HbA1c levels measured by enzymatic assay during off-site health checkups are lower than those measured by on-site HPLC assay
Tóm tắt
HbA1c is widely used as a therapeutic target marker and as a diagnostic marker for diabetes mellitus. This has led to an increasing frequency of HbA1c measurements in current health checkups throughout Japan. In the present study, we compared the HbA1c levels measured by an enzymatic assay (EA-HbA1c) off-site during health checkups with the HbA1c levels measured by on-site