A1c Gear

Laboratory quality HbA1c measurement at the point of care

Adetoun Ejilemele, Jamie Unabia, Hyunsu Ju, John R. Petersen

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Introduction: HbA1c is an important part of assessing the diabetic control and since the use of point-of-care devices for monitoring HbA1c is increasing, it is important to determine how these devices compare to the central laboratory. Methods: One hundred and twenty patient samples were analyzed on the Bio-Rad Variant™II and one POC analyzer (Sakae A1c Gear). Three patient sample pools containing ~. 5%, ~. 7%, and ~. 10% HbA1c levels were run over 20. days. Three reagent lots and three instruments were evaluated for the A1c Gear. Results: The 120 patient samples showed strong correlation (R2>0.989) when compared to the Variant™II with means=8.06% and 7.81%, for Variant IIand A1c Gear, respectively. Changing reagent lots or instruments had no impact for the A1c Gear. The ~5%, ~7%, and ~10% pools within-run and between-run imprecision was between 0.87-1.33% and 1.03-1.32%, and 1.41-2.35% and 1.24-1.89% with total imprecision of 1.67-2.35% and 1.61-2.31% for the A1c Gear and Variant II, respectively. The A1c Gear showed a small negative bias (0.25% HbA1c) across HbA1c measurement ranges of <11.5%. This bias was, however, acceptable and not considered to be clinically significant. Conclusions: The A1c Gear meets the criteria of total CV < 3% leading us to the conclusion that the A1c Gear can give results as precise as the laboratory at the POC.

Original languageEnglish (US)
Pages (from-to)139-142
Number of pages4
JournalClinica Chimica Acta
Volume445
DOIs
StatePublished - May 1 2015

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Point-of-Care Systems
Gears
Equipment and Supplies

Keywords

  • Diabetes
  • HbA1c
  • POCT

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

A1c Gear : Laboratory quality HbA1c measurement at the point of care. / Ejilemele, Adetoun; Unabia, Jamie; Ju, Hyunsu; Petersen, John R.

In: Clinica Chimica Acta, Vol. 445, 01.05.2015, p. 139-142.

Research output: Contribution to journalArticle

Ejilemele, Adetoun ; Unabia, Jamie ; Ju, Hyunsu ; Petersen, John R. / A1c Gear : Laboratory quality HbA1c measurement at the point of care. In: Clinica Chimica Acta. 2015 ; Vol. 445. pp. 139-142.
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abstract = "Introduction: HbA1c is an important part of assessing the diabetic control and since the use of point-of-care devices for monitoring HbA1c is increasing, it is important to determine how these devices compare to the central laboratory. Methods: One hundred and twenty patient samples were analyzed on the Bio-Rad Variant™II and one POC analyzer (Sakae A1c Gear). Three patient sample pools containing ~. 5{\%}, ~. 7{\%}, and ~. 10{\%} HbA1c levels were run over 20. days. Three reagent lots and three instruments were evaluated for the A1c Gear. Results: The 120 patient samples showed strong correlation (R2>0.989) when compared to the Variant™II with means=8.06{\%} and 7.81{\%}, for Variant IIand A1c Gear, respectively. Changing reagent lots or instruments had no impact for the A1c Gear. The ~5{\%}, ~7{\%}, and ~10{\%} pools within-run and between-run imprecision was between 0.87-1.33{\%} and 1.03-1.32{\%}, and 1.41-2.35{\%} and 1.24-1.89{\%} with total imprecision of 1.67-2.35{\%} and 1.61-2.31{\%} for the A1c Gear and Variant II, respectively. The A1c Gear showed a small negative bias (0.25{\%} HbA1c) across HbA1c measurement ranges of <11.5{\%}. This bias was, however, acceptable and not considered to be clinically significant. Conclusions: The A1c Gear meets the criteria of total CV < 3{\%} leading us to the conclusion that the A1c Gear can give results as precise as the laboratory at the POC.",
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