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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Biomedia srl
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Responsible Editor
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 A. Fortunato

La ricerca degli anticorpi anti-nucleo non è sempre di facile interpretazione
Anti-nucleus antibodies detection is not always easy to interpret
s. Silvestri \| V. Falciani \| A. Costantini \| A. Fortunato \|
<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
A. Clerico \| M. Zaninotto \| M.S. Graziani \| M. Mion \| S. Masotti \| C. Prontera \| M. Migliardi \| A. Fortunato \| M. Plebani \|
<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 ≤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 “high-sensitivity” 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 “high-sensitivity” methods. The first criterion is that the total imprecision (CV) at the 99th percentile value should be ≤10%. The second criterion is that these methods should measure cTn concentrations at least in 50% (and ideally >95%) of both healthy adult men and women with value above the assay’s limit of detection. The aim of this SIBioC document is to discuss some critical aspects related to definition of “high-sensitivity” cTn methods, including: analytical performance, pathophysiological interpretations, and clinical relevance of “high-sensitivity” 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
A. Fortunato \|
<p>Although the patient’s wellbeing is the primary aim of Laboratory Medicine, great attention should be given to laboratory efficiency, particularly for reagent expenses. Without quantitative data it is difficult for a laboratory manager to know the relationship between the number of assays that theoretically can be performed with a reagent package and the number of produced reports. Many factors can affect these data; for instance, the calibration frequency or the number of repetitions of a sample, the scheduled turnaround time for the assay, the number of samples to run or the reagent stability. In this study, a software for the laboratory warehouse management was used to evaluate the actual yield of reagent packs and to estimate the real cost of measurements. Costs for reagent purchase in a 12-month time period and data of 1440 different product stock movements for issuing 550,000 reports were analyzed for tests ranging from less than 100 to over 250,000 requests/year. The distribution of the calculated yield for reagent packs was between 16.7% and 98.5%, with a median value of 65.5% (confidence interval, 55.0-79.0). On average, the percentage yield for reagent packs rapidly grows in proportion to the number of determinations performed up to 10,000 tests per year. For assays with a request number exceeding 10,000 the yield was almost always >80%.</p>
Biochimica Clinica ; 39(3) 178-183 Contributi scientifici - Scientific Papers