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Gion M.,Centro Regionale Specializzato Biomarcatori Diagnostici Prognostici e Predittivi | Maggino T.,Unita Operativa di Ostetricia e Ginecologia
Biochimica Clinica | Year: 2013

A general consensus exists on the effectiveness of CA125 in ovarian cancer management, where it is currently used as an aid in clinical decisions for the initial work-up, post-operative follow-up and for monitoring chemotherapy in advanced disease. It is, however, apparent that no effective marker is presently available for costeffective screening of asymptomatic population. The debate is still open on the role of markers in the differential diagnosis of adnexal masses and some agreement exists on the following issues: 1) the referral to a gynecologic oncologist improves outcome for ovarian cancer patients, including overall survival; 2) markers should not be intended as a cancer diagnostic test, but as one of the criteria for the selection of patients with adnexal mass at a higher cancer risk; 3) CA125 appears to have several shortcomings: Low sensitivity for early stage disease and low specificity, especially in premenopausal women; 4) algorithms combining CA125, age and imaging to assess the risk of a mass being malignant improve diagnostic accuracy of CA125 used alone; 5) among novel markers, HE4 has emerged as the most effective, overperforming CA125 mainly in premenopausal women; 6) mixed data have been reported on the advantages of ROMA, a diagnostic algorithm integrating HE4, CA125 and menopausal status, vs. HE4 alone; 7) conflicting data suggest that properly designed and well performed studies are still needed to identify the most effective diagnostic approach to assess cancer risk in patients with adnexal mass. Source

Leon A.E.,Centro Regionale Specializzato Biomarcatori Diagnostici Prognostici e Predittivi | Squarcina E.,Centro Regionale Specializzato Biomarcatori Diagnostici Prognostici e Predittivi | Maggino T.,U.O. Ostetricia e Ginecologia | Romagnolo C.,Ospedale G. Fracastoro | And 4 more authors.
Biochimica Clinica | Year: 2013

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. Source

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