biochimica clinica

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Volume:

Biochimica Clinica, 2024; 48(1) 88-100

Pubblicato on-line:

Gennaio 30, 2024

DOI:

10.19186/BC_2024.003

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Indicazioni per l’armonizzazione del referto dell’elettroforesi delle sieroproteine e della tipizzazione delle componenti monoclonali

AUTORI

Marcella Savoia1, Laura Michetti2, Giovanni Cigliana3, Fiorella Turra4, Daria Debbia5, Valeria Visconti6, Sara Altinier7, Silvia Gelsumini2, Umberto Basile8, Patrizia Natali5, Massimo Pieri9, Ivana Cataldo10, Michele Mussap11, Maria Stella Graziani12, Giovanni Palladini13 per il Gruppo di Studio Proteine di SIBioC
1 Dipartimento di Medicina Molecolare e Biotecnologie Mediche, Università degli Studi di Napoli Federico II, DAI Medicina di Laboratorio e Trasfusionale, Azienda Ospedaliera Universitaria Federico II, Napoli
2 SC SMeL2 Analisi Chimico Cliniche, ASST Papa Giovanni XXIII, Bergamo
3 Patologia Clinica e Biobanca Oncologica, IRCCS Istituto Nazionale Tumori Regina Elena - Roma
4 Azienda Unità Sanitaria Locale di Bologna, Laboratorio Unico Metropolitano, Bologna
5 Dipartimento di Medicina di Laboratorio, Azienda Unità Sanitaria Locale e Azienda Ospedaliera Universitaria di Modena, Modena
6 UO Medicina di Laboratorio, Ospedale Policlinico San Martino, Istituto di Ricovero e Cura a Carattere Scientifico per l’Oncologia, Genova
7 U.O.C. Medicina di Laboratorio, Azienda Ospedale Università di Padova, Padova
8 Unità Operativa Complessa Patologia Clinica DEA II Livello Ospedale Santa Maria Goretti, ASL Latina, Latina
9 Dipartimento di Medicina Sperimentale e Dipartimento Ospedaliero di Medicina di Laboratorio, Università di Roma “Tor Vergata”, Roma
10 Asl2 Lanciano Vasto Chieti, Patologia Clinica Aziendale, Ospedale SS. Annunziata- Chieti
11 Laboratorio molecolare, Dipartimento di Scienze Chirurgiche, Facoltà di Medicina e Chirurgia, Università degli Studi, Cagliari
12 Sezione di Biochimica Clinica, Università di Verona, Verona
13 Centro per lo Studio e la Cura delle Amiloidosi Sistemiche, Laboratorio Biochimica - Biotecnologie e Diagnostica avanzata, Fondazione IRCCS Policlinico San Matteo, Dipartimento di Medicina Molecolare, Università di Pavia, Pavia

ABSTRACT

Harmonizing serum protein electrophoresis and monoclonal component characterization laboratory report

The Italian Society of Clinical Biochemistry and Molecular Biology (SIBioC) has long promoted harmonizing activities, focusing on the laboratory reports to guarantee accuracy and comparability of the results. There is a wealth of guidelines on the clinical usefulness and diagnostic accuracy of serum protein electrophoresis (SPE), but only few provide specific recommendations for reporting and commenting the results. According to surveys and international multi-center studies, there is considerable variability between SPE reports among laboratories, which negatively impacts the management of patients with monoclonal gammopaties (MGs). This document issued by the SIBioC Study Group on Proteins, provides guidance on how to standardize and harmonize laboratory SPE reports, formulated on the basis on the available reference literature as well as on expert consensus. Each SPE report should be accompanied by a descriptive comment, mainly related to the management of samples with monoclonal components (detection, quantification and immunotyping). Examples of comments are provided. Special attention should be dedicated to samples showing a possible interference by therapeutic monoclonal antibodies (tmAb) currently used for the treatment of Multiple Myeloma (MM). Failure to detect interference due to tmAb can lead to further unnecessary diagnostic procedures or incorrect interpretations of the efficacy of treatment, such as the failure to detect a complete response to treatment in MM patients. Close collaboration between laboratory professionals and clinicians is therefore of paramount importance to provide correct information that will be useful in every step of the management of MGs patients.

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