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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

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

Publisher
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
email: biochimica.clinica@sibioc.it

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

BC: Articoli scritti da U. Basile

Diagnosi di crioproteinemia: preziosa collaborazione tra laboratorio e clinica per la corretta gestione di una patologia rara
Diagnosis of cryoproteinemia: important collaboration between the laboratory and clinicians for the proper management of a rare disease.
P. Natali \| D. Debbia \| J. Sheldon \| A. Bari \| U. Basile \| F. Lavatelli \| D. Patel \| M. Galli \| E. Villa \| C. Salvarani \| G. Palladini \| M.T. Mascia \| G. Sandri \|
<p>Cryoglobulinemia is a rare pathologic condition that can be difficult to diagnose both clinically and in the laboratory, which is why close collaboration between the clinic and laboratory is essential. The laboratory needs the skills and experience to interpret the laboratory tests and the clinician should not hesitate to contact the laboratory when the result is not supported by the clinical signs. To strengthen this collaboration, the Protein Study Group of the Italian Society of Clinical Biochemistry (SIBioC) in collaboration with the Italian Association for the Fight against Cryglobulinemia (ALCRI) under the patronage of the University of Modena and Reggio Emilia, organised a conference in Modena on September 2021 entitled "Cryoglobulinemia: laboratory and clinic, a virtuous collaboration for the correct management of a rare pathology". This collective paper is aimed to summarize the topics discussed during the meeting. The conference consisted of two parts: the first aimed at highlighting the critical components of the pre-, intra- and post-analytical phases of cryoglobulin investigation. Cryoprotein testing remains totally manual and operator dependent so it was important to identify areas where best practice guidance or even harmonisation of the laboratory investigation would be beneficial. The second part of the conference focused on clinical aspects and the effects of therapies, including antiviral drugs with direct action against HCV. These drugs are able to eradicate the virus, but the elimination of HCV-related cryoglobulins is seen in only about half of cases. Finally, the clinical consequences of the diagnosis of cryoglobulinemia and the multidisciplinary implications that this entails were highlighted, underlining how the continuous dialogue between the laboratory and clinic is crucial for the correct management of the patient.</p>
Biochimica Clinica ; 46(2) 166-175 Documenti - Documents

Revisione e aggiornamento del documento di consenso SIBioC per la ricerca e quantificazione della proteina di Bence Jones
Update of the Italian Society of Clinical Biochemistry (SIBioC) Consensus document on the detection and quantification of the Bence Jones protein
P. Natali \| G. Cigliana \| M. Savoia \| S. Gelsumini \| U. Basile \| A. Vernocchi \| MS. Graziani \| M. Mussap \| G. Palladini \|
<p>Bence Jones protein (BJP) refers to urine monoclonal free immunoglobulin light chains produced by the clonal expansion of a plasma cell in the bone marrow. BJP is strongly associated with systemic amyloidosis AL, light chain deposition disease, and multiple myeloma; less frequently, BJP may be recognized either in patients with monoclonal gammopathies of uncertain significance (MGUS) and with other plasma cell dyscrasias or in patients with malignant non-Hodgkin's lymphomas and chronic lymphocytic leukemia. This paper contains updated recommendations for the detection and the measurement of BJP in clinical practice from the Working Group “Proteins” of the Italian Society of Clinical Biochemistry (SIBioC), with specific indications for improving all the steps of the preanalytical, analytical, and postanalytical phases. The first morning void is the urine sample recommended for BJP detection, while 24-hours urine collection is preferred for BJP quantification. Native urine cannot be used for samples with low or very low content in urine total protein; in these cases, samples should be concentrated by using specific disposables, such as ultrafiltration membranes retaining proteins with molecular weight around 10 kDa. The required degree of concentration may vary according to sensitivity of the electrophoretic method utilized and the protein content of the sample. The detection of BJP may be performed directly by the recommended method agarose gel immunofixation (IFE) with specific polyvalent immunoglobulin antisera IgG-IgA-IgM, total  and  light chains; alternatively, an electrophoretic screening may be acceptable to rule out negative test results. However, positive test results should be confirmed by IFE. Tests based on immunometric methods can be used neither as screening test, nor for the BJP quantification; however, it could be useful for monitoring purposes, provided that the renal function of the patient is preserved. BJP measurement should be performed by the densitometric scanning of the electrophoretic peak corresponding to BJP, and results should be expressed as ratio of the BJP peak percentage to the urine total protein. Test results should be always integrated by standardized interpretative comments included in the laboratory reports.</p>
Biochimica Clinica ; 45(1) 075-086 Documenti SIBioC - SIBioC Documents

Efficacia e utilità del monitoraggio terapeutico di autoanticorpi e farmaci inibitori del Tumor Necrosis Factor alpha in pazienti in trattamento per patologie autoimmuni
Therapeutic monitoring of autoantibodies Tumor Necrosis Factor α inhibitor drugs: efficacy and benefit for patients with autoimmune diseases
V. Pecoraro \| T. Trenti \| C. Bonaguri \| E. De Santis \| B. Lo Sasso \| U. Basile \|
<p>Therapeutic monitoring of autoantibodies Tumor Necrosis Factor α inhibitor drugs: efficacy and benefit for patients with autoimmune diseases. Tumor necrosis factor alpha (TNFα) is a proinflammatory cytokine involved in the pathogenesis of chronic inflammatory disease, such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Chron’s disease and ulcerative colitis. TNFα inhibitors (anti-TNFα) are monoclonal antibodies drugs directed against TNFα (i.e. adalimumab, infliximab, etarnecept, golimumab and certolizumab). Their effect consists in reducing the inflammatory response of autoimmune diseases. Several randomized controlled trials and observational studies evaluated the therapeutic efficacy of these drugs and reported a clear benefit for patients affected by chronic inflammatory disease treated with anti-TNFα, but also a high risk of reactions and infections in the injection site. These drugs are immunogenic, and consequent anti-drug antibodies (ADA) formation may decrease the functional drug concentration resulting in a loss of response. Therefore, we evaluated the impact of ADA on therapeutic response through meta-analyses, showing that detectable ADA significantly reduced TNFα inhibitors response. ADA could interfere with drugs and compromise their effects, so the determination of serum ADA levels could improve the patient’s management. Even if the decrease of therapeutic response, due to ADA production, is well documented, the clinical benefit of serum ADA determination remains unclear. At the moment, there are many indications about the use of immunogenicity test to guide the therapy, but more information should be acquired before implementing this test in clinical practice.</p>
Biochimica Clinica ; 42(3) 266-273 Documenti SIBioC - SIBioC Documents

Il contributo della diagnostica proteica nella gestione delle gammopatie monoclonali
Protein diagnostics in the management of monoclonal gammopathies
M.S. Graziani \| U. Basile \| I. Cataldo \| G. Cigliana \| M.T. Muratore \| M. Mussap \| A. Terreni \| A. Vernocchi \| G. Merlini \| Gruppo di Studio SIBioC Proteine \|
<p>This document examines laboratory tests to be used for the management of monoclonal gammopathies in different clinical scenarios, from screening to monitoring and assessment of the response to therapy. The content is based on international recommendations and guidelines currently available. It includes sections on the analytical aspects of different tests (serum protein electrophoresis, typing and quantification of monoclonal components, Bence Jones protein determination and free light chain measurement) and on their clinical significance as well. Different clinical settings are examined: screening, diagnosis, risk stratification, monitoring and response assessment. For each of those, laboratory tests to be used are indicated. Aim of the document is to help clinical laboratories avoiding unnecessary tests, ensuring in the meantime that all the investigations required for a optimal patient management are carried out.</p>
Biochimica Clinica ; 38(1) 47-53 Documenti SIBioC - SIBioC Documents

Rispondono gli Autori dell’articolo in questione
In reply
G. Passerini \| U. Basile \|

Biochimica Clinica ; 38(1) 74 Lettere all'Editore - Letters to the Editor

Razionale e prospettive della determinazione delle catene leggere libere del siero nelle patologie infiammatorie croniche
Rationale and prospects of serum immunoglobulin free light chain (FLC) determination in chronic inflammatory disease
U. Basile \| M. Mussap \|
<p>The development of serum assays for free FLC <span style="font-family:symbol">k</span> and<span style="font-family:symbol"> l</span> has opened the door to new applications increasing their clinical importance beyond monoclonal gammopathies and plasma cell dyscrasias. In particular, the availability of these tests may open new prospects for diagnosing and managing various diseases characterized by chronic inflammation, namely autoimmune disease, allergic disease, viral infections, inflammatory disorders of the central nervous system and others. For most of these diseases, serum polyclonal FLC concentrations correlate with disease activity, being a potential useful index for adjusting therapeutic regimens. The aim of this review is to summarize current available data from the literature and to analyze the possible role of FLC in improving the clinical management of patients with chronic inflammatory disorders.</p>
Biochimica Clinica ; 37(5) 357-364 Rassegne - Reviews

Una gammopatia monoclonale di difficile tipizzazione
A monoclonal gammopathy of difficult characterization
F. Gulli \| U. Basile \| S. Borrello \| C. Zuppi \|
<p>IgD monoclonal gammopathy is a rare event, but its recognition and management are quite important because the condition is potentially life-threatening. This paper reports a peculiar case of IgD monoclonal gammopathy. The monoclonal protein was rapidly degraded by proteolysis and the usual laboratory tests showed different immunochemical patterns. The study of the proteolitic dynamic of the monoclonal immunoglobulin allowed us to obtain the complete characterization of the monoclonal component.</p>
Biochimica Clinica ; 37(1) 64-67 Casi Clinici - Case Report

Determinazione del CD138 solubile nel siero di pazienti affetti da mieloma multiplo IgD
Soluble CD138 concentrations in serum of patients with IgD myeloma
U. Basile \| F. Gulli \| G. Cigliana \| S. Storti \|

Biochimica Clinica ; 35(1) 56 CASI CLINICI - CASI CLINICI