title: Comparison of LUMIPULSE(®) G1200 With Kryptor and Modular E170 for the Measurement of Seven Tumor Markers.
abstract: BACKGROUND
  Tumor marker measurements are becoming essential for prognosis and follow-up of patients in oncology. In this context, we aimed to compare a new analyzer, Lumipulse(®) G1200 (Fujirebio group, distributed in Europe by the Innogenetics group) with Kryptor(®) (Thermo Fisher Scientific B.R.A.H.M.S, Asnières, France) and Modular(®) Elecsys E170 (Roche Diagnostics, Meylan, France) for the measurement of seven tumor markers: PSA, AFP, CEA, CA 15-3, CA 125, CA 19-9, and Cyfra 21-1.
  
  
  METHODS
  A total of 471 serum samples from patients with elevated tumor markers and 100 serum from healthy patients were analyzed with Lumipulse(®) G1200 and either Kryptor(®) (for AFP) or Modular(®) (for the six other markers).
  
  
  RESULTS
  The good precision of Lumipulse(®) G1200 assays was confirmed with CVs < 2.5% and < 5.0%, obtained, respectively, for within-run imprecision and intermediate imprecision (except for Cyfra 21-1: CV < 13%). For all markers, Lumipulse results were well correlated with Modular or Kryptor results (r ≥ 0.94). Concordance of results interpretation was > 95% and tumor marker kinetics were all similar.
  
  
  CONCLUSIONS
  We confirmed the analytical performances of Lumipulse(®) tumor marker assays except for the CYFRA 21-1 assay for which performances were poor in this study. We noticed a few discrepancies for the CEA assay. Besides, values obtained for CA 19-9 were higher with Lumipulse leading to a bias (slope = 1.5). But for the four other tumor markers assays (PSA, AFP, CA 125, CA 15-3), the results were directly transferable between Lumipulse and Kryptor or Modular, thus facilitating an eventual substitution of one system by another.
authors.affiliation: Service de Biochimie métabolique, Groupe hospitalier Pitié Salpêtrière, 47-83 bd de l'Hôpital, 75013, Paris, France.
authors.forename: Julien
authors.initials: J
authors.lastname: Marlet
authors.affiliation: Service de Biochimie métabolique, Groupe hospitalier Pitié Salpêtrière, 47-83 bd de l'Hôpital, 75013, Paris, France.|Unité pédagogique de Biochimie, Faculté des Sciences Pharmaceutiques et Biologiques, Paris Descartes, Paris, France.
authors.forename: Maguy
authors.initials: M
authors.lastname: Bernard
mesh_terms: D014408:Biomarkers, Tumor / Q000097:blood*; D006801:Humans; D007700:Kinetics; D011933:Reagent Kits, Diagnostic; D012044:Regression Analysis
chemical_list: D014408:Biomarkers, Tumor; D011933:Reagent Kits, Diagnostic
keywords: CA-125 antigen; CA-19-9 antigen; alpha-fetoproteins; comparability; evaluation; imprecision; kinetic; luminescent measurements; mucin-1; prostate-specific antigen