A novel Sigma metric encompasses global multi-site performance of 18 assays on the Abbott Alinity system

作者：Jennifer Taher, Jake Cosme, Brian A. Renley, David Daghfal, Paul S. F. Yip · 发表于：Clinical Biochemistry · 年份：2018 · DOI：10.1016/j.clinbiochem.2018.10.003 · 被引用次数：25 · 研究领域：Pesticide Residue Analysis and Safety、Analytical Methods in Pharmaceuticals、Biosensors and Analytical Detection

OBJECTIVES: The Abbott Alinity family of chemistry and immunoassay systems recently launched with early adopters contributing imprecision and bias data, which was consolidated to assess the performance of Alinity assays across multiple sites using the Sigma metric. Multi-site Sigma metrics were determined for 3 ion-selective electrodes, 12 photometric assays, and 3 immunoassays across 11 independent laboratory sites in 9 countries. METHODS: Total allowable error (TEa) goals followed a previously defined hierarchy that used CLIA as the primary goal. Bias was calculated against the Abbott ARCHITECT system using Passing-Bablok regression analysis using individual site data or pooled aggregate data. Sigma metrics were calculated as (%TEa - |% bias|)/%CV. For individual-site analysis, the Sigma metrics for each assay were compared using the individual-site and the pooled biases. For multi-site analysis, the average CV and the pooled bias were used to generate a Pooled Sigma metric encompassing the global performance for a given assay. RESULTS: A total of 97 individual-site and 18 Pooled Sigma metrics were calculated for available assays. Individual Sigma metrics varied across sites, with 90% of assays performing 4 Sigma or higher, and 17 of 18 Pooled Sigma metrics indicated performance greater than 4 Sigma. Sigma metrics were significantly improved in 16 assays when using pooled bias rather than individual-site bias. CONCLUSIONS: This multi-center study applies a novel application...