Immediate HbA1c results

Performance of new HbA1c system in pediatric outpatient population

David Marrero, Julie L. Vandagriff, Reid Gibson, S. Edwin Fineberg, Naomi S. Fineberg, Charles E. Hiar, Lawrence E. Crowley

Research output: Contribution to journalArticle

41 Citations (Scopus)

Abstract

OBJECTIVE - This study compared the performance of a new device that uses an IA to measure HbA1c in 9 min with a 1-μl capillary blood sample with AC and CE methods in both nondiabetic and diabetic pediatric patients. RESEARCH DESIGN AND METHODS - Two hundred seven pediatric subjects (103 nondiabetic, 104 with insulin-dependent diabetes mellitus) had HbA1c measured with the IA method and compared with total GHb values determined by AC and HbA1 by the CE method with the same whole-blood capillary aliquot. Glucose values were also obtained from the same blood samples. RESULTS - Correlations and regression analyses show excellent correspondence between the three assays. The correlation between the AC and CE methods is 0.98 (P < 0.001) with a slope of 1.615 ± 0.0125 and intercept of 4.00 ± 0.20. The correlation between the LA and AC methods is 0.99 (P < 0.001) with a slope of 0.608 ± 0.007 and intercept of 1.326 ± 0.066. The correlation between the IA and CE methods is 0.97 (P < 0.001), with a slope of 0.983 ± 0.018 and intercept of 1.122 ± 0.153. The average difference and average percentage difference between methods were also significant (P < 0.001), reflecting the differences in GHb components measured. There was a significant correlation (P < 0.001) between each method and glucose values (IA r= 0.72, AC r = 0.70, CE r = 0.73). Within-run precision for IA ranged from 1.7 to 3.5% and between-run precision 2.7 to 4.1%. CONCLUSIONS - Study results suggest that the IA method gives extremely accurate and reliable values over the clinical range of interest. The instrument is small, portable, easy to use, and provides information within 9 min for both physicians and patients.

Original languageEnglish
Pages (from-to)1045-1049
Number of pages5
JournalDiabetes Care
Volume15
Issue number8
StatePublished - Aug 1992

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Outpatients
Pediatrics
Population
Glucose
Glycosylated Hemoglobin A
Type 1 Diabetes Mellitus
Research Design
Regression Analysis
Physicians
Equipment and Supplies

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Marrero, D., Vandagriff, J. L., Gibson, R., Fineberg, S. E., Fineberg, N. S., Hiar, C. E., & Crowley, L. E. (1992). Immediate HbA1c results: Performance of new HbA1c system in pediatric outpatient population. Diabetes Care, 15(8), 1045-1049.

Immediate HbA1c results : Performance of new HbA1c system in pediatric outpatient population. / Marrero, David; Vandagriff, Julie L.; Gibson, Reid; Fineberg, S. Edwin; Fineberg, Naomi S.; Hiar, Charles E.; Crowley, Lawrence E.

In: Diabetes Care, Vol. 15, No. 8, 08.1992, p. 1045-1049.

Research output: Contribution to journalArticle

Marrero, D, Vandagriff, JL, Gibson, R, Fineberg, SE, Fineberg, NS, Hiar, CE & Crowley, LE 1992, 'Immediate HbA1c results: Performance of new HbA1c system in pediatric outpatient population', Diabetes Care, vol. 15, no. 8, pp. 1045-1049.
Marrero D, Vandagriff JL, Gibson R, Fineberg SE, Fineberg NS, Hiar CE et al. Immediate HbA1c results: Performance of new HbA1c system in pediatric outpatient population. Diabetes Care. 1992 Aug;15(8):1045-1049.
Marrero, David ; Vandagriff, Julie L. ; Gibson, Reid ; Fineberg, S. Edwin ; Fineberg, Naomi S. ; Hiar, Charles E. ; Crowley, Lawrence E. / Immediate HbA1c results : Performance of new HbA1c system in pediatric outpatient population. In: Diabetes Care. 1992 ; Vol. 15, No. 8. pp. 1045-1049.
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N2 - OBJECTIVE - This study compared the performance of a new device that uses an IA to measure HbA1c in 9 min with a 1-μl capillary blood sample with AC and CE methods in both nondiabetic and diabetic pediatric patients. RESEARCH DESIGN AND METHODS - Two hundred seven pediatric subjects (103 nondiabetic, 104 with insulin-dependent diabetes mellitus) had HbA1c measured with the IA method and compared with total GHb values determined by AC and HbA1 by the CE method with the same whole-blood capillary aliquot. Glucose values were also obtained from the same blood samples. RESULTS - Correlations and regression analyses show excellent correspondence between the three assays. The correlation between the AC and CE methods is 0.98 (P < 0.001) with a slope of 1.615 ± 0.0125 and intercept of 4.00 ± 0.20. The correlation between the LA and AC methods is 0.99 (P < 0.001) with a slope of 0.608 ± 0.007 and intercept of 1.326 ± 0.066. The correlation between the IA and CE methods is 0.97 (P < 0.001), with a slope of 0.983 ± 0.018 and intercept of 1.122 ± 0.153. The average difference and average percentage difference between methods were also significant (P < 0.001), reflecting the differences in GHb components measured. There was a significant correlation (P < 0.001) between each method and glucose values (IA r= 0.72, AC r = 0.70, CE r = 0.73). Within-run precision for IA ranged from 1.7 to 3.5% and between-run precision 2.7 to 4.1%. CONCLUSIONS - Study results suggest that the IA method gives extremely accurate and reliable values over the clinical range of interest. The instrument is small, portable, easy to use, and provides information within 9 min for both physicians and patients.

AB - OBJECTIVE - This study compared the performance of a new device that uses an IA to measure HbA1c in 9 min with a 1-μl capillary blood sample with AC and CE methods in both nondiabetic and diabetic pediatric patients. RESEARCH DESIGN AND METHODS - Two hundred seven pediatric subjects (103 nondiabetic, 104 with insulin-dependent diabetes mellitus) had HbA1c measured with the IA method and compared with total GHb values determined by AC and HbA1 by the CE method with the same whole-blood capillary aliquot. Glucose values were also obtained from the same blood samples. RESULTS - Correlations and regression analyses show excellent correspondence between the three assays. The correlation between the AC and CE methods is 0.98 (P < 0.001) with a slope of 1.615 ± 0.0125 and intercept of 4.00 ± 0.20. The correlation between the LA and AC methods is 0.99 (P < 0.001) with a slope of 0.608 ± 0.007 and intercept of 1.326 ± 0.066. The correlation between the IA and CE methods is 0.97 (P < 0.001), with a slope of 0.983 ± 0.018 and intercept of 1.122 ± 0.153. The average difference and average percentage difference between methods were also significant (P < 0.001), reflecting the differences in GHb components measured. There was a significant correlation (P < 0.001) between each method and glucose values (IA r= 0.72, AC r = 0.70, CE r = 0.73). Within-run precision for IA ranged from 1.7 to 3.5% and between-run precision 2.7 to 4.1%. CONCLUSIONS - Study results suggest that the IA method gives extremely accurate and reliable values over the clinical range of interest. The instrument is small, portable, easy to use, and provides information within 9 min for both physicians and patients.

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