title: Multicentre evaluation of the Premier Hb9210 HbA1c analyser.
abstract: BACKGROUND
  The accurate and precise quantification of HbA1c is essential for the diagnosis and routine monitoring of patients with diabetes. We report an evaluation of the Trinity Biotech Premier Hb9210 analyser (Bray, Ireland/Kansas City, MO, USA), a boronate affinity chromatography-based high performance liquid chromatography (HPLC) system for the measurement of glycated haemoglobin.
  
  
  METHODS
  We evaluated the analytical performance of the Hb9210 as part of a multicentre evaluation. The effect of haemoglobin variants, other potential interferences and the performance in comparison to both the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and National Glycohemoglobin Standardization Program (NGSP) reference systems, was assessed. Most of the centres participating also act as reference laboratories for both the IFCC standardisation network for HbA1c and the NGSP.
  
  
  RESULTS
  The combined data from all centres showed total coefficients of variation (CV) of 2.71%, 2.32% and 2.14% at low, medium and high values, respectively, for mmol/mol (SI units) and 1.62%, 1.59% and 1.68% for % (NGSP units), which are well below the recommended upper limits of 3% CV for mmol/mol (SI units) and 2% CV for % (NGSP). The analyser showed a good correlation to HbA1c methods currently used in clinical practice and the IFCC reference method procedure. Haemoglobin variants AC, AS, AE and AD do not affect the measurement of HbA1c. Overall the Hb9210 performs well across the whole analytical range.
  
  
  CONCLUSIONS
  The Hb9210 performs well and is suitable for clinical application in the analysis of HbA1c.
authors.forename: W Garry
authors.initials: WG
authors.lastname: John
authors.forename: Randie
authors.initials: R
authors.lastname: Little
authors.forename: David B
authors.initials: DB
authors.lastname: Sacks
authors.forename: Cas
authors.initials: C
authors.lastname: Weykamp
authors.forename: Erna
authors.initials: E
authors.lastname: Lenters-Westra
authors.forename: Theresa
authors.initials: T
authors.lastname: Hornsby
authors.forename: Zhen
authors.initials: Z
authors.lastname: Zhao
authors.forename: Carla
authors.initials: C
authors.lastname: Siebelder
authors.forename: Alethea
authors.initials: A
authors.lastname: Tennill
authors.forename: Emma
authors.initials: E
authors.lastname: English
mesh_terms: D002851:Chromatography, High Pressure Liquid; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D015337:Multicenter Studies as Topic; D012680:Sensitivity and Specificity
chemical_list: D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human