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.

Comparison of Four Automated Carcinoembryonic Antigen Immunoassays: ADVIA Centaur XP, ARCHITECT I2000sr, Elecsys E170, and Unicel Dxi800

“…This might be due to the fact that these two immunoassay analyzers use a single monoclonal antibody for two-step sandwich immunoassay, while the other two assays use one or more different antibodies. Several comparative studies of CEA assays have been reported [ 12 15 18 19 20 ]. In one of these studies, CEA data obtained by Unicel DxI800 showed the highest degree of correlation with those measured by ADVIA Centaur XP [slope (95% CI), 0.910 (0.883 to 0.947); intercept (95% CI), −0.240 (−0.362 to −0.171)] [ 19 ].…”

Protein induced by vitamin K absence or antagonist-II (PIVKA-II) specifically increased in Italian hepatocellular carcinoma patients

“…The levels of PIVKA-II and AFP were measured by LUMIPULSE V R G1200 (Fujirebio-Europe, Belgium). [15] All assays were performed according to the manufacturers' instructions.…”

Serum CA125 is a predictive marker for breast cancer outcomes and correlates with molecular subtypes

“…Quantitative variations of serum tumor markers have been developed as non-invasive tools for the assessment of treatment efficiency in human malignancies [ 5 – 6 ]. In breast cancer, carcinoembryonic antigen (CEA), cancer antigen 125 (CA125) and cancer antigen 15-3 (CA15-3) are the most widely used serum tumor markers in clinical routine, although their usefulness remains controversial [ 5 , 7 ]. CEA is a glycoprotein, relevant for cell adhesion, and was the first tumor antigen that has been studied [ 8 ].…”