A-312 Evaluation of the Analytical Performance of the Hepatitis B Surface Antigen and confirmatory assays 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 Hepatitis B surface Antigen II (HBsII) assay and its confirmatory assay (HBsII Conf) 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 HBsII assay on the Atellica IM and Atellica CI Analyzers. Samples were classified as reactive (Index >=1.00) or nonreactive (Index <1.00). Contrived human serum samples prepared by mixing HBsAg reactive samples with individual HBsAg negative samples to Index levels ranging from 1.00 to 50.00 were used to evaluate the Atellica HBsII Conf assay on the Atellica IM and Atellica CI Analyzers. The HBsII Conf assay, automatically performed by the Atellica analyzers, is used to confirm samples as HBsAg positive for repeatedly reactive HBsII samples with a value >=1.00 Index but <=50.00 Index. Results HBsII repeatability %CV was 1.9% at 811.87 Index and 5.3% at 0.73 Index, respectively, while within-lab %CVs were 3.0% and 6.2% at the same levels. Negative and positive percent agreement were 100% for the 104 nonreactive and the 101 HBsII reactive samples tested on the Atellica CI Analyzer and Atellica IM Analyzer. Confirmed agreement for the Atellica IM HBsII Conf assay was 100% for the 101 HBsII reactive samples tested on both analyzers. Conclusion Evaluation of the Atellica IM HBsII assay using the Atellica CI Analyzer demonstrated acceptable precision. Additionally, both the Atellica IM HBsII and HBsII Conf assays on the Atellica CI Analyzer showed equivalent performance compared to the same assays on the Atellica IM Analyzer.