Development of Free Testosterone Chemiluminescence Detection Kit and Its Clinical Application

The study developed a chemiluminescence detection kit for free testosterone, addressing issues of sensitivity, complexity, and cost in existing methods. The kit was evaluated using samples from 1615 male and 2035 female patients, showing excellent performance with a linear r > 0.99, accuracy deviation < 5%, and stability for 12 months. It demonstrated no cross-reactivity and met clinical requirements with a correlation coefficient r of 0.9941. The study found significant differences in free testosterone levels among male patients with various diagnoses, indicating its potential as a reference indicator for diagnosing and assessing diseases, including those related to hair loss. The kit is cost-effective, automated, and suitable for clinical use.