Evaluation of the UniCel(TM) DxI 800 Immunoassay Analyzer in Measuring Five Tumor Markers
Yonsei Medical Journal
;
: 557-564, 2012.
Artigo
em Inglês
| WPRIM
| ID: wpr-190365
ABSTRACT
PURPOSE:
Tumor marker concentrations in a given specimen measured by different analyzers vary according to assay methods, epitopes for antibodies used, and reagent specificities. Although great effort in quality assessment has been instituted, discrepancies among results from different analyzers are still present. We evaluated the assay performance of the UniCel(TM) DxI 800 automated analyzer in measuring the alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), carbohydrate antigen (CA) 125, CA 15-3 and CA 19-9 tumor markers. MATERIALS ANDMETHODS:
The linearity and precision performance of the five tumor marker assays were evaluated, and concentrations of the respective markers as measured by DxI were compared to those measured by other conventional analyzers (ADVIA Centaur(TM) and Vitros(TM) ECi) using 200 specimens collected from 100 healthy persons and 100 patients with respective cancers.RESULTS:
The linear fits for all five tumor markers were statistically acceptable (F=4648 for AFP, F=15846 for CEA, F=6445 for CA 125, F=2285 for CA 15-3, F=7459 for CA 19-9; p<0.0001 for all). The imprecision of each tumor marker assay was less than 5% coefficient of variation, except for low and high concentrations of AFP. The results from UniCel(TM) DxI 800 were highly correlated with those from other analyzers.CONCLUSION:
Our results demonstrate that UniCel(TM) DxI 800 has good linearity and precision performance for the tumor markers assayed in this study. However, there were discrepancies between assaying methods. Efforts to standardize tumor marker assays should be undertaken, and the redetermination of cut-off levels is necessary when developing methods of analyzing tumor markers.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Imunoensaio
/
Alfa-Fetoproteínas
/
Antígeno Carcinoembrionário
/
Biomarcadores Tumorais
/
Antígeno CA-19-9
/
Antígeno Ca-125
Limite:
Humanos
Idioma:
Inglês
Revista:
Yonsei Medical Journal
Ano de publicação:
2012
Tipo de documento:
Artigo
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