Evaluation of the performance of an immunoturbidimetric HbA1c reagent applied to the Siemens ADVIA 2400 automatic analyzer

• Published in: Clinical biochemistry 2015-02, Vol.48 (3), p.177-180
• Main Authors: Barbaro, Mosé, Ku-Chulim, Carlos, Johnston, Fran, Cochrane, Rebecca, Rota, Fabio, Passerini, Gabriella, Guerra, Elena, Ceriotti, Ferruccio, Carobene, Anna
• Format: Article
• Language: English
• Subjects: Automation; Capillary Electrophoresis; CLSI; Electrophoresis, Capillary; Glycated Hemoglobin; Glycated Hemoglobin A - analysis; Humans; Immunoassay; Immunohistochemistry - instrumentation; Indicators and Reagents; Method evaluation; Nephelometry and Turbidimetry - instrumentation; NGSP; Reproducibility of Results
• ISSN: 0009-9120; 1873-2933
• DOI: 10.1016/j.clinbiochem.2014.11.001

A new immunochemical reagent based on latex particles and antibodies against HbA1c (Axis-Shield), using Siemens ADVIA 2400 Instrument was evaluated. Intra-assay and total imprecision, interferences studies (bilirubin ~850μmol/L, triglycerides ~16.9mmol/L, total protein ~140g/L, sodium cyanate ~50mg/dL, ascorbic acid ~50mg/dL, urea ~24.99mmol/L, glucose ~105.46mmol/L, rheumatoid factor ~600U/mL), method comparison vs Capillary Electrophoresis (Sebia), Lot to Lot reproducibility, linearity and carry over were conducted on ADVIA 2400 according to CLSI protocols. Additionally, 40 samples were measured by the two methods and also by a NGSP reference lab. CVs % obtained by intra-assay imprecision, on 3 human HbA1c specimens at different concentrations (48, 48–64 and >64mmol/mol) in 20 replicates, were 64mmol/mol), resulted 64mmol/mol) without obtaining significant biases (