Challenges in developing accurate assays for the measurement of estradiol and testosterone in postmenopausal women

Circulating concentrations of estradiol (E₂) and testosterone (T) have been measured in postmenopausal women for many years, predominantly by immunoassays and mass spectrometry (MS) assays. Although the accuracy of E₂ and T assays is very important to provide clinically meaningful results, there are challenges in establishing their accuracy. MS assays demonstrate higher accuracy for steroid hormone measurements, but immunoassays can provide clinically meaningful results, especially at high concentrations. The Centers for Disease Control and Prevention (CDC) has established a program to standardize and improve the measurement of steroid hormones, including E₂ and T, using liquid chromatography-tandem MS (LC-MS/MS). In addition, the CDC has partnered to establish postmenopausal reference ranges for T and is developing reference intervals for E₂. Minimizing some of the technical limitations of the current immunoassays and MS assays should provide better and more accurate assays for patient care.