Comparison of the second-generation Beckman Coulter IVD and first-generation AnshLabs ELISA assays for anti-M  llerian hormone in XXXX undergoing IVF treatment.

@entity1 @entity249 @entity248
OBJECTIVES: Ovarian reserve is the main factor influencing the efficacy of @entity249 treatment. Currently the anti- M  llerian 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 @entity248 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. MATERIALS AND METHODS: Serum samples (n=520) were collected from female @entity1 undergoing routine @entity248 evaluation before entering an IVF program. We chose samples of @entity1 with the lowest correlation between the @entity248 serum level and response to stimulation. The @entity248 serum levels of the @entity1 were examined using two @entity248 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 @entity248 serum levels of 130 @entity1 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 @entity248 assays was 0.871. CONCLUSION: 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.
