A-078 Accuracy Based Sigma Metrics of Alinity c System as Benchmarked against Roche c701

Abstract

Abstract Background Assay performance is dependent on the accuracy and precision of a given method. Sigma metric is a well-established tool for objectively assessing such performances. The objective of the study is to evaluate the Alinity c system using a representative set of clinical chemistry assays in an independent central laboratory setting. The analytical performance of the Alinity c assays was compared with the Roche c701 assays using accuracy-based Sigma metrics. Methods Analytical performance of 7 clinical chemistry assays, including sodium, potassium, chloride (Integrated Chip Technology or ICT), Glucose, ALT, AST and creatine kinase (CK), was assessed on the Alinity c System as benchmarked against the Roche c701. The accuracy of the assays was evaluated by testing reference standard materials sourced from Reference Material Institute for Clinical Chemistry Standards (ReCCS)) in Japan or National Institute of Standards and Technology (NIST) in America. The 5-day precision evaluation per CLSI EP15-A3 was performed using the Bio-Rad Lyphochek® Assayed Chemistry Control and two patient sample pools. Linearity was assessed using 9 levels of patient sample pools covering the measuring interval of each assay. Method comparison with Roche c701 assays was performed per CLSI EP9-A3 using 60 patient samples spanning the measurement range. Sigma metrics for each assay were determined relative to the total allowable errors according to the Clinical Laboratory Improvement Amendments (CLIA) specifications. Results Within-lab (total) imprecision for the 7 assays on Alinity c and Roche were all <3.5% CV for both the Bio-Rad Control and patient pools. Alinity c assays showed a better precision performance in all of assays tested. Bias of the 7 assays in reference to the assigned values was all below 7.5% for both platforms. Alinity c exhibited a good correlation with Roche c701 on all 7 assays in the method comparison evaluation. Linearity of the Alinity c assays was validated for the measuring intervals as claimed by the manufacturer. Majority of the assays on both analzyers demonstrated at least 6 sigma performance with Alinity c showing better sigma scores. Conclusion The Alinity c System demonstrated excellent accuracy, precision and linearity in an evaluation of 7 clinical chemistry assays. A majority of the assays demonstrated at least 6 sigma performance, supporting the fitness for clinical use.