An Italian program of External Quality Control for chromogranin A (CgA) assay: performance evaluation of CgA determination.
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.
Unit of Medical Statistics and Biometry, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. paolo.verdeiro@istitutotumori.mi.it
Paolo
P
Verderio
Ruggero
R
Dittadi
Ettore
E
Marubini
Sara
S
Pizzamiglio
Massimo
M
Gion
Leandro
L
De Apollonia
Angelo
A
Paradiso
D002624:Chemistry, Clinical / Q000379:methods; D053379:Chromogranin A / Q000032:analysis* / Q000097:blood*; D019411:Clinical Laboratory Techniques / Q000592:standards*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods / Q000592:standards*; D006801:Humans; D015592:Immunoradiometric Assay / Q000592:standards*; D007558:Italy; D007753:Laboratories; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results
D053379:Chromogranin A