Evaluation demonstrates that the Atellica IM aHBs2 assay matches performance in reactive and nonreactive samples, indicating reliable results.
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 Anti-Hepatitis B surface Antigen 2 (aHBs2) 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 and quantitative method comparison studies were conducted in accordance with CLSI EP12-A2 and CLSI EP09c, respectively. Individual native human serum samples were tested using the Atellica IM aHBs2 assay on the Atellica IM and Atellica CI Analyzers. A comparison was also performed against the predicate ADVIA Centaur aHBs2 assay using the ADVIA Centaur XP system. The results were assessed using both numerical mIU/mL values and qualitative interpretation. Samples were classified as reactive (mIU/mL >=10.0) or nonreactive (mIU/mL <10.0) based on the established 10 mIU/mL cutoff for anti-HBs serum, which serves as an indicator of immune status. LoB, LoD, and LoQ were determined as described in CLSI protocol EP17-A2. Results aHBs2 repeatability %CV was 0.9% at 775.5 mIU/mL and 4.4% at 9.9 mIU/mL, respectively. aHBs2 within-lab %CV was 1.3% at 775.5 mIU/mL and 7.8% at 5.0 mIU/mL, respectively. Negative and positive percent agreement were 100% for the 122 nonreactive and the 118 aHBs2 reactive samples tested on the Atellica CI Analyzer, Atellica IM Analyzer and the ADVIA Centaur XP system. Quantitative method comparison slopes determined by the weighted Deming linear regression were approximately 1 (0.97-1.09 range) across the sample interval tested. Detection capability for the Atellica aHBs2 assay on the Atellica CI Analyzer was estimated at 1.7 mIU/mL and 3.1 mIU/mL for LoB, LoD, and LoQ respectively. Conclusion Evaluation of the Atellica IM aHBs2 assay using the Atellica CI Analyzer demonstrated acceptable precision and equivalent performance compared to the same assay on the Atellica IM Analyzer
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