Highly Sensitive Detection of Hormone Estradiol E2 Using SERS-based Immunoassays for the Clinical Diagnosis of Precocious Puberty.

17 β-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 chemi-luminescence 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.