Robert H Christenson1, Denise R Cervelli2, Jamie Sterner2, Lauren M Bachmann3, Heather Rebuck4, Jeffery Gray4, Walter E Kelley5. 1. University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: RCHRISTENSON@umm.edu. 2. Siemens Healthcare Diagnostics, Newark, DE, USA. 3. VCU Health System, Richmond, VA, USA. 4. University of Maryland School of Medicine, Baltimore, MD, USA. 5. University of Maryland Medical Center, Baltimore, MD, USA.
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 AND 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.
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 AND 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.
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