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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

Editorial Secretary
Andrea di Bello
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282


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

BC: Articoli scritti da M. Plebani

Approcci diagnostici innovativi per le malattie infiammatorie croniche intestinali
New diagnostic approaches for inflammatory bowel diseases
<p>Inflammatory bowel diseases (IBD), that include ulcerative colitis (UC) and Crohn&rsquo;s disease (CD) are among the most serious and perplexing digestive diseases. Indeed, diagnosis is sometimes delayed due to the variability and subtlety of its initial manifestations, especially in CD. Since no gold standard is currently defined for the diagnosis and monitoring of IBD, a number of genomic, metabolomic and proteomic studies have tried to address this issue. After illustrating the traditional diagnostic approach (mainly fecal calprotectin), this Opinion Paper reports about the utility of some new biomarkers (micro-RNA, proteomic and metabolomic markers). In particular, the results of a study on fecal peptides are commented. After verifying that proteolytic degradation was clearly visible in fecal samples of a number of control (n=34) and patients with IBD (n=133), the matrix-assisted laser desorption ionization (MALDI) time of flight (TOF) mass spectrometry was used to evaluate peptides patterns of fecal samples, in a range from 1000 to 4000 Da. This cohort was used to derive an algorithm for IBD diagnosis. Diagnostic performances were then estimated using an additional validation cohort, including subjects with IBD (n=42) and without IBD (n= 28). Sensitivity was 54.8% (95%CI: 38.7%&ndash;70.2%) and specificity 96.4% (95%CI: 81.7%&ndash;99.9%) with a positive and a negative predictive value of 95.8% (95%CI: 76.7%&ndash;99.4%) and 58.7% (95%CI: 50.3&ndash;66.6%), respectively. In comparison, fecal calprotectin, achieved sensitivity and specificity of 78.6% (95%CI: 63.2%&ndash;89.7%) and 42.9% (95%CI: 24.5%&ndash;62.8%). In spite of the obtained good diagnostic performances, any candidate biomarker, once identified, should be carefully validated before being translated into clinical practice.</p>
Biochimica Clinica ; 45(1) 052-056
Opinioni - Opinions
Cinetica e caratteristiche biologiche della risposta umorale all’infezione da SARS-CoV-2: implicazioni vaccinali
Kinetics and biological characteristics of humoral response developing after SARS-CoV-2 infection: implications for vaccination
<p>With the ongoing coronavirus disease 2019 (COVID-19) pandemic outbreak spreading all around the world, an extensive vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is now universally regarded as one of the most effective strategies for counteracting the unremittent spread of this novel coronavirus. Nonetheless, the reasonable need to identify segments of the population in which vaccination shall be prioritized for avoiding a possible shortage of vaccines seems to collide with indications provided by many national and international healthcare organizations, that endorse widespread vaccination irrespective of a positive history of prior symptomatic or asymptomatic SARS-CoV-2 infection. To this end, this document provides an ad interim guidance aimed at prioritizing SARS-CoV-2 vaccination in people who are more likely to be infected, re-infected and/or to develop more aggressive COVID-19 illness, essentially based on routine assessment and monitoring of anti-SARS-CoV-2 immune response.</p>
Biochimica Clinica ; 45(1) 087-090
Documenti SIBioC - SIBioC Documents
Diagnosi biochimica precoce di preeclampsia: un traguardo possibile?
Biochimica Clinica ; 45(1) 011-012
Editoriale - Editorial
I micro-RNA quali potenziali biomarcatori per la diagnosi e la prognosi del cancro del pancreas: scelte metodologiche e criticità
Micro-RNAs as potential diagnostic and prognostic biomarkers in pancreatic cancer: methodological choices and issues
<p>Pancreatic cancer is the fourth cause of the death by cancer worldwide. It remains the only cancer whose survival has not improved in the last 40 years (only 18% of patients are still alive after 1 year, and 5% after 5 years), because of the high metastatic capacity and chemoresistance of the tumour. Complete tumour resection offers a chance to improve prognosis, but only 20% of patients are suitable for surgery. Although carcinoembryonic antigen (CEA) and carbohydrate antigen 19-9 (CA 19-9) are commonly used biomarkers in clinical practice, they are not sufficiently sensitive and specific for early diagnosis neither for predicting response to treatment. The search for biomarkers for early diagnosis, post-operative surveillance and prognosis prediction is therefore fundamental in the context of pancreatic cancer.<br />Circulating micro-RNAs (miRNAs), emerging regulators of gene expression, have been reported by several studies as powerful non-invasive biomarkers in the pancreatic cancer setting, because of their presence and stability in human body fluids. Distinctive miRNAs expression profiles have been associated to pancreatic cancer; furthermore, changes in their expression seems to identify cancer development and response to treatment. Although many papers have been published in this field, the results are still controversial and no consensus has reached about sample type, methodologies and protocols to be adopted thus hampering their introduction into routine practice. This paper aims to summarize the methodological choices in the analysis of circulating miRNAs with particular focus on the critical points of the different phases of the process.</p>
Biochimica Clinica ; 45(1) 026-034
Rassegne - Reviews
Raccomandazioni ad interim di SIBioC per l’analisi sierologica dell’infezione da SARS-CoV-2
Ad interim SIBioC recommendations for serological assessment of SARS-CoV-2 infection
<p>The recent pandemic outbreak caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and associated with the pathology called COVID-19 (coronavirus disease 2019), has now become one of the most strenuous health care challenges since the emergence of the three pandemics caused by influenza viruses during the past century. Throughout the clinical decision-making of COVID-19, laboratory tests are essential for supporting the screening, diagnosis, prognostication and therapeutic monitoring of this severe infectious disease. Serological testing, that reflects the humoral immune response developing after interaction between the host and the virus (or its components), enables to garner a vast array of clinical information which can be especially used in seroprevalence or seroconversion studies. To this end, the Task Force on COVID-19 of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) has endorsed a series of technical, practical and clinical ad interim recommendations, aimed at facilitating and optimizing the introduction, clinical usage and governance of SARS-CoV-2 serological immunoassays in routine practice.</p>
Biochimica Clinica ; 45(1) 091-099
Documenti SIBioC - SIBioC Documents
Il valore della medicina di laboratorio nella pandemia da SARS-CoV-2
The value of laboratory medicine in SARS-CoV-2 outbreak
M. Plebani  | 
<p>Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) represents a challenge to all heathcare systems. It represents, however, a formidabile opportunity to highlight the value of laboratory medicine. Laboratory tests, in fact, play a key role in allowing the etiological diagnosis thanks to the reverse transcription-plymerase chain reaction (rRT-PCR) to detect the virus in nasopharingeal specimes as well as in other samples collected by using a flocked swab. The second essential contribution that laboratory tests are providing encompasses staging, prognostication and therapeutic monitoring of COVID-19. Finally, serological tests play a central role for surveillance purposes, for using plasma containing antibodies from recovered patients as experimental treatment and for better understanding the immune response to SARS-CoV-2 to eventually address vaccine developments.</p>
Biochimica Clinica ; 44(4) 001-002
Medicina nel laboratorio. Gli esami: quando, come e perché
M. Plebani  | 
Biochimica Clinica ; 44(4) 410-411
Recensioni - Book Review
Polimorfismi dei geni KLK3, RASA1 e NAALADL2: rischio di cancro alla prostata, aggressività della neoplasia e livelli sierici dell’Antigene Prostatico-Specifico
Polymorphisms of KLK3, RASA1 and NAALADL2 genes: prostate cancer risk, aggressiveness of neoplasia and serum PSA levels
D. Bozzato  |  C.F. Zambon  |  A. Padoan  |  M. Pelloso  |  A. Aita  |  S. Moz  |  F. Navaglia  |  T.P. Galetti  |  F. Zattoni  |  D. Basso  |  M. Plebani  | 
