title: Evaluation of a CLEIA automated assay system for the detection of a panel of tumor markers.
abstract: Tumor markers are commonly used to detect a relapse of disease in oncologic patients during follow-up. It is important to evaluate new assay systems for a better and more precise assessment, as a standardized method is currently lacking. The aim of this study was to assess the concordance between an automated chemiluminescent enzyme immunoassay system (LUMIPULSE® G1200) and our reference methods using seven tumor markers. Serum samples from 787 subjects representing a variety of diagnoses, including oncologic, were analyzed using LUMIPULSE® G1200 and our reference methods. Serum values were measured for the following analytes: prostate-specific antigen (PSA), alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), cancer antigen 125 (CA125), carbohydrate antigen 15-3 (CA15-3), carbohydrate antigen 19-9 (CA19-9), and cytokeratin 19 fragment (CYFRA 21-1). For the determination of CEA, AFP, and PSA, an automatic analyzer based on chemiluminescence was applied as reference method. To assess CYFRA 21-1, CA125, CA19-9, and CA15-3, an immunoradiometric manual system was employed. Method comparison by Passing-Bablok analysis resulted in slopes ranging from 0.9728 to 1.9089 and correlation coefficients from 0.9977 to 0.9335. The precision of each assay was assessed by testing six serum samples. Each sample was analyzed for all tumor biomarkers in duplicate and in three different runs. The coefficients of variation were less than 6.3 and 6.2 % for within-run and between-run variation, respectively. Our data suggest an overall good interassay agreement for all markers. The comparison with our reference methods showed good precision and reliability, highlighting its usefulness in clinical laboratory's routine.
authors.affiliation: Laboratory of Tumor Markers, Department of Molecular Medicine, University "Sapienza", Viale Regina Elena 324, 00161, Rome, Italy.
authors.forename: Renato
authors.initials: R
authors.lastname: Falzarano
authors.forename: Valentina
authors.initials: V
authors.lastname: Viggiani
authors.forename: Simona
authors.initials: S
authors.lastname: Michienzi
authors.forename: Flavia
authors.initials: F
authors.lastname: Longo
authors.forename: Silvestra
authors.initials: S
authors.lastname: Tudini
authors.forename: Luigi
authors.initials: L
authors.lastname: Frati
authors.forename: Emanuela
authors.initials: E
authors.lastname: Anastasi
mesh_terms: D000951:Antigens, Neoplasm / Q000097:blood; D014408:Biomarkers, Tumor / Q000097:blood*; D016022:Case-Control Studies; D005188:False Negative Reactions; D006801:Humans; D053539:Keratin-19 / Q000097:blood; D008163:Luminescent Measurements; D009369:Neoplasms / Q000097:blood / Q000175:diagnosis*; D012016:Reference Values
chemical_list: D000951:Antigens, Neoplasm; D014408:Biomarkers, Tumor; D053539:Keratin-19; C102012:antigen CYFRA21.1