Document Detail

Performance characteristics of seven automated CA 15-3 assays.
MedLine Citation:
PMID:  16707378     Owner:  NLM     Status:  MEDLINE    
Measurements of serum cancer antigen (CA) 15-3 are used to monitor tumor recurrence and treatment of advanced disease. We evaluated the performance characteristics, including limit of detection, linearity, method comparison, and reference intervals, of 7 automated methods for CA 15-3, including the Access 2 (Beckman Coulter, Brea, CA), ADVIA Centaur (Bayer Diagnostics, Tarrytown, NY), ARCHITECT i2000 and AxSYM (Abbott Diagnostics, Abbott Park, IL), Elecsys 2010 (Roche Diagnostics, Indianapolis, IN), IMMULITE 2000 (Diagnostic Products, Los Angeles, CA), and VITROS ECi (Ortho Clinical Diagnostics, Raritan, NJ) assays. The limit of detection for each assay was less than 1.0 kU/L. The maximum deviation for the target values for linearity samples was less than 10% for all methods. Method comparison studies revealed large differences for some individual samples. Overall slopes ranged from 0.50 to 1.48, and correlation coefficients were 0.90 to 0.96 when the ADVIA Centaur was the comparison method. The 97.5 percentile upper reference limit ranged from 23.3 to 51.7 kU/L. Additional standardization efforts are needed, and the availability of reference material is required. Substantial intermethod differences exist for some patient samples, indicating that redetermining the baseline is required when changing methods.
Patricia R Slev; Mindy L Rawlins; William L Roberts
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American journal of clinical pathology     Volume:  125     ISSN:  0002-9173     ISO Abbreviation:  Am. J. Clin. Pathol.     Publication Date:  2006 May 
Date Detail:
Created Date:  2006-05-18     Completed Date:  2006-05-30     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  0370470     Medline TA:  Am J Clin Pathol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  752-7     Citation Subset:  AIM; IM    
Department of Pathology, University of Utah Health Sciences Center, Salt Lake City, UT, USA.
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MeSH Terms
Mucin-1 / blood*
Neoplasm Recurrence, Local / blood,  diagnosis
Neoplasms / blood*,  diagnosis*
Reference Values
Reproducibility of Results
Tumor Markers, Biological / blood
Reg. No./Substance:
0/Mucin-1; 0/Tumor Markers, Biological

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