B-120 Atellica® Ci 1900 Assay Sigma Metrics Evaluation

Abstract

Abstract Background The Atellica® CI 1900 Analyzer is a stand-alone, integrated clinical chemistry and immunoassay analyzer. Offering the same assay portfolio as the Atellica® Solution, the Atellica® CI 1900 analyzer is designed to complement the Atellica® Solution in hub-and-spoke settings, enabling labs of every size to offer state-of-the-art patient testing. Six Sigma is synonymous with process performance, and Sigma metrics have become the analytical quality benchmark for the medical device industry. In this study, Sigma metrics were calculated for a total of 71 Atellica® assays to provide a simple, translatable value to evaluate a given assay’s performance on the Atellica® CI 1900 Analyzer. Methods Allowable total error (ATE) for each assay was defined from the Clinical Laboratory Improvement Amendment (CLIA) table. When an analyte was not present in the CLIA table, alternative sources were consulted, including the RiliBÄK table, Royal College of Pathologists of Australasia (RCPA) table, and Ricos Biological Variability. Precision studies were conducted in accordance with Clinical and Laboratory Standards Institute (CLSI) document EP05-A3 over 20 days (n = 80 replicates) using the Atellica® CI 1900 Analyzer. Method comparison studies conducted on the Atellica® CI and Atellica® CH/IM Analyzers, with at least 100 patient samples spanning the assay’s measuring interval in accordance with CLSI document EP09-A3, were used to establish bias at the selected target precision concentration. Sigma metrics were determined for each assay using the equation Sigma metric = (ATE – %bias)/(Within-lab %coefficient of variation [CV]). Results Sigma metrics were determined for a total of 71 Atellica® assays, resulting in 93% of assays performing above Five or Six Sigma and 0 assays performing below 4 Sigma. Of these, 44 of 52 clinical chemistry and 15 of 19 immunoassays performed above the 6 Sigma level. Conclusions Sigma metrics that provide a benchmark for laboratory quality classify over 90% of assays on the Atellica® CI 1900 Analyzer with scores of 5 or 6, corresponding to the classification of excellent or world-class performance. Therefore, laboratories can expect high quality assay performance with strong comparability between the Atellica® CI 1900 Analyzer and the Atellica® Solution. **Not available for sale in the US. Product availability varies by country.