B-118 Evaluation of Thirteen Commercially Available Clinical Chemistry Assays on the Alinity® c System

Abstract

Abstract Background Expansion of instrument analyte menus is often needed to accommodate country specific needs. To address specific needs in China, thirteen clinical chemistry assays have been modified for evaluation on the Alinity c system. These analytes are used in the investigation of several diseases including liver disease, hepatobiliary disease, cardiovascular and cerebrovascular disease, kidney disease, inflammation, infectious disease, alcoholism and glucose metabolism disease. Methods The following analytes were evaluated: a1-Microglobulin (a1-MG), Ischemia modified albumin (IMA), Glutamate Dehydrogenase (GLDH), Fibrin Degradation Products (FDP), Myeloperoxidase (MPO), Fibronectin (FN), Pyruvate (PYR), Monoamine Oxidase (MAO), Heart-type Fatty Acid-Binding Protein (H-FABP), Cholyglycine (CG), Serum Amyloid A Protein (SAA), Ethanol (EtOH) and Ferritin (Fer). Reagents from Beijing Strong Biotechnologies Inc. (BSBE) were evaluated on the ABBOTT Alinity c system. Precision, LoQ and linearity range were evaluated with guidance from CLSI documents EP15-A3, EP17-A2 and EP06-Ed2. Correlation to commercially available assays were performed using human serum/plasma/urine samples across the measuring range. Results The table below summarizes key performance of assays. Conclusions These initial results are very promising. All the assays tested exhibit good precision, linearity, anti-interference, and LOQ performances on Alinity c system. In addition, they also have excellent correlation with Jinya assays from BSBE on ARCHITECT system except SAA assay, and SAA has excellent correlation with Siemens BNII SAA assay.