title: [The importance of methodology in serum testosterone measurement: comparison between a direct immunoassay and a method based on high performance liquid chromatography and tandem mass spectrometry (HPLC/MS-MS)].
abstract: Serum testosterone in its total or free form, is a highly valuable diagnostic test and is available in the great majority of clinical laboratories. This reality was possible due to the development of simple and direct assays, adaptable to large automatic systems. Recent publications have called attention to the limitations of these simplified methodologies, mainly in samples with low concentration, as women and children. In this paper we present results obtained using a reference method based on high performance liquid chromatography and tandem mass spectrometry (HPLC/MS-MS) and its comparison with those obtained with a commercial routine immunoassay (electrochemiluminescent assay, ECLIA). Methods were compared in total testosterone measurement (n = 213), as well as in free testosterone evaluation based on calculation including sex hormone-binding protein (SHBG) levels (n = 135). Values obtained with ECLIA were significantly higher, with more marked dispersion in low concentration. This phenomenon is clearer when presented as a Bland-Altman plot. Difficulties in the implementation of reference methods as the one presented are discussed, as well as the necessity of caution in the interpretation of values obtained with routine assays, a matter of several publications in recent literature.
authors.affiliation: Setores de Imunologia de Fleury Medicina e Saúde, São Paulo, SP, Brasil. jose.vieira@fleury.com.br
authors.forename: José Gilberto H
authors.initials: JG
authors.lastname: Vieira
authors.forename: Odete H
authors.initials: OH
authors.lastname: Nakamura
authors.forename: Cláudia Maria
authors.initials: CM
authors.lastname: Ferrer
authors.forename: Teresinha T
authors.initials: TT
authors.lastname: Tachibana
authors.forename: Maria Helena K
authors.initials: MH
authors.lastname: Endo
authors.forename: Valdemir M
authors.initials: VM
authors.lastname: Carvalho
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003627:Data Interpretation, Statistical; D004563:Electrochemistry; D005260:Female; D006801:Humans; D008163:Luminescent Measurements / Q000379:methods*; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D012680:Sensitivity and Specificity; D012738:Sex Hormone-Binding Globulin / Q000032:analysis; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013739:Testosterone / Q000097:blood*; D055815:Young Adult
chemical_list: D012738:Sex Hormone-Binding Globulin; D013739:Testosterone