Alternative antibody for the detection of CA15-3 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access® BR Monitor assay on the UniCel® DxI 800 Immunoassay System
-
Rafael Molina
Abstract
Background: Cancer antigen CA15-3 antigen is known as a valuable marker for the management of breast cancer.
Methods: The analytical and clinical performance of the Access® BR Monitor Immunoassay System (Beckman Coulter) was evaluated at five different European sites and compared with a reference system, defined as CA15-3 on the Elecsys® System (Roche Diagnostics).
Results: Total imprecision (%CV) of the BR Monitor ranged between 5.5% and 11.7%, and inter-laboratory reproducibility between 3.4% and 5.1%. Linearity upon dilution showed a mean recovery of 98.5% (SD±9.1%). Endogenous interferents had no influence on BR Monitor levels (mean recoveries: hemoglobin 112%, bilirubin 111%, triglycerides 108%). There was no high-dose hook effect up to 13,540 kU/L. Clinical performance investigated in sera from 1811 individuals showed a general correlation between the Access BR Monitor and Elecsys CA15-3 (R=0.797), with a slope of 1.383. CA15-3 serum levels, as measured by the BR Monitor, were low in healthy individuals (n=267, median=11.9 kU/L, 95th percentile=23.5 kU/L), higher in individuals with various benign diseases (n=549, medians=11.3–15.6 kU/L, 95th percentiles=21.6–54.6 kU/L) and even higher in individuals suffering from various cancers (n=995, medians=11.2–22.8 kU/L, 95th percentiles=30.0–429.7 kU/L). Best diagnostic accuracy for cancer detection against the relevant benign control group by the BR Monitor was found for locoregional and metastatic breast cancer, as well as for ovarian cancer [area under the curve (AUC) 0.619, 0.897 and 0.774]. Results for the reference CA15-3 assay were comparable (AUC 0.611, 0.887 and 0.818).
Conclusions: The Access BR Monitor provides accurate methodological characteristics and demonstrates an analytical and clinical correlation with Elecsys CA15-3. Best diagnostic accuracy for the BR Monitor was found in breast and ovarian cancer. Our results also suggest a clinical value of the BR Monitor in other cancers.
Clin Chem Lab Med 2008;46:612–22.
©2008 by Walter de Gruyter Berlin New York
Articles in the same Issue
- Editorial
- Comparability of tumor marker immunoassays: still an important issue for clinical diagnostics?
- Review
- The diagnostic role of autoantibodies in the prediction of organ-specific autoimmune diseases
- Validation and Outcome Studies
- Alternative antibody for the detection of CA125 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access® OV Monitor assay on the UniCel® DxI 800 Immunoassay System
- Alternative antibody for the detection of CA19-9 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access® GI Monitor assay on the UniCel® DxI 800 Immunoassay System
- Alternative antibody for the detection of CA15-3 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access® BR Monitor assay on the UniCel® DxI 800 Immunoassay System
- Toward metrological traceability in the determination of prostate-specific antigen (PSA): calibrating Beckman Coulter Hybritech Access PSA assays to WHO standards compared with the traditional Hybritech standards
- Multicentre evaluation of a new point-of-care test for the determination of CK-MB in whole blood
- Down's syndrome screening: population statistic dependency of screening performance
- General Clinical Chemistry and Laboratory Medicine
- Association between plasma thiols and immune activation marker neopterin in stable coronary heart disease
- Role for mitochondrial uncoupling protein-2 (UCP2) in hyperhomocysteinemia and venous thrombosis risk?
- Plasma procalcitonin measured by time-resolved amplified cryptate emission (TRACE) in liver transplant patients. A prognosis marker of early infectious and non-infectious postoperative complications
- Interactions of lipoprotein(a) with diabetes mellitus, apolipoprotein B and cholesterol enhance the prognostic values for coronary artery disease
- Association of thyroid stimulating hormone and coronary lipid risk factors with lipid peroxidation in hypothyroidism
- The effect of the mode of delivery on the maternal-neonatal carnitine blood levels and antioxidant status
- Time to reconsider the clinical value of immunoglobulin G4 to foods?
- Reference Values
- Determination of reference intervals for 26 commonly measured biochemical analytes with consideration of long-term within-individual variation
- Beverage-specific effects of ethanol consumption on its biological markers
- Limits of preservation of samples for urine strip tests and particle counting
- Reference ranges and diagnostic thresholds of laboratory markers of cardiac damage and dysfunction in a population of apparently healthy black Africans
- Letters to the Editor
- External quality assessment schemes for real-time PCR: a statistical procedure to corrective actions
- Application of two different microarray-based copy-number detection methodologies – array-comparative genomic hybridization and array-multiplex amplifiable probe hybridization – with identical amplifiable target sequences
- Criticism to the article: “Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: I. Analyte definition and proposal of a candidate reference method.” Authors: J.O. Jeppsson et al. Clin Chem Lab Med 2007;45(4):558–562
- Standardization of carbohydrate-deficient transferrin: reply to the letter by Tagliaro and Bortolotti
- Comment on: Bellini C, Serra G, Risso D, Mazzella M, Bonioli E. Reliability assessment of glucose measurement by HemoCue analyser in a neonatal intensive care unit. Clin Chem Lab Med 2007;45(11):1549–54
- Reliability assessment of glucose measurement by HemoCue analyzer in a neonatal intensive care unit: reply to Dr. Joakim Hagvik
Articles in the same Issue
- Editorial
- Comparability of tumor marker immunoassays: still an important issue for clinical diagnostics?
- Review
- The diagnostic role of autoantibodies in the prediction of organ-specific autoimmune diseases
- Validation and Outcome Studies
- Alternative antibody for the detection of CA125 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access® OV Monitor assay on the UniCel® DxI 800 Immunoassay System
- Alternative antibody for the detection of CA19-9 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access® GI Monitor assay on the UniCel® DxI 800 Immunoassay System
- Alternative antibody for the detection of CA15-3 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access® BR Monitor assay on the UniCel® DxI 800 Immunoassay System
- Toward metrological traceability in the determination of prostate-specific antigen (PSA): calibrating Beckman Coulter Hybritech Access PSA assays to WHO standards compared with the traditional Hybritech standards
- Multicentre evaluation of a new point-of-care test for the determination of CK-MB in whole blood
- Down's syndrome screening: population statistic dependency of screening performance
- General Clinical Chemistry and Laboratory Medicine
- Association between plasma thiols and immune activation marker neopterin in stable coronary heart disease
- Role for mitochondrial uncoupling protein-2 (UCP2) in hyperhomocysteinemia and venous thrombosis risk?
- Plasma procalcitonin measured by time-resolved amplified cryptate emission (TRACE) in liver transplant patients. A prognosis marker of early infectious and non-infectious postoperative complications
- Interactions of lipoprotein(a) with diabetes mellitus, apolipoprotein B and cholesterol enhance the prognostic values for coronary artery disease
- Association of thyroid stimulating hormone and coronary lipid risk factors with lipid peroxidation in hypothyroidism
- The effect of the mode of delivery on the maternal-neonatal carnitine blood levels and antioxidant status
- Time to reconsider the clinical value of immunoglobulin G4 to foods?
- Reference Values
- Determination of reference intervals for 26 commonly measured biochemical analytes with consideration of long-term within-individual variation
- Beverage-specific effects of ethanol consumption on its biological markers
- Limits of preservation of samples for urine strip tests and particle counting
- Reference ranges and diagnostic thresholds of laboratory markers of cardiac damage and dysfunction in a population of apparently healthy black Africans
- Letters to the Editor
- External quality assessment schemes for real-time PCR: a statistical procedure to corrective actions
- Application of two different microarray-based copy-number detection methodologies – array-comparative genomic hybridization and array-multiplex amplifiable probe hybridization – with identical amplifiable target sequences
- Criticism to the article: “Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: I. Analyte definition and proposal of a candidate reference method.” Authors: J.O. Jeppsson et al. Clin Chem Lab Med 2007;45(4):558–562
- Standardization of carbohydrate-deficient transferrin: reply to the letter by Tagliaro and Bortolotti
- Comment on: Bellini C, Serra G, Risso D, Mazzella M, Bonioli E. Reliability assessment of glucose measurement by HemoCue analyser in a neonatal intensive care unit. Clin Chem Lab Med 2007;45(11):1549–54
- Reliability assessment of glucose measurement by HemoCue analyzer in a neonatal intensive care unit: reply to Dr. Joakim Hagvik
