Certified testosterone immunoassays for hyperandrogenaemia

Luque‐Ramírez, Manuel; Jiménez-Mendiguchia, Lucía; García-Cano, Ana; Fernández‐Durán, Elena; Rosa, Verónica de Dios; Nattero‐Chávez, Lía; Ortiz-Flores, A.E.; Escobar‐Morreale, Héctor F.

doi:10.1111/eci.13029

Cited by 8 publications

(6 citation statements)

References 29 publications

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“…Still, even when a very specific immunoassay is used, some have found that an isolated androgen measurement is unlikely to identify the hyperandrogenic mix that characterises patients with functional ovarian hyperandrogenism and PCOS [25]. Others would go further and argue that LC-MS/MS should preferably be used to identify the androgens instead [26,27].…”

Section: Introductionmentioning

confidence: 99%

Steroid Mass Spectrometry for the Diagnosis of PCOS

Keevil

2019

Medical Sciences

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The most appropriate steroids to measure for the diagnosis of hyperandrogenism in polycystic ovary syndrome (PCOS) are still open to debate but should preferably be measured using a high-quality method such as liquid chromatography tandem mass spectrometry (LC-MS/MS). Measurement of testosterone is recommended in all of the current clinical guidelines but other steroids, such as androstenedione and dehydroepiandrosterone sulfate (DHEAS), have also been shown to be useful in diagnosing PCOS and may give additional information on metabolic risk. The 11-oxygenated steroids, and in particular 11KT derived mainly from the adrenal gland, are also increasing in prominence and have been shown to be the dominant androgens in this condition. Polycystic ovary syndrome is a complex syndrome and it is not surprising that each of the clinical phenotypes are associated with different patterns of steroid hormones; it is likely that steroid profiling with LC-MS/MS may be better at identifying hyperandrogensim in each of these phenotypes. Research into PCOS has been hampered by the small sample size of clinical studies previously undertaken and larger studies, preferably using LC-MS/MS profiling of steroids, are needed

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Section: Introductionmentioning

confidence: 99%

Steroid Mass Spectrometry for the Diagnosis of PCOS

Keevil

2019

Medical Sciences

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“…Serum for sex steroid measurements was frozen at 280°C until thawed for analysis. Technical characteristics of the assays used for biochemical and hormone measurements have been described in detail elsewhere (2,4). We performed hormone assays at the same time using kits from the same production lots.…”

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confidence: 99%

Sexual Dimorphism and Sex Steroids Influence Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes

et al. 2019

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“…* (above the boxes) significant differences between those PCOS phenotypes PCOM definition in our series changed the PCOS phenotype of 16.8% women but, unlike the findings of the Italian study, most of our patients were reassigned from the classic phenotype to the normoandrogenic one. This apparent discrepancy may rely on: i) we used two different immunoassays throughout the recruitment period previously compared in terms of performance for phenotyping women with PCOS [14]. Our unextracted direct RIA found hyperandrogenemia in 17.2% more women than the ICLA did.…”

Section: Discussionmentioning

confidence: 92%

“…We defined clinical hyperandrogenism as hirsutism by a modified Ferriman-Gallwey score ≥ 8. In the clinical setting, immunoassays were used to estimate biochemical hyperandrogenism using local in-house cut-offs for each assay derived from a sample of non-hyperandrogenic premenopausal female volunteers presenting with regular menses (Table 1) [13,14].…”

Section: Subjectsmentioning

confidence: 99%

“…None of these controls had a history of infertility, oophorectomy, or hysterectomy nor had received treatment with hormonal contraceptives, antiandrogens, or insulin sensitizers for at least 6 months before sampling. Of note, this population of control women derived from a similar sample of nonhyperandrogenic individuals than that previously used in establishing local in-house normality values for routine androgen assays [13,14]. In the subset of women in whom sonography exploration was available, we also determined the optimal AMH threshold value in identifying PCOM by means of the Youden's J statistics.…”

Section: Assaysmentioning

confidence: 99%

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Influence of state-of-the-art laboratory techniques on the phenotyping of women with polycystic ovary syndrome in the clinical setting

Luque-Ramírez,

Martínez-García,

Insenser

et al. 2024

J Endocrinol Invest

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Purpose Evidence-based guidelines for the management of polycystic ovary syndrome (PCOS) recommend clinical laboratories use liquid chromatography-tandem mass spectrometry (LC–MS/MS) for diagnosing biochemical hyperandrogenism. However, automated immunoassays are still mostly used in routine laboratories worldwide. Another hurdle for PCOS phenotyping in the clinical setting is ultrasound assessment of polycystic ovarian morphology. We address the impact of using state-of-the-art (LC–MS/MS) and of an anti-müllerian hormone (AMH) assay on the diagnosis of PCOS in routine practice. Methods In a cross-sectional study, we included 359 premenopausal women consecutively evaluated because of symptoms of functional androgen excess or hyperandrogenemia, and finally diagnosed with PCOS. Patients were submitted to routine phenotyping based on serum androgen measurements by immunoassays and an ovarian ultrasound when necessary. Samples of all patients were also assayed by LC–MS/MS for hyperandrogenemia and for circulating AMH. Results The observed agreement between immunoassays and LC–MS/MS in identifying hyperandrogenemia was poor [78.0%; k(95%CI): 0.366 (0.283;0.449)]. The observed agreement between ultrasound and increased AMH was 27.3% [(95%CI): 0.060 (0.005; 0.115)]. Using LC–MS/MS changed PCOS phenotypes in 60(15.8%) patients. Fifty-two (18.3%) individuals with hyperandrogenemia by routine immunoassays no longer presented with androgen excess by LC–MS/MS. Overall diagnostic agreement between routine assessment using immunoassays and ultrasound and that derived from LC–MS/MS and the addition of AMH to US was moderate [weighted κ (linear weights): 0.512 (0.416;0.608)]. Conclusions Immunoassays used in routine practice are unacceptably inaccurate for phenotyping women with PCOS. Our data cast some doubts upon the interchangeability of serum AMH and ultrasound examination for the diagnosis of PCOS.

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Certified testosterone immunoassays for hyperandrogenaemia

Abstract: 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.

Cited by 8 publications

References 29 publications

Steroid Mass Spectrometry for the Diagnosis of PCOS

Steroid Mass Spectrometry for the Diagnosis of PCOS

Sexual Dimorphism and Sex Steroids Influence Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes

Influence of state-of-the-art laboratory techniques on the phenotyping of women with polycystic ovary syndrome in the clinical setting

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