Abstract
Abstract Background The Atellica® CI 1900 Analyzer is an automated, mid-throughput, integrated chemistry and immunoassay analyzer utilizing both Atellica CH and Atellica IM assays. This study was designed to evaluate the analytical performance of the Atellica IM Vitamin D (VitD) and Intact Parathyroid Hormone (PTH) and Atellica CH Inorganic Phosphorus (IP) assays* on the Atellica CI 1900 Analyzer*. Methods The Atellica CI 1900 VitD, PTH, and IP assays use the same reagents and calibrators as the Atellica IM VitD and PTH and CH IP assays. Precision and method comparison (MC) were used as performance indicators for the Atellica CI 1900 Analyzer. Precision studies were performed according to CLSI EP05-A3 using native and contrived human serum (VitD and IP) or plasma (PTH) samples. One aliquot of each sample pool was tested in duplicate in two runs per day >2 h apart on each analyzer for >20 days. MC studies were performed according to CLSI EP09-A3. Native and contrived human samples were analyzed using the Atellica IM VitD and PTH assays on both the Atellica IM and Atellica CI 1900 Analyzers. For IP, native and contrived human samples were analyzed using the Atellica CH IP assay on both the Atellica CH and Atellica CI 1900 Analyzers. Results Representative precision and MC results for each assay across indicated sample ranges are listed in the table. For the three assays tested, repeatability and within-lab %CVs were <4.5% and <10%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1. Conclusion Evaluation of the Atellica IM VitD and PTH and Atellica CH IP assays using the Atellica CI 1900 Analyzer demonstrated good precision and equivalent performance compared to the same assays on their respective Atellica IM and Atellica CH Analyzers. *The products/features mentioned are not commercially available in all countries. Their future availability cannot be guaranteed.
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