Development of filter paper hemoglobin A1c assay applicable to newborn screening.

PURPOSE

Gestational diabetes influences risk for future metabolic disease including type 2 diabetes. Hemoglobin A1c (HbA1c) measurement assesses hemoglobin A glycosylation, and could theoretically be used as a test to estimate gestational glucose exposure. HbA1c assay on dried blood spots (DBS) is needed before potential application to statewide newborn screening (NBS) population studies. The study aimed to establish a reliable method to measure HbA1c on NBS DBS specimens. De-identified blood was used to generate trials to evaluate stability of HbA1c in DBS, optimal elution time, and stability of eluted blood.

RESULTS

Analysis of DBS stability HbA1c measurements from 3 to 6days after collection overestimated HbA1c values by a bias factor between 0.83 and 0.87. Sixty minutes of elution time produced maximal reproducibility and minimal bias of results. Within assay standard deviation: 0.058; average bias: -0.02%. Stability of eluted blood did not vary significantly between days 0-2 after DBS elution.

CONCLUSIONS

Measurement of HbA1c levels on DBS from human blood is feasible. Results suggest new method using DBS to measure HbA1c level with the following characteristics: optimal time for sample analysis 3-6days after collection, elution time of 60min and eluted blood analysis within 2days of elution. Measurement of neonatal HbA1c could provide insight regarding the infant's in utero exposure to glucose.