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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 BRAHMS Procalcitonin (PCT) Assay, and the Atellica CH Revised C-Reactive Protein (RCRP) and Lactate₃ (Lac₃) Assays on the Atellica CI Analyzer. Methods Precision studies were performed according to CLSI EP05-A3 using native and contrived human serum (PCT, RCRP) or plasma and cerebrospinal fluid (Lac₃) 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 on one to two systems. Method comparison (MC) studies were performed using three reagent lots according to CLSI EP09c. Individual native and contrived human serum (PCT, RCRP) or plasma and cerebrospinal fluid (Lac₃) samples were analyzed using the Atellica IM PCT Assay on the Atellica IM Analyzer, the Atellica CH RCRP, Lac₃ Assays on the Atellica CH Analyzer and all three Atellica IM and CH Assays listed above on the Atellica CI Analyzer. Results Representative precision and MC results for each assay are listed in the table. For the three assays tested, repeatability and within-lab %CVs were 1. 4% and 8. 9%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1. Conclusions Evaluation of the Atellica IM PCT and Atellica CH RCRP, Lac₃ Assays 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.
Frenna et al. (Tue,) studied this question.
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