title: Validation of an immunoassay for anti-Müllerian hormone measurements and reference intervals in healthy Brazilian subjects.
abstract: BACKGROUND
  Anti-Müllerian hormone is marker of ovarian and testicular reserve. The clinical use of this hormone requires proper standardization of reference intervals. The aims of this study were to validate the Anti-Müllerian hormone Gen II immunoassay, to establish Anti-Müllerian hormone reference intervals in healthy subjects, and to evaluate the influence of hormonal contraceptives, smoking, and body mass index on Anti-Müllerian hormone.
  
  
  METHODS
  The validation of the Anti-Müllerian hormone Gen II assay (Beckman Coulter Company, TX, USA) was performed using a simplified protocol recommended by Clinical Laboratory Standard Institute. One-hundred and thirty-three healthy females and 120 males were prospectively selected for this study.
  
  
  RESULTS
  The analytical and functional sensitivities of the Anti-Müllerian hormone Gen II immunoassay were 0.02 and 0.2 ng/mL, respectively. Intra-assay coefficients ranged from 5.2 to 9.0%, whereas inter-assay precision ranged from 4.6 to 7.8% at different concentrations. In females, Anti-Müllerian hormone showed progressive decline with increasing age (r=-0.4, p<0.001), whereas in males, age showed no influence on Anti-Müllerian hormone concentrations. In females, Anti-Müllerian hormone concentrations did not differ between users and non-users of hormonal contraceptives, smokers, and non-smokers and obese and lean individuals. However, there was a negative and significant correlation between Anti-Müllerian hormone and body mass index in males (r=-0.3, p=0.008).
  
  
  CONCLUSIONS
  Anti-Müllerian hormone Gen II assay was reliable for determining serum Anti-Müllerian hormone concentrations. Anti-Müllerian hormone concentrations declined with aging and presented a wide inter-individual variability. The lack of influence of hormonal contraceptives, smoking, and obesity on Anti-Müllerian hormone in both sexes allowed us to refine the normative concentrations for the Brazilian population.
authors.affiliation: Departamento de Clínica Médica, Disciplina de Endocrinologia e Metabologia, Laboratório de Hormônios e Genética Molecular LIM/42, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brasil.
authors.forename: Renata Reis
authors.initials: RR
authors.lastname: Woloszynek
authors.affiliation: Departamento de Clínica Médica, Disciplina de Endocrinologia e Metabologia, Laboratório de Hormônios e Genética Molecular LIM/42, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brasil.
authors.forename: Luciana Pinto
authors.initials: LP
authors.lastname: Brito
authors.affiliation: Departamento de Clínica Médica, Disciplina de Endocrinologia e Metabologia, Laboratório de Hormônios e Genética Molecular LIM/42, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brasil.
authors.forename: Marcelo Cidade
authors.initials: MC
authors.lastname: Batista
authors.affiliation: Departamento de Clínica Médica, Disciplina de Endocrinologia e Metabologia, Laboratório de Hormônios e Genética Molecular LIM/42, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brasil.
authors.forename: Helena Panteliou Lima
authors.initials: HP
authors.lastname: Valassi
authors.affiliation: Departamento de Clínica Médica, Disciplina de Endocrinologia e Metabologia, Laboratório de Hormônios e Genética Molecular LIM/42, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brasil.
authors.forename: Berenice Bilharinho
authors.initials: BB
authors.lastname: Mendonca
authors.affiliation: Departamento de Clínica Médica, Disciplina de Endocrinologia e Metabologia, Laboratório de Hormônios e Genética Molecular LIM/42, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brasil vinicius.brito@hc.fm.usp.br.
authors.forename: Vinicius Nahime
authors.initials: VN
authors.lastname: Brito
mesh_terms: D000293:Adolescent; D000328:Adult; D054304:Anti-Mullerian Hormone / Q000097:blood*; D015415:Biomarkers / Q000097:blood; D015992:Body Mass Index; D001938:Brazil; D003278:Contraceptives, Oral, Hormonal / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000592:standards*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000097:blood*; D015588:Observer Variation; D011446:Prospective Studies; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012737:Sex Factors; D012907:Smoking / Q000097:blood
chemical_list: D015415:Biomarkers; D003278:Contraceptives, Oral, Hormonal; D054304:Anti-Mullerian Hormone
keywords: Clinical studies; endocrinology; immunoassay