A-313 Analytical Performance Evaluation of the Hepatitis A Total Antibodies 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 Hepatitis A Total (aHAVT) assay 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 aHAVT assay on the Atellica IM and Atellica CI Analyzers. A comparison was also performed against the predicate ADVIA Centaur aHAVT assay using the ADVIA Centaur XP system. The results reported in Index were classified as reactive (Index >=cutoff) or nonreactive (Index less than cutoff) based on the 1.00 Index cutoff equivalent to 20 mIU/mL when standardized to the World Health Organization (WHO) Second International Reference Standard for Anti-Hepatitis Immunoglobulin (97/646). Results aHVAT repeatability %CVs were 1.3% and 6.4% at 4.00 and 0.74 Index, respectively, while within-lab %CVs were 2.0% and 8.1% at the same levels. Negative and positive percent agreement were 99.10% for the 111 nonreactive and 100% for the 176 aHAVT reactive samples tested on the Atellica CI and Atellica IM Analyzers. Negative and positive percent agreement were 98.18% for the 110 nonreactive and 98.80% for the 166 aHAVT reactive samples tested on the Atellica CI and the ADVIA Centaur XP system. Conclusion Evaluation of the Atellica IM aHAVT assay using the Atellica CI Analyzer demonstrated acceptable precision and equivalent performance compared to the same assay on the Atellica IM Analyzer.