<p>Background: prostate cancer (Pca) is the second most common cancer among men and the sixth leading cause of death due to cancer among men worldwide. We aimed to verify if serum PSA levels and PCa risk/aggressiveness are modulated by polymorphisms of KLK3, RASA1 and NAALADL2 genes.<br />Methods: 1058 men have been studied; they consecutively underwent prostate biopsy for clinical suspicion of PCa. PCa was histologically diagnosed in 401 and ruled out in 657 men. Gleason score in PCa patients was &le;6 in 261, 7 in 83 and &gt;7 in the remaining 57 PCa. tPSA and f/tPSA levels were determined. Four polymorphisms were studied: rs35148638 (RASA1), rs78943174 (NAALADL2), rs2735839 and rs17632542 (KLK3).<br />Results: PCa diagnosis was significantly predicted by the KLK3 rs17632542 polymorphism (p&lt;0.001), tPSA (p&lt;0.001) and f/tPSA (p&lt;0.001). Carriers of the KLK3 rs17632542C rare allele had a significantly higher risk of PCa (p&lt;0.001) (OR 2.1, 95% CI 1.40-3.19). Gleason score &gt;7 was associated with increased tPSA (p&lt;0.001), decreased f/tPSA (p=0.003) and the KLK3 rs2735839 A rare allele (p= 0.004). In controls, tPSA was significantly lower in subjects bearing NAALADL2 rs78943174T rare allele (p=0.029). f/tPSA was higher in subjects with the KLK3 rs17632542C rare allele (p&lt;0.001) and with the RASA1 rs35148638 C/C genotypes (p=0.009). In PCa subjects, tPSA was not associated with the polymorphisms studied.<br />Conclusions: KLK3 rs17632542 and rs2735839 polymorphisms were significantly associated with the risk and aggressiveness of PCa respectively. NAALADL2, KLK3 rs17632542 and RASA1 polymorphisms were correlated with tPSA and f/tPSA serum levels, suggesting a genetically-based PSA expected values in absence of tumor. These results suggest a potential role of these polymorphisms as biomarkers for PCa in association with the diagnostic and prognostic indexes currently recognized.</p>
Biochimica Clinica ; 44(4) 359-366
Contributi Scientifici - Sscientific Papers
Il futuro della Medicina di Laboratorio: un Manifesto per i suoi professionisti
Future of laboratory medicine: a Manifesto for laboratory professionals
M. Plebani  | 
<p>In the last decades, the landscape of clinical laboratories has experienced monumental changes due to both technological developments and new challenges. Laboratory medicine has been strongly influenced by technological developments, but also by a wide range of other issues such as the healthcare system organization, medical practice and, more recently, patient empowerment. In the coming decade, many and different trends will intersect, interact, and over lap each other, and with current laboratory practices. These dramatic innovations make of critical importance for leaders to prepare for a future with the understanding of possible collisions between linear trends and nonlinear external forces. The aim of the present paper is to discuss the future of clinical laboratories according to two different approaches: technological and professional viewpoints. In particular, a revised version of the &ldquo;ten points manifesto&rdquo; for the future of laboratory professionals is described, with a focus on the main drivers and efforts that should be done to demonstrate the added value and true role of laboratory medicine in modern health care systems. The main goal of the manifesto is to emphasize the central role and the vital contribution of clinical laboratories and their professionals to improved health care, patient safety and clinical outcomes.</p>
Biochimica Clinica ; 44(3) 263-269
Opinioni - Opinions
Il sedimento urinario: atlante per immagini
M. Plebani  | 
Biochimica Clinica ; 44(3) 318-319
Recensioni - Book Review
Valutazione precoce del danno cardiaco da farmaci chemioterapici: importanza della misura delle troponine cardiache I e T con metodi ad alta-sensibilità analitica
High-sensitivity cardiac troponin I and T methods for the early detection of myocardial injury in patients on chemotherapy
<p>Important advances achieved in pharmacological cancer treatment have led progressively to a reduction in mortality from many forms of cancer, and increasing numbers of previously incurable patients can now hope to become cancer-free. Yet, to achieve these improved outcomes a high price has been paid in terms of untoward side effects associated with treatment, cardiotoxicity in particular. Several recent studies have reported that cardiac troponin assay using high-sensitivity methods (hs-cTn) can enable the early detection of myocardial injury related to chemotherapy or abuse of drugs that are potentially cardiotoxic. Several authors have recently suggested that changes in hs-cTn values enable the early diagnosis of cardiac injury from chemotherapy, thus potentially benefitting cancer patients with increased troponin values by initiating early cardioprotective therapy. However, large randomised clinical trials are needed in order to evaluate the cost/benefit ratio of standardised protocols for the early detection of cardiotoxicity using the hs-cTn assay in patients treated with chemotherapy.</p>
Biochimica Clinica ; 44(3) 279-286
Documenti SIBioC - SIBioC Documents
Calcolo e valutazione dei valori di riferimento della troponina cardiaca I (cTnI) misurata in un gruppo di volontari sani italiani con metodi immunometrici ad alta sensibilità: uno studio multicentrico
Establishment and evaluation of cardiac troponin I reference values measured in a group of Italian healthy volunteers using high-sensitivity methods: a multi-center study.
<p>Introduction: this study compares the cardiac troponin I (cTnI) values measured with three high-sensitivity (hs) different methods in apparently healthy volunteers enrolled in a multicenter study.<br />Methods: heparinized plasma samples were collected from 1511 volunteers in 8 Italian clinical institutions (mean age 51.5 years, SD 14.2, range 18-86, female to male ratio 0.94). All volunteers denied chronic or acute diseases and had normal values of routine laboratory tests and ECG. The reference laboratory of the study (Laboratorio Fondazione CNR Regione Toscana G. Monasterio, Pisa, Italy) assayed all plasma samples with three hs-methods: Architect hs-cTnI, Access hs-cTnIand ADVIA Centaur XPT hs-cTnI. After the exclusion of outlier values, calculation of 99th percentile (Upper Reference Limit, URL) values was performed using both robust nonparametric and bias corrected and accelerated bootstrap methods.<br />Results: large between-method differences were found. ADVIA Centaur measured higher cTnI values (up to 2-fold) than the two other methods. cTnI values were significantly higher in men than in women, and progressively increased with age over 55 years. Moreover, 99th percentile URL values also depended on the statistical approach used for calculation (robust non-parametric versusbootstrap). All 99th percentile URL values calculated with non-parametric robust method were on average slightly lower than those suggested by manufacturers (mean difference 4.2 ng/L, standard error 1.7, p=0.0273).<br />Conclusion: clinicians should be advised that plasma samples from the same patient should be measured for hs-cTnI in the same laboratory. Specific clinical studies are needed to establish the most appropriate statistical approach to calculate 99th percentile URL values for hs-cTnI methods.</p>
Biochimica Clinica ; 44(2) S032-S047
Contributi Scientifici - Scientific Papers
La misura combinata dei biomarcatori cardio-specifici è utile nei pazienti con sospetto di malattie cardiovascolari
The combined measurement of cardio-specific biomarkers is a useful tool in patients with suspected cardiovascular disease
<p>A huge amount of experimental and clinical evidences clearly demonstrate that the measurement of cardio-specific biomarkers [cardiac natriuretic peptides (CNP), and cardiac troponins (cTns)] can significantly and independently improve the diagnostic accuracy and risk stratification in cardiovascular diseases. Furthermore, several recent studies report that the measurement of cardio-specific biomarkers has a beneficial impact also on management and outcome of patients with cardiovascular diseases. Considering the significant and independent information associated to cardio-specific biomarkers, several studies have recently reported that the combined assay of CNP and cTns may be cost effective not only for diagnosis, prognosis and treatment of cardiac disease, but also for screening in general population of individuals at high cardiovascular risk. Due to the higher cost of their measurement in comparison to other laboratory tests, the clinical appropriateness of the combined measurement of CNP and cTns should be accurately evaluated. Accordingly, an increase in clinical utilization of a laboratory test should be based not only on the peculiar pathophysiological characteristics of a biomarker, but also on the high performance of immunoassay methods used for the biomarker measurement. From a pathophysiological point of view, elevated CNP values indicate that some stressor substances or situations are having an adverse impact on cardiac function; while an increase in cTn levels above the cut-off value indicates that a sustained or powerful stress has actually produced a damage on cardiomyocytes (i.e. a myocardial injury). Consequently , the combined measurement of CNP and cTns gives complementary and distinct rather than redundant clinical information. These two distinct pathophysiological mechanisms also explain why cardiovascular risk is strongly increased in patients with both CNP and cTns elevated. In conclusions, the combined measurement of CNP and cTns is a useful tool for diagnosis, follow-up, and stratification of risk in all patients with suspected cardiac disease, especially those admitted to the emergence department.</p>
Biochimica Clinica ; 44(2) S017-S031
Rassegne - Reviews
Le troponine I e T sono biomarcatori cardiaci interscambiabili?
Are troponin I and T interchangeable biomarkers?
