Analytical Performance Evaluation for Estradiol using Liquid Chromatography-Tandem Mass Spectrometry

Area of Science:

• Endocrinology
• Analytical Chemistry
• Mass Spectrometry

Background:

• Accurate estradiol measurement is crucial for diagnosing endocrine disorders.
• Liquid chromatography-tandem mass spectrometry (LC-MS/MS) offers a reliable method for steroid hormone quantification.
• Existing methods may require sample derivatization, potentially impacting accuracy and efficiency.

Purpose of the Study:

• To develop and validate a sensitive, derivatization-free LC-MS/MS method for quantifying estradiol.
• To evaluate the analytical performance of the developed LC-MS/MS assay.
• To compare LC-MS/MS results with a conventional chemiluminescent immunoassay.

Main Methods:

• Estradiol was analyzed using Sciex Triple Quad 6500+ LC-MS/MS.
• Analytical performance was assessed for linearity, precision, LoD, LoQ, accuracy, and carryover.
• LC-MS/MS results were compared against a chemiluminescent microparticle immunoassay.

Main Results:

• The LC-MS/MS method demonstrated linearity from 0.2 to 10311.6 pmol/L.
• Intra-laboratory precision ranged from 3.0-10.1%, with LoD and LoQ at 2.8 and 7.5 pmol/L, respectively.
• Accuracy was within 15% bias, and results correlated well with immunoassay (r² = 0.9843), despite a noted negative bias.

Conclusions:

• A highly sensitive, derivatization-free LC-MS/MS method for estradiol quantification was successfully established.
• This method provides a valuable tool for estradiol measurements in clinical settings.
• The assay is particularly beneficial for patients with estradiol-related endocrine disorders.