title: Haemoglobin A1c: evaluation of a new HbA1c point-of-care analyser Bio-Rad in2it in comparison with the DCA 2000 and central laboratory analysers.
abstract: BACKGROUND
  Point-of-care-testing (POCT) of haemoglobin Alc (HbA1c) is popular due to its fast turnaround of results in the outpatient setting. The aim of this project was to evaluate the performance of a new HbA1c POCT analyser, the Bio-Rad in2it, and compare it with the Siemens DCA 2000, Bio-Rad Variant II and Roche Tina-quant HbA1c Gen 2 assay on the cobas c501.
  
  
  METHODS
  Imprecision of the four methods were compared by computing total imprecision from within-run and between-run data. A total of 80 samples were also compared and analysed by Deming regression and Altman-Bland difference test.
  
  
  RESULTS
  Study of total imprecision of the in2it at HBA1c levels of 6.0% and 10.4% produced a coefficient of variation (%CV) of 3.8% and 3.7%, respectively. These results were more favourable as compared with the DCA 2000 but did not match the low imprecision of the central laboratory methods, the Bio-Rad Variant II and the Roche cobas c501. Comparison between the in2it and the central laboratory analysers, Bio-Rad variant II and cobas c501, revealed positive bias of 12% and 10%, respectively, supported by corresponding Deming regression equation slopes of +1.18 and +1.14. Comparison between the DCA 2000 and the central laboratory analysers revealed a bias that became increasingly positive with rising HbA1c concentrations with Deming regression analysis also revealing proportional and constant differences.
  
  
  CONCLUSIONS
  The in2it is a suitable POCT analyser for HbA1c but its less than ideal precision performance and differences with the central laboratory analysers must be communicated to and noted by the users.
authors.affiliation: Clinical Biochemistry Laboratories, Department of Pathology, Singapore General Hospital, Singapore, Singapore. yeo.chin.pin@sgh.com.sg
authors.forename: Chin-Pin
authors.initials: CP
authors.lastname: Yeo
authors.forename: Carol Hui-Chen
authors.initials: CH
authors.lastname: Tan
authors.forename: Edward
authors.initials: E
authors.lastname: Jacob
mesh_terms: D001774:Blood Chemical Analysis / Q000295:instrumentation*; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D019095:Point-of-Care Systems; D012044:Regression Analysis
chemical_list: D006442:Glycated Hemoglobin