title: 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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: RCHRISTENSON@umm.edu.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Christenson
authors.affiliation: Siemens Healthcare Diagnostics, Newark, DE, USA.
authors.forename: Denise R
authors.initials: DR
authors.lastname: Cervelli
authors.affiliation: Siemens Healthcare Diagnostics, Newark, DE, USA.
authors.forename: Jamie
authors.initials: J
authors.lastname: Sterner
authors.affiliation: VCU Health System, Richmond, VA, USA.
authors.forename: Lauren M
authors.initials: LM
authors.lastname: Bachmann
authors.affiliation: University of Maryland School of Medicine, Baltimore, MD, USA.
authors.forename: Heather
authors.initials: H
authors.lastname: Rebuck
authors.affiliation: University of Maryland School of Medicine, Baltimore, MD, USA.
authors.forename: Jeffery
authors.initials: J
authors.lastname: Gray
authors.affiliation: University of Maryland Medical Center, Baltimore, MD, USA.
authors.forename: Walter E
authors.initials: WE
authors.lastname: Kelley
mesh_terms: D015295:Antigens, Tumor-Associated, Carbohydrate / Q000032:analysis*; D014408:Biomarkers, Tumor / Q000032:analysis*; D018394:CA-125 Antigen / Q000032:analysis; D018395:CA-19-9 Antigen / Q000032:analysis; D002272:Carcinoembryonic Antigen / Q000032:analysis; D019937:Diagnostic Techniques and Procedures / Q000295:instrumentation* / Q000592:standards; D006801:Humans; D057230:Limit of Detection; D018396:Mucin-1 / Q000032:analysis; D009369:Neoplasms / Q000175:diagnosis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D000509:alpha-Fetoproteins / Q000032:analysis*
chemical_list: D015295:Antigens, Tumor-Associated, Carbohydrate; D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; D018395:CA-19-9 Antigen; D002272:Carcinoembryonic Antigen; D018396:Mucin-1; D000509:alpha-Fetoproteins