Why This Study Matters

Serum testosterone plays a crucial role in diagnosing endocrine disorders such as male hypogonadism and polycystic ovary syndrome (PCOS). However, accurate diagnosis depends on reliable reference ranges, which vary across populations.

Currently, most laboratories in India rely on immunoassays that have limitations in accuracy, especially at low testosterone levels. Although LC-MS/MS is the gold standard, normative reference ranges for the Indian population are lacking, leading to potential misclassification and diagnostic uncertainty .

Objectives

• Generate age-specific reference ranges for serum testosterone in healthy Indian men and women
• Establish normative data using gold-standard LC-MS/MS assays
• Develop reference ranges for related metabolic parameters (HbA1c, lipid profile)
• Provide population-specific data to improve diagnostic accuracy

Expected Outcomes

• Reliable, population-specific testosterone reference ranges for India
• Improved diagnosis of hypogonadism and PCOS
• Standardization of hormone assessment using LC-MS/MS
• Enhanced clinical decision-making and patient care