| Selected performance characteristics of the Roche Elecsys testosterone II assay on the Modular analytics E 170 analyzer. | |
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MedLine Citation:
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PMID: 20385114 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Serum testosterone measurements have utility in diagnosis of clinical conditions characterized by both increased and decreased testosterone concentrations. Studies have indicated that testosterone immunoassays may give inaccurate results for women and children. We evaluated the performance of a second generation testosterone immunoassay from Roche Diagnostics. METHODS: Testo II performed on a Modular Analytics E 170 analyzer is an automated random access electrochemiluminometric assay. We evaluated limit of blank (LoB), imprecision, linearity, interference, and method comparison with liquid chromatography-tandem mass spectrometry assay (LC-MS/MS). Method comparison included the current generation Roche testosterone assay (Testo I) and the Access 2 testosterone chemiluminometric assay (Beckman Coulter). Results for men and women were analyzed for analytic concordance. The relative % differences of immunoassay compared to LC-MS/MS results were evaluated. RESULTS: The LoB was 0.07nmol/l. Total imprecision was <6%. The assay was linear from 0.2 to 46.6nmol/l. Negative interference was observed for lipemia at concentrations >22.5g/l. Analytic concordance showed improved specificity for women. Comparison of results to LC-MS/MS indicated comparable performance with other immunoassays for men and improved performance for women, boys, and girls with mean differences of 0.5%, -0.7%, and 24.4%, respectively. CONCLUSIONS: The Roche Testo II assay demonstrated excellent precision. Comparison to 2 other automated immunoassays showed comparable performance for men and improved performance for women and children. However, challenges still exist for quantifying testosterone concentrations <10.4nmol/l for men and <1.7nmol/l for women and children by immunoassay. |
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Authors:
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William E Owen; Mindy L Rawlins; William L Roberts |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't Date: 2010-04-10 |
Journal Detail:
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Title: Clinica chimica acta; international journal of clinical chemistry Volume: 411 ISSN: 1873-3492 ISO Abbreviation: Clin. Chim. Acta Publication Date: 2010 Aug |
Date Detail:
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Created Date: 2010-06-10 Completed Date: 2010-09-10 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 1302422 Medline TA: Clin Chim Acta Country: Netherlands |
Other Details:
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Languages: eng Pagination: 1073-9 Citation Subset: IM |
Copyright Information:
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Copyright 2010 Elsevier B.V. All rights reserved. |
Affiliation:
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ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, United States. william.roberts@aruplab.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Age Factors Blood Chemical Analysis Child Child, Preschool Chromatography, Liquid Female Humans Immunoassay / methods* Infant Infant, Newborn Male Sex Factors Tandem Mass Spectrometry Testosterone / analysis*, blood, immunology |
| Chemical | |
Reg. No./Substance:
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58-22-0/Testosterone |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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