Lab Med Online LMO Laboratory Medicine Online 2093-6338 The Korean Society for Laboratory Medicine 10.3343/lmo.2012.2.3.131 Original Article Clinical Chemistry Evaluation of the Performance of Lumipulse G1200 for Tumor Marker Assays Cho Jin-Hee M.D. 1 Lee Chul-Moon M.T. 1 Park Chul Min M.D. 1 Moon Hee-Won M.D. 1 Hur Mina M.D. 1 Yun Yeo-Min M.D. 1 Lee Woochang M.D. 2 Chun Sail M.D. 2 Min Won-Ki M.D. 2 Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea. Department of Laboratory Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea. Corresponding author: Yeo-Min Yun, M.D. Department of Laboratory Medicine, Konkuk University Hospital, Konkuk University School of Medicine, 4-12 Hwayang-dong, Gwangjin-gu, Seoul 143-729, Korea. Tel: +82-2-2030-5582, Fax: +82-2-2030-5587, ymyun@kuh.ac.kr 07 2012 01 07 2012 2 3 131 138 09 11 2011 03 04 2012 04 04 2012 © 2012, Laboratory Medicine Online 2012

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 Background

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.

 Methods

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, α-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.

 Results

Lumipulse G1200 yielded acceptable precision with total CV≤5% and within-run CV≤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.

 Conclusions

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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Linearity of concentrations estimated by the Lumipulse G1200 assay for 9 tumor markers. Concentration of each tumor marker is shown on a separate graph (A-I).

Abbreviations: AFP, α-fetoprotein; CEA, carcinoembryonic antigen; CA 125, cancer antigen 125; CA 15-3, cancer antigen 15-3; CA 19-9, cancer antigen 19-9; PSA, prostate specific antigen; PIVKA-II, protein induced by vitamin K absence or antagonist-II.

Regression plots of concentrations of 9 tumor markers measured using Lumipulse G1200 and other analyzers. (A) AFP: Modular analytics E170 vs. Lumipulse G1200, (B) AFP: Architect i2000 vs. Lumipulse G1200, (C) CEA: Modular analytics E170 vs. Lumipulse G1200, (D) CEA: Architect i2000 vs. Lumipulse G1200, (E) CA 125: Modular analytics E170 vs. Lumipulse G1200, (F) CA 125: Architect i2000 vs. Lumipulse G1200, (G) CA 19-9: Modular analytics E170 vs. Lumipulse G1200, (H) CA 19-9: Cobas 6000 vs. Lumipulse G1200, (I) CA 15-3: Modular analytics E170 vs. Lumipulse G1200, (J) PSA: Modular analytics E170 vs. Lumipulse G1200, (K) PIVKA-II: EP-one vs. Lumipulse G1200, (L) Pepsinogen I: TBA-200 FR Neo vs. Lumipulse G1200, (M) Pepsinogen II: TBA-200 FR Neo vs. Lumipulse G1200. The blue line represents the linear regression, and the gray line is a theoretical line with a slope of 1.0 and a Y intercept of 0.

Abbreviations: AFP, α-fetoprotein; CEA, carcinoembryonic antigen; CA 125, cancer antigen 125; CA 15-3, cancer antigen 15-3; CA 19-9, cancer antigen 19-9; PSA, prostate specific antigen; PIVKA-II, protein induced by vitamin K absence or antagonist-II.

Bland-Altman plots showing the means of the paired difference in the concentrations of tumor markers measured using Lumipulse G1200 and different analyzers. (A) AFP: Modular analytics E170 vs. Lumipulse G1200, (B) AFP: Architect i2000 vs. Lumipulse G1200, (C) CEA: Modular analytics E170 vs. Lumipulse G1200, (D) CEA: Architect i2000 vs. Lumipulse G1200, (E) CA 125: Modular analytics E170 vs. Lumipulse G1200, (F) CA 125, Architect i2000 vs. Lumipulse G1200, (G) CA 19-9: Modular analytics E170 vs. Lumipulse G1200, (H) CA 19-9: Cobas 6000 vs. Lumipulse G1200, (I) CA 15-3: Modular analytics E170 vs. Lumipulse G1200, (J) PSA: Modular analytics E170 vs. Lumipulse G1200, (K) PIVKA-II: EP-one vs. Lumipulse G1200, (L) Pepsinogen I: TBA-200 FR Neo vs. Lumipulse G1200, (M) Pepsinogen II: TBA-200 FR Neo vs. Lumipulse G1200. Thick solid lines show the means of the paired differences, and thin solid lines represent lines of identity. Dashed lines show 95% limits of agreement (means of paired differences±1.96 SD).

Abbreviations: AFP, α-fetoprotein; CEA, carcinoembryonic antigen; CA 125, cancer antigen 125; CA 15-3, cancer antigen 15-3; CA 19-9, cancer antigen 19-9; PSA, prostate specific antigen; PIVKA-II, protein induced by vitamin K absence or antagonist-II.

Precision profiles for the 9 tumor markers

*Within-subject biological variation and desirable analytical precision criteria are referred from Rico et al. [8] and the biological variation database specification in Westgard's web site (http://www.westgard.com/biodatabase1.htm) [11].

Abbreviations: CVw, within-subject biologic variation; AFP, α-fetoprotein; CEA, carcinoembryonic antigen; CA 15-3, cancer antigen 15-3; CA 19-9, cancer antigen 19-9; CA 125, cancer antigen 125; PSA, prostate specific antigen; PIVKA-II, protein induced by vitamin K absence or antagonist-II; NA, not applicable.

Linearity of the results obtained using Lumipulse G1200

Abbreviations: AFP, α-fetoprotein; CEA, carcinoembryonic antigen; CA 15-3, cancer antigen 15-3; CA 19-9, cancer antigen 19-9; CA 125, cancer antigen 125; PSA, prostate specific antigen; PIVKA-II, protein induced by vitamin K absence or antagonist-II.

Comparison of results obtained using Lumipulse G1200 and other analyzers

Abbreviations: AFP, α-fetoprotein; CEA, carcinoembryonic antigen; CA 15-3, cancer antigen 15-3; CA 19-9, cancer antigen 19-9; CA 125, cancer antigen 125; PSA, prostate specific antigen; PIVKA-II, protein induced by vitamin K absence or antagonist-II.