title: Comparison of the second-generation Beckman Coulter IVD and first-generation AnshLabs ELISA assays for anti-Müllerian hormone in patients undergoing IVF treatment.
abstract: OBJECTIVE
  Ovarian reserve is the main factor influencing the efficacy of infertility treatment. Currently the anti- Müllerian hormone is the main indicator of the ovarian reserve and has a wide spectrum of clinical importance. It achieved a high clinical value right after the introduction of the first commercial AMH assays in 2005. Lack further research and development of the tests and monopoly on their production have led to a significant reduction of their quality resulting in lowered veracity and usefulness. Therefore, we searched for an alternative to the Beckman Coulter assay. The objective of the study was to draw a comparison between the commonly used second-generation assay by Beckman Coulter and the ultra-sensitive first-generation assay by AnshLabs.
  
  
  METHODS
  Serum samples (n=520) were collected from female patients undergoing routine AMH evaluation before entering an IVF program. We chose samples of patients with the lowest correlation between the AMH serum level and response to stimulation. The AMH serum levels of the patients were examined using two AMH tests, the second-generation assay by Beckman Coulter and the first-generation assay by AnshLabs. Precision and accuracy of both methods were determined and the results of AMH serum levels of 130 patients were correlated with the number of: antral follicles (AFC), follicles after stimulation, and the obtained cumulus cells.
  
  
  RESULTS
  Both precision and accuracy of the compared methods were highly satisfactory. The coefficients of variation obtained in the study conducted on two different levels of control material were lower than 12% and the load did not exceed 9%. The study proved that both of the methods yielded comparable results. The coefficient of variation between the first-generation and the second-generation AMH assays was 0.871.
  
  
  CONCLUSIONS
  Both methods might be applied in the evaluation of the ovarian reserve. The first- and second-generation assays show comparable correlation with the clinical effects of stimulation, however it seems that first-generation assays are a better alternative to the unstable second-generation kits. The results from the first-generation assays are distributed on a wider range, which facilitates clinical interpretation.
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Lukaszuk
authors.forename: Waldemar
authors.initials: W
authors.lastname: Kuczynski
authors.forename: Michal
authors.initials: M
authors.lastname: Kunicki
authors.forename: Beata
authors.initials: B
authors.lastname: Ludwikowska
authors.forename: Joanna
authors.initials: J
authors.lastname: Liss
authors.forename: Iwona
authors.initials: I
authors.lastname: Malinowska
authors.forename: Aron
authors.initials: A
authors.lastname: Lukaszuk
authors.forename: Alicja
authors.initials: A
authors.lastname: Bednarowska
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Kuczynska
authors.forename: Pawel
authors.initials: P
authors.lastname: Kuc
authors.forename: Ewa
authors.initials: E
authors.lastname: Pastuszek
mesh_terms: D000328:Adult; D054304:Anti-Mullerian Hormone / Q000032:analysis*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D005307:Fertilization in Vitro; D006801:Humans; D008875:Middle Aged; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods
chemical_list: D054304:Anti-Mullerian Hormone