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CLSI C57-Ed1 (R2020)

Mass Spectrometry for Androgen and Estrogen Measurements in Serum

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.


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Clinical And Laboratory Standards Institute [clsi]


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