B-055 Analytical Evaluation and Sigma Metrics of Next Generation Chemistry assays on the Alinity c and ARCHITECT Systems

Abstract Background We evaluated the analytical performance of four newly developed clinical chemistry assays [Creatinine, Uric Acid, Lactate, Lactate Dehydrogenase (LDH)] on the Abbott Alinity c and ARCHITECT c8000 system. These clinical chemistry assays incorporate a multianalyte calibrator, which has extended stability. For the enzyme assay LDH, both the multianalyte calibrator and a factor calibration are offered. Precision, linearity, method comparison and accuracy were assessed per CLSI guidelines. Sigma metrics were determined to examine the assay variability in relation to allowable performance limits. Methods Precision was assessed by measuring two levels of quality control material (Biorad Chemistry UA) and three pooled patient samples in replicates of five, twice per day, for five days. Method comparison was performed by measuring 134 serum/plasma specimens in duplicate on the new and current Alinity c or ARCHITECT methods. Linearity was evaluated using five to six levels of commercially available linearity material, measured in triplicate. Acceptability criteria were based on the Accreditation Canada Diagnostics (ACD) recommendations. Accuracy was determined in replicates of ten using external NIST standards. For assays where an external standard was not available, calibrators were used. The imprecision and bias from the target value were used to calculate the Sigma value. Total allowable error limits were obtained from the Clinical Laboratory Improvement Amendments (CLIA) and ACD guidelines. Results The results from the precision, accuracy, linearity, and method comparison studies are summarized in the table below. All the next generation chemistry assays demonstrated = 6 Sigma performance on the ARCHITECT and Alinity c systems based on CLIA guidelines. The performance of the factor calibration for the LDH assay was equivalent (data not shown). Conclusion The four next generation clinical chemistry assays (Creatinine2, Uric Acid2, Lactate2, Lactate Dehydrogenase2) demonstrated acceptable performance for precision, accuracy, linearity, and Sigma values on the Alinity c and ARCHITECT system. There was good agreement with the on-market Alinity c and ARCHITECT clinical chemistry assays.