Lab Med Online.  2012 Jul;2(3):131-138.

Evaluation of the Performance of Lumipulse G1200 for Tumor Marker Assays

  • 1Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea.
  • 2Department of Laboratory Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.


Tumor markers are used for diagnosing cancers and monitoring responses to cancer therapy. In this study, we evaluated the performance of Lumipulse G1200 (Fujirebio, Japan), a fully automated serum analyzer, for immunoassays of tumor markers.
We determined the precision and linearity of assays performed using Lumipulse G1200 and the correlation between the results of this and other analyzers used for tumor markers according to the guidelines of the Clinical and Laboratory Standards Institute (CLSI). We used 9 tumor markers, namely, carcinoembryonic antigen, alpha-fetoprotein, cancer antigen 125, cancer antigen 15-3 (CA 15-3), cancer antigen 19-9, prostate specific antigen, protein induced by vitamin K absence or antagonist-II, and pepsinogens I and II. Further, we validated reference intervals using 20 serum samples of healthy individuals.
Lumipulse G1200 yielded acceptable precision with total CV< or =5% and within-run CV< or =3% for all markers. Total CV for all markers was 2.4-3.7%, with the exception of CA 15-3 and pepsinogens I and II (CV, 4.0-5.0%). Linearity was observed for all markers over the entire analytical range. Results of Lumipulse G1200 were in good agreement with those of currently used analyzers with correlation coefficients>0.975 for all markers, except pepsinogen I (0.9569). The reference intervals provided by the manufacturer met the criteria mentioned in the CLSI guideline.
Assays using Lumipulse G1200 had high precision, clinically acceptable linearity, and good correlation with the established assays. This indicates that Lumipulse G1200 can be potentially used in routine laboratories.


Tumor maker; Lumipulse G1200; Precision; Linearity; Method comparison
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