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Performance of glycated hemoglobin (HbA(1c)) methods evaluated with EQAS studies using fresh blood samples: Still space for improvements.
Clin Chim Acta. 2015 Dec 07; 451(Pt B):305-9.CC

Abstract

BACKGROUND

The determination of glycated hemoglobin is a key indicator for the management of diabetic patients. A reference measurement system for its determination is available and IVD manufacturers should have aligned their assay to this system.

METHODS

Two fresh blood samples were distributed by courier to 206 Italian laboratories asking for the determination of their HbA1c concentration. Target HbA1c values were assigned by the IFCC reference measurement procedure.

RESULTS

From 193 laboratories using analytical systems from five manufacturers (Bio-Rad Laboratories, A. Menarini Diagnostics, Roche Diagnostics, Sebia and Tosoh), we obtained a global variability of 5.3% (in terms of CV) and of 3.8% at an HbA1c value of 37.4 mmol/mol (sample 1) and 62.0 mmol/mol (sample 2), respectively. With a goal for the allowable total error (TE) of 6.0%, 70% and 77% of the participants met this criterion for samples 1 and 2, respectively. Inter-laboratory CVs, were between 3.3 and 5.0% and between 2.2 and 3.7% for samples 1 and 2, respectively. Tosoh users registered the smallest inter-laboratory CV in sample 1, and Sebia's in sample 2. With regard to trueness, all methods had a mean bias of ≤ 2.8% with respect to the target values, with the exception of Tosoh (bias of + 6.1 and + 5.8%, for samples 1 and 2, respectively).

CONCLUSION

These results are in good agreement with those obtained by the CAP 2014 GH2-A survey, suggesting then that still there is an urgent need for improving a significant part of the methods currently used to measure HbA1c.

Authors+Show Affiliations

Centro per la Riferibilità Metrologica in Medicina di Laboratorio (CIRME), Dip. di Fisiopatologia medico-chirurgica e dei trapianti, Università degli Studi di Milano, Milano, Italy. Electronic address: andrea.mosca@unimi.it.Centro per la Riferibilità Metrologica in Medicina di Laboratorio (CIRME), Dip. di Fisiopatologia medico-chirurgica e dei trapianti, Università degli Studi di Milano, Milano, Italy.Laboratorio di Standardizzazione, Servizio Medicina di Laboratorio, Ospedale San Raffaele, Milano, Italy.Department of Clinical Chemistry, Location Queen Beatrix Hospital, Winterswijk, The Netherlands; European Reference Laboratory, Location Queen Beatrix Hospital, Winterswijk, The Netherlands.Laboratorio di Standardizzazione, Servizio Medicina di Laboratorio, Ospedale San Raffaele, Milano, Italy.

Pub Type(s)

Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26483128

Citation

Mosca, Andrea, et al. "Performance of Glycated Hemoglobin (HbA(1c)) Methods Evaluated With EQAS Studies Using Fresh Blood Samples: Still Space for Improvements." Clinica Chimica Acta; International Journal of Clinical Chemistry, vol. 451, no. Pt B, 2015, pp. 305-9.
Mosca A, Paleari R, Carobene A, et al. Performance of glycated hemoglobin (HbA(1c)) methods evaluated with EQAS studies using fresh blood samples: Still space for improvements. Clin Chim Acta. 2015;451(Pt B):305-9.
Mosca, A., Paleari, R., Carobene, A., Weykamp, C., & Ceriotti, F. (2015). Performance of glycated hemoglobin (HbA(1c)) methods evaluated with EQAS studies using fresh blood samples: Still space for improvements. Clinica Chimica Acta; International Journal of Clinical Chemistry, 451(Pt B), 305-9. https://doi.org/10.1016/j.cca.2015.10.014
Mosca A, et al. Performance of Glycated Hemoglobin (HbA(1c)) Methods Evaluated With EQAS Studies Using Fresh Blood Samples: Still Space for Improvements. Clin Chim Acta. 2015 Dec 7;451(Pt B):305-9. PubMed PMID: 26483128.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Performance of glycated hemoglobin (HbA(1c)) methods evaluated with EQAS studies using fresh blood samples: Still space for improvements. AU - Mosca,Andrea, AU - Paleari,Renata, AU - Carobene,Anna, AU - Weykamp,Cas, AU - Ceriotti,Ferruccio, Y1 - 2015/10/22/ PY - 2015/10/01/received PY - 2015/10/15/revised PY - 2015/10/15/accepted PY - 2015/10/21/entrez PY - 2015/10/21/pubmed PY - 2016/7/28/medline KW - Accuracy KW - Diabetes KW - Standardization KW - Traceability SP - 305 EP - 9 JF - Clinica chimica acta; international journal of clinical chemistry JO - Clin Chim Acta VL - 451 IS - Pt B N2 - BACKGROUND: The determination of glycated hemoglobin is a key indicator for the management of diabetic patients. A reference measurement system for its determination is available and IVD manufacturers should have aligned their assay to this system. METHODS: Two fresh blood samples were distributed by courier to 206 Italian laboratories asking for the determination of their HbA1c concentration. Target HbA1c values were assigned by the IFCC reference measurement procedure. RESULTS: From 193 laboratories using analytical systems from five manufacturers (Bio-Rad Laboratories, A. Menarini Diagnostics, Roche Diagnostics, Sebia and Tosoh), we obtained a global variability of 5.3% (in terms of CV) and of 3.8% at an HbA1c value of 37.4 mmol/mol (sample 1) and 62.0 mmol/mol (sample 2), respectively. With a goal for the allowable total error (TE) of 6.0%, 70% and 77% of the participants met this criterion for samples 1 and 2, respectively. Inter-laboratory CVs, were between 3.3 and 5.0% and between 2.2 and 3.7% for samples 1 and 2, respectively. Tosoh users registered the smallest inter-laboratory CV in sample 1, and Sebia's in sample 2. With regard to trueness, all methods had a mean bias of ≤ 2.8% with respect to the target values, with the exception of Tosoh (bias of + 6.1 and + 5.8%, for samples 1 and 2, respectively). CONCLUSION: These results are in good agreement with those obtained by the CAP 2014 GH2-A survey, suggesting then that still there is an urgent need for improving a significant part of the methods currently used to measure HbA1c. SN - 1873-3492 UR - https://www.unboundmedicine.com/medline/citation/26483128/Performance_of_glycated_hemoglobin__HbA_1c___methods_evaluated_with_EQAS_studies_using_fresh_blood_samples:_Still_space_for_improvements_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0009-8981(15)30017-6 DB - PRIME DP - Unbound Medicine ER -