Comparison of Lumipulse® G1200 with Kryptor and Modular E170 for the measurement of 7 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: 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. Conclusion: We confirmed the analytical performances of Lumipulse tumor marker assays except the CYFRA 21-1 assay, which performances were not acceptable in this study. Also, we demonstrated that 5 out of 7 tumor markers assays results (PSA, AFP, CA 125, CA 15-3, CYFRA 21-1) are directly transferable between Lumipulse and Kryptor or Modular, thus facilitating an eventual replacement of one system by another.
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Julien Marlet, Maguy Bernard. Comparison of Lumipulse® G1200 with Kryptor and Modular E170 for the measurement of 7 tumor markers. "This is the pre-peer reviewed version of the following article: "Comparison of LUMIPULSE® G1200 .. 2014. 〈inserm-01230750〉

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