A comparison of fetal hemoglobin interference in routine high-performance liquid chromatography, immunoassay, and enzymatic methods of glycated hemoglobin measurement.
Sheila X Soh, Tze Ping Loh, Qinde Liu, Hong Liu, Madeline Tjai, Hwee Tong Tan, Tang Lin Teo, Robert C Hawkins, Sunil K Sethi, Lizhen Ong
{"title":"A comparison of fetal hemoglobin interference in routine high-performance liquid chromatography, immunoassay, and enzymatic methods of glycated hemoglobin measurement.","authors":"Sheila X Soh, Tze Ping Loh, Qinde Liu, Hong Liu, Madeline Tjai, Hwee Tong Tan, Tang Lin Teo, Robert C Hawkins, Sunil K Sethi, Lizhen Ong","doi":"10.1093/labmed/lmae109","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Fetal hemoglobin (HbF) is known to cause method-specific interference in glycated hemoglobin A1c (HbA1c) measurement. Data on HbF interference, however, is currently either lacking for some platforms (eg, the Abbott Core Laboratory Alinity c and Beckman Coulter AU5800) or available only for HbF levels lower than the maximum claimed by the manufacturer (eg, Bio-Rad D-100).</p><p><strong>Methods: </strong>We examined the effect of HbF interference on 7 HbA1c platforms using a series of spiked adult whole blood samples with increasing HbF levels (0% to 35%) and either low (approximately 5%) or high (approximately 9%) HbA1c levels, using isotope dilution mass spectrometry as a reference measurement procedure.</p><p><strong>Results: </strong>For the high-performance liquid chromatography (HPLC)-based platforms (Bio-Rad VARIANT II TURBO 2.0 and D-100), relative deviation from expected values was not clinically significant, even at an HbF level of 35%. In contrast, immunoassay (AU5800; Roche Diagnostics cobas c311 and cobas b101; and Siemens Healthineers DCA Vantage) and enzymatic (Alinity c) methods showed clinically significant deviation at HbF levels above 10%.</p><p><strong>Discussion: </strong>Our data suggest that the HPLC methods tested can be used for the majority of patients with elevated HbF. For patients with HbF levels above 10%, immunoassay and enzymatic methods appear to be unsuitable, and alternative HbA1c methods are still advised.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Laboratory medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/labmed/lmae109","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Fetal hemoglobin (HbF) is known to cause method-specific interference in glycated hemoglobin A1c (HbA1c) measurement. Data on HbF interference, however, is currently either lacking for some platforms (eg, the Abbott Core Laboratory Alinity c and Beckman Coulter AU5800) or available only for HbF levels lower than the maximum claimed by the manufacturer (eg, Bio-Rad D-100).
Methods: We examined the effect of HbF interference on 7 HbA1c platforms using a series of spiked adult whole blood samples with increasing HbF levels (0% to 35%) and either low (approximately 5%) or high (approximately 9%) HbA1c levels, using isotope dilution mass spectrometry as a reference measurement procedure.
Results: For the high-performance liquid chromatography (HPLC)-based platforms (Bio-Rad VARIANT II TURBO 2.0 and D-100), relative deviation from expected values was not clinically significant, even at an HbF level of 35%. In contrast, immunoassay (AU5800; Roche Diagnostics cobas c311 and cobas b101; and Siemens Healthineers DCA Vantage) and enzymatic (Alinity c) methods showed clinically significant deviation at HbF levels above 10%.
Discussion: Our data suggest that the HPLC methods tested can be used for the majority of patients with elevated HbF. For patients with HbF levels above 10%, immunoassay and enzymatic methods appear to be unsuitable, and alternative HbA1c methods are still advised.