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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 A. Fortunato

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 ; 44(4) 400-406
Documenti SIBioC - SIBioC Documents
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
La ricerca degli anticorpi anti-nucleo non è sempre di facile interpretazione
Anti-nucleus antibodies detection is not always easy to interpret
<p>Antinuclear antibodies (ANA) displaying densefine speckled pattern on HEp-2/HEp-2000 cells are frequently observed in clinical laboratory, often associated withanti-DFS70 antibodies. Anti-DFS70 positive patients rarely develop systemic autoimmune rheumatic disease,especially in the absence of clinical evidence or additional antibodies.<br />A 60-years old woman complaining severe muscle weakness of the legs was tested positive for dense fine speckledANA pattern by indirect immune-fluorescence. Immunoblot analysis revealed the presence of anti-DFS70 antibodies.Positivity for anti-dsDNA antibodies, not revealed by immunoblot, was also found by Crithidia luciliae(CL). All theresults were confirmed by a different laboratory.<br />This case underlines the complex interpretation of a laboratory scenario where anti-DFS70 possibly coexist with muchmore specific and clinically relevant ANA. The discrepancies (observed in both laboratories) between CL and theother methods is puzzling, and may be due to different reasons, including false positive CL results or interference.</p>
Biochimica Clinica ; 43(3) e31-e35
Casi Clinici - Case Report
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
Gestione informatizzata del magazzino di laboratorio e valutazione dei costi reali
Computerized laboratory warehouse management and assessment of actual costs
<p>Although the patient&rsquo;s wellbeing&nbsp;is the primary aim of Laboratory Medicine, great attention should be given to laboratory efficiency, particularly&nbsp;for reagent expenses. Without quantitative data it is difficult for a laboratory manager to know the relationship&nbsp;between the number of assays that theoretically can be performed with a reagent package and the number of&nbsp;produced reports. Many factors can affect these data; for instance, the calibration frequency or the number of&nbsp;repetitions of a sample, the scheduled turnaround time for the assay, the number of samples to run or the reagent&nbsp;stability. In this study, a software for the laboratory warehouse management was used to evaluate the actual yield of&nbsp;reagent packs and to estimate the real cost of measurements. Costs for reagent purchase in a 12-month time period&nbsp;and data of 1440 different product stock movements for issuing 550,000 reports were analyzed for tests ranging from&nbsp;less than 100 to over 250,000 requests/year. The distribution of the calculated yield for reagent packs was between&nbsp;16.7% and 98.5%, with a median value of 65.5% (confidence interval, 55.0-79.0). On average, the percentage yield&nbsp;for reagent packs rapidly grows in proportion to the number of determinations performed up to 10,000 tests per year.&nbsp;For assays with a request number exceeding 10,000 the yield was almost always &gt;80%.</p>
Biochimica Clinica ; 39(3) 178-183
Contributi scientifici - Scientific Papers