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

Paolo Verderio, Ruggero Dittadi, Ettore Marubini, Sara Pizzamiglio, Massimo Gion, Leandro De Apollonia, Angelo Paradiso

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1244-1250
Number of pages7
JournalClinical Chemistry and Laboratory Medicine
Volume45
Issue number9
DOIs
Publication statusPublished - Sep 1 2007

Fingerprint

Chromogranin A
Quality Control
Quality control
Assays
Immunoradiometric Assay
Immunosorbents
Enzyme-Linked Immunosorbent Assay
Enzymes
Neuroendocrine Cells
Principal Component Analysis
Italy
Glycoproteins
Principal component analysis
Neurons
Health

Keywords

  • Chromogranin A
  • Control chart
  • Enzyme-linked immunosorbent assay (ELISA)
  • External quality control program
  • Immunoradiometric assay (IRMA)
  • Principal component analysis

ASJC Scopus subject areas

  • Clinical Biochemistry

Cite this

An Italian program of External Quality Control for chromogranin A (CgA) assay : Performance evaluation of CgA determination. / Verderio, Paolo; Dittadi, Ruggero; Marubini, Ettore; Pizzamiglio, Sara; Gion, Massimo; De Apollonia, Leandro; Paradiso, Angelo.

In: Clinical Chemistry and Laboratory Medicine, Vol. 45, No. 9, 01.09.2007, p. 1244-1250.

Research output: Contribution to journalArticle

Verderio, Paolo ; Dittadi, Ruggero ; Marubini, Ettore ; Pizzamiglio, Sara ; Gion, Massimo ; De Apollonia, Leandro ; Paradiso, Angelo. / An Italian program of External Quality Control for chromogranin A (CgA) assay : Performance evaluation of CgA determination. In: Clinical Chemistry and Laboratory Medicine. 2007 ; Vol. 45, No. 9. pp. 1244-1250.
@article{1d54e609d6e6408c9391046790ce8854,
title = "An Italian program of External Quality Control for chromogranin A (CgA) assay: Performance evaluation of CgA determination",
abstract = "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.",
keywords = "Chromogranin A, Control chart, Enzyme-linked immunosorbent assay (ELISA), External quality control program, Immunoradiometric assay (IRMA), Principal component analysis",
author = "Paolo Verderio and Ruggero Dittadi and Ettore Marubini and Sara Pizzamiglio and Massimo Gion and {De Apollonia}, Leandro and Angelo Paradiso",
year = "2007",
month = "9",
day = "1",
doi = "10.1515/CCLM.2007.251",
language = "English",
volume = "45",
pages = "1244--1250",
journal = "Clinical Chemistry and Laboratory Medicine",
issn = "1434-6621",
publisher = "Walter de Gruyter GmbH",
number = "9",

}

TY - JOUR

T1 - An Italian program of External Quality Control for chromogranin A (CgA) assay

T2 - Performance evaluation of CgA determination

AU - Verderio, Paolo

AU - Dittadi, Ruggero

AU - Marubini, Ettore

AU - Pizzamiglio, Sara

AU - Gion, Massimo

AU - De Apollonia, Leandro

AU - Paradiso, Angelo

PY - 2007/9/1

Y1 - 2007/9/1

N2 - 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.

AB - 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.

KW - Chromogranin A

KW - Control chart

KW - Enzyme-linked immunosorbent assay (ELISA)

KW - External quality control program

KW - Immunoradiometric assay (IRMA)

KW - Principal component analysis

UR - http://www.scopus.com/inward/record.url?scp=34548599886&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=34548599886&partnerID=8YFLogxK

U2 - 10.1515/CCLM.2007.251

DO - 10.1515/CCLM.2007.251

M3 - Article

C2 - 17663633

AN - SCOPUS:34548599886

VL - 45

SP - 1244

EP - 1250

JO - Clinical Chemistry and Laboratory Medicine

JF - Clinical Chemistry and Laboratory Medicine

SN - 1434-6621

IS - 9

ER -