Hormones Reference Method Laboratories

The Hormone Reference Method Laboratory (HRML) utilizes reference methods for total testosterone and estradiol in serum. These reference method services are available to laboratories by request.

The maximum allowable accuracy for HRML reference methods is much tighter than for methods used in patient care and research. This ensures measurement results are highly certain, and can be used to assess the measurement accuracy of clinical steroid hormone tests. These methods are not intended for use in patient care or research.

CDC’s reference methods for total testosterone and estradiol use high-performance liquid chromatography coupled with tandem mass spectrometry. These methods have a high level of specificity, and meet stringent analytical performance criteria1,2.

The reference methods are calibrated using certified reference material (A-NMI M914b for testosterone and NMIJ CRM 6004-a for estradiol). Therefore, measurement results obtained with these reference methods are traceable to the International System of Units (SI), in accordance with the International Organization for Standardization (ISO) standard for traceability in laboratory medicine. CDC’s reference methods are list in the database of the Joint Committee for Traceability in Laboratory Medicine.

Please contact Standardization@cdc.gov with questions about HRML’s reference measurements.

1 Botelho JC, Ribera A, Cooper HC, Vesper HW. Evaluation of an Isotope Dilution HPLC Tandem Mass Spectrometry Candidate Reference Measurement Procedure for Total 17-β Estradiol in Human Serum. Anal Chem. 2016;88:11123-11129

2 Botelho JC, Shacklady C, Cooper HC, Tai SS, Van Uytfanghe K, Thienpont LM, Vesper HW. Isotope-dilution liquid chromatography-tandem mass spectrometry candidate reference method for total testosterone in human serum. Clin Chem. 2013;59:372-380