<p>The most recent international guidelines recommend that high-sensitivity (hs) methods should be preferred for the measurement of cardiac troponin I (cTnI) and T (cTnT) for the detection of myocardial injury and the differential diagnosis of acute coronary syndromes. Furthermore, these guidelines state that there is no significant difference in accuracy among hs cTnI and cTnT methods for diagnosis of acute myocardial infarction. Myocardial injury is a prerequisite for the diagnosis of acute myocardial infarction, but it is also a distinct entity. The 2018 Fourth Universal Definition of Myocardial Infarction states that myocardial injury is detected when at least one value above the 99th percentile upper reference limit is measured in a patient by high-sensitivity methods for cTnI or cTnT. Occasionally, discrepancies between hs-cTnI and hs-cTnT test results can be found, when tested in the same blood sample. Several studies have reported discrepancies between hs-cTnI and hs-cTnT test results in some clinical conditions (especially chronic neuromuscular diseases) or even in apparently healthy subjects. This review, summarizes and discusses the biochemical, pathophysiological and analytical possible mechanisms causing discrepancies between hs-cTnI and hs-cTnT test results.</p>
Biochimica Clinica ; 44(2) S008-S016
Rassegne - Reviews
Metodo ad alta sensibilità per la misura della troponina I ed efficienza: risultati di un'esperienza
High-sensitive method to measure troponin I and efficiency: the results of an experience
AI. Leahu  |  MM. Mion  |  A. Padoan  |  M. Zaninotto  |  M. Plebani  | 
<p>Background: the development of improved methods for cardiac troponins measurement, characterized by higher analytical sensitivity, allows to adopt rapid rule-in and rule-out strategies by increasing diagnostic accuracy and optimizing the clinical and organizational pathways.<br />Methods: the efficiency achieved with the adoption of a high sensitive troponin I method, defined by its analytical characteristics a &ldquo;new generation&rdquo; method (STAT high sensitive troponin I, hs-TnI, Abbott Diagnostics), in place of a previous assay (LOCI CTNI, Siemens Health Care Diagnostics), has been evaluated. The results obtained in 1000 consecutive patients admitted to the Emergency Department (ED) with acute chest pain, in 2015 (before the new method) have been compared with those obtained in 1004 consecutive patients admitted in 2017 (after theintroduction of the hs-TnI method).<br />Results: in 2017 an increased number of troponin I baseline values higher than 99th percentile (10.7 versus8.3% in 2015, p = 0.089) has been observed. Furthermore, an improvement on the following clinical and organizational aspects has been detected in 2017: the adoption of an accelerated algorithm, being the median interval between two consecutive measurements 3 h and 18 min in 2017 and 4 h and 30 min in 2015 (p &lt;0.001); in the 75% of patients showing either positive or negative value at admission, the second measurement has been carried out within 180 min and 225 min (p = 0.024), respectively (in 2015 the timings were 239 e 337 min, p &lt;0.001, respectively). Finally, in 2017 a third troponin I measurement has been carried out in 0.4% of patients only (it was 3.5% in 2015, p = 0.044).<br />Conclusions: These data demonstrate a significant improvement in the patient management as well as an optimization of human and organizational resources with the adoption of a method with improved analytical performances to measure troponin I in ED.</p>
Biochimica Clinica ; 44(2) S054-S058
Contributi Scientifici - Scientific Papers
Patologie cardiovascolari e troponine cardiache: la storia di un legame indissolubile
Cardiovascular diseases and cardiac troponins: the history of a lasting connection
<p>The evolution of the biochemical diagnosis of cardiac diseases, represents a paradigm of the laboratory medicine evolution in the recent years.<br />Starting from the use of poor specific and sensitive biomarkers, the &ldquo;so-called&rdquo; cardiac enzymes (aspartate aminotransferase; lactate dehydrogenase; creatine kinase) recommended by World Health Organization for the acute myocardial infarction (AMI) diagnosis, a fundamental development in biochemical knowledge has been obtained, providing new biomarkers (CK-MB, myoglobin) for a more specific and early diagnosis according to the clinical and therapeutic needs. However, the revolutionary biochemical issue has been represented by the discovery of cardiac troponins and by the implementation of methods allowing their measurement in emergency setting in patients with acute chest pain. Cardiac troponins, are characterized by an absolute cardiac specificity and by a high sensitivity that allow to carry out a timely and safe diagnosis of AMI, being recognized as &ldquo;gold standard&rdquo; in all clinical and biochemical guidelines. In patients with acute chest pain and in ischemic clinical setting, a typical kinetic release of biomarker concentration may be suggestive of AMI even if ECG typical patterns are lacking. The actual improvement in analytical performance of troponins methods, particularly in the analytical sensitivity, allows to extend the measurement also in diagnosis of minor myocardial damage in patients suffering from different cardiac disease, to monitor the efficacy of therapy, the progression of the disease and to provide prognostic information and risk-stratification in addition to the clinical pathway.</p>
Biochimica Clinica ; 44(2) S067-S073
Opinioni - Opinions
Troponina cardiaca ad alta sensibilità: risultati preliminari di un confronto tra un nuovo strumento “point-of-care” e i più comuni analizzatori impiegati nei laboratori clinici
High sensitivity cardiac troponin: preliminary results of a new point-of-care analyzer compared with the analyzers routinely used in clinical laboratories
<p>Introduction: cardiac troponin concentration measured using a point-of-care testing (POCT) analyzer could accelerate the management of patients awaiting assessment for suspected acute coronary syndrome without persistent ST-segment elevation in the emergency department (ED).<br />Methods: we evaluated a new high sensitivity cardiac troponin I (hs-cTnI) assay applied to the POCT PATHFAST&trade; (Gepa, Italia). The study of imprecision was carried out using commercial control materials and lithium-heparin plasma pools. The percentages of detectable hs-cTnI values between the Limit of Detection (LoD) and the 99th percentile as declared by the manufacturer were studied in a population of reference donors. The clinical diagnostic performance was evaluated in a population of patients presenting to the ED with chest pain (lithium-heparin plasma samples were collected at admission and 3 hours later), in comparison to the most common methods that measure hs-cTnI in clinical laboratories: Architect PLUS i2000SR, Dimension Vista, Advia Centaur XPT, UniCel DXI 800. Using the gender-specific 99thpercentile as declared from each manufacturer, the percentages of agreement and disagreement for the classification of hs-cTnI results were calculated as well as the Cohen&rsquo;s Kappa values.<br />Results: imprecision: concentration range (CV% range)=14.6-12227.3 ng/L (2.8-9.8%); % of hs-cTnI &gt;LoD and &lt;99th percentile in males and females were 30.0% and 18.5% respectively. The percentage ranges of agreement versus disagreement observed in the clinical study were 76.8-96.3% versus3.7-23.2% respectively, and the corresponding Cohen&rsquo;s Kappa values ranged from 0.532 to 0.864. The prevalence of discordant results was obtained on admission sample (range=59.1-83.3%).<br />Discussion: the observed analytical imprecision was satisfactory while the percentages of subjects with hs-cTnI&gt;LoD and &lt;99thpercentile were lower than those declared by the manufacturer because a limited number of subjects has been evaluated. The clinical performance has shown an overall satisfactory agreement with all the analytical platforms used.</p>
Biochimica Clinica ; 44(2) S059-S066
Contributi Scientifici - Scientific Papers
Valutazione del rischio cardiovascolare e del danno cardiaco asintomatico nella popolazione generale utilizzando la misura della troponina cardiaca con metodi ad alta sensibilità
Evaluation of cardiovascular risk and asymptomatic myocardial injury in the general population with high-sensitivity methods for cardiac troponin assay
<p>Only very recently the set-up of some immunoassay methods with high-sensitivity analytical performance allowed the accurate detection of cardiac troponin I (cTnI) and T (cTnT) levels in healthy adult subjects. Several studies have demonstrated the association between the risk of major cardiovascular events and cardiac troponin concentrations even for biomarker values within the reference intervals. High-sensitivity cTnI and cTnT methods enable to monitor myocardial renewal and remodelling, and to promptly identify patients at highest risk to heart failure development. An early and effective treatment of individuals at higher cardiovascular risk may revert the initial myocardial remodelling and slow down heart failure progression. Dedicated trials are needed also in Italian population to demonstrate the efficiency of general population screening by means of cost benefit analysis for individuals at higher risk for heart failure progression.</p>
Biochimica Clinica ; 44(2) S086-S096
Documenti SIBioC - SIBioC Documents
Determinazione della presepsina: non solo diagnosi di sepsi
Presepsin measurement: beyond sepsis diagnosis
G. Bragato  |  MM. Mion  |  A. Padoan  |  M. Zaninotto  |  M. Plebani  | 
<p>As sepsis is the leading cause of death among critically ill patients, early diagnosis is essential for the subsequent treatment to improve the outcome. Several diagnostic pathways have been proposed considering multiparametric approaches that combine clinical and biochemical evaluations. Among the several biomarkers proposed, procalcitonin measurement has been obtained significant consensus particularly in the evaluation of the efficacy of the therapeutic treatment. However, the need to define the prognosis and the outcome and to identify the patients at major risk of events during the hospitalization or at a short time later, seems to be an additional clinical value. The soluble cluster of differentiation 14 (S-CD14-ST or presepsin) is a free fragment of a glycoprotein expressed on monocytes and macrophages; several studies have demonstrated the significative prognostic value of the biomarker blood concentrations (at admission in particular) while the diagnostic performance of presepsin remains unclear. In a study carried out in a population of old patients (67-102 years) suffering from suspected pneumonia (n=50) the results of presepsin at admission in association with a Muldimensional Prognostic Index (MPI) score allow to identify the patients at major risk of adverse events (mortality) within 30 days. The prognostic efficiency of presepsin has been evaluated in different studies confirming, in different patient populations, the additional clinical value of this biomarker. Therefore, presepsin and prolacitonin measurements may provide complementary information that, in addition to clinical score and blood culture or molecular biology, can improve the management of patients with suspected sepsis.</p>
Biochimica Clinica ; 44(1) 068-072
Opinioni - Opinions
Droni o laboratori clinici a chilometro zero?
