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

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
☩Howard Morris Australia
Mario Plebani Italy
Sverre Sandberg Norway
Ana-Maria Simundic Croatia
☩Jill Tate Australia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada


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Giuseppe Agosta

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Arianna Lucini Paioni
Biomedia srl
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email: biochimica.clinica@sibioc.it



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BC: Articoli scritti da M. Zaninotto

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
 
Troponine cardiache: attualità analitiche e prospettive di applicazioni cliniche
Biochimica Clinica ; 44(2) S005-S007
Editoriale - Editorial
 
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
 
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
 
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
 
Il consolidamento dei Servizi di Medicina di Laboratorio
Biochimica Clinica ; 43(2) 123-124
Editoriale - Editorial
 
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
 
Glycated albumin is correlated to insulin resistance and β-cell secretory function in subjects at risk of developing diabetes
<p>Insulin resistance and &beta;-cell secretory function represent two main issues in the pathogenesis of type 2 diabetes mellitus (T2DM). Conflicting results have been obtained about the association between glycated albumin (GA) and body mass index (BMI), insulin resistance and &beta;-cell function in diabetic patients. Actually, the relationship (if any) between GA and the markers of glucose homeostasis and insulin resistance in subjects at risk of developing diabetes, has not been completely elucidated yet. Two hundred and one patients undergoing to oral glucose tolerance test (OGTT) were enrolled in the study. Routine laboratory tests, including fasting insulin, were performed at enrollment. GA was measured on plasma-EDTA by quantILab<sup>&reg;</sup> Glycated Albumin (Instrumentation Laboratory, A Werfen Company) on ILab Taurus analyzer. According to the plasma glucose concentration measured after 2 hours of glucose intake (2h- PG), 13 subjects (6.4%) were classified as impaired glucose tolerance (IGT). GA weakly correlated with fasting plasma glucose (FPG) (r=0.21; P=0.002), with HbA1c (r=0.16; P=0.024) but not with 2h-PG (P=0.7). GA, but not HbA1c, was negatively correlated to HOmeostasis Model Assessment for &beta; cell fuction (HOMA-&beta;) (r<sup>2</sup>=0.23; P&lt;0.001), to HOMA for insulin resistence (HOMA-IR) (r<sup>2</sup>=0.15; P&lt;0.0001) and to BMI (r<sup>2</sup>=0.05; P=0.001). In a stepwise multivariate regression analysis including HbA1c, HOMA-&beta;, plasma albumin, BMI, eGFR, age, FPG, and HOMA-IR as predictors of GA, only HbA1c (&beta;-coefficient: 0.04; P=0.038) and HOMA-&beta; (&beta;-coefficient: -0.01; P&lt;0.0001) were able to predict GA levels (r<sup>2</sup>=0.26; P&lt;0.001 for the model). Our results demonstrated that GA was associated to HOMA-&beta; and, to a lesser extent, to HOMA-IR and BMI. The increase of GA values can be explained by the reduction of &beta;-cell secretory function in subjects with no significant increase of FPG and 2h-PG.</p>
Biochimica Clinica ; 42(3) 234-239
Contributi Scientifici - Scientific papers
 
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
 
La diagnostica di laboratorio delle dislipidemie
The laboratory diagnosis of dyslipidemia
<p>Dyslipidemias represent a major contributor to cardiovascular risk in Western countries, including Italy, that can be modified. After examining familial dyslipidemias and describing the essential issues for clinical and laboratory diagnostics, the paper considers the laboratory testing in detail. The preanalytical sources of variability (biological, sample collection and handling) are reviewed and essential indications to reduce them are given. About the analytical variability, the paper examines the methods routinely used for measuring the basic lipid parameters (total, LDL and HDL cholesterol, triglycerides and apolipoproteins A-I and B) and describes the state of art of the standardization of these analytes. The last section of the document deals with the reporting of laboratory results. The main indications of the document are the following: a) report the desirable values established by the European guidelines besides the measured concentrations; b) make always clear that the reported values are decisional cut points and not reference limits; c) add a note stating that the reported desirable values refer to individuals at low risk; d) report as critical values lipid concentrations deserving rapid clinical attention, i.e., total cholesterol, &ge;8,00 mmol/L (310 mg/dL); LDL cholesterol, &ge;4,90 mmol/L (190 mg/dL); triglycerides, &ge;10,0 mmol/L (880 mg/dL).</p>
Biochimica Clinica ; 40(4) 338-346
Documenti SIBioC - SIBioC Documents
 
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
 
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
 
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
 
Raccomandazioni per la diagnosi neonatale delle emoglobinopatie
Recommendations for the diagnosis of hemoglobinopathies at birth
<p>The laboratory plays an important role in the&nbsp;diagnosis of hemoglobin defects at any age. At the time of birth its role is particularly significant, considering that&nbsp;frequently the newborn has not clinical signs, even when he is carrying thalassemia or other structural defects of&nbsp;hemoglobin. The diagnostic precocity in the affected newborn will help to predict risk, determine appropriate prophylaxis&nbsp;and prevent complications. It may also be helpful for programming treatment and parent control, and planning a&nbsp;prevention for a future pregnancy. In Italy, there have been important demographic and social health changes over the&nbsp;past decade that have suggested the implementation of hemoglobinopathy screening at birth. In addition, the need to&nbsp;know the hemoglobin pattern of the cord blood for possible biobank storage should be regarded as another relevant&nbsp;target. Therefore, it seems timely to define pathways, scope and limits of a correct thalassemia diagnosis at birth through&nbsp;specific recommendations. The Italian Society of Thalassemias and Haemoglobinopathies (SITE) had already published&nbsp;recommendations for first level thalassemia diagnosis, which were primarily focused on preconceptional prevention. This&nbsp;new document provides essential guidance about laboratory methods, pre- and post analytical information flows and&nbsp;about the most appropriate approach to be followed.</p>
Biochimica Clinica ; 39(2) 116-134
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