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.
Author(s): Christenson RH, Cervelli DR, Sterner J, Bachmann LM, Rebuck H, Gray J, Kelley WE
Publication: Clin Biochem, 2011, Vol. 44, Page 1128-36
PubMed ID: 21704611 PubMed Review Paper? No
Purpose of Paper
Conclusion of Paper
Studies
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Study Purpose
The purpose of this study was to evaluate the effects of anticoagulant, storage, and assay type on the measurement of cancer biomarkers in blood.
Summary of Findings:
For the Dimension VISTA assay, the type of anticoagulant used had no effects on the measurement of CA 15-3, CA19-9, CA 125 II, AFP or CEA. After storage for 12 months at -70 degrees C or -20 degrees C, more than 90% of CA 15-3 and CA 19-9 was recovered from serum, lithium heparin-plasma, sodium heparin-plasma and 4 of 5 EDTA specimens, the fifth one having 81% of CA 19-9 recovered. After storage for 9 months at -70 degrees C, more than 90% of CA 125 II was recovered from serum and plasma, regardless of anticoagulant; however, after 9 months of storage at -20 degrees C, only 89% of CA 125 was recovered from lithium heparin specimens, but more than 90% of CA 125 was recovered with all other anticoagulants. After storage of serum or lithium heparin specimens for 7 days at 4 degrees C or 7 or 120 days at -20 degrees C, more than 93.7% of AFP was recovered. CEA recovery was greater than 96.7% for specimens stored for 7 days at any temperature and greater than 98.6% for specimens stored at -20 or -70 degrees C. CEA was lower in non-smokers than in smokers. A high degree of correlation was found between the Dimension VISTA and other analyzers during the course of patient treatment. Overall expression level patterns agreed for CA 15-3, CA 19-9, CA 125 II, AFP and CEA in 89% of breast cancer, 92% of pancreatic cancer, 98% ovarian cancer, 90% of testicular cancer and 94% of colorectal cancer specimens, respectively. Lot to lot correlation between reagents on the Dimension Vista was high.
Biospecimens
Preservative Types
- None (Fresh)
- Frozen
Diagnoses:
- Neoplastic - Carcinoma
- Neoplastic
Platform:
Analyte Technology Platform Protein Clinical chemistry/auto analyzer Pre-analytical Factors:
Classification Pre-analytical Factor Value(s) Storage Storage temperature 4 degrees C
-20 degrees C
-70 degrees C
Storage Storage duration 7 days
120 days
9 months
12 months
0 days
Clinical chemistry/auto analyzer Specific Technology platform Dimension VISTA
ADVIA Centaur
Abbott AxSym
Beckmann Access
Biospecimen Preservation Type of fixation/preservation Frozen
None (fresh)
Clinical chemistry/auto analyzer Specific Detection method Lot 1
Lot 2
Biospecimen Acquisition Anticoagulant EDTA
Lithium heparin
Sodium heparin
None