M. Plebani  | 
Biochimica Clinica ; 44(1) 103-105
Lettere all'Editore - Letters to the Editor
Pazienti diabetici di tipo 2, non in terapia insulinica e albumina glicata: una valutazione multidimensionale
Insuline-Naive type 2 diabetic patients: a multidimensional evaluation on the role of glycated albumin
<p>Insuline-Naa&iuml;ve type 2 diabetic patients: a multidimensional evaluation on the role of glycated albumin Introduction: glycated Albumin (GA) is an innovative glycemic marker, that could be used in the clinical practice, as an add-on strategy, to the traditional glycemic monitoring systems, such as glycated haemoglobin (Hb1Ac) and fasting plasma glucose (FPG). The study aims at presenting the results of a multidimensional analysis conducted in Italy, exploring the main clinical, economic, ethical, social and organizational implications, related to the introduction of GA. Methods: an Health Technology Assessment (HTA) approach was implemented. The analysis considered the Italian National Healthcare Service (NHS) perspective, and assumed a 12-month time horizon, focusing on type 2 diabetes patients insulin-na&iuml;ve, assuming oral therapy. The 9 HTA dimensions (derived from the Core Model developed by the European Network of HTA &ndash; EUnetHTA) were deployed, considering scientific evidence, health economics tools and qualitative approaches, through the administration of specific questionnaires to 15 diabetes experts. Results: literature reported better GA safety and efficacy profiles, thus being a predictor of the relative risk for diabetes complications development, and increasing the therapeutic success after 3 months of therapy (97.0% versus71.6%). From an economic point of view, GA introduction resulted in an economic advantage of 1.06% and in a better trade-off between costs sustained and efficacy gained. Considering a 7-item Likert Scale (ranging from -3 to +3), negative perceptions emerged with regard to equity aspects (0.13 versus0.72) due to GA limited accessibility, whereas it would improve both patients (2.17 versus1.33) and care givers (1.50 versus0.83) quality of life. In the short term, GA required training courses and equipment update, whereas, in the long term, it could be considered the preferable solution from an organizational perspective (0.30 versus0.01). Conclusions: the results of this study demonstrated GA strategic relevance, its economic sustainability and feasibility, as well as the potential clinical pathway improvement.</p>
Biochimica Clinica ; 44(1) 052-060
Contributi Scientifici - Scientific Papers
La Medicina di Laboratorio: gli specialisti di domani
Laboratory Medicine: specialists of tomorrow
<p>Laboratory Medicine rides the wave of technological progress, the metamorphosis of information systems and data management. The Young Specialist is not a mere observer, but rather takes a leading role in this change, taking advantage of the opportunities offered by &ldquo;omics&rdquo; technologies, capturing new ideas and innovative stimuli that lead to a new concept of work and research oriented to health and prevention. Thanks to the support of international web platforms, training and exchange programs supported by the International Scientific Societies and Federations that favor professional and scientific growth, Young Scientists work in a global context. In this scenario, the SIBioC Young Scientists Study Group, with the auspices of SIBioC, EFLM and IFCC, organized a meeting on &quot;Laboratory Medicine: Specialists of tomorrow&quot; with the aim of discussing and highlighting some of the most important challenges, such as technological progress, training and internationalization of young people. Finally, the future of laboratory medicine looks at a multidisciplinary approach that leads to integrated diagnosis, identification of the frail patient, the use of the Point of Care Testing as an indispensable tool in crisis areas, making the dialogue between physician and laboratory specialist a fundamental step for the diagnosis and treatment with the final aim of a better outcome for the patient.</p>
Biochimica Clinica ; 43(4) 424-434
Documenti - Documents
Ridurre l’inappropriatezza in medicina di laboratorio: come, quando e perchè
Improving appropriateness in laboratory medicine: how, when and why
<p><span style="color:rgb(33, 29, 30); font-size:9pt">The issue of the appropriateness in laboratory medicine has been discussed from several years in association to theparallel onset of two aspects: 1) the significant increase in tests demand and utilization, thanks to the developmentof laboratory automation and information laboratory systems (LIS), that allow to provide timely and reliable results toclinicians; 2) the opportunity, thanks to new pathophysiological knowledge and new technologies to introduce newand more sophisticated tests in clinical practice, providing a relevant support to the clinician in the management ofpatients, according to the improved vision of personalized medicine. As a consequence, the potentialinappropriateness in test utilization and the need to manage demand and to reduce the redundant testing havereceived increasing concern. Several papers, in the recent literature, demonstrated that the inappropriateness inlaboratory test utilization may represent a potential source of errors, and interesting strategies have been proposedand progressively adopted in order to limit this problematic outcome. An essential issue is to assure appropriatenessnot only in test request, but in all steps of the testing cycle. In particular, some of the more relevant issues has beenlinked to: rationalization of laboratory test ordering prescription, thanks to development of a computerized clinicaldecision support systems; implementation of the reflexing tests rule; definition of the minimum retesting intervalaccording to the clinical and pathophysiological criteria; timely revision of the available panel tests in order to deletethose considered obsolete from clinical and analytical point-of-view and, finally, improving the education in demandmanagement. The &ldquo;clinical laboratory stewardship&rdquo; seems to be the new and shared strategy, that guarantees notonly the appropriate utilization and interpretation of laboratory tests improving efficacy and providing efficiency but,more importantly, the future of the discipline and the role of laboratory professionals in the context of new and morecomplicated clinical and economical scenarios.</span></p>
Biochimica Clinica ; 43(3) 305-312
Documenti SIBioC - SIBioC Documents
Garantire la comparabilità dei risultati nel rispetto dei requisiti di qualità e delle esigenze organizzative: l’esempio di una procedura operativa
How to guarantee the comparability of test results in compliance with the quality requirements andorganizational needs: the example of an operative procedure
<p>Medical laboratories are responsible for the qualityof test results, also when the same patient sample is evaluated using different analytical systems within the same lab.Indeed, as stated by ISO 15189:2012, laboratories should define means to compare procedures for evaluating thecomparability of patients&rsquo; samples results within the same healthcare system. In this study we report the approachused to define a procedure for assessing results comparability, developed in our laboratory before the ISO15189:2012 accreditation in 2016. Firstly, the approach was focused on the identification of all the different situationsthat may potentially require alignment of test results within the laboratory. Therefore, after evaluating guidelines anddocuments available in the literature, we defined a workflow applicable both to quantitative and qualitative methods.For quantitative methods, bias was estimated by means of statistical analyses such as Bland Altman and PassingBablok. For qualitative methods, results comparability was assessed by concordance. Criteria for defining theacceptability of systematic errors were also included in the procedure.</p>
Biochimica Clinica ; 43(2) 135-142
Contributi Scientifici - Scientific Papers
Gli esami urgenti nel consolidamento dei laboratori: analisi decentrate, “Point-of-Care and Near-Patient testing”
Urgent testing and laboratory consolidation: Extra-laboratory, Point-of-care and Near-Patient testing.
M. Plebani  | 
<p>Urgenttests requesting is variable across different institutions in the same country and at international level. The percentageof urgent testing has been found to be about 33% in Italy, but only some of these tests are really related to clinicalneeds. Various reports are available to document the growth of extra-laboratory testing, otherwise referred to as nearpatient, bedside or Point-of-Care testing (POCT). The key objective of extra-laboratory testing, particularly POCT, isto generate a result quickly so that appropriate treatment can be implemented rapidly, but few data are available todemonstrate an effective improvement in operational and clinical outcomes. This paper sets out the requirements fordelivering an effective extra-laboratory testing by reviewing the data of the literature as well as the performancespecifications for assuring quality and patient safety.</p>
Biochimica Clinica ; 43(2) 162-167
Opinioni - Opinion
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
Laboratorio clinico: non sempre più grande è migliore
Clinical laboratories: not always bigger is better.
