Abstract
Abstract Background The aim of this study was to evaluate the analytical performance of 5 Abbott next generation (Sigma Strong) clinical chemistry assays on the Abbott Alinity c system. Method comparison, precision, linearity, accuracy, and sigma metrics were assessed for Albumin BCG2 (Bromocresol green), Albumin BCP2 (Bromocresol purple), Cholesterol2, Total Protein2 and Amylase2. Methods Method comparison between new (second generation) and current on market Alinity assays was performed by measuring 126–138 serum/plasma samples in duplicate. Assessment of imprecision was performed by running 2 levels of quality control material (BioRad; Chemistry UA) and 3 pooled patient samples 5x twice per day for 5 days. 10 replicates of ERM-DA470 k IFCC material for albumin, ERM-AD456 k IFCC material for amylase, NIST SRM 927 material for total protein, and NIST 1951cL1 for cholesterol were run to determine the accuracy and calculated sigma value for each analyte. Linearity testing was performed by running 5–6 levels of commercially available linearity materials in replicates of 3. Bias, acceptable imprecision, and total allowable error were based on Clinical Laboratory Improvement Amendments and Accreditation Canada Diagnostics guidelines. Statistical analysis was performed using EP evaluator. Results Data for method comparison (Passing Bablok), precision (Range of total %CV across 5 concentrations), accuracy (% Bias from target value), and linearity (Range of % recovery) for 5 Abbott second generation clinical chemistry assays are shown in Table 1. All assays demonstrated ≥6 Sigma performance. Conclusion The Abbott second generation (Sigma Strong) clinical chemistry assays on the Alinity c system showed acceptable performance for precision, accuracy, linearity, and agreement with the on-market Alinity c clinical chemistry assays.
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