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Certified testosterone immunoassays for hyperandrogenaemia.

Manuel Luque-Ramírez1,2, Lucía Jiménez-Mendiguchia3, Ana García-Cano3

  • 1Diabetes, Obesity and Human Reproduction Research Group, Centro de Investigación Biomédica en Red Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, Spain.

European Journal of Clinical Investigation
|September 20, 2018
PubMed
Summary

Laboratory standardization of testosterone assays impacts diagnosis of hyperandrogenism in women. A CDC-certified assay identified fewer cases of hyperandrogenism compared to a routine assay, affecting clinical diagnosis.

Keywords:
androgensfunctional hyperandrogenismlaboratory standardizationpolycystic ovary syndrometestosterone

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Area of Science:

  • Endocrinology
  • Reproductive Health
  • Clinical Diagnostics

Background:

  • Accurate testosterone (T) measurement in women is crucial for diagnosing hyperandrogenic disorders.
  • Laboratory standardization of commercial assays is an ongoing challenge.
  • The Centers for Diseases Control and Prevention (CDC) has certified a new total T immunoassay.

Purpose of the Study:

  • To assess the impact of a CDC-certified total T immunoassay on the clinical diagnosis of functional hyperandrogenic disorders in women.
  • To compare diagnostic performance with a local routine direct radioimmunoassay.

Main Methods:

  • Cross-sectional study of 263 premenopausal women with functional ovarian hyperandrogenism (including PCOS) and 73 controls.
  • Total T measured by routine direct radioimmunoassay and CDC-certified immunochemiluminescence assay.
  • Outcome measures included total T, calculated free T, and hyperandrogenemia prevalence.

Main Results:

  • Poor concordance between routine and CDC-certified assays for total and free T.
  • Hyperandrogenemia identified in 56% (routine) vs. 41% (CDC-certified) of women.
  • Women diagnosed with hyperandrogenemia by the routine assay alone showed higher obesity and insulin resistance.

Conclusions:

  • Isolated androgen measurements, even from specific assays, may not fully capture the hyperandrogenic state in functional ovarian hyperandrogenism and PCOS.
  • Assay standardization is critical for accurate diagnosis and management of hyperandrogenic disorders.