Current immunoassay methods and their applications to clinically used biomarkers of breast cancer.

Breast cancer is the leading cause of cancer-related mortality worldwide, with a higher incidence in developed countries. The biomarkers for breast cancer such as estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2, CA (cancer antigen) 15-3, CA 27.29, and carcinoembryonic antigen have been recommended for use in the laboratory based on the guidelines of American and European societies. Immunoassays have been frequently and consistently used to detect these clinically established biomarkers of breast cancer. Despite the higher accessibility of serum biomarkers, including CA 15-3, CA 27.29, and CEA, compared to tissue markers, variations in immunoassays affect their standardization and clinical utility. When reviewing the immunoassays used to detect these serum markers, we found that the most frequently used immunoassay was enzyme-linked immunosorbent assay, followed by electrochemiluminescent immunoassay, and then chemiluminescence immunoassay for CA 15-3 and CEA. Meanwhile, the chemiluminescence immunoassay was the most common technique for CA27.29. The electrochemiluminescent immunoassay and monoclonal fluorometric assay have become the preferred methods in 2010-2019 compared to 2000-2009. Analytical and clinical performance factors such as sensitivity, specificity, detection limit, hazard risk to laboratory personnel, speed, and economic feasibility influenced these changes in user preference. When using the immunoassays, there should be a comprehensive understanding of the principles, advantages, vulnerability, and precautions for interpretation. In the future, a combination of immunological biomarkers and genetic platforms will benefit patients with breast cancer by facilitating prognosis prediction and guiding therapeutic intervention.