A-033 Evaluation of the Analytical Performance of the Enhanced Estradiol Assay on the Atellica CI Analyzer

Abstract 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 Enhanced Estradiol (eE2) 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 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 native human serum 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 150) and three lots per CLSI EP09c-ed3. Results LoB, LoD, and LoQ were determined to be 7.94, 13.27, 13.27 pg/mL (29.14, 48.70, 48.70 pmol/L), respectively. Linear range was 11.80-3000.00 pg/mL (43.31-11,010.00 pmol/L). Coefficients of variation (CV) for eE2 repeatability were 1.3-8.1% and within lab, 2.2-15.9% at 19.71-1408.17 pg/mL (72.34-5167.98 pmol/L). eE2 reproducibility CVs were lowest, 2.5% at 717.48 pg/mL (2633.15 pmol/L) and highest, 13.7% at 30.27 pg/mL (111.09 pmol/L). Comparing the eE2 performance on Atellica IM vs Atellica CI analyzers, using Weighted Deming regression, yielded y=1.02x+0.68 pg/mL (y=1.02x+2.50 pmol/L) at 15.31-2836.03 pg/mL (56.19-10,408.23 pmol/L) with r=0.998. Conclusion The Atellica IM eE2 on the Atellica CI Analyzer demonstrated acceptable precision and equivalent performance to the Atellica IM Analyzer.