CLSI C57
Mass Spectrometry for Androgen and Estrogen Measurements in Serum
CLSI C57 provides essential guidance on the use of mass spectrometry (MS) for androgen and estrogen measurements in serum, ensuring accurate and standardized quantitation. This guideline covers key aspects, including pre-examination considerations, MS technologies, validation of measurement procedures, and post-examination best practices. Designed for laboratory professionals, C57 establishes uniform practices to improve data quality and clinical reliability in hormone testing.
This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of August 2020.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute document C57—Mass Spectrometry for Androgen and Estrogen Measurements in Serum is intended to aid the laboratorian in developing appropriate procedures for the use of mass spectrometry (MS) in the measurement of androgens and estrogens. The primary objectives of this document are to provide guidance and establish uniform practices necessary for producing quality data for quantitation of androgens and estrogens. The guideline provides details specific to androgen and estrogen measurement procedures with respect to preexamination (preanalytical) considerations, MS technologies, measurement procedure and run validation, as well as postexamination (postanalytical) considerations.
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. 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.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
This document is available in electronic format only.
Clinical and Laboratory Standards Institute document C57—Mass Spectrometry for Androgen and Estrogen Measurements in Serum is intended to aid the laboratorian in developing appropriate procedures for the use of mass spectrometry (MS) in the measurement of androgens and estrogens. The primary objectives of this document are to provide guidance and establish uniform practices necessary for producing quality data for quantitation of androgens and estrogens. The guideline provides details specific to androgen and estrogen measurement procedures with respect to preexamination (preanalytical) considerations, MS technologies, measurement procedure and run validation, as well as postexamination (postanalytical) considerations.
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. 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.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
This document is available in electronic format only.