A-261 Evaluation of the Analytical Performance of the Total Antibodies to Hepatitis B Core Antigen Assay on the Atellica CI Analyzer

Background The Atellica CI Analyzer is an automated, high-throughput integrated chemistry and immunoassay analyzer utilizing both Atellica CH and Atellica IM Assays. This study evaluated the analytical performance of the Atellica IM HBc Total 2 (HBcT2) assay, which is used in the qualitative determination of total antibodies to the core antigen of the hepatitis B virus, on the Atellica CI Analyzer. Methods Precision studies were performed according to CLSI EP05-A3 using 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. Precision studies were evaluated with one reagent lot on two systems. Qualitative method comparison studies were conducted in accordance with CLSI EP12-A2. Individual native human serum samples were tested using the Atellica IM HBcT2 assay on the Atellica IM and Atellica CI Analyzers. A comparison was also performed against the predicate ADVIA Centaur HBcT2 assay using the ADVIA Centaur XP system. Samples were classified as reactive (Index value>=1.00) or nonreactive (Index value <1.00) based on the clinically established 1.00 Index cutoff. Results HBcT2 repeatability %CV was 3.1% at 3.19 Index and 4.6% at 8.52 Index, respectively. HBcT2 within-lab %CV was 6.3% at 1.56 Index and 9.1% at 8.52 Index, respectively. Negative and positive percent agreement were 100% for the 100 nonreactive and the 100 HBcT2 reactive samples tested on the Atellica CI Analyzer, Atellica IM Analyzer and the ADVIA Centaur XP system. Conclusion Evaluation of the Atellica IM HBcT2 assay using the Atellica CI Analyzer demonstrated acceptable precision and equivalent performance compared to the same assay on the Atellica IM Analyzer.