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- Title
Performance criteria for testosterone measurements based on biological variation in adult males: recommendations from the Partnership for the Accurate Testing of Hormones.
- Authors
Yun, Yeo-Min; Botelho, Julianne Cook; Chandler, Donald W; Katayev, Alex; Roberts, William L; Stanczyk, Frank Z; Vesper, Hubert W; Nakamoto, Jon M; Garibaldi, Luigi; Clarke, Nigel J; Fitzgerald, Robert L
- Abstract
Testosterone measurements that are accurate, reliable, and comparable across methodologies are crucial to improving public health. Current US Food and Drug Administration-cleared testosterone assays have important limitations. We sought to develop assay performance requirements on the basis of biological variation that allow physiologic changes to be distinguished from assay analytical errors.
- Publication
Clinical chemistry, 2012, Vol 58, Issue 12, p1703
- ISSN
1530-8561
- Publication type
Journal Article
- DOI
10.1373/clinchem.2012.186569