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Haemoglobin A1c: evaluation of a new HbA1c point-of-care analyser Bio-Rad in2it in comparison with the DCA 2000 and central laboratory analysers.
Ann Clin Biochem. 2009 Sep; 46(Pt 5):373-6.AC

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+Show Affiliations

Clinical Biochemistry Laboratories, Department of Pathology, Singapore General Hospital, Singapore, Singapore. yeo.chin.pin@sgh.com.sgNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

19487414

Citation

Yeo, Chin-Pin, et al. "Haemoglobin A1c: Evaluation of a New HbA1c Point-of-care Analyser Bio-Rad In2it in Comparison With the DCA 2000 and Central Laboratory Analysers." Annals of Clinical Biochemistry, vol. 46, no. Pt 5, 2009, pp. 373-6.
Yeo CP, Tan CH, Jacob E. Haemoglobin A1c: evaluation of a new HbA1c point-of-care analyser Bio-Rad in2it in comparison with the DCA 2000 and central laboratory analysers. Ann Clin Biochem. 2009;46(Pt 5):373-6.
Yeo, C. P., Tan, C. H., & Jacob, E. (2009). Haemoglobin A1c: evaluation of a new HbA1c point-of-care analyser Bio-Rad in2it in comparison with the DCA 2000 and central laboratory analysers. Annals of Clinical Biochemistry, 46(Pt 5), 373-6. https://doi.org/10.1258/acb.2009.009008
Yeo CP, Tan CH, Jacob E. Haemoglobin A1c: Evaluation of a New HbA1c Point-of-care Analyser Bio-Rad In2it in Comparison With the DCA 2000 and Central Laboratory Analysers. Ann Clin Biochem. 2009;46(Pt 5):373-6. PubMed PMID: 19487414.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Haemoglobin A1c: evaluation of a new HbA1c point-of-care analyser Bio-Rad in2it in comparison with the DCA 2000 and central laboratory analysers. AU - Yeo,Chin-Pin, AU - Tan,Carol Hui-Chen, AU - Jacob,Edward, Y1 - 2009/06/01/ PY - 2009/6/3/entrez PY - 2009/6/3/pubmed PY - 2009/11/5/medline SP - 373 EP - 6 JF - Annals of clinical biochemistry JO - Ann Clin Biochem VL - 46 IS - Pt 5 N2 - 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. SN - 1758-1001 UR - https://www.unboundmedicine.com/medline/citation/19487414/Haemoglobin_A1c:_evaluation_of_a_new_HbA1c_point_of_care_analyser_Bio_Rad_in2it_in_comparison_with_the_DCA_2000_and_central_laboratory_analysers_ L2 - https://journals.sagepub.com/doi/10.1258/acb.2009.009008?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -