Identification and Validation of Cerebrospinal fluid (CSF) Biomarker in Bodily fluids and Development of Point of Care Device for Diagnosing CSF leak

This prospective cross-sectional observational study aims to develop a standardized, accurate, and rapid clinically validated point-of-care testing (POCT) method for diagnosing cerebrospinal fluid (CSF) leaks in body fluids. The goal is to improve diagnostic accuracy and reduce the time required for CSF leak diagnosis, which currently relies primarily on radiological examination. Although radiological examinations are precise and accurate, they require skilled operators, high-end equipment, and may pose risks and burdens on patients. Therefore, developing non-invasive laboratory-based methods for diagnosing CSF leaks with a standardized assay through POCT will reduce risks and burdens for both patients and investigators.This single-centered study will validate biomarkers and evaluate the performance of the developed POCT by collecting clinical samples from 255 patients and comparing the results with a reference standard used for diagnosis. The primary outcome is to measure the specificity, sensitivity, and diagnostic accuracy of the identified biomarker and developed assay methods over three years. The secondary outcome is to identify a more sensitive and specific biomarker at the one-year mark and evaluate the diagnostic performance of the developed POCT in a clinical setting over 18 months.