A-083 Evaluation of the Analytical Performance of the Androstenedione Assay on the Atellica CI Analyzer

Background The Atellica CI Analyzer is an automated, mid-throughput integrated chemistry and immunoassay analyzer employing both Atellica CH and Atellica IM assays. Leveraging the same reagents and calibrators as Atellica CH and Atellica IM analyzers. This study evaluated the analytical performance of the Atellica IM Androstenedione (ANDRO) Assay on the Atellica CI Analyzer. Methods Limits of blank, detection, and quantitation (LoB, LoD, and LoQ) samples were tested on three reagent lots and one analyzer per CLSI EP17-A2. Linearity studies tested at least N of 10 levels of mixed high, and low samples (N=5/level) over 1 day/lot for three lots per CLSI EP06-ed2. Precision studies were performed per CLSI EP05-A3 using human serum samples and quality control samples. Repeatability and within-lab precision samples were tested in duplicate/run, 2 runs/day for 20 days (N=80) using one reagent lot and two analyzers. Reproducibility samples were assayed in five replicates/run, 1 run/day for 5 days using three lots on three analyzers. Method comparison studies compared assay performance on Atellica IM and Atellica CI analyzers using singlicate native human serum and contrived samples (N greater than or equal to 105) and three lots per CLSI EP09c-ed3. Results LoB, LoD, and LoQ were determined to be 0.14, 0.18, 0.20 ng/mL (0.49, 0.63, 0.70 nmol/L), respectively. Linear range was 0.30-9.00 ng/mL (1.05-31.42 nmol/L). Coefficients of variation (CV) for ANDRO repeatability were 1.8-3.7% and within lab, 2.9-7.3% at 0.41-6.77 ng/mL (1.43-23.64 nmol/L). ANDRO reproducibility CVs were lowest, 2.9% at 4.48 ng/mL (15.64 nmol/L) and highest, 7.3% at 0.41 ng/mL (1.43 nmol/L). Comparison of ANDRO performance on the Atellica IM and Atellica CI analyzers, using Weighted Deming regression analysis, yielded y=1.01x+ -0.03 ng/mL (y=1.01+ -0.10 nmol/L) at 0.33 to 8.96 ng/mL (1.15 to 31.28 nmol/L) with r=0.998. Conclusion The Atellica IM ANDRO on the Atellica CI Analyzer demonstrated acceptable analytical performance; MC showed equivalent results comparing to the Atellica IM Analyzer.