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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Editorial Board Member: Gillery, Philippe / Kazmierczak, Steven / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Whitfield, John B.

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Experimental validation of specificity of the squamous cell carcinoma antigen-immunoglobulin M (SCCA-IgM) assay in patients with cirrhosis

Jessica Zuin1 / Gianluca Veggiani1 / Paolo Pengo1 / Andrea Gallotta1 / Alessandra Biasiolo2 / Natascia Tono3 / Angelo Gatta2 / Patrizia Pontisso2 / Radovan Toth4 / Dean Cerin4 / Vladimir Frecer4 / Sabrina Meo5 / Massimo Gion6 / Giorgio Fassina1 / Luca Beneduce1

1Xeptagen SpA, Marghera, Venice, Italy

2Department of Clinical and Experimental Medicine, University of Padua, Padua, Italy

3Istituto Oncologico Veneto – I.O.V. (IRCCS), Padua, Italy

4Laboratory of Molecular, Biostructural and Nanomaterial Modeling, Consorzio per l'AREA di Ricerca Scientifica e Tecnologica di Trieste, AREA Science Park, Trieste, Italy

5ABO Association, Center for the Study of Biological Markers of Malignancy, AULSS12, Venice, Italy

6Center for the Study of Biological Markers of Malignancy, AULSS12, Venice, Italy

Corresponding author: Luca Beneduce, PhD, XEPTAGEN S.p.A., Via delle Industrie 9, 30175 Marghera Venice, Italy Phone: +39 041 5093910, Fax: +39 041 5093884,

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 48, Issue 2, Pages 217–223, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2010.044, December 2009

Publication History:
Received:
2009-09-22
Accepted:
2009-10-11
Published Online:
2009-12-10

Abstract

Background: Squamous cell carcinoma antigen-immunoglobulin M (SCCA-IgM) is a useful biomarker for the risk of development of hepatocellular carcinoma (HCC) in patients with cirrhosis due to its progressive increase associated to HCC evolution. In patients with cirrhosis, other assays have been affected by interfering reactivities of IgM. In this study, the analytical specificity of the SCCA-IgM assay was assessed by evaluating SCCA-IgM measurement dependence on different capture phases, and by measuring the recovery of SCCA-IgM reactivity following serum fractionation.

Methods: Serum samples from 82 patients with cirrhosis were analyzed. SCCA-IgM was measured using the reference test (Hepa-IC, Xeptagen, Italy) that is based on rabbit oligoclonal anti-squamous cell carcinoma antigen (SCCA) and a dedicated ELISA with a mouse monoclonal anti-SCCA as the capture antibody.

Results: SCCA-IgM concentrations measured with the reference assay (median value=87 AU/mL) were higher than those measured with the mouse monoclonal test (median value=78 AU/mL). However, the differences in the SCCA-IgM distribution were not statistically significant (p>0.05). When SCCA-IgM concentrations measured with both tests were compared, a linear correlation was found (r=0.77, p<0.05). Fractionation of the most reactive sera by gel-filtration chromatography showed that total recovery of SCCA-IgM reactivity was seen only in the fractions corresponding to components with a molecular weight higher than IgM and SCCA (>2000 kDa) with both tests.

Conclusions: The equivalence of both SCCA-IgM assays and the absence of reactivity not related to immune complexes support the analytical specificity of SCCA-IgM measurements. The results validate the assessment of SCCA-IgM for prognostic purposes in patients with cirrhosis.

Clin Chem Lab Med 2010;48:217–23.

Keywords: autoantibodies; cancer biomarker; cell carcinoma antigen-immunoglobulin M; diagnostic assay; hepatocellular carcinoma; immune complexes; immunesurveillance; natural IgM

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