A-036 Assessing the Analytical Performance of the Anti-Müllerian Hormone Assay on the Atellica CI Analyzer

Abstract Background The Atellica CI Analyzer is an automated, high-throughput integrated chemistry and immunoassay analyzer utilizing both Atellica CH and Atellica IM Assays. This study evaluated the analytical performance of the Atellica IM Anti-Müllerian Hormone (AMH) assay on the Atellica CI Analyzer. Methods Precision studies were performed according to CLSI EP05-A3 using contrived human serum samples. One aliquot of each sample pool was tested in duplicate in two runs per day >=2 hours apart on each analyzer for 20 days. Precision studies were evaluated with one reagent lot on two systems. Method comparison studies were performed using three reagent lots according to CLSI EP09c. Individual native and contrived human serum samples (n=128) were analyzed using the Atellica IM AMH assay on the Atellica IM Analyzer and the Atellica CI Analyzer. Limits of blank, detection, and quantitation (LoB, LoD, and LoQ) were determined on three reagent lots as described in CLSI protocol EP17-A2. Linear interval was established using 11 specimens (5 replicates/specimen) and three reagent lots following CLSI EP06-ED2 guidelines. Results Coefficient of variations (CV) for AMH repeatability were 1.1% at 6.899 ng/ml (49.259 pmol/L) and 2.5% at 0.106 ng/mL (0.757 pmol/L). Within-lab CVs were 2.4% at 6.899 ng/ml (49.259 pmol/L) and 3.2% at 16.647 ng/mL (118.860 pmol/L). Method comparison slopes as determined by the weighted Deming linear regression were equal to 1.00 across the sample interval tested. Detection capability for the Atellica IM AMH assay on the Atellica CI Analyzer was estimated to be 0.008 ng/mL (0.057 pmol/L), 0.011 ng/mL (0.079 pmol/L) and 0.043 ng/mL (0.307 pmol/L) for LoB, LoD, and LoQ respectively. The Atellica IM AMH assay was linear on the Atellica CI Analyzer across the measuring interval of 0.043–24.0 ng/mL (0.307–171 pmol/L). Conclusion Evaluation of the Atellica IM AMH assay using the Atellica CI Analyzer demonstrated acceptable precision and equivalent performance compared to the same assay on the Atellica IM Analyzer.