Lumipulse G1200의 종양표지자 분석능 평가
Evaluation of the Performance of Lumipulse G1200 for Tumor Marker Assays
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초록
배경: 종양표지자(tumor marker)는 각종 암의 진단과 치료효과 판정에 널리 이용된다. 최근 Lumipulse G1200 (Fujirebio, Japan) 면역장비가 국내에 도입되어 종양표지자 측정에 있어 임상검사실에서의 유용성을 평가하고자 하였다. 방법: CLSI 지침에 따라, 9가지 항목의 종양표지자(CEA, AFP, CA 125, CA 15-3, CA 19-9, PSA, PIVKA-II, Pepsinogen I과 II)에 대해정밀도, 직선성, 기존 장비와의 상관성을 평가하였다. 또한, 건강검진 환자에서 수집한 20검체를 대상으로 참고 구간을 검증하였다. 기존 장비와의 비교 평가 시, Modular analytics E170 (Roche Diagnostics,IN, USA)과는 AFP, CEA, CA 125, CA19-9, CA 15-3, PSA, Architect i2000 (Abbott Diagnostics, IL, USA)과는 AFP, CEA, CA125,Cobas 600 (Roche Diagnostics)과는 CA 19-9, EP-one (Sanko Junyaku Co., Japan)과는 PIVKA-II, TBA-200 FR Neo와는 Pepsinogen I과 II 항목을 비교하였다. 결과: 9가지 항목의 총 정밀도는 5% 이내였고, 검사내 정밀도는3% 이내였다. CA15-3, Pepsinogen I과 II를 제외한 모든 항목의 총정밀도는 2.4-3.7%였다. 모든 검사 항목은 분석 범위에서 직선성이우수하였다. 기존 검사와의 상관성 평가에서 Pepsinogen I을 제외한 모든 항목에서 상관성이 0.975 이상으로 밀접한 상관관계를 보였다. 제조사에서 제시한 참고 구간은 CLSI 기준에 적합하였다. 결론: Lumipulse 2000은 종양표지자 측정에 있어 정밀도, 직선성및 기존 장비와의 상관성이 우수하여 임상 검사실에서 유용하게사용될 수 있을 것으로 판단된다.
Abstract
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.
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