Key points
The Hormones Reference Laboratory utilizes reference methods for total testosterone and estradiol in serum. These reference method services are available to laboratories by request.
Hormones reference measurement procedures
The ÐÇ¿ÕÓéÀÖ¹ÙÍø Hormones Reference Laboratory operates highly precise and accurate laboratory methods for testosterone and estradiol. These reference measurement procedures (RMPs) are used to assign reference values to serum and other materials, which then can be used for calibration or to verify calibration of routine methods. Furthermore, these materials can be used as trueness control samples to assess measurement accuracy.
RMPs 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 criteria. Descriptions of the RMPs can be found at in the following publications:
The RMPs are calibrated using certified reference materials provided by national metrology organizations (A-NMI M914b for testosterone and NMIJ CRM 6004-a for estradiol) and meet requirements outlined in international standard ISO 15193:2009. Therefore, measurement results obtained with these RMPs are traceable to the (SI), in accordance with the (ISO) standard for traceability in laboratory medicine (ISO 17511:2020). ÐÇ¿ÕÓéÀÖ¹ÙÍø's reference methods are list in the database of the .
Hormones Reference Laboratory 101
What do ÐÇ¿ÕÓéÀÖ¹ÙÍø's steroid hormones reference methods measure?
ÐÇ¿ÕÓéÀÖ¹ÙÍø's steroid hormone reference methods provide highly accurate measurements of total testosterone1 and estradiol2 in human serum and other materials.
What is traceability in laboratory medicine?
Traceability in laboratory medicine describes a process used to link a patient's results to the highest available reference. This is typically a reference material or reference measurement procedure (RMP). For example, the primary reference material used to calibrate the ÐÇ¿ÕÓéÀÖ¹ÙÍø reference measurement procedures for testosterone is A-NMI M914b, and NMIJ CRM 6004-a for estradiol.
The ÐÇ¿ÕÓéÀÖ¹ÙÍø RMPs assigns reference values to serum samples. These serum samples are then used to calibrate a routine steroid hormone test that measures patient samples. In this process, measurement results for patient samples are traceable to A-NMI M914b for testosterone, and NMIJ CRM 6004-a for estradiol through the ÐÇ¿ÕÓéÀÖ¹ÙÍø RMPs.
Establishing traceability in laboratory medicine is important because it defines the point of reference to which patient measurements are linked. This helps to ensure comparable measurements in patient care.
Can ÐÇ¿ÕÓéÀÖ¹ÙÍø assign values to samples provided by my laboratory?
ÐÇ¿ÕÓéÀÖ¹ÙÍø works on meeting these requests, but such services are subject to availability of resources. For more information on reference measurement services, contact [email protected].
Contact the Hormones Reference Lab
Please contact [email protected] with questions about steroid hormones reference measurements.