title: Evaluation of the performance of an immunoturbidimetric HbA1c reagent applied to the Siemens ADVIA 2400 automatic analyzer.
abstract: OBJECTIVE
  A new immunochemical reagent based on latex particles and antibodies against HbA1c (Axis-Shield), using Siemens ADVIA 2400 Instrument was evaluated.
  
  
  METHODS
  Intra-assay and total imprecision, interferences studies (bilirubin ~850 μmol/L, triglycerides ~16.9 mmol/L, total protein ~140 g/L, sodium cyanate ~50 mg/dL, ascorbic acid ~50 mg/dL, urea ~24.99 mmol/L, glucose ~105.46 mmol/L, rheumatoid factor ~600 U/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.
  
  
  RESULTS
  CVs % obtained by intra-assay imprecision, on 3 human HbA1c specimens at different concentrations (48, 48-64 and >64 mmol/mol) in 20 replicates, were <4%. CVs % by total imprecision, performed over 20 days with 4 calibrations on 3 human HbA1c samples (48, 48-64 and >64 mmol/mol), resulted <4%. Interferences were studied on two human samples (42-53 and>64 mmol/mol) without obtaining significant biases (<10%). Methods comparison vs Capillary Electrophoresis, performed on 120 samples ranging 23-137 mmol/mol, obtaining r = 0.974 as regression coefficient and a mean bias at decision level (48 mmol/mol) <3%. The results obtained with the NGSP samples have allowed the certification of the new reagent.
  
  
  CONCLUSIONS
  The ASD reagent met the needs of clinical laboratories, fulfilling both NGSP and IFCC requirements and it is robust to endogenous interferences.
authors.affiliation: Servizio di Medicina di Laboratorio, Ospedale San Raffaele, Via Olgettina 60, 20132 Milano, Italy.
authors.forename: Mosé
authors.initials: M
authors.lastname: Barbaro
authors.affiliation: Hospital Centro Médico de las Américas, Mèrida, Yucatán, Mexico.
authors.forename: Carlos
authors.initials: C
authors.lastname: Ku-Chulim
authors.affiliation: Axis-Shield Diagnostics Ltd, Technology Park, DD2 1XA Dundee, UK.
authors.forename: Fran
authors.initials: F
authors.lastname: Johnston
authors.affiliation: Axis-Shield Diagnostics Ltd, Technology Park, DD2 1XA Dundee, UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Cochrane
authors.affiliation: Axis-Shield Diagnostics Ltd, Technology Park, DD2 1XA Dundee, UK.
authors.forename: Fabio
authors.initials: F
authors.lastname: Rota
authors.affiliation: Servizio di Medicina di Laboratorio, Ospedale San Raffaele, Via Olgettina 60, 20132 Milano, Italy.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Passerini
authors.affiliation: Servizio di Medicina di Laboratorio, Ospedale San Raffaele, Via Olgettina 60, 20132 Milano, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Guerra
authors.affiliation: Servizio di Medicina di Laboratorio, Ospedale San Raffaele, Via Olgettina 60, 20132 Milano, Italy.
authors.forename: Ferruccio
authors.initials: F
authors.lastname: Ceriotti
authors.affiliation: Servizio di Medicina di Laboratorio, Ospedale San Raffaele, Via Olgettina 60, 20132 Milano, Italy. Electronic address: carobene.anna@hsr.it.
authors.forename: Anna
authors.initials: A
authors.lastname: Carobene
mesh_terms: D001331:Automation; D019075:Electrophoresis, Capillary; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007150:Immunohistochemistry / Q000295:instrumentation*; D007202:Indicators and Reagents; D009391:Nephelometry and Turbidimetry / Q000295:instrumentation*; D015203:Reproducibility of Results
chemical_list: D006442:Glycated Hemoglobin; D007202:Indicators and Reagents
keywords: CLSI; Capillary Electrophoresis; Glycated Hemoglobin; Immunoassay; Method evaluation; NGSP