M. Plebani  | 
<p>Laboratory services are undergoing substantial consolidation and changes through mechanisms ranging from mergers, acquisitions and outsourcing, primarily based on the expectation towards increasing volumes, improving efficiency, and reducing cost per test. However, in laboratory medicine the relationship between volume and costs is not linear, as numerous variables may influence the comprehensive costs. In particular, the relationship between volumes and costs does not span the entire pattern of clinical laboratories: high costs are associated with low volumes up to a threshold of about one million test per year. Over this threshold, there is no linear association between volumes and costs, as the laboratory organization rather than test volumes affects the final costs more significantly. Available evidence collected in the last decades, namely data on laboratory errors and associated diagnostic errors and risk for patient harm emphasizes the need for a paradigmatic shift: from a focus on volumes and efficiency to a patient-centered vision restoring the nature of laboratory services as an integral part of the diagnostic and therapy process. In particular, the vulnerability of extraanalytical phases and the lack of reliable quality specifications in pre- and post-analytical steps do not allow an improvement in the ultimate laboratory information. Process and outcome quality indicators have been proposed as effective tools to measure and improve laboratory services by stimulating a competition based on intra- and extraanalytical performance specifications, intermediate outcomes and customer satisfaction. Rather than competing with economic value, clinical laboratories should adopt a strategy based on a set of harmonized quality indicators and performance specifications, active laboratory stewardship, and improved patient safety.</p>
Biochimica Clinica ; 43(2) 156-161
Opinioni - Opinions
Siero o plasma? Un quesito non nuovo che attende risposte nuove
Serum or plasma? An old question awaiting for new answers.
<p>There is a continual debate on what type of sample a clinical laboratory should use. While serum is still considered the gold standard and remains the required sample matrix for some assays, laboratories must consider turn-around time, which is an important metric for laboratory performance and, more importantly, plays a critical role in patient care. In addition, a body of evidence emphasize the choice of plasma samples in order to prevent modifications of some measurands due to the coagulation process and related interferences. Advantages and disadvantages of serum and plasma are discussed on the basis of current literature and evidence. In addition, data are provided on the current utilization of the matrix (serum or plasma) in Italy and in other Countries. Finally, a rational for a possible shift from serum to plasma is provided.</p>
Biochimica Clinica ; 43(2) 178-186
Documenti - Documents
In ricordo di Jillian (Jill) Tate
In memory of Jillian (Jill) Tate
Biochimica Clinica ; 43(1) 115-117
Notizia SiBioC - News SIBioC
Qualità delle raccomandazioni o raccomandazioni di qualità? Il caso antigene prostatico specifico nello screening del carcinoma della prostata
Quality of recommendations or recommandations of quality? The case of PSA-based screening for prostate cancer
M. Plebani  | 
<p>Quality of recommendations or recommandations of quality? The case of PSA-based screening for prostate cancer. The l&rsquo;US Preventive Services Task Force (USPSTF) has recently revisited the evidence on PSA-based screening for prostate cancer recognizing the consistent 25% to 30% relative reduction in deaths from prostate cancer observed in two clinical trials. The most recent Task Force recommendation statement, supported by the evidence report and systematic review, has rightly changed the recommendation for prostate cancer screening - from a grade of D to a grade of C - stating that men aged 55 to 69 years should make an informed decision whether to undergo screening. This change was based on a better understanding of the evidence supporting early detection and recognition that active surveillance, rather than treatment, of low-risk cancers was becoming much more common. The USPSTF has provided a timely and careful approach to reassessment of the benefits and harms of PSA-based screening for prostate cancer. Patients, together with their physicians, should decide whether prostate cancer screening is right for the individual patient.</p>
Biochimica Clinica ; 42(4) 318-320
Opinioni - Opinions
Specifiche di qualità, terminologia e definizione dei metodi di misura delle troponine cardiache Ie T
Quality specifications, terminology and definition of the methods for the measurement of cardiac troponins
<p>All guidelines recommend that cardiac troponin I (cTnI) and T (cTnT) should be considered the preferred biomarkers for the differential diagnosis of acute coronary syndrome (ACS), and also that the 99th upper reference population limit value for cardiac troponins should be measured with an imprecision &le;10 CV%. However, only after the year 2006, some cTn methods showed analytical performances in accordance with the quality specifications required by guidelines. The cTn methods with the best analytical performances (currently named &ldquo;high-sensitivity&rdquo; methods) should be preferred for the early diagnosis of ACS and also for risk stratification of cardiovascular disease both in general population and cardiac patients. The most recent international guidelines recommend that two basic criteria are needed to define the characteristics required for cTn immunoassays in order to be defined as &ldquo;high-sensitivity&rdquo; methods. The first criterion is that the total imprecision (CV) at the 99th percentile value should be &le;10%. The second criterion is that these methods should measure cTn concentrations at least in 50% (and ideally &gt;95%) of both healthy adult men and women with value above the assay&rsquo;s limit of detection. The aim of this SIBioC document is to discuss some critical aspects related to definition of &ldquo;high-sensitivity&rdquo; cTn methods, including: analytical performance, pathophysiological interpretations, and clinical relevance of &ldquo;high-sensitivity&rdquo; cTn assays with particular attention to routine practice of clinical laboratories in Italy, recommending the use of an accurate terminology to avoid the usage of potentially misleading terms.</p>
Biochimica Clinica ; 42(4) 335-342
Documenti SIBioC - SIBioC Documents
Comunicare i risultati critici: raccomandazioni e stato-dell’arte
Management of critical results: recommendations and state of the art
M. Plebani  | 
Biochimica Clinica ; 42(2) 093-094
Editoriale - Editorial
La check list in medicina di laboratorio quale strumento di assicurazione della qualità e sicurezza del paziente: l'esempio del prelievo venoso
Check-list in laboratory medicine: an important tool to improve patient safety. The blood collection
A. Aita  |  R. Marin  |  C. Pozzato  |  E. Piva  |  L. Sciacovelli  |  M. Plebani  | 
<p>This work aims to describe the results concerning the implementation of a check-list (CL) on blood collection procedures as a tool to prevent errors in laboratory medicine. Literature and operating procedures carried out in three outpatients phlebotomy sites (SMa, SMb, PN) were analysed to identify check-points (CPs). CL draft was evaluated by a multidisciplinary team and tested for one month (September 2014) by 25 physicians and 15 nurses. The filled in CLs were analysed together with the involved staff and a final version was released. CL effectiveness was evaluated immediately after experimentation and one year later. 5661 CL were filled in, out of 9469 venipunctures (59.8%). The percentages of CPs filled in within SMa, SMb and PN were respectively: 100% patient identification and label-sample-identification matching; 80.2, 73.1 and 51.9% vein selection; 96.7, 95.8 and 97.9% needle selection; 82.5, 85.8 and 89.9% tourniquet application time; 98.9, 97.9 and 98.7% tubes filling; 98.4, 97.4 and 98.7% tubes mixing; 27.6, 23.5 and 15% temperature transport; 16.4, 20.8 and 1.3% time transport. The percentages of unsuitable samples in SM and PN were respectively: 0.040 and 0.013% (September 2014); 0.041 and 0.012% (October 2014); 0.024 and 0.16% (September-October 2015). The insufficient number of available CLs, difficulties over communication concerning purpose and methodology, and patients crowding affected the results in SM; anyway the CL was very helpful for trainees. An effective CL should: include only critical CPs, be shared with the staff, take into account organizational peculiarities. CL is a powerful tool to ensure patient safety only when it becomes an integral part of quality management system.</p>
