B-040 Performance Evaluation of Five Reproductive Endocrinology Assays on the Atellica CI 1900 Analyzer

Abstract

Abstract Background The Atellica® CI 1900 Analyzer is an automated, mid-throughput, integrated chemistry and immunoassay analyzer utilizing both Atellica CH and Atellica IM assays. This study was designed to evaluate the analytical performance of the Atellica IM Luteinizing Hormone (LH), Progesterone (PRGE), Follicle Stimulating Hormone (FSH), Prolactin (PRL), and Total hCG (ThCG) assays* on the Atellica CI 1900 Analyzer. Methods The Atellica CI 1900 LH, PRGE, FSH, PRL, and ThCG assays use the same reagents and calibrators as the comparable Atellica IM assays. Precision and method comparison (MC) studies were used as performance indicators for the Atellica CI 1900 Analyzer. Precision studies were performed according to CLSI EP05-A3 using quality control material and native and 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 with one reagent lot on two systems. MC studies were performed according to CLSI EP09-A3. Individual native human serum samples were analyzed using the Atellica IM assays on both the Atellica IM and Atellica CI 1900 Analyzers. Results Representative precision and MC results are listed for each assay in the table. Over the five assays tested, repeatability and within-lab %CVs were <7% and <13.5%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1. Conclusion Evaluation of the Atellica IM LH, PRGE, FSH, PRL, and ThCG assays using the Atellica CI 1900 Analyzer demonstrated good precision and equivalent performance compared to the same assays on the Atellica IM Analyzer. *The products/features mentioned here are not commercially available in all countries. Their future availability cannot be guaranteed.