A-260 Analytical Performance Evaluation of the HIV Antigen/Antibody Combo Assay on the Atellica CI Analyzer

Abstract 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 HIV Antigen/Antibody Combo (CHIV) assay on the Atellica CI Analyzer. Methods Precision studies were performed according to CLSI EP05-A3 using native and contrived human serum samples. CHIV assay was evaluated with one reagent lot on two Atellica CI analyzers. One aliquot of each sample was tested in duplicate in two runs per day >=2 hours apart on each analyzer for >=20 days. Method comparison studies were conducted in accordance with CLSI EP12-A2. Individual native human serum samples were analyzed using the Atellica IM CHIV assay on both the Atellica IM and Atellica CI Analyzers. A comparison was also performed against the predicate ADVIA Centaur CHIV assay using the ADVIA Centaur XP system. The results were evaluated based on Index values, distinguishing reactive (Index >=cutoff value) and nonreactive (Index less than cutoff) specimens for the presence of antibodies to HIV-1 (including group “O”) and/or HIV-2 and/or p24 antigen. Results CHIV repeatability %CVs were 1.6% at 1.48 Index and 7.5% at 0.16 Index. Within-lab %CVs were 3.0 % at 1.48 Index and 8.8% at 0.16 Index, respectively. Negative and positive percent agreement were 100% for the 110 nonreactive and the 105 CHIV reactive samples tested on the Atellica CI and Atellica IM Analyzers. Negative and positive percent agreement were 100% for the 109 nonreactive and the 104 CHIV reactive samples tested on the Atellica CI and the ADVIA Centaur XP system. Overall agreement between the CHIV assay on the Atellica CI Analyzer, Atellica IM Analyzer and ADVIA Centaur XP system was 100%. Conclusion Evaluation of the Atellica IM CHIV assay using the Atellica CI Analyzer demonstrated acceptable precision and equivalent performance compared to the same assay on the Atellica IM Analyzer.