Biochimica Clinica ; 42(2) 131-140
Contributi Scientifici - Scientific papers
Un caso di anemia multifattoriale
A case of anemia from intricate causes
<p>A 52 year old female, born in Ecuador, was admitted to the medical ward because of dizziness, blurred vision, sweating and vomiting started 3 days earlier. Complete blood count showed a severe anemia, while mean corpuscolar volume, mean corpuscolar hemoglobin, white blood cell, differential and platelet count were normal. Biochemical tests revealed a very high LDH and a low haptoglobin value. The blood smear revealed marked anisocytosis, hypocromia, oval erythrocytes, teardrop cells and fragments, with the presence of hypersegmented neuthrophils. These morphological features, together with the information obtained by the hematology analyzers, gave rise to the suspicion of vitamin B12 deficiency. Further investigation confirmed a low level of vitamin B12. Variant hemoglobin was detected by high performance liquid chromatography and capillary electrophoresis; an elevated soluble transferrin receptor value was observed. A diagnosis of sickle cell disorder associated to alpha thalassemia with iron and B12 deficiency was formulated.</p>
Biochimica Clinica ; 42(2) e18-e21
Casi clinici - Case report
Valutazione delle caratteristiche analitiche dei metodi di misura delle troponine cardiache I e T: dalla teoria alla pratica di laboratorio. Documento congiunto del Gruppo di Studio Biomarcatori Cardiovascolari di SIBioC-Medicina di Laboratorio ed Europea
Evaluation of analytical performance of immunoassay methods for cardiac troponin I and T: from theory to laboratory practice. Joint document of SIBioC and European Ligand Assay Society
<p>All the national and international guidelines recommend that cardiac troponins (cTnI and cTnT) should be considered the preferred biomarkers for the differential diagnosis of acute coronary syndrome (ACS), and also that the 99th upper reference population limit (URL) value for cardiac troponins should be measured with an imprecision &le;10 CV%. Indeed, the measurement of the 99th URL of cTnI and cTnT is a very hard analytical challenge due to low biomarker concentrations in healthy subjects. For this reason, only after the year 2006, some manufacturers set up the first new generation of cTnI and cTnT immunoassays with improved analytical sensitivity in accordance with the quality specifications indicated by international guidelines. The most recent international guidelines recommend that immunoassays for cTnI and cTnT measurement, able to completely satisfy these quality specifications, should be defined high-sensitivity methods. These methods should be preferred for early diagnosis of ACS syndrome and also for stratification of cardiovascular risk in both general population and cardiac patients. Therefore, understanding the analytical performance of immunoassay methods for cTnI and cTnT, especially at the low normal concentration range, is critically important for both laboratory professionals and clinicians. The aim of this document is to discuss some theoretical considerations related to the definition of analytical sensitivity, as well as some critical aspects concerning the experimental protocols commonly adopted for evaluation and comparison of analytical performances of cardiac troponin immunossays.</p>
Biochimica Clinica ; 42(2) 155-166
Documenti - Documents
Il ricordo di un Maestro del laboratorio clinico: Giovanni Ceriotti
In memory of Giovanni Ceriotti
M. Plebani  | 
Biochimica Clinica ; 42(1) 83-84
Notizie SIBioC - SIBioC News
Appropriatezza della richiesta di esami ed esiti clinici: il caso delle malattie renali, tiroidee e della celiachia
Appropriateness of test request and clinical outcome: the example of kidney, thyroid and coeliac disease
<p>This document analyzes the topic of appropriateness of test request. It is organized in 4 parts. The first deals with the theme of appropriateness, the consequences of insufficient or excessive test request and the need to balance guideline indications with the clinical need of a single patient. The other 3 parts present the cases of thyroid, chronic kidney and coeliac disease. With regard to the thyroid function, population screening, excluding neonates, is not recommended; on the contrary, it is highly recommended to evaluate the thyroid function in any individual with even only a minimal clinical suspect. The thyrotropin (TSH) is the test of choice with reflex free T4 and free T3, according to specific algorithms. The contemporaneous measurement of free FT3, free FT4 and TSH, except for specific cases, should be discouraged due to the high frequency of unjustified abnormal findings. Anti-thyroperoxidase antibodies are the test of choice for autoimmune thyroid diseases. In chronic kidney disease (CKD), the estimated glomerular filtration rate (eGFR) based on serum creatinine in most cases is the best indicator of renal function, provided that creatinine is measured with the accurate enzymatic method. In borderline situations, a confirmatory eGFR calculation based on cystatin C is recommended. Urinary albumin, expressed as albumin/creatinine ratio, is an essential complement for CKD staging. The diagnosis of coeliac disease requires integration between clinical, histological and serological data. The anti-transglutaminase IgA is the test of choice; only when an IgA deficit is present, the test to be used is IgG antigliadin deamidate peptides. The genetic HLA DQ2/DQ8 test is indicated for screening of subjects at risk: if negative, coeliac disease can be excluded.</p>
Biochimica Clinica ; 41(3) 266-285
Documenti - Documents
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
Esami di laboratorio in Pronto Soccorso: una proposta di consenso SIBioC - Medicina di Laboratorio e Academy of Emergency Medicine and Care
Laboratory tests in the Emergency Department: a consensus document by SIBioC-Medicina di Laboratorio and the Academy of Emergency Medicine and Care
<p>Laboratory diagnostics in the emergency setting encompasses the identification of appropriate testing according to specific acute conditions. Since the pathway of ordering tests in the Italian Emergency Departments (EDs) is rather heterogeneous, SIBioC-Medicina di Laboratorio and the Academy of Emergency Medicine and Care designed a survey aimed to generate consensus pertaining to appropriate laboratory tests in most frequent acute conditions. A questionnaire including a panel of laboratory tests was administered to 8 representative members of each of the two societies, who were asked to provide a score between 1 and 3 for the various tests, where a score of 1 entailed &ldquo;highly recommended&rdquo;, 2 &ldquo;recommended in specific conditions&rdquo; and 3 identified &ldquo;highly discouraged&rdquo; tests. The results of the questionnaire are shown as mean (&plusmn;SD) of individual responses, thus allowing to define a scale of priority comprised between &ldquo;highly recommended&rdquo; and &ldquo;highly discouraged&rdquo;. Overall, 24 tests were classified as &ldquo;highly recommended&rdquo;, whereas 6 were &ldquo;highly discouraged&rdquo;. The remaining 16 tests were classified as &ldquo;somehow recommended&rdquo; or &ldquo;somehow discouraged&rdquo;. In the expectations of the two societies, this document may represent a first step towards harmonizing the laboratory test ordering in Italian EDs.</p>
Biochimica Clinica ; 41(2) 183-188
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
Contenimento dei costi nel laboratorio clinico: razionamento o razionalizzazione?
Cost containment in clinical laboratories: rationing or rationalization?
