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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 Digoxin (Dig), and the Atellica CH Lithium₂ (LITH₂) Assays 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 to three lots of reagent lot on one to two systems. Method comparison studies were performed using three reagent lots according to CLSI EP09c. Individual native and contrived human serum samples were analyzed using the Atellica IM Dig Assay on the Atellica IM Analyzer, the Atellica CH LITH₂ Assay on the Atellica CH Analyzer and both assays on the Atellica CI Analyzer. Results Representative precision and method comparison results for each assay are listed in the table. For the two assays tested, repeatability and within-lab %CVs were 5. 4% and 8. 0%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1. Conclusions Evaluation of the Atellica IM Dig Assay and the Atellica CH LITH₂ Assay using the Atellica CI Analyzer demonstrated good precision and equivalent performance compared to the same assays on their respective Atellica CH and Atellica IM Analyzers.
Huff et al. (Tue,) studied this question.