Hemoglobin A1c

Assessment of three POC analyzers relative to a central laboratory method

John R. Petersen, Felix O. Omoruyi, Amin A. Mohammad, Thomas J. Shea, Anthony Okorodudu, Hyunsu Ju

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Background: Glycosylated hemoglobin evaluation is very important for assessing the control of diabetes. Since the use of point-of-care (POC) devices for monitoring HbA1c is increasing, it is important to determine how these devices compare in relation to instrumentation used in the central laboratory (CL). Methods: Eighty-eight randomly selected samples previously analyzed using the Bio-Rad Variant™ II Hemoglobin Testing System were run on three POC Analyzers (Siemens DCA Vantage™ Analyzer, Axis-Shield Afinion™ AS100 Analyzer, and Bio-Rad In2it™ Analyzer). Results: All POC instruments showed good correlation to the CL method (R2>0.95 for all methods). HbA1c levels obtained using Variant II (mean=7.9; 95% CI=7.5-8.3%) and In2it (mean=7.9; 95% C.I.=7.5-8.2%) instruments were found to have no statistical mean difference (p=0.21), while the values obtained using DCA Vantage (mean=7.2% C.I.=6.9-7.5%) and Afinion (mean=7.3% C.I.=7.0-7.6%) instruments were different (p<0.001) from those of the CL method. The Afinion and DCA Vantage instruments increasingly underestimated the HbA1c compared to the CL as the HbA1c values increased. These differences were even more striking when the estimated average glucose is calculated. Conclusions: Despite significant variation of results among the POC instruments evaluated relative to the CL method and pending resolution of HbA1c standardization issues, we conclude that all of the POC instruments can be used for HbA1c determination if clinicians are given instrument specific reference ranges.

Original languageEnglish (US)
Pages (from-to)2062-2066
Number of pages5
JournalClinica Chimica Acta
Volume411
Issue number23-24
DOIs
StatePublished - Dec 14 2010

Fingerprint

Point-of-Care Systems
Hemoglobins
Equipment and Supplies
Glycosylated Hemoglobin A
Reference Values
Medical problems
Standardization
Glucose
Monitoring
Testing

Keywords

  • HbA1c
  • Hemoglobin A1c
  • POCT
  • Point-of-care testing

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

Hemoglobin A1c : Assessment of three POC analyzers relative to a central laboratory method. / Petersen, John R.; Omoruyi, Felix O.; Mohammad, Amin A.; Shea, Thomas J.; Okorodudu, Anthony; Ju, Hyunsu.

In: Clinica Chimica Acta, Vol. 411, No. 23-24, 14.12.2010, p. 2062-2066.

Research output: Contribution to journalArticle

Petersen, John R. ; Omoruyi, Felix O. ; Mohammad, Amin A. ; Shea, Thomas J. ; Okorodudu, Anthony ; Ju, Hyunsu. / Hemoglobin A1c : Assessment of three POC analyzers relative to a central laboratory method. In: Clinica Chimica Acta. 2010 ; Vol. 411, No. 23-24. pp. 2062-2066.
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AU - Omoruyi, Felix O.

AU - Mohammad, Amin A.

AU - Shea, Thomas J.

AU - Okorodudu, Anthony

AU - Ju, Hyunsu

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N2 - Background: Glycosylated hemoglobin evaluation is very important for assessing the control of diabetes. Since the use of point-of-care (POC) devices for monitoring HbA1c is increasing, it is important to determine how these devices compare in relation to instrumentation used in the central laboratory (CL). Methods: Eighty-eight randomly selected samples previously analyzed using the Bio-Rad Variant™ II Hemoglobin Testing System were run on three POC Analyzers (Siemens DCA Vantage™ Analyzer, Axis-Shield Afinion™ AS100 Analyzer, and Bio-Rad In2it™ Analyzer). Results: All POC instruments showed good correlation to the CL method (R2>0.95 for all methods). HbA1c levels obtained using Variant II (mean=7.9; 95% CI=7.5-8.3%) and In2it (mean=7.9; 95% C.I.=7.5-8.2%) instruments were found to have no statistical mean difference (p=0.21), while the values obtained using DCA Vantage (mean=7.2% C.I.=6.9-7.5%) and Afinion (mean=7.3% C.I.=7.0-7.6%) instruments were different (p<0.001) from those of the CL method. The Afinion and DCA Vantage instruments increasingly underestimated the HbA1c compared to the CL as the HbA1c values increased. These differences were even more striking when the estimated average glucose is calculated. Conclusions: Despite significant variation of results among the POC instruments evaluated relative to the CL method and pending resolution of HbA1c standardization issues, we conclude that all of the POC instruments can be used for HbA1c determination if clinicians are given instrument specific reference ranges.

AB - Background: Glycosylated hemoglobin evaluation is very important for assessing the control of diabetes. Since the use of point-of-care (POC) devices for monitoring HbA1c is increasing, it is important to determine how these devices compare in relation to instrumentation used in the central laboratory (CL). Methods: Eighty-eight randomly selected samples previously analyzed using the Bio-Rad Variant™ II Hemoglobin Testing System were run on three POC Analyzers (Siemens DCA Vantage™ Analyzer, Axis-Shield Afinion™ AS100 Analyzer, and Bio-Rad In2it™ Analyzer). Results: All POC instruments showed good correlation to the CL method (R2>0.95 for all methods). HbA1c levels obtained using Variant II (mean=7.9; 95% CI=7.5-8.3%) and In2it (mean=7.9; 95% C.I.=7.5-8.2%) instruments were found to have no statistical mean difference (p=0.21), while the values obtained using DCA Vantage (mean=7.2% C.I.=6.9-7.5%) and Afinion (mean=7.3% C.I.=7.0-7.6%) instruments were different (p<0.001) from those of the CL method. The Afinion and DCA Vantage instruments increasingly underestimated the HbA1c compared to the CL as the HbA1c values increased. These differences were even more striking when the estimated average glucose is calculated. Conclusions: Despite significant variation of results among the POC instruments evaluated relative to the CL method and pending resolution of HbA1c standardization issues, we conclude that all of the POC instruments can be used for HbA1c determination if clinicians are given instrument specific reference ranges.

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