M. Plebani  | 
<p>Although expenditures for laboratory tests&nbsp;represent a relatively small part of total healthcare costs, clinical laboratories have not been spared from cost&nbsp;containment projects. In particular, the indiscriminate use and overuse of laboratory testing contribute a significant&nbsp;and unnecessary burden on the healthcare system. Controlling laboratory testing should be based on four strategies:&nbsp;1) reducing reimbursement; 2) linking test demand to medical necessity; 3) active management of test utilization by&nbsp;laboratory staff; and 4) developing formularies and controlling expenditures. The first approach, based on the simple&nbsp;reduction of reimbursement, is effective in the short run, but presents several fundamental flaws. The second&nbsp;approach aims to decrease utilization of tests that are not medically necessary, for example eliminating duplicate&nbsp;orders for tests within specified time frames. The third approach ranges from simply having laboratory staff acting as&nbsp;gatekeeper, namely for specific test at high costs, to more systematic approaches. Finally, the fourth approach is&nbsp;similar to mechanisms used to guide appropriate drug utilization and control expenditures. All strategies present&nbsp;advantages and limitations and the optimal approach should require a combination of different options. Laboratory&nbsp;professionals are expert in monitoring test utilization and clinical laboratories are an important checkpoint in any&nbsp;control measures. Cost saving and waste avoidance represent an ethical duty to permit universal coverage and&nbsp;patient safety.</p>
Biochimica Clinica ; 40(2) 123-128
Opinioni - Opinions
L’iniziativa dei laboratori della Regione Veneto “Passaggio al Litro”
"Switching to the Liter": the initiative of laboratories in Veneto Region
Biochimica Clinica ; 40(2) 166-167
Lettere all'Editore - Letters to the Editor
Il laboratorio nella terapia anticoagulante orale
The role of laboratory medicine in monitoring oral anticoagulant therapy
A. Tosetto  |  S. Testa  |  W Ageno  |  C. Legnani  |  O. Paoletti  |  M. Plebani  |  D. Poli  |  D. Giavarina  | 
<p>The oral anticoagulant therapy is used&nbsp;in the prevention and treatment of venous and arterial thromboembolism in many different clinical settings. For this&nbsp;purpose, vitamin K antagonists (VKA), which indirectly reduce the activity of factors II, VII, IX and X preventing the&nbsp;vitamin K-mediated carboxylation of specific glutamic acid residues, and direct oral anticoagulants (DOAC), providing&nbsp;direct inhibition of thrombin (factor IIa) or factor Xa, are available. The VKA monitoring represents a daily challenge for&nbsp;clinical laboratories, due to the increasing number of patients, frequency of needed controls and the management&nbsp;complexity. Several solutions have been proposed to improve the management of patients treated by VKA, such as&nbsp;surveillance in dedicated clinics and use of portable monitors to allow patient self-testing and self-management.&nbsp;Although DOAC have been declared not requiring a standard laboratory monitoring, laboratory testing for measuring&nbsp;drug anticoagulant activity is however needed in many situations, such as in case of bleeding or thromboembolic&nbsp;complications, surgery or invasive procedures, suspected overdose and drug interactions, noncompliance or presence&nbsp;of renal or liver disease.</p>
Biochimica Clinica ; 40(1) 13-20
Rassegne - Reviews
Medicina personalizzata e laboratorio clinico: osare con cura
Personalized medicine and clinical laboratories: challenges and opportunities
M. Plebani  | 
<p>Personalized medicine is an&nbsp;emerging field with the goal of applying the concept of individual variability to determine the predisposition to disease,&nbsp;timely and accurate diagnoses and tailored therapeutic strategies. Laboratory medicine plays a key role in translating&nbsp;the concepts of personalized medicine into clinical practice. Following the sequencing of human genome, many new&nbsp;&ldquo;omics&rdquo; disciplines have emerged. These new disciplines are the key to the development of personalized medicine&nbsp;as they contribute to the understanding of disease at a molecular level and to the identification of new biomarkers as&nbsp;quantified parameters predictive to the development of a disease, its prognosis or clinical response, and as target for&nbsp;new treatments. A multiple approach integrating various technologies needs to be pursued and the implementation&nbsp;of new statistical methods and novel algorithms is required. Laboratory professionals have to assure not only the&nbsp;development of robust and accurate assays, but to promote harmonized procedures for sample collection, handling&nbsp;and storage. Finally, a closer interaction with clinicians should be provided as there is an increasing recognition of the&nbsp;need of clinical advice for an appropriate test request and result interpretation and utilization.</p>
Biochimica Clinica ; 40(1) 33-39
Opinioni - Opinions
Sindrome POEMS: “Hevylite” e “Freelite” a confronto
POEMS syndrome: Heavy Light Chains vs Free Light Chains measurements
<p>POEMS syndrome is a rare paraneoplastic, multisystemic, plasma cell discrasia characterized by Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin changes. Most patients have high serum free light chains (sFLC) concentrations but a normal sFLC ratio. Hevylite (HLC) is a new method that allows separated quantification of the serum k and l bounded levels of the six isotype specific immunoglobulins. In this study HLC and sFLC were measured in serum samples during the follow up of two patients with POEMS syndrome. The HLC ratio of the involved monoclonal immunoglobulin could provide additional information to assess residual disease, allowing&nbsp; detection of relapse earlier than clinical symptoms in patients with POEMS syndrome.</p>
Biochimica Clinica ; 40(1) e1-e3
Casi clinici - Case report
Armonizzazione della notifica dei valori critici come contributo al miglioramento della sicurezza e della cura del paziente
Harmonization of the notification of critical values as contribution to the improvement of patient safety and care
<p>A project for harmonizing the notification of critical values was performed in our department, which covers 3&nbsp;different hospitals. We achieved the harmonization of definitions by distinguishing critical values, critical tests and&nbsp;abnormal results, according to the Joint Commission proposal. For critical tests, the requesting physicians should&nbsp;verify the availability of results as soon as possible, while the laboratory professionals must ensure appropriate and&nbsp;timely results. As an example, all requests from the Emergency Room are relevant and considered as critical tests,&nbsp;avoiding overload of alarms or calls, which distract the busy medical team. Identification of critical values was based&nbsp;on consensus, guidelines and clinicians&rsquo; opinion. The practice was harmonized by automated notification systems&nbsp;and by establishing who should report critical values on an established time frame to the responsible licensed&nbsp;caregiver, so that the patient can be promptly treated. Timeliness was linked with clinical effectiveness with the aim<br />to provide the best outcome at the lowest cost. Finally, harmonization was directed to develop quality indicators&nbsp;regarding the policies of critical value communication, the monitoring of the timeliness in reporting and the need to&nbsp;evaluate how the effectiveness of improved communication assures better clinical outcomes. The realization of&nbsp;harmonized critical value notification may support the clinical decision making, leading to an improvement in patient&nbsp;safety and care.</p>
Biochimica Clinica ; 39(6) 595-600
Contributi scientifici - Scientific Papers
Armonizzazione in Medicina di Laboratorio
Harmonization in Laboratory Medicine
F. Ceriotti  |  M. Panteghini  |  A. Tosetto  |  V. Valentini  |  L. Politi  |  R. Rolla  |  T. Guastafierro  |  T. Köken  |  E. Capoluongo  |  C. Mazzaccara  |  V. D'Argenio  |  V. D'Argenio  |  G. Lippi  |  M. Plebani  |  D. Giavarina  |  M. Berardi  |   A survey on sample matrix and preanalytical management in clinical laboratories  |  D. Bozzato  |  G. Messeri  |  M. Zaninotto  |  M. Vidali  |  A. Padoan  |  M. Panteghini  |  F. Braga  |  G. Gessoni  |  M. Montagnana  |  N. Doğan  |  M. Barberis  |  M. Barberis  |  A. Marchetti  |  F. Borrillo  |  L. Bonfanti  |  P.M. Ness  |  G. Messeri  |  S. Nannini  |  J. Queraltò  |  E. Fiorio  |  L. Crinò  |  M. A. V. Willrich  |  A. Modenese  |  M. Berardi  |  G. Nordera  |  M. Girelli  |  R. Tomaiuolo  |  R. Danesi  |  M. Locatelli  |  M. Savoia  |  S. Bernardini  |  C. Domenichini  |  M. Lamonaca  |  P. Pradella  |  A. D'Avolio  | 
Biochimica Clinica ; 39(6) 546-547
Editoriale - Editorial
Gli indicatori di qualità nel processo di armonizzazione in Medicina di Laboratorio
Harmonization of quality indicators in Laboratory Medicine
<p>According to the International Standard for medical&nbsp;laboratories accreditation ISO 15189:2012, the laboratory should establish and periodically review quality indicators&nbsp;(QIs) to monitor and evaluate performance throughout critical aspects of pre-, intra and post-analytical processes.&nbsp;The use of QIs is needed to provide information and accountability to users and to establish a program of continuous&nbsp;improvement to ensure the quality of care and patient safety. In this context, we designed a QIs system as a part of&nbsp;a coherent and integrated quality improvement strategy. The management of QIs is based on an internal assessment&nbsp;system (IAS), which allows us to evaluate our performance over time and on the participation in an interlaboratory&nbsp;comparison managed as an EQA program, in order to compare our performance with other laboratories. The IAS&nbsp;includes a list of QIs, a form describing the specifications of each QI and a standard operating procedure. We&nbsp;participated in the project developed by the Working Group &ldquo;Laboratory errors and patient safety&rdquo; of IFCC on QIs.&nbsp;The project aims to identify a model of QIs that can be used worldwide through an EQA program. This paper aims to&nbsp;stimulate harmonization initiatives concerning QIs on the basis of the method and results of described experience.</p>
