English 
Italian CONTRIBUTI SCIENTIFICI – Scientific Papers
Volume:
Biochimica Clinica 2013; 37(3) 200-207
Pubblicato on-line:
DOI:
Confronto tra due metodi per la misura nel siero della proteina 4 dell’epididimo umano (HE4) nella diagnosi di carcinoma ovarico
AUTORI
1Centro Regionale Specializzato Biomarcatori Diagnostici Prognostici e Predittivi, Dipartimento di Patologia Clinica, Azienda ULSS 12 Veneziana, Venezia
2U.O. Ostetricia e Ginecologia, Dipartimento Materno Infantile, Azienda ULSS12 Veneziana, Ospedale dell’Angelo, Zelarino, VE
3Ospedale G. Fracastoro, U.O.C. Ginecologia ed Ostetricia, San Bonifacio, VR
4Oncologia Ginecologica, Istituto Nazionale Tumori, CRO Aviano, PN
5CRO-Biobank, Centro di Riferimento Oncologico, IRCCS, Aviano, PN
ABSTRACT
Comparison between two methods for the determination of serum human epididymis protein 4 (HE4) in the diagnosis of ovarian cancer
Analytical performance and diagnostic accuracy of two commercial immunoassays for the determination of HE4 in the diagnosis of ovarian cancer were evaluated. HE4 was determined on sera consecutively obtained from 205 women (163 with benign ovarian or adnexal disease and 42 with ovarian cancer) by using a manual EIA (Fujirebio Diagnostics, Inc.) and an automated chemiluminescent microparticle assay (CMIA) (Abbott Architect platform). The intra- and interassay imprecision for EIA and CMIA was satisfactory (CV <10%). The linearity test showed recovery values between 86% and 120%. Comparison analysis showed an acceptable agreement between the two methods (r=0.99), with an average bias of 1.2%. ROC curve analysis showed an area under the curve of 0.893 for EIA and 0.899 for CMIA, respectively. Setting the specificity of each assay at 95% (cutoff, 102,7 pmol/L for EIA and 101,8 pmol/L for CMIA), the sensitivity for both methods was 67%. Both EIA and CMIA appear reliable for clinical application.