We report the development of a surface-enhanced Raman scattering (SERS)-based lateral flow immunoassay (LFIA) sensor for the highly sensitive detection of thyroid-stimulating hormone (TSH) in clinical fluids. Here, Raman reporter-labeled gold nanoparticles (AuNPs) were used as SERS nano tags. Using this SERSbased LFIA test strip, the presence of TSH could be identified through a color change in the test line. In addition, quantitative evaluation of TSH was possible by monitoring the characteristic Raman peak intensity of SERS nano tags. The limit of detection (LOD) was estimated to be 0.025 mu IU/mL, which is approximately two orders of magnitude more sensitive than that achieved from the conventional colorimetric LFIA sensor based on the naked eye. Consequently, it is possible to diagnose hyperthyroidism as well as hypothyroidism since a TSH concentration lower than 0.5 mu IU/mL can be detected using this SERSbased LFIA detection technique. Therefore, this approach has strong potential feasibility for application in the early diagnosis of TSH hormone-related diseases. (C) 2016 Elsevier B.V. All rights reserved.