Biochimica Clinica ; 39(6) 601-608
Contributi scientifici - Scientific Papers
Caso atipico di orticaria
A case of atypical urticaria
<p>Adult onset Still&rsquo;s disease (AOSD) is a rare clinical entity with unknown etiology and&nbsp;pathogenesis, characterized by high spiking fevers, arthritis, typical evanescent, nonpruritic, macular and salmon<br />coloured rash, and multiorgan involvement. AOSD remains a diagnostic challenge due to the overlapping features&nbsp;with numerous infective, neoplastic and rheumatological conditions. A case of AOSD with atypical cutaneous&nbsp;manifestations in a 50-year-old female is reported. The patient&rsquo;s symptoms included: remittent fever, widespread&nbsp;urticarial, maculopapular erythema and a sore throat. Hematological investigations showed leukocytosis with&nbsp;neutrophilia. There were markedly elevated levels of serum ferritin (20.920 &mu;g/L) and mild liver dysfunction. A&nbsp;glycosylated ferritin assay was performed because of a severe hyperferritinemia, showing a reduction of the&nbsp;glycosylated fraction (&lt;20%), a newly proposed diagnostic criteria for AOSD. We emphasize the diagnostic value of&nbsp;low glycosylated ferritin concentration for the differential diagnosis of this rare disease, particularly in case of atypical&nbsp;presentation.</p>
Biochimica Clinica ; 39(5) e10-e12
Casi clinici - Case report
Armonizzazione in laboratorio: verso una visione globale
Harmonization in Laboratory Medicine: towards a global vision
Biochimica Clinica ; 39(1) 012-014
Editoriale - Editorial
I laboratori clinici nell’emergenza dei focolai epidemici infettivi: Ebola e oltre
Clinical laboratories and infectious outbreak emergencies: Ebola and beyond
G. Lippi  |  C. Mattiuzzi  |  M. Plebani  | 
Biochimica Clinica ; 38(6) 604-606
Editoriale - Editorial
In ricordo di Lauro Galzigna
In memory of Lauro Galzigna
M. Plebani  | 
Biochimica Clinica ; 38(4) 352
Notizie SIBioC - SIBioC News
Emoglobinuria parossistica notturna
Paroxysmal nocturnal hemoglobinuria
<p>Paroxysmal nocturnal hemoglobinuria (PNH) is a rare acquired&nbsp;hematological disease of the hematopoietic stem cell. PNH arises as a consequence of non-malignant clonal&nbsp;expansion of hematopoietic stem cells and progeny mature blood cells of both myeloid and monocyte lineage, which&nbsp;are deficient in some surface proteins, including the two complement regulators CD55 and CD59. As a result, PNH&nbsp;erythrocytes are incapable to modulate on their surface physiologic complement activation, leading to complement-mediated&nbsp;intravascular hemolysis, which is the central clinical feature of PNH. Diagnosis and monitoring of PNH&nbsp;clones currently rely on the analysis of CD59 expression on red blood cells and FLAER (fluorescent aerolysin) and&nbsp;some glycophosphatidylinositol-anchored proteins on granulocyte and monocyte lineages by flow cytometry. Despite&nbsp;the availability of safe and effective targeted therapy that controls intravascular hemolysis, the management of PNH&nbsp;remains difficult because of disease heterogeneity and close association with bone marrow failure syndromes.</p>
Biochimica Clinica ; 37(4) 268-274
Rassegne - Reviews
Note metodologiche sull’acquisizione e sull’uso dei sistemi chiusi sottovuoto per il prelievo, il trattamento e la conservazione dei campioni ematici venosi destinati alla diagnostica di laboratorio
Methodological notes on acquisition and use of close evacuated systems for collection, handling and storage of venous blood samples for laboratory diagnostics
M. Plebani  |  M. Caputo  |  D. Giavarina  |  G. Lippi  | 
<p>Evacuated systems for collection of venous blood&nbsp;are integrated systems of medical and in vitro diagnostic medical devices regulated under European Directives and&nbsp;Italian Legislative Decrees. Both Directives and Decrees endorse the requirement that the whole combination of&nbsp;devices, representing an integrated apparatus, must be safe and not impair the specific performance of each single&nbsp;device. According to mandatory requirements, manufacturers must ensure full compatibility between each component&nbsp;of the system, while the users are responsible for verifying the compatibility of different devices in order to avoid&nbsp;potential quality and safety problems. The acquisition of various devices from different manufacturers may lead to&nbsp;combinations that are not validated by manufacturers themselves and are thus expected to be validated and verified&nbsp;by the users to demonstrate that the system remains safe and will not impair the performance of the individual&nbsp;elements. Therefore, the possibility of purchasing different devices separately should be carefully weighted in terms&nbsp;of risk-benefit, taking into consideration the additional costs of the validation/verification process that should be&nbsp;carried out by the potential user. Since preanalytical problems are the major source of errors in the total testing&nbsp;process, the selection and acquisition of close evacuated systems for blood collection should be considered a critical&nbsp;issue for assuring quality, safety and efficiency of the preanalytical phase of laboratory diagnostics and, therefore, of&nbsp;the total testing process.</p>
Biochimica Clinica ; 37(4) 303-311
Documenti SIBioC - SIBioC Documents
Un caso di emoglobinuria parossistica notturna associata a mielodisplasia
A case of paroxysmal nocturnal hemoglobinuria in a patient with myelodysplasia
<p>Paroxysmal nocturnal&nbsp;hemoglobinuria (PNH) is a rare acquired hematological disease of the hematopoietic stem cell. PNH arises as a&nbsp;consequence of non-malignant clonal expansion of hematopoietic stem cells and progeny mature blood cells of both&nbsp;myeloid and monocyte lineage, which are deficient in some surface proteins, including the two complement regulators&nbsp;CD55 and CD59. As a result, PNH erythrocytes are incapable to modulate on their surface physiologic complement&nbsp;activation, leading to complement-mediated intravascular hemolysis, which is the central clinical feature of PNH. We&nbsp;present a case of a 16 years old Ukrainian boy who presented with a diagnosis of myelodysplastic syndrome and&nbsp;who was found to be affected by PNH.</p>
Biochimica Clinica ; 37(4) 326-328
Casi clinici - Case Report
Necessità di una descrizione completa dei metodi di laboratorio e del trattamento del campione nella pubblicazione di studi clinici: un appello agli editori di riviste mediche
An appeal to medical journal editors: the need for a full description of laboratory methods and specimen handling in clinical study reports.
N. Rifai  |  T.M. Annesley  |  J.P. Berg  |  C. Brugnara  |  E. Delvin  |  E.J. Lamb  |  P.M. Ness  |  M. Plebani  |  M.R. Wick  |  A. Wu  |  J. Delanghe  | 
<p>As editors of the laboratory medicine journals we urge the medical journal editors to adopt and enforce the following requirements for clinical studies that include laboratory testing for biomarkers: 1) for commercial diagnostic tests, authors must include the actual name and generation of assay, the manufacturer and the instrument used for analyses; 2) authors must report performance characteristics, such as the imprecision of the assay in the investigators&#8217; laboratories, the assay&#8217;s reportable range, and any reference interval used in the study; 3) authors must clearly indicate the types of specimens analyzed and the storage conditions for these specimens.</p>
Biochimica Clinica ; 36(3) 193-195
Opinioni - Opinions
Una rilettura di “Funzione e compiti del laboratorio nell’ospedale moderno” a 40 anni di distanza
Re-reading the Ceriotti’s paper 40 years later
M. Plebani  | 
<p>In 1972, the opening lecture of the SIBioC Congress by Giovanni Ceriotti and Carlo Riga recognized two main missions of the clinical laboratory: its role in assuring a valuable diagnostic-therapeutic process and the need to improve the scientific knowledge for achieving a more effective clinical practice. In the same document, the Authors identified the main duties of laboratory professionals, ranging from the choice of analytical methods and their automation to the clinical advice on test request and result interpretation. In the same year, George Lundberg described the &#8220;brain-to-brain loop&#8221; concept that basically identified all pre-, intra- and post-analytical steps of the total testing process, stressing the need of assuring quality and safety in every step for finally achieving satisfactory clinical outcomes. The changing face of clinical laboratories due to the impressive advancement in analytical techniques, automation and informatics has led to a dramatic switch of the role and duties of laboratory professionals from diagnostic operators to designers of diagnostic operations. However, it is still debatable how laboratorians may better translate into clinical practice the innovation due to technological and scientific developments to assure a more visible and reliable appreciation of their role in the modern healthcare system.</p>
Biochimica Clinica ; 36(1) 33-35
Opinioni - Opinions
Identificazione di potenziali biomarcatori sierici di adenocarcinoma pancreatico
Identification of potential serum biomarkers of pancreatic cancer
A. Padoan  |  P. Fogar  |  E. Greco  |  E. Fadi  |  D. Bozzato  |  S. Moz  |  F. Navaglia  |  C.F. Zambon  |  R. Seraglia  |  M. Pelloso  |  A. Rossi  |  M. Plebani  | 
Biochimica Clinica ; 35(4) 280
Valore prognostico della determinazione di MR-proadrenomedullina e copeptina nello scompenso cardiaco cronico
MR-proadrenomedullin and copeptin: prognostic role in chronic heart failure
M.M. Mion  |  M. Zaninotto  |  B. Boffa  |  F. Tona  |  G. Masiero  |  F. Calabrò  |  S. Iliceto  |  M. Plebani  | 
Biochimica Clinica ; 35(3) 193
Linee guida per la gestione dei programmi di Valutazione Esterna di Qualità
Guidelines for External Quality Assessment Scheme organization
Biochimica Clinica ; 35(2) 107
Point-of-care testing - Needs, Opportunity, and innovation (3rd edition)
Point-of-care testing - Needs, Opportunity, and innovation (3rd edition)
M. Plebani  | 
Biochimica Clinica ; 35(1) 62
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 ; 17(1)
Contributi Scientifici - Scientific Papers