ESPEYB21 14. The Year in Science and Medicine Risk and Outcome (5 abstracts)
14.13. Influence of state-of-the-art laboratory techniques on the phenotyping of women with polycystic ovary syndrome in the clinical setting
M. Luque-Ramirez , M. Á. Martinez-Garcia , M. Insenser , E. Fernandez-Duran , A. Quintero-Tobar , T. Fiers , J-M. Kaufman , A.M. Garcia-Cano , M. Rosillo Coronado , L. Nattero-Chavez & H.F. Escobar-Morreale
J Endocrinol Invest. 2024 Jun 24. doi: 10.1007/s40618-024-02416-0
Brief Summary:This cross-sectional study investigated assay methods for diagnosing PCOS among 359 premenopausal women presenting with functional androgen excess or hyperandrogenemia. Serum androgens and AMH were measured by both immunoassay and LC–MS/MS, and ovarian ultrasound was performed. Steroid immunoassays used in routine practice were unacceptably inaccurate compared to LC-MS/MS, and ‘PCOS-positive’ serum AMH measurements were often not confirmed by ovarian ultrasound.
Immunoassays for measuring serum androgens have long been shown to be inaccurate. Instead it has long been recommended to use validated chromatographic, mass spectrometric methods for measuring not only androgens but steroids in general. Evidence-based practice guidelines for the management of PCOS recommend the use of validated liquid chromatography–tandem mass spectrometry (LC–MS/MS) assays for diagnosing biochemical hyperandrogenism in patients with PCOS. However, this has not been implemented broadly in clinical routine.
This comparative study of methods quantifies the inaccuracy (20%) of measuring androgens in PCOS women by immunoassays compared to LC-MS/MS. As a consequence, 17% of the patients were reclassified from hyperandrogenic to non-hyperandrogenic PCOS, and in 5% the diagnosis of PCOS could not be confirmed.
Regarding serum AMH measurements in PCOS, the study shows that AMH had high specificity to predict polycystic ovarian morphology (PCOM) found by ultrasound, but sensitivity was very poor resulting in very poor negative prediction of PCOM.
This study nicely illustrates that methods do matter and may frequently lead to wrong diagnostic labels. Established, easy-to-use routine analyses can be outdated and should be replaced as soon as better methods are available, even if newer methods are more costly and/or tedious.
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ESPE Yearbook of Paediatric Endocrinology
ISSN 1662-4009 (Online)
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