Highly Sensitive Detection of Hormone Estradiol E2 Using Surface-Enhanced Raman Scattering Based Immunoassays for the Clinical Diagnosis of Precocious Puberty

The hormone estradiol (17β-estradiol, E2) plays an important role in sexual development and serves as an important diagnostic biomarker of various clinical conditions. Particularly, the serum E2 concentration is very low (<10 pg/mL) in prepubertal girls. Accordingly, many efforts to develop a sensitive method of detection and quantification of E2 in human serum have been made. Nonetheless, current clinical detection methods are insufficient for accurate assessment of E2 at low concentrations (<10 pg/mL). Thus, there is an urgent need for new technologies with efficient and sensitive detection of E2 for use in routine clinical diagnostics. In this study, we introduce a new E2 assay technique using a surface-enhanced Raman scattering (SERS)-based detection method. The SERS-based assay was performed with 30 blood samples to assess its clinical feasibility, and the results were compared with data obtained using the ARCHITECT chemiluminescence immunoassay. Whereas the commercial assay system was unable to quantify serum levels of E2 lower than 10 pg/mL, the limit of detection of E2 using the novel SERS-based assay described in this study was 0.65 pg/mL. Thus, the proposed SERS-based assay has a strong potential to be a valuable tool in the early diagnosis of precocious puberty due to its excellent analytical sensitivity.

雌二醇激素（17β-雌二醇，E2）在性发育中发挥着重要作用，并且是各种临床病症的重要诊断生物标志物。特别是，青春期前女孩的血清 E2 浓度非常低（<10 pg/mL）。因此，人们做出了许多努力来开发一种灵敏的检测和定量人血清中 E2 的方法。尽管如此，目前的临床检测方法不足以准确评估低浓度（<10 pg/mL）的E2。因此，迫切需要能够有效、灵敏地检测 E2 的新技术，用于常规临床诊断。在这项研究中，我们引入了一种新的 E2 测定技术，使用基于表面增强拉曼散射 (SERS) 的检测方法。使用 30 个血液样本进行基于 SERS 的测定，以评估其临床可行性，并将结果与​​使用 ARCHITECT 化学发光免疫测定获得的数据进行比较。尽管商业测定系统无法量化低于 10 pg/mL 的 E2 血清水平，但使用本研究中描述的新型基于 SERS 的测定法的 E2 检测限为 0.65 pg/mL。因此，所提出的基于 SERS 的检测由于其出色的分析灵敏度，很有可能成为性早熟早期诊断的有价值的工具。