Comparison of fifteen immunoassays for the measurement of serum MUC-1/CA 15-3 in breast cancer patients
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Marie-France Pichon
Abstract
Background: Quality control results for serum MUC-1/CA 15-3 assays have always shown large discrepancies.
Methods: This multicentre study of 15 methods (labelled M1-M15) measured coded sera from 35 patients with breast cancer without recurrence (group 1), 46 patients at 1st metastasis (group 2), and 39 patients with advanced metastases (group 3). Results were compared using parametric statistics, ANOVA, principal component analysis, and receiver operating characteristic (ROC) curves.
Results: Mean MUC-1/CA 15-3 concentrations varied widely (75.1–303.0 U/mL, 24.8%) among methods. The false positive (FP) rate for group 1 was 8/521 (1.5%); for group 2 and group 3 false negative (FN) results were 21/680 (3.1%) and 11/583 (1.9%), respectively. Using the ROC cut-offs, we found no FPs for group 1 and no FNs for group 3. However, group 2 showed 16 FNs. All p-values for Pearson's correlation were <0.0001 between methods, except for M11. When comparing methods using different antibodies, discordance rates reached a maximum of 15.2%. Principal component analysis revealed a grouping of methods using: CanAg monoclonal antibodies (mAbs) (M2, M7 and M12); Centocor/Fujirebio mAbs (M3-M6, M8-M10, M14-M15) and Biomira mAbs (M1 and M13); and Centocor/Fujirebio mAbs (M11).
Conclusions: Results were more consistent among methods using the same antibody type. Principal component analysis showed that antibody type was the strongest determinant of immunoassay results.
Clin Chem Lab Med 2009;47:985–92.
©2009 by Walter de Gruyter Berlin New York
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Articles in the same Issue
- Editorial
- Hemolysis index: quality indicator or criterion for sample rejection?
- Review
- Neutrophil CD64: a diagnostic marker for infection and sepsis
- Genetics and Molecular Diagnostics
- Chromosome 9p21 polymorphism is associated with myocardial infarction but not with clinical outcome in Han Chinese
- Differential expression of microRNAs in the placentae of Chinese patients with severe pre-eclampsia
- Clinical, biochemical, and genetic analysis of a Korean neonate with hereditary tyrosinemia type 1
- General Clinical Chemistry and Laboratory Medicine
- Multicenter evaluation of the hemolysis index in automated clinical chemistry systems
- Haemolysis index – an estimate of preanalytical quality in primary health care
- Evaluation of the Innovance D-DIMER analytical performance
- Heterophile antibodies may falsely increase or decrease thyroglobulin measurement in patients with differentiated thyroid carcinoma
- Variation of barrier permeability for albumin and immunoglobulin G influx into cerebrospinal fluid
- Anti-citrullinated protein antibody and rheumatoid factor in patients with end-stage renal disease
- Reference Values and Biological Variations
- Quality of interpretative commenting on common clinical chemistry results in the Asia-Pacific region and Africa
- Analysis and interpretation of drug testing results from patients on chronic pain therapy: a clinical laboratory perspective
- Cancer Diagnostics
- HER1-4 protein concentrations in normal breast tissue from breast cancer patients are expressed by the same profile as in the malignant tissue
- Comparison of fifteen immunoassays for the measurement of serum MUC-1/CA 15-3 in breast cancer patients
- Serum levels of matrix metalloproteinase-2 and -9 and conventional tumor markers (CEA and CA 19-9) in patients with colorectal and gastric cancers
- Unstimulated high sensitive thyroglobulin measurement predicts outcome of differentiated thyroid carcinoma
- Relationship of serum antioxidant micronutrients and sociodemographic factors to cervical neoplasia: a case-control study
- Letters to the Editor
- Clinical efficacy of two cardiac troponin I assays
- Impeded centrifugation in plasmocytoma serum
