Development of a CDC-certified total testosterone assay for adult and pediatric samples using LC–MS/MS

BACKGROUND: Highly accurate and sensitive method to measure testosterone in hypogonadal male, female and children is vital for proper diagnosis of hormone-related conditions and their treatment. OBJECTIVE: To develop an accurate and robust total testosterone ESI-LC-MS/MS quantification method with a simple sample preparation workflow and sufficient sensitivity for serum or plasma samples of all gender and age groups, via ketone functional group derivatization (using Amplifex™ Keto Reagent). METHOD: EDTA) were compared. The calculated % difference between matched adult serum and plasma samples was ∼1%. CONCLUSIONS: EDTA).