scope:

This guideline describes principles, requirements, and recommendations of current mass spectrometry (MS) measurement procedures for routine analysis of androgens and estrogens in serum. The main focus of this document is on the analytical validation and clinical application of androgen and estrogen measurement procedures using MS. It includes guidance, references, and QA parameters that will assist with the implementation and operation of MS systems. Information on maintaining appropriate instrument settings and performance parameters, approaches to ensure accurate and precise measurements, measurement procedure validation requirements, QA procedures, and interpretation and reporting of results are included. Recommendations are included for sample preparation, and pre- and postexamination (pre- and postanalytical) considerations.

The intended users of this guideline are laboratorians who perform or plan to perform androgen and/or estrogen tests by MS, MS assay developers, and physicians and researchers involved in androgen and/or estrogen testing.

A general, comprehensive review of MS technologies in the clinical laboratory is provided in CLSI document C50.³ This guideline is limited to the measurement of total androgens and/or estrogens in serum, referring to the free, bioavailable, albumin-bound androgens and estrogens, and free, bioavailable, sex hormone-binding globulin (SHBG)-bound androgens and estrogens. The focus of this guideline is limited to the measurement of androgens and estrogens commonly used in clinical and research settings that include, but are not limited to: dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEAs), androstenedione, testosterone (T), dihydrotestosterone (DHT), estrone (E1), estrone sulfate (E1s), estradiol (E2), and estriol (E3). This guideline provides information on MS that relates to testing of the above-mentioned steroid hormones. In addition, the purpose of this document is to provide guidance on the appropriate use of MS for androgen and estrogen measurements and cannot cover all the possibilities in this rapidly developing field. The recommendations provided should be interpreted in light of the continuing progression in this discipline.

³ CLSI. Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline. CLSI document C50-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2007.