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The Effect of Elevated Fetal Hemoglobin on Hemoglobin A1c Results
Five Common Hemoglobin A1c Methods Compared With the IFCC Reference Method

Curt L. Rohlfing, Shawn M. Connolly, Jack D. England, Steven E. Hanson, Christina M. Moellering MD, Janielle R. Bachelder MD, Randie R. Little PhD
DOI: http://dx.doi.org/10.1309/YFVTUD0GHJF7D16H 811-814 First published online: 1 May 2008


Hemoglobin A1c (HbA1c) is an important indicator of risk for complications in patients with diabetes mellitus. Elevated fetal hemoglobin (HbF) levels have been reported to interfere with results of some HbA1c methods, but it has generally been assumed that results from boronate-affinity methods are not HbA1c affected by elevated HbF levels. None of the previous studies used the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference method. We, method as the comparative HbA1c in samples with normal therefore, measured HbA1c and elevated HbF levels by several common assay methods and compared the results with those of the IFCC reference method.

HbF levels of more than 20% artificially lowered results from the Primus CLC 330/385 (Primus HbA1c Diagnostics, Kansas City, MO), Siemens DCA2000 (Siemens Healthcare Diagnostics, Tarrytown, NY), and Tosoh 2.2+ (Tosoh Bioscience, South San Francisco, CA), but not the Bio-Rad Variant II (Bio-Rad Laboratories, Hercules, CA) and Tosoh G7. Physicians and laboratory professionals need to be aware of potential interference from elevated HbF levels that results, including those from could affect HbA1c boronate-affinity methods.

Key Words:
  • Hemoglobin A, glycosylated
  • Fetal hemoglobin
  • Hemoglobins, abnormal
  • Diabetes mellitus
  • Chemistry, clinical