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.

中文翻译：

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当前的免疫测定方法及其在临床上用于乳腺癌的生物标志物的应用。

乳腺癌是全世界与癌症相关的死亡率的主要原因，在发达国家发病率更高。根据美国和美国的指南，建议在实验室中使用乳腺癌的生物标记物，例如雌激素受体，孕激素受体，人表皮生长因子受体2，CA（癌抗原）15-3，CA 27.29和癌胚抗原。欧洲社会。免疫测定法已被经常和一致地用于检测乳腺癌的这些临床确定的生物标志物。尽管与组织标志物相比，血清生物标志物（包括CA 15-3，CA 27.29和CEA）具有更高的可及性，但免疫测定方法的变化会影响其标准化和临床应用。在审查用于检测这些血清标志物的免疫分析方法时，我们发现，最常用的免疫测定是酶联免疫吸附测定，然后是电化学发光免疫测定，然后是化学发光免疫测定，用于CA 15-3和CEA。同时，化学发光免疫分析是CA27.29的最常用技术。与2000-2009年相比，2010年至2019年，电化学发光免疫测定和单克隆荧光测定已成为首选方法。分析和临床性能因素（例如敏感性，特异性，检测限，对实验室人员的危害风险，速度和经济可行性）影响了用户偏好的这些变化。使用免疫测定时，应该对原理，优点，易损性和解释注意事项有一个全面的了解。在将来，