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

This version was published on 1 September 2009

Ann Clin Biochem 2009;46:373-376
doi:10.1258/acb.2009.009008
© 2009 Association for Clinical Biochemistry

 

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Original Articles


Chin-Pin Yeo,
Carol Hui-Chen Tan and
Edward Jacob


Clinical Biochemistry Laboratories, Department of Pathology, Singapore General Hospital, Singapore, Singapore


Corresponding author: Dr Chin-Pin Yeo. Email: yeo.chin.pin{at}sgh.com.sg


Background: Point-of-care-testing (POCT) of haemoglobin Alc (HbA1c) is populardue to its fast turnaround of results in the outpatient setting.The aim of this project was to evaluate the performance of anew HbA1c POCT analyser, the Bio-Rad in2it, and compare it withthe Siemens DCA 2000, Bio-Rad Variant II and Roche Tina-quantHbA1c Gen 2 assay on the cobas c501.

Methods: Imprecision of the four methods were compared by computing totalimprecision from within-run and between-run data. A total of80 samples were also compared and analysed by Deming regressionand 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 ascompared with the DCA 2000 but did not match the low imprecisionof the central laboratory methods, the Bio-Rad Variant II andthe Roche cobas c501. Comparison between the in2it and the centrallaboratory analysers, Bio-Rad variant II and cobas c501, revealedpositive bias of 12% and 10%, respectively, supported by correspondingDeming regression equation slopes of +1.18 and +1.14. Comparisonbetween the DCA 2000 and the central laboratory analysers revealeda bias that became increasingly positive with rising HbA1c concentrationswith Deming regression analysis also revealing proportionaland constant differences.

Conclusions: The in2it is a suitable POCT analyser for HbA1c but its lessthan ideal precision performance and differences with the centrallaboratory analysers must be communicated to and noted by theusers.

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