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 evaluated the analytical performance of the Atellica IM Thyroid Stimulating Hormone 3 Ultra™ (TSH3-UL), Free Triiodothyronine (FT3), and Free Thyroxine (FT4) assays* on the Atellica CI 1900 Analyzer. Methods The Atellica CI 1900 TSH3-UL, FT3, and FT4 assays use the same reagents and calibrators as the Atellica IM assays. Precision and method comparison studies were performed according to CLSI EP05-A3 and CLSI EP09-A3 using native and contrived human serum (TSH3-UL, FT3, and FT4) and plasma (TSH3-UL) 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. FT3 and FT4 were evaluated with one reagent lot on two systems. TSH3-UL was evaluated with two reagent lots on two systems. For the method comparison, individual native human serum samples were analyzed using the Atellica IM TSH3-UL, FT3, and FT4 assays on both the Atellica IM and Atellica CI 1900 Analyzers. Results Representative precision and MC results are listed for each assay in the table. Slopes determined by the Deming linear regression model were approximately equal to 1. Conclusion Evaluation of the Atellica IM TSH3-UL, FT3, and FT4 assays using the Atellica CI 1900 Analyzer demonstrated good precision and equivalent performance compared to the same assays on the Atellica IM Analyzer. *The products/features mentioned herein are not commercially available in all countries. Their future availability cannot be guaranteed.
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