Development of filter paper hemoglobin A1c assay applicable to newborn screening

Clin Chim Acta. 2016 Jun 1:457:24-6. doi: 10.1016/j.cca.2016.03.014. Epub 2016 Mar 23.

Abstract

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.

Keywords: Diabetes; Filter paper; Hemoglobin A1c; Newborn screening; Obesity.

MeSH terms

  • Dried Blood Spot Testing*
  • Glycated Hemoglobin / analysis*
  • Humans
  • Infant, Newborn
  • Neonatal Screening / methods*
  • Reproducibility of Results

Substances

  • Glycated Hemoglobin
  • hemoglobin A1c protein, human