title: Multicentre evaluation of glycated haemoglobin (HbA1c) of Roche Diagnostics in Andalusia.
abstract: BACKGROUND
  A Spanish multicentre evaluation of the third generation of Roche Diagnostics immunoturbidimetric inhibition method (TINIA) is presented for quantification of haemoglobin A1c (HbA1c) in whole blood.
  
  
  METHODS
  The analytical performance of the TINIA test was evaluated and blood sample results were compared with two other widely used analysers, Bio-Rad Variant II and Adams Arkray HA-8160, based on HPLC.
  
  
  RESULTS
  Within- and between-batch imprecision (coefficients of variation (CVs)) for HbA1c levels of 5, 6, 7 and 8% were 0.77, 1.23, 1.35 and 1.26% and 2.38, 1.51, 1.76 and 2.16%, respectively. For low (5.4% A1c) and high (10.1% A1c) quality control samples, the within and between-batch %CV were: 1.26; 1.43 and 2; 1.71 respectively. The test met the expected performance in most aspects, except for linearity, that is under the reported range, and HbF interferences, detected for levels over 7.5%. There was a good concordance between the results of TINIA and Variant-IIt in the whole range and with HA-8160 only up to levels of 9%. Between-batch imprecision suggests more frequent calibrations than reported by the provider to maintain variability within the limits established by clinical practice guidelines.
  
  
  CONCLUSIONS
  The assay meets the necessary quality standards for routine use, as long as we keep the analytical variability within narrow limits. The results may be interchangeable with the tested HPLC systems, but HbF interference is not detected and it happens at lower levels than reported.
authors.affiliation: H.U. Puerta del Mar, Cádiz, Spain. Electronic address: anasaezbenito@gmail.com.
authors.forename: Ana
authors.initials: A
authors.lastname: Sáez-Benito Godino
authors.affiliation: H.U. Puerta del Mar, Cádiz, Spain.
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Vergara Chozas
authors.affiliation: H.U. J.R. Jiménez, Huelva, Spain.
authors.forename: Apolonia
authors.initials: A
authors.lastname: Márquez Ronchel
authors.affiliation: H.U. J.R. Jiménez, Huelva, Spain.
authors.forename: Fátima
authors.initials: F
authors.lastname: Barrero Alor
authors.affiliation: H.U. San Cecilio, Granada, Spain.
authors.forename: Lara
authors.initials: L
authors.lastname: Papay Ramírez
authors.affiliation: H.U. San Cecilio, Granada, Spain.
authors.forename: Nieves María
authors.initials: NM
authors.lastname: Coronado Álvarez
authors.affiliation: H. Axarquía, Vélez-Málaga, Spain.
authors.forename: José
authors.initials: J
authors.lastname: de la Torre Fernández
authors.affiliation: H. Axarquía, Vélez-Málaga, Spain.
authors.forename: Federico
authors.initials: F
authors.lastname: Navajas Luque
authors.affiliation: C.H. Ciudad de Jaén, Jaén, Spain.
authors.forename: M Victoria
authors.initials: MV
authors.lastname: Camacho Reina
authors.affiliation: C.H. Ciudad de Jaén, Jaén, Spain.
authors.forename: Rosario
authors.initials: R
authors.lastname: Aguilar Peña
authors.affiliation: H. Cabra, Córdoba, Spain.
authors.forename: M Lourdes
authors.initials: ML
authors.lastname: de la Peña Carretero
authors.affiliation: H. Cabra, Córdoba, Spain.
authors.forename: M Victoria
authors.initials: MV
authors.lastname: Romero Sotomayor
mesh_terms: D002851:Chromatography, High Pressure Liquid; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D015203:Reproducibility of Results; D013030:Spain
chemical_list: D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
keywords: Diabetes; Evaluation; Glycated haemoglobin; HbA1c; Immunoturbidimetric inhibition method; Multicentre study