EDUCATION :: HEMOGLOBIN A1C
techniques without concern for an unknown interference and undetected misreporting of results. Those patients with incidental hemoglobinopathies detected would have their clinicians notified and be flagged for future monitoring by a separation technique or by an alternate analyte, as appropriate. This approach could be viewed as a modification of approaches suggested elsewhere16,17
especially for screening populations with high hemoglobinopathy incidence.
Despite decades of use for the diagnosis and monitoring of diabetes, laboratory standards have only recently addressed how HbA1c testing should account for the presence of hemo- globinopathies that could potentially interfere, both analyt- ically and clinically, with the result. The use of a separation technique for HbA1c measurement allows for the detection of hemoglobin variants and thalassemia without the associated cost of additional testing. Recent advances in result review and workflow have mitigated the throughput, complexity, and labor intensity surrounding the use of these higher-resolution techniques and will enable labs to release timely A1c results with confidence.
REFERENCES
1. Kohne E. Hemoglobinopathies: clinical manifestations, diagnosis, and treatment. Dtsch Arztebl Int. 2011;108(31-32):532-540. doi:10.3238/ arztebl.2011.0532.
2. Summary of Revisions: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018;41(Suppl 1):S4-S6. doi:10.2337/dc18-Srev01.
3. Flamini, M. A holistic overview of hemoglobinopathies interactions with glycated hemoglobin. Medical Laboratory Observer. Published August 24, 2022. Accessed July 19, 2023.
https://www.mlo-online.com/disease/ diabetes/article/21276454/a-holistic-overview-of-hemoglobinopathies-inter- actions-with-glycated-hemoglobin.
4. HbA1c Assay Interferences.
Ngsp.org. Accessed July 19, 2023. https://
ngsp.org/interf.asp.
5. Lacy ME, Wellenius GA, Sumner AE, et al. Association of sickle cell trait with hemoglobin A1c in African Americans. JAMA. 2017;317(5):507-515. doi:10.1001/jama.2016.21035.
6. Herman WH, Ma Y, Uwaifo G, et al. Diabetes Prevention Program Research Group. Differences in A1c by race and ethnicity among patients with impaired glucose tolerance in the Diabetes Prevention Program. Diabetes Care. 2007;30(10):2453-7. doi:10.2337/dc06-2003.
7. Pratumvinit B, Reesukumal K, Hanyongyuth S,
et.al. Hemoglobin A1c Levels Are Slightly but Significantly Lower in Normoglycemic Subjects with the Hemoglobin E Phenotype. Ann Lab Med. 2019;39(2):209-213. doi:10.3343/ alm.2019.39.2.209.
8. Paisooksantivatana K, Kongsomgan A, Banyatsuppasin W, Khupulsup K. Influence of hemoglboin E on measurement of hemoglobin A1c by immunoassays. Diabetes Res Clin Pract. 2009;83(3):e84-5. doi:10.1016/j. diabres.2008.11.021.
9. Solanki DL, McCurdy PR, Cuttitta FF, Schechter GP. Hemolysis in sickle cell disease as measured by endogenous carbon monoxide production. A pre- liminary report. Am J Clin Pathol. 1988;89(2):221-5. doi:10.1093/ajcp/89.2.221.
10. Rodriguez-Capote K, Estey MP, Barakauskas VE,
et.al. Identification of Hb Wayne and its effects on HbA1c measurement by 5 methods. Clin Biochem. 2015;48(16-17):1144-50. doi:10.1016/
j.clinbiochem.2015.07.100.
11. Kangastupa P, Akerman K, Risku S,
et.al. The prevalence of hemoglobin Tacoma in Finland detected by HbA1c capillary electrophoresis. Scand J Clin Lab Invest. 2023;83(1):51-57. doi:10.1080/00365513.2022.2164739.
12. Li Y, Tang J, Zheng L, Tang K, Li L. False hemoglobin A1c value as a result of compound heterozygotes of hemoglobin E and hemoglobin New York. J Diabetes Investig. 2023;14(3):494-497. doi:10.1111/jdi.13971.
13. McKeague S, Peake N, Lovelock D, Chow J, Benson R, Fanning S. Acquired HbH disease diagnosed by Hb A1c capillary electrophoresis. Br J Haematol. 2023;200(6):687. doi:10.1111/bjh.18587.
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14. Karimi SS, Jin M, Murga-Zamalloa C. Analytical and clinical signifi- cance of rare hemoglobin variants during HbA1c monitoring in patients with diabetes mellitus: Two cases of hemoglobin G-Ferrara and hemoglobin G-Copenhagen in dia- betic patients with sickle cell trait. J Appl Lab Med. 2023;6;8(2):407-412. doi:10.1093/jalm/jfac135.
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15. American Diabetes Association. 2. Classifi- cation and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018;41(Suppl 1):S13-S27. doi:10.2337/dc18-S002.
16. Gordon DK, Hussain M, Kumar P, Khan S, Khan S. The sickle effect: The silent titan affecting glycated hemoglobin reliability. Cureus. 2020;12;12(8):e9685. doi:10.7759/cureus.9685.
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17. Today C. ‘Hundreds of variants’—Staying alert to HbA1c method interference. CAP TODAY - Pathology/Laboratory Medicine/Laboratory Management. Published May 17, 2023. Accessed July 19, 2023.
https://www.captodayonline.com/ hundreds-of-variants-staying-alert-to-hba1c- method-interference/.
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Matthew C. Wagner received his PhD in Chemical Engineering in 2006 from Georgia Institute of Technology. Since transitioning to industry, he works as a Scientific Affairs Specialist for Sebia Electrophoresis, provider of
capillary and gel electrophoresis assays, including Capillary Hemoglobin A1c.
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