A-020 Evaluation of the Analytical Performance of BNP and NT-proBNP Assays on the Atellica CI 1900 Analyzer

Abstract

Abstract Background The Atellica® CI 1900 Analyzer is an automated, high-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 B-type Natriuretic Peptide (BNP) and NT-proBNP (PBNP) assays* on the Atellica CI 1900 Analyzer. Methods The Atellica CI 1900 BNP and PBNP assays use the same reagents and calibrators as the Atellica IM assays. Precision and method comparison were used as performance indicators for the Atellica CI 1900 Analyzer. Precision studies were performed according to CLSI EP05-A3 and method comparison according to CLSI EP09-A3 using native and contrived human plasma (BNP) and serum (PBNP) samples. One aliquot of each sample pool was tested in duplicate in two runs per day >2 h apart on each analyzer for >20 days. BNP and PBNP were evaluated with one reagent lot on two systems. For the method comparison, individual native and contrived human plasma samples (BNP) or native human serum samples (PBNP) were analyzed using the Atellica IM BNP and PBNP assays on both the Atellica IM and Atellica CI 1900 Analyzers. Results Representative precision and MC results for each assay are listed in the table. For the two assays tested, repeatability and within-lab %CVs were <2.5% and <3.0%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1. Conclusion Evaluation of the Atellica IM BNP and PBNP assays using the Atellica CI 1900 Analyzer demonstrated acceptable precision and equivalent performance compared to the same assays on the Atellica IM Analyzer.