Haemoglobin A1c: evaluation of a new HbA1c point-of-care analyser Bio-Rad in2it in comparison with the DCA 2000 and central laboratory analysers.

摘要

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.