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Maria Stella Graziani

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Giuseppe Agosta

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BC: Articoli scritti da M. Migliardi

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
 
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
 
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
 
Durata della fibrinolisi post-operatoria e rischio trombotico dopo somministrazione di acido tranexamico negli interventi di protesi d’anca e ginocchio
Duration of post-operative fibrinolysis and thrombotic risk after tranexamic acid administration in hip and knee prosthesis interventions
<p>Strong evidence indicates that TXA reduces blood loss and blood transfusion requirement in orthopedic surgery. However, drug safety and side effects are still a controversial issue, because TXA may increase thromboembolic risk. Aim of our study was to quantify the duration of postoperative fibrinolysis and to assess the impact of TXA administration after total hip (THR) and total knee replacement (TKR). Fifteen patients undergoing THR and 10 undergoing TKR were included in the study. Among these patients, 14 THR and 8 TKR received TXA, while 3 (one THR and 2 TKR) were employed as controls (i.e., no TXA administration). D-dimer and thrombin generation time were measured prior to surgery as well as 3, 6, 24 and 72 h after. No statistically significant difference in D-dimer was observed between patients treated and not treated with TXA, even if D-dimer increased postoperatively (6 h) more in patients not treated with TXA than in patients receiving TXA. Thrombin peak was lower in patients treated with TXA than in patients not receiving it. Our study shown that TXA limits postoperative fibrinolysis after THR and TKR, as evidenced by a lesser increase in D-dimer in patients receiving TXA, with no increase in prothrombotic risk.</p>
Biochimica Clinica ; 41(3) 235-238
Contributi scientifici - Scientific papers
 
Presenza concomitante di anticorpi tipo Lupus e malattia di von Willebrand: una condizione reale?
Combined von Willebrand factor and lupus anticoagulant abnormalities: a true finding?
<p>We present a case of a 74-year-old woman with myelofibrosis, hypothyroidism and negative bleeding history, showing a prolonged APTT performed within a pre-intervention screening. The laboratory tests showed a positivity for the presence of lupus anticoagulant antibodies (LA). Further investigations revealed normal intrinsic factor and von Willebrand factor (VWF) antigen concentrations, and normal to only slightly reduced VWF Ristocetin Cofactor (VWF:RCo) by chemiluminescent assay and by platelet agglutination. The VWF:RCo by a latex- immunoturbidimetric method was strongly reduced and the platelet function test was found to be abnormal. The negative bleeding history, the myeloproliferative chronic disease, the LA positivity and the other laboratory findings were consistent with the presence of acquired VWF disease. However, the disproportionate values of VWF:RCo measurements obtained by the latex method and all the other assays, made us to conclude for the presence of an interference (possibly due to autoantibodies) on latex VWF:RCo immunoassay and the patient went successfully to surgery without anti-haemorrhagic prophylaxis.</p>
Biochimica Clinica ; 41(1) e4-e8
Casi Clinici - Case Report
 
Documento congiunto di SIBIOC, della Società Italiana dell’Osteoporosi, del Metabolismo Minerale e delle Malattie dello Scheletro (SIOMMMS), della Sezione Italiana della European Ligand Assay Society (ELAS), e della Associazione Medici Endocrinologi (AME)
Joint Document from: Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC), Italian Society of Osteoporosis, Mineral Metabolism, and Skeletal Diseases (SIOMMMS), Italina Section of Ligand Assay (ELAS), Association of Endocrinolo
<p>Vitamin D, and its metabolites, have key roles in the functioning of virtually all tissues. Indeed, besides the unquestioned role in bone mineral metabolism, evidences have pointed out roles in inflammation and autoimmunity, skeletal muscle and cardiac function, neuromuscular communication. Therefore, vitamin D deficiency associates with&nbsp;rickets in the child, osteomalacia and increased risk of fracture in the adulthood and possibly with the increased risk<br />of other pathological conditions. In order to regulate the prescription of vitamin D supplementation (cholecalciferol, cholecalciferol/calcium salts, calcifediol) to the adult population, and consequently to contain the costs sustained by the National Health System, the Italian Medicine Agency (AIFA) has recently drafted the &ldquo;Nota 96&rdquo; identifying the categories of patients, based on the laboratory measurement of serum levels of 25(OH)D, that can benefit from the reimbursement of vitamin D therapy. If the &ldquo;Nota 96&rdquo;, AIFA has the merit to define rules in a field only sligtly regulated, several considerations emerged from its analysis. From an analytical point of view, the &ldquo;Nota 96&rdquo; does not consider the issues of reliability and reproducibility of 25(OH)D measurement and standardization of the units of measurement and reporting. On the clinical side, the &ldquo;Nota 96&rdquo; does not consider the epidemic vitamin D insufficiency/deficiency that needs an adequate preventive approach and, furthermore, beyond its roles, the agency indicates the clinical conditions for whom vitamin D prescription is allowed. This document analyses the content of &ldquo;Nota 96&rdquo; highlighting the points that need further evaluations and by giving possible different solutions; the document provides also recommendations on laboratory reporting of vitamin D measurements.</p>
Biochimica Clinica ; 17(1)
Documenti SIBioC - SIBioC Documents