{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T12:28:09Z","timestamp":1753878489266,"version":"3.41.2"},"reference-count":27,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2018,10,8]],"date-time":"2018-10-08T00:00:00Z","timestamp":1538956800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100004587","name":"Instituto de Salud Carlos III","doi-asserted-by":"publisher","award":["PI1400649","PI151686","PIE1600050"],"award-info":[{"award-number":["PI1400649","PI151686","PIE1600050"]}],"id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Eur J Clin Investigation"],"published-print":{"date-parts":[[2018,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Testosterone (T) measurement in women is problematic leading to initiatives aiming to improve laboratory standardization of commercial assays. We assessed the impact on the clinical diagnosis of functional hyperandrogenic disorders of a total T immunoassay recently certified by the Centers for Diseases Control and Prevention (CDC).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We conducted a cross\u2010sectional study including 263 consecutive adult premenopausal women presenting with functional ovarian hyperandrogenism\u2014including polycystic ovary syndrome (PCOS)\u2014and 73 nonhyperandrogenic female volunteers who served to define reference ranges. Total T was measured by a local routine direct radioimmunoassay and by a CDC\u2010certified immunochemiluminescence assay. The main outcome measures were total and calculated free T concentrations and percentage of patients with hyperandrogenaemia.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Both assays showed a poor concordance for total and calculated free T measurements. Hence, 147 (56%) and 109 (41%) of women had hyperandrogenaemia with the routine and CDC\u2010certified assays, respectively [<jats:italic>\u03ba<\/jats:italic> (95%CI): 0.538 (0.441\u20100.634)]. Free T levels calculated from total T using both assays showed similar correlations with metabolic variables. Women showing hyperandrogenaemia by both methods had the worst metabolic profiles, yet women presenting with hyperandrogenaemia only when using the CDC\u2010certified assay did not show any significant difference compared to nonhyperandrogenic women in anthropometric or metabolic variables. Those women with hyperandrogenaemia only when using the routine assay were more obese and insulin resistant than normoandrogenaemic hirsute patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>An isolated androgen measurement, even a very specific one, is unlikely to identify the hyperandrogenic milieu that characterizes patients with functional ovarian hyperandrogenism and PCOS.<\/jats:p><\/jats:sec>","DOI":"10.1111\/eci.13029","type":"journal-article","created":{"date-parts":[[2018,9,19]],"date-time":"2018-09-19T12:21:04Z","timestamp":1537359664000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Certified testosterone immunoassays for hyperandrogenaemia"],"prefix":"10.1111","volume":"48","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6002-4237","authenticated-orcid":false,"given":"Manuel","family":"Luque\u2010Ram\u00edrez","sequence":"first","affiliation":[{"name":"Diabetes, Obesity and Human Reproduction Research Group Centro de Investigaci\u00f3n Biom\u00e9dica en Red Diabetes y Enfermedades Metab\u00f3licas Asociadas (CIBERDEM) Instituto Ram\u00f3n y Cajal de Investigaci\u00f3n Sanitaria (IRYCIS) Hospital Universitario Ram\u00f3n y Cajal Universidad de Alcal\u00e1 Madrid Spain"},{"name":"Department of Endocrinology and Nutrition Hospital Universitario Ram\u00f3n y Cajal Madrid Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luc\u00eda","family":"Jim\u00e9nez\u2010Mendiguchia","sequence":"additional","affiliation":[{"name":"Department of Clinical Biochemistry Hospital Universitario Ram\u00f3n y Cajal Madrid Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana","family":"Garc\u00eda\u2010Cano","sequence":"additional","affiliation":[{"name":"Department of Clinical Biochemistry Hospital Universitario Ram\u00f3n y Cajal Madrid 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