high (79.5%).</p>
Biochimica Clinica ; 40(3) 195-203
Contributi scientifici - Scientific Papers
 
Armonizzazione del referto ematologico con l’impego di unità di misura conformi al Sistema Internazionale
Harmonization of the hematology test report by using units according to the International System (SI)
<p>The&nbsp;need for harmonizing hematology reporting units remains an important challenge for the clinical laboratory community.&nbsp;In 2014, the SIBioC Diagnostic Hematology Study Group (GdS-DE) carried out a survey to assess the state-of-the-art&nbsp;of the Italian hematology laboratories. The survey showed that the majority of laboratories report results using units of&nbsp;measurement that do not conform to SI. In some European countries, initiatives to harmonize hematology reporting&nbsp;units were taken some years ago. In particular, in the UK for the reporting of laboratory hematology results the SI units&nbsp;have been used since April 2013 (this includes hemoglobin and mean corpuscular hemoglobin concentrations in g/L).&nbsp;The aim of this GdS-DE proposal is to advocate a national initiative for promoting the adoption of SI units for&nbsp;hematology reporting. This will optimise the comparability of results among different laboratories and prevent the&nbsp;misinterpretation of data, which may worsen the patient&#39;s outcome.</p>
Biochimica Clinica ; 39(6) 627-630
Opinioni - Opinions
 
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
 
Stato dell’arte della diagnostica ematologica nei servizi di Medicina di Laboratorio in Italia
State of the art of diagnostic hematology in clinical laboratories in Italy
<p>One of the challenges for laboratories&nbsp;performing diagnostic hematology is the harmonization of diagnostic process. This is a consequence of the rapid&nbsp;technological advancement that has characterized the recent development of automated blood cell counters, with&nbsp;new automation models and new types of parameters provided. In this context, the SIBioC Study Group of Diagnostic&nbsp;Hematology has conducted a survey among Italian laboratories. The aim was to focus on the different ways of&nbsp;organizing the service. The questionnaire consisted of 36 questions, made available on the SIBioC website for&nbsp;members and non members of the society. Responses were received via e-mail, regular mail or fax from 78&nbsp;laboratories. The survey showed differences among laboratories with regard to the organizational models adopted,&nbsp;degree of automation and completeness of final laboratory reports. However, a relative homogeneity in the validation<br />rules, review rate, turnaround time and amount and type of available resources was observed. An unexpected finding&nbsp;was the low relevance that the majority of laboratories gave to the occurrence of atypical lymphocytes, thus not&nbsp;reporting the presence of these cells in interpretative comments.</p>
Biochimica Clinica ; 39(1) 025-040
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
 
L’analisi del liquido cefalorachidiano
Cerebrospinal fluid (CSF) analysis
<p>The laboratory investigation of CSF has been developed over the years as a&nbsp;diagnostic tool for many neurological diseases. Although minimally invasive, CSF is obtained with a traumatic&nbsp;procedure; therefore, the whole laboratory process should be established to maximize the analytical performance.&nbsp;Based on the review of international guidelines and on the experience developed by members of the SIBioC Working&nbsp;Group, the present document provides practical information for laboratory professionals to better address the CSF&nbsp;analysis in different diagnostic situations. The report faces the pathophysiologic meaning of the determination of&nbsp;biochemical parameters, such as glucose, lactate, albumin, immunoglobulins, <span style="font-family:symbol">b</span>-amyloid, tau protein, and the cellular&nbsp;content, providing also evidence on the proper methodological approach. Quantitative and qualitative CSF parameters&nbsp;useful to diagnose an inflammatory process of the central nervous system are discussed, particularly with reference to&nbsp;multiple sclerosis. Indications on how laboratory data should be presented to meet international recommendations are&nbsp;also included.</p>
Biochimica Clinica ; 38(3) 238-254
Documenti - Documents
 
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
 
Elementi utili per implementare un sistema per il controllo dell'accuratezza dei risultati nella diagnostica di SARS-COV-2 (RNA virale, antigeni e anticorpi)
Useful elements for implementing a system to control the accuracy of results in the diagnosis of SARS-CoV-2 (viral RNA, antigens and antibodies)
<p>As SARS-CoV-2 swiftly spread globally becoming a pandemic, the urgent need to provide a laboratory diagnosis of the infection - to allow both the clinical management of individual patients and to monitor the outbreak in the community by health authorities - arose. This resulted in a rapid development of diagnostic tests - promptly available on the market - including methods for the direct detection of the virus in biological samples (molecular and antigenic tests) and for indirect detection by documenting a contact with SARS-CoV-2 (serological antibodies tests). To fast-track the availability of these tests, an &quot;emergency&quot; authorization was issued for their use in medical laboratories, which then resulted in the urge to verify their reliability and to monitor carefully their performances, in order to avoid the risk to provide inaccurate results. This document illustrates the main potential sources of error, which can be pre-pre-analytical (i.e. test utilization in an incorrect diagnostic window), pre-analytical (i.e. incorrect collection, manipulation, sample transport and storage), analytical (i.e. pipetting errors during manual sample dispensing, incorrect RNA extraction, cDNA synthesis and amplification) and post-analytical (i.e. incorrect test report and interpretation). Furthermore, the key elements for creating a system to keep continuously under control these potential sources of error are presented, both implementing an adequate control of the</p>
Biochimica Clinica ; 17(1)
Opinioni - Opinions
 
Errori di identificazione del paziente: un progetto SIBioC orientato alla gestione di un problema persistente
Wrong blood in tube: a SIBioC project for a persistent problem
A. Aita  |  A. Padoan  |  R. Guerranti  |  M. Fiorini  |  C. Bellini  |  F. Tosato  |  M. Pelloso  |  E. Piva  |  R. Pajola  |  M. Lorubbio  |  B. Cremonesi  |  A. Bassi  |  R. Rolla  |  G. Introcaso  |  M. Plebani  |  S. Buoro  |  F. Balboni  | 
<p>Introduction: recently, multi-analytes delta-check (MDC) has been proposed as a more effective tool in identification errors (IE) prevention. In this context, &ldquo;Haematology&rdquo; and &ldquo;Clinical Risk&rdquo; SIBioC working groups launched a project aiming to develop a cell blood count (CBC) MDC. This work is aimed to describe the project and some preliminary results.<br />Methods: the project consists of four phases: collection of CBC results from 15 Italian laboratories to create an original dataset (OD); pilot study on a smaller dataset (SD) i.e., creation of an artificial mix-up dataset-MD containing IE by casual resampling of the SD and identification of the best statistical model to create a MDC; identification of the most accurate MDC on OD; testing the MDC in involved labs and verification of its effectiveness.<br />Results: the SD included 2,367 pair of consecutive results for the same patient (patients&rsquo; age: 0-100 years; the majority of repetitions were within days). The SD casual resampling generated a MD with 2,000 pair of patient-mixed consecutive results. When one of the most frequent used delta-check alert (&Delta;MCV=7fL) was applied to detect IE in MD, the method accuracy was low (AUC=0.542). On the contrary, testing of a multivariate model, obtained by a stepwise logistic analysis, allowed to obtain a more accurate MDC in IE detection (AUC=0.931, sensitivity=91.6%, specificity=94%).<br />Conclusions: MDC may offer a practical strategy to identify IE prior to test reporting, improving patient safety. However a good planning of project workflow, selection of methodology, tools and staff competence are key elements to reach the objectives.</p>
Biochimica Clinica ; 17(1)
Contributi Scientifici - Scientific Papers
 
Ruolo del laboratorio nella diagnostica differenziale di un grave caso di anemia
The role of the clinical laboratory in the differential diagnosis in a patient with severe anemia
M. Seghezzi  |  A. Carobene  |  S. Buoro  | 
<p>A male, 54 years old, presented to the emergency department of Bergamo Papa Giovanni XXIII hospital, with confusion and neurological symptoms.<br />The peripheral blood cells count, performed on the Sysmex XN-20, showed a severe macrocytic anemia: hemoglobin 42 g/L, mean corpuscular volume 107 fL, accompanied by the morphology flag &ldquo;fragments&rdquo;. The morphological evaluation on the blood smear, strongly recommended with a blood cell count showing such values, confirmed the presence of erythroblasts, and revealed several morphological alterations (remarkable anisopoikilocytosis, basophilic stippling, hypersegmented neutrophils). The patient was admitted to the hospital and transfused. Further investigations showed a severe deficiency of vitamin B12, an abnormal lactate dehydrogenase activity, and an undetectable haptoglobin concentration. After the transfusions, the patient recovered quickly, and was able to report about a previous gastric resection; the information was missed at admission because of the patients confusional state. The possibility of metal poisoning or cupper deficiency were not investigated.</p>
Biochimica Clinica ; 17(1)
Casi clinici - Case report