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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

EIC Assistant
Francesco Busardò

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
Chiara Riva
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282


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

BC: Articoli scritti da Gruppo di Studio SIBioC Proteine

Valutazione dell’impatto delle raccomandazioni del Gruppo di Studio SIBioC Proteine sull’operatività dei laboratori italiani
Evaluation of the impact of recommendations by the SIBioC Proteins Study Group on Italian laboratory procedures
<p>Protein diagnostics is central in the management of subjects with monoclonal gammopathy. Laboratory&nbsp;should provide the most useful information to ensure the best patient outcome. To assess if recommendations issued&nbsp;after the 2007 survey have impacted on Italian laboratories contributing to a better harmonization of the post-analytical&nbsp;phase, the SIBioC Proteins Study Group has repeated a similar survey in February 2015. Twenty questions were&nbsp;electronically submitted to all SIBioC members using the software &quot;Survey monkey&quot;. 103 responses were collected,&nbsp;corresponding to ~6% of Italian laboratories. 47% of laboratories add an appropriate comment to the serum protein&nbsp;electrophoresis report when no monoclonal component (MC) is detected (36% in 2007). MC are correctly defined by&nbsp;63% of the laboratories; however, 11% reports MC as &ldquo;thickening&rdquo; or &ldquo;asymmetry&rdquo; or &ldquo;homogeneous peak&rdquo;. These&nbsp;ambiguous terms were used by roughly the same percentage (14%) in 2007. In 2015, the number of laboratories&nbsp;performing a MC typing only when requested by the clinician is reduced by 10% when compared to 2007. In both&nbsp;surveys, the percentage of laboratories performing and reporting the MC quantification is 77%. The worse results were&nbsp;obtained for Bence Jones protein (BJP) determination (not investigated in 2007): only 66% of laboratories utilize the&nbsp;immunofixation to detect the BJP and 57% do not quantify the protein. Although some progresses in harmonization of&nbsp;reporting are observed in CM testing over years, there is still room for significant improvement.</p>
Biochimica Clinica ; 39(6) 585-590
Contributi scientifici - Scientific Papers
L’aggiornamento dei criteri per la diagnosi di mieloma multiplo da parte dell’“International Myeloma Working Group”
The update of the criteria for the diagnosis of multiple myeloma by the International Myeloma Working Group (IMWG)
<p>The IMWG has recently updated the disease definition of multiple myeloma, by adding validated biomarkers&nbsp;to the existing requirements of organ damage (hypercalcemia, renal insufficiency, anemia, bone lesions). These&nbsp;changes are based on the identification of biomarkers able to detect the subset of patients with smouldering multiple&nbsp;myeloma at imminent risk of developing organ damage and should, therefore, be considered for therapy. Considering&nbsp;that the clinical laboratory is involved in the measurement of these new markers, this paper is aimed to illustrate the&nbsp;proposed changes giving at the same time some indications for their accurate measurements. As for the organ&nbsp;damage, the major change is related to the evaluation of renal function: the new criteria include the estimation of the&nbsp;glomerular filtration rate using established formulas (eGFR) rather than the use of serum creatinine concentrations&nbsp;alone, as previously indicated. The diagnosis of renal insufficiency requires an eGFR &lt;40 mL/min/1.73 m<sup>2</sup>. The&nbsp;criteria for anemia and hypercalcemia remain unchanged. As biomarker of malignancy, a ratio &gt;100 of involved to&nbsp;uninvolved serum free light chains is recognized. Another relevant modification is the elimination of the monoclonal&nbsp;protein quantification; it is based on the consideration that an important percentage of patients with multiple myeloma&nbsp;does not show a serum or urine monoclonal protein. Other changes based on imaging techniques or bone marrow&nbsp;examination do not involve the clinical laboratory and are not discussed in this paper. Additional biomarkers will&nbsp;probably be indentified in the near future, but they need to be validated by more independent studies.</p>
Biochimica Clinica ; 39(4) 275-280
Opinioni - Opinions
Indicazioni per la quantificazione delle componenti monoclonali nel siero
Recommendations for the quantification of serum monoclonal components (MC)
<p>The quantification of MC&nbsp;provides a surrogate for monitoring the size of the population of malignant cells in patients affected by plasma cell&nbsp;disease (PCD). Consequently, clinical and laboratory guidelines on diagnosis, risk stratification and monitoring of PCD&nbsp;recommend MC quantification as a key information for patient management. To do that, liquid phase immunochemical&nbsp;determination of IgG, IgA and IgM in serum should not be used, because of the inability of the technique to distinguish&nbsp;between monoclonal and polyclonal immunoglobulins. However, new available immunoassays specifically measuring&nbsp;free light chains, or the &ldquo;so-called&rdquo; Hevylite assay, may reliably quantify specific MC. As a general recommendation, MC&nbsp;should be quantified on agarose gel electrophoresis by scanning densitometry or from capillary zone electrophoresis&nbsp;readout only, provided that a high resolution electrophoresis is performed and a low concentration MC obscured by other&nbsp;proteins is not present. For integration of the MC peak on electrophoresis, perpendicular drop method is recommended.&nbsp;MC is a critical &ldquo;analyte&rdquo; as the potential analytical pitfalls (detection limit depending on the position of the MC and on&nbsp;the polyclonal background, poor linearity of scanning methods, precision performance) show. Thus, a comprehensive&nbsp;program of IQC of MC quantification should be implemented as well as an EQAS.</p>
Biochimica Clinica ; 39(3) 199-207
Documenti SIBioC - SIBioC Documents
Documento di consenso SIBioC e Società Italiana di Radiologia Medica (SIRM) sulla richiesta di esami di laboratorio per la valutazione del danno renale da mezzi di contrasto
SIBioC-SIRM consensus document on the request of laboratory tests for evaluation of contrast media nephrotoxicity
<p>The contrast media, widely used in imaging diagnostics, show a favorable safety profile. As the&#160;presence of pre-existing disease is considered a risk factor for adverse events, patients should be carefully evaluated&#160;prior to the procedure. The aim of this consensus document is to recommend appropriate biochemical tests to be&#160;performed for an early recognition of individuals at higher risk of contrast media nephrotoxicity. This condition is defined&#160;by an increase of serum creatinine concentrations of at least 0.50 mg/dL and/or 25% within 3-4 days from contrast media&#160;exposure. The most important risk factor is renal insufficiency [estimated glomerular filtration rate (eGFR) &lt;60&#160;mL/min/1.73 m<sup>2</sup> or serum creatinine &gt;1.50 mg/dL]. Other risk factors are age &gt;75 years, dehydration, diabetes, heart&#160;failure and anemia. Monoclonal gammopathies, multiple myeloma, Waldenstr&#246;m macroglobulinemia and amyloidosis&#160;are not considered risk factors per se. On the basis of available guidelines, it is recommended: a) prior to the&#160;examination, to measure serum creatinine baseline with a method traceable to the international reference measurement&#160;system and report its concentration together with the eGFR using the Chronic Kidney Disease &#8211; Epidemiology&#160;Collaboration (CKD-EPI) equation; b) for monitoring, to measure serum creatinine more than once calculating the delta&#160;from the baseline value: if serum creatinine increases &gt;5%, repeat the test within 48-72 h. Performing of laboratory tests&#160;to exclude the presence of monoclonal gammopathies (i.e., serum protein electrophoresis, Bence Jones protein&#160;determination, serum free light chain measurements) is not required.</p>
Biochimica Clinica ; 38(2) 139-142
Documenti SIBioC - SIBioC Documents
Il contributo della diagnostica proteica nella gestione delle gammopatie monoclonali
Protein diagnostics in the management of monoclonal gammopathies
<p>This document examines laboratory tests&nbsp;to be used for the management of monoclonal gammopathies in different clinical scenarios, from screening to&nbsp;monitoring and assessment of the response to therapy. The content is based on international recommendations and&nbsp;guidelines currently available. It includes sections on the analytical aspects of different tests&nbsp;(serum&nbsp;protein&nbsp;electrophoresis, typing and quantification of monoclonal components, Bence Jones protein determination and free&nbsp;light chain measurement) and on their clinical significance as well. Different clinical settings are examined: screening,&nbsp;diagnosis, risk stratification, monitoring and response assessment. For each of those, laboratory tests to be used are&nbsp;indicated. Aim of the document is to help clinical laboratories avoiding unnecessary tests, ensuring in the meantime&nbsp;that all the investigations required for a optimal patient management are carried out.</p>
Biochimica Clinica ; 38(1) 47-53
Documenti SIBioC - SIBioC Documents