Takenori Nitta1, Yasuhiro Yamashiro2, Yukio Hattori2, Tomoko Ezumi3, Mituaki Nishioka3, Junji Nakamura3. 1. Department of Health Science, Yamaguchi University Graduate School of Medicine, Ube, Japan s002ur@yamaguchi-u.ac.jp. 2. Department of Health Science, Yamaguchi University Graduate School of Medicine, Ube, Japan. 3. Department of Clinical Laboratory, Yamaguchi University Hospital, Ube, Japan.
Abstract
BACKGROUND: High performance liquid chromatography and immunological and enzymatic methods are known as the methods for HbA1c measurement. However, the differences in the principles of the methods may cause slight discrepancies, which become problems especially in the regions where hemoglobinopathies that have high HbF concentrations are commonly seen. In this report, we discuss the effect of HbF on the HbA1c measurement by the enzymatic method (BM Test HbA1c) which can be applied to automatic analyzer of high sample throughput. METHODS: Thirty-five samples (HbF concentration: between 1.4 and 90.1%) and 68 samples (HbF concentration: <1.0%) were analyzed by high performance liquid chromatography (Tosoh G8) and BM Test HbA1c. The results by BM Test HbA1c were compared with those by the high performance liquid chromatography and International Federation of Clinical Chemistry reference method. RESULTS: The high and positive correlation coefficient was demonstrated between the enzymatic and International Federation of Clinical Chemistry methods for the samples with normal HbF concentration. The samples with high HbF concentration exhibited high and positive correlation coefficient, although the figure is lower than that of the normal HbF concentration group. CONCLUSIONS: BM Test HbA1c revealed a high and positive correlation with high performance liquid chromatography and International Federation of Clinical Chemistry reference methods. However, the HbA1c values by BM Test HbA1c and high performance liquid chromatography method were lower than those by International Federation of Clinical Chemistry reference method when the HbF concentration was high. BM Test HbA1c had some deviation from the International Federation of Clinical Chemistry reference method, while no significant interference was seen when the HbF values were less than 15%. When HbF is higher than 15%, however, the interpretation of HbA1c by BM Test may require some special consideration.
BACKGROUND: High performance liquid chromatography and immunological and enzymatic methods are known as the methods for HbA1c measurement. However, the differences in the principles of the methods may cause slight discrepancies, which become problems especially in the regions where hemoglobinopathies that have high HbF concentrations are commonly seen. In this report, we discuss the effect of HbF on the HbA1c measurement by the enzymatic method (BM Test HbA1c) which can be applied to automatic analyzer of high sample throughput. METHODS: Thirty-five samples (HbF concentration: between 1.4 and 90.1%) and 68 samples (HbF concentration: <1.0%) were analyzed by high performance liquid chromatography (Tosoh G8) and BM Test HbA1c. The results by BM Test HbA1c were compared with those by the high performance liquid chromatography and International Federation of Clinical Chemistry reference method. RESULTS: The high and positive correlation coefficient was demonstrated between the enzymatic and International Federation of Clinical Chemistry methods for the samples with normal HbF concentration. The samples with high HbF concentration exhibited high and positive correlation coefficient, although the figure is lower than that of the normal HbF concentration group. CONCLUSIONS: BM Test HbA1c revealed a high and positive correlation with high performance liquid chromatography and International Federation of Clinical Chemistry reference methods. However, the HbA1c values by BM Test HbA1c and high performance liquid chromatography method were lower than those by International Federation of Clinical Chemistry reference method when the HbF concentration was high. BM Test HbA1c had some deviation from the International Federation of Clinical Chemistry reference method, while no significant interference was seen when the HbF values were less than 15%. When HbF is higher than 15%, however, the interpretation of HbA1c by BM Test may require some special consideration.
Authors: María Zulema Chaila; Matías Viniegra; Juan José Gagliardino; Alfredo Martínez; María Gabriela Simesen de Bielke; Mauro Frusti; Luis Monaco; Pablo Salgado; Carlos Buso; Claudio Daniel Gonzalez; Víctor Francisco Commendatore Journal: J Diabetes Sci Technol Date: 2021-03-09