B-042 Evaluation of the Analytical Performance of Three Prostate-specific Antigen Immunoassays on the Atellica CI 1900 Analyzer

Abstract

Abstract Background The Atellica® CI 1900 Analyzer is an automated, mid-throughput, integrated chemistry and immunoassay analyzer employing both Atellica CH and Atellica IM assays. This study was designed to evaluate the analytical performance of the Atellica IM Prostate-Specific Antigen (PSA)*, Complexed Prostate-Specific Antigen (cPSA)*, and Free Prostate-Specific Antigen (fPSA)* assays on the Atellica CI 1900 Analyzer. Methods The Atellica CI 1900 PSA, cPSA, and fPSA assays use the same reagents and calibrators as the comparable Atellica IM assays. Limit of quantitation (LoQ), precision, and method comparison (MC) were used as performance indicators for the Atellica CI 1900 Analyzer. LoQ studies were performed in accordance with CLSI EP17-A2 using native and contrived human serum samples. 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. 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 LoQ is defined as the lowest amount of analyte in a sample at which the within-laboratory %CV is ≤20%. Representative precision and MC results for each assay across indicated sample ranges are listed in the table. Over the three assays tested, repeatability and within-lab %CVs were ≤8.0% and ≤15.5%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1. Conclusion Evaluation of the Atellica IM PSA, cPSA, and fPSA 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. fPSA assay is not available for sale in US.