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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

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter

IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

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Volume 45, Issue 9


An Italian program of External Quality Control for chromogranin A (CgA) assay: performance evaluation of CgA determination

Paolo Verderio
  • 1Unit of Medical Statistics and Biometry, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Ruggero Dittadi / Ettore Marubini / Sara Pizzamiglio
  • 4Unit of Medical Statistics and Biometry, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Massimo Gion
  • 5Center for the Biological Markers of Malignancy-Consortium Istituto Oncologico Veneto IRCCS, c/o Clinical Pathology Laboratory, AULSS 12, Venice, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Leandro De Apollonia / Angelo Paradiso /
Published Online: 2007-09-11 | DOI: https://doi.org/10.1515/CCLM.2007.251


Background: Chromogranin A (CgA) is an acidic glycoprotein produced by many neuroendocrine cells and neurons. Currently, two different methods for assaying CgA, immunoradiometric assay (IRMA) and enzyme-linked immunosorbent assay (ELISA), are widely used in routine practice. Within the framework of a Ministry of Health project, an External Quality Control program was developed to investigate the state of the art of CgA determination in Italy and to monitor the performance of laboratories carrying out this assay. This paper reports the results regarding laboratory performance.

Methods: A total of 43 laboratories participated in this program, in which 21 used the ELISA method and 22 the IRMA method. Each laboratory received six samples, three aliquots of serum and three of plasma, at high, intermediate and low concentrations. The results provided by the two assay methods were analyzed separately using two statistical approaches, the principal component analysis and the control chart method.

Results: For the IRMA method, questionable results for all samples were obtained by two laboratories, while in two other laboratories performance was questionable for only one sample. For the ELISA method, questionable performances were obtained in only one laboratory for the low and intermediate concentration samples, whereas in three laboratories performance was questionable for only one sample. Interestingly, the coefficients of variation increased approximately five-fold when shifting from the IRMA to the ELISA method.

Conclusions: This program demonstrated both the requirement and demand for external quality assessment of CgA assay.

Clin Chem Lab Med 2007;45:1244–50.

Keywords: chromogranin A; control chart; enzyme-linked immunosorbent assay (ELISA); external quality control program; immunoradiometric assay (IRMA); principal component analysis

About the article

Corresponding author: Dr. Paolo Verderio, Unità Operativa di Statistica Medica e Biometria, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian, 1, 20133 Milan, Italy Phone: +39-02-2390-3201, Fax: +39-02-2390-2095,

Received: 2007-03-28

Accepted: 2007-05-04

Published Online: 2007-09-11

Published in Print: 2007-09-01

Citation Information: Clinical Chemical Laboratory Medicine, Volume 45, Issue 9, Pages 1244–1250, ISSN (Online) 14374331, ISSN (Print) 14346621, DOI: https://doi.org/10.1515/CCLM.2007.251.

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