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Evaluation of the UniCel™ DxI 800 Immunoassay Analyzer in Measuring Five Tumor Markers
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...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Yonsei University College of Medicine
2012
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3343438/ https://www.ncbi.nlm.nih.gov/pubmed/22477000 http://dx.doi.org/10.3349/ymj.2012.53.3.557 |
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author | Park, Younhee Park, Yongjung Park, Jungyong Kim, Hyon-Suk |
author_facet | Park, Younhee Park, Yongjung Park, Jungyong Kim, Hyon-Suk |
author_sort | Park, Younhee |
collection | PubMed |
description | 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™ 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 AND METHODS: 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™ and Vitros™ 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™ DxI 800 were highly correlated with those from other analyzers. CONCLUSION: Our results demonstrate that UniCel™ 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. |
format | Online Article Text |
id | pubmed-3343438 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | Yonsei University College of Medicine |
record_format | MEDLINE/PubMed |
spelling | pubmed-33434382012-05-15 Evaluation of the UniCel™ DxI 800 Immunoassay Analyzer in Measuring Five Tumor Markers Park, Younhee Park, Yongjung Park, Jungyong Kim, Hyon-Suk Yonsei Med J Original Article 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™ 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 AND METHODS: 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™ and Vitros™ 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™ DxI 800 were highly correlated with those from other analyzers. CONCLUSION: Our results demonstrate that UniCel™ 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. Yonsei University College of Medicine 2012-05-01 2012-03-28 /pmc/articles/PMC3343438/ /pubmed/22477000 http://dx.doi.org/10.3349/ymj.2012.53.3.557 Text en © Copyright: Yonsei University College of Medicine 2012 http://creativecommons.org/licenses/by-nc/3.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Park, Younhee Park, Yongjung Park, Jungyong Kim, Hyon-Suk Evaluation of the UniCel™ DxI 800 Immunoassay Analyzer in Measuring Five Tumor Markers |
title | Evaluation of the UniCel™ DxI 800 Immunoassay Analyzer in Measuring Five Tumor Markers |
title_full | Evaluation of the UniCel™ DxI 800 Immunoassay Analyzer in Measuring Five Tumor Markers |
title_fullStr | Evaluation of the UniCel™ DxI 800 Immunoassay Analyzer in Measuring Five Tumor Markers |
title_full_unstemmed | Evaluation of the UniCel™ DxI 800 Immunoassay Analyzer in Measuring Five Tumor Markers |
title_short | Evaluation of the UniCel™ DxI 800 Immunoassay Analyzer in Measuring Five Tumor Markers |
title_sort | evaluation of the unicel™ dxi 800 immunoassay analyzer in measuring five tumor markers |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3343438/ https://www.ncbi.nlm.nih.gov/pubmed/22477000 http://dx.doi.org/10.3349/ymj.2012.53.3.557 |
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