Analytical performance and clinical concordance of the cancer biomarkers CA 15-3, CA 19-9, CA 125 II, Carcinoembryonic Antigen, and Alpha-Fetoprotein on the Dimension Vista® System.
Clin Biochem
; 44(13): 1128-1136, 2011 Sep.
Article
em En
| MEDLINE
| ID: mdl-21704611
ABSTRACT
OBJECTIVES:
We examined analytical characteristics of new CA 15-3, CA 19-9, CA 125 II, Carcinoembryonic Antigen (CEA), and Alpha-Fetoprotein (AFP) assays on the Dimension Vista® System. DESIGN ANDMETHODS:
Imprecision studies used CLSI-EP5-A2, Limit of Blank and Limit of Detection used CLSI-EP17 and measurement ranges were determined. Method comparisons were evaluated with Passing-Bablok, least-squares regression and residual plots. Reference intervals were determined and valid specimen types, lot-to-lot variability and sample storage stability were defined. Clinical monitoring patterns for each tumor marker in patients were examined.RESULTS:
Reproducibility for each method was <6.5%. Limits of Blank and Detection were low. Comparisons between methods showed slopes ranging from 0.89 to 1.32 with low y-intercepts and scatter. Minimal lot-to-lot variability was documented; serum/plasma specimens provide valid results; sample stability at -70°C was >9months. Clinical monitoring patterns correlated with established methods in >89% of cases.CONCLUSIONS:
Measurement of CA 15-3, CA 19-9, CA 125 II, CEA and AFP on the Dimension Vista® System is an attractive alternative.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Antígenos Glicosídicos Associados a Tumores
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Alfa-Fetoproteínas
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Biomarcadores Tumorais
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Técnicas e Procedimentos Diagnósticos
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Neoplasias
Tipo de estudo:
Diagnostic_studies
/
Evaluation_studies
Limite:
Humans
Idioma:
En
Revista:
Clin Biochem
Ano de publicação:
2011
Tipo de documento:
Article