Mammaglobin as a Novel Breast Cancer Biomarker: Multigene Reverse Transcription-PCR Assay and Sandwich ELISA

• Published in: Clinical chemistry (Baltimore, Md.) Md.), 2004-11, Vol.50 (11), p.2069-2076
• Main Authors: Zehentner, Barbara K, Persing, David H, Deme, Amadou, Toure, Papa, Hawes, Stephen E, Brooks, Lisa, Feng, Qinghua, Hayes, Dawn C, Critichlow, Cathy W, Houghton, Raymond L, Kiviat, Nancy B
• Format: Article
• Language: English
• Subjects: Adult; Aged; Analytical, structural and metabolic biochemistry; Biological and medical sciences; Biomarkers; Biomarkers, Tumor - analysis; Biomarkers, Tumor - blood; Biomarkers, Tumor - genetics; Biopsy; Blood; Breast cancer; Breast Neoplasms - diagnosis; Breast Neoplasms - pathology; Cell Line, Tumor; Cells; Enzyme-Linked Immunosorbent Assay - methods; Female; Fundamental and applied biological sciences. Psychology; Genes; Humans; Investigative techniques, diagnostic techniques (general aspects); Lymphatic system; Mammaglobin A; Medical sciences; Metastasis; Middle Aged; Neoplasm Proteins - analysis; Neoplasm Proteins - blood; Neoplasm Proteins - genetics; Neoplasm Staging; Nitrogen; Proteins; Reference Values; Reverse Transcriptase Polymerase Chain Reaction - methods; Sensitivity and Specificity; Uteroglobin - analysis; Uteroglobin - blood; Uteroglobin - genetics; Womens health
• ISSN: 0009-9147; 1530-8561
• DOI: 10.1373/clinchem.2004.038687

The aim of this study was to examine the potential usefulness of a mammaglobin multigene reverse transcription-PCR (RT-PCR) assay and a mammaglobin sandwich ELISA as diagnostic tools in breast cancer. We studied peripheral blood samples from 147 untreated Senegalese women with biopsy-confirmed breast cancer and gathered patient information regarding demographic, and clinical staging of disease. The samples were tested for mammaglobin and three breast cancer-associated gene transcripts by a multigene real-time RT-PCR assay and for serum mammaglobin protein by a sandwich ELISA assay. In 77% of the breast cancer blood samples, a positive signal was obtained in the multigene RT-PCR assay detecting mammaglobin and three complementary transcribed genes. Fifty samples from healthy female donors tested negative. Significant correlations were found between mammaglobin protein in serum, presence of mammaglobin mRNA-expressing cells in blood, stage of disease, and tumor size. Circulating mammaglobin protein was detected in 68% of the breast cancer sera, and was increased in 38% in comparison with a mixed control population. The RT-PCR assay and the ELISA for mammaglobin produced a combined sensitivity of 84% and specificity of 97%. The ELISA and RT-PCR for mammaglobin and mammaglobin-producing cells could be valuable tools for diagnosis and prognosis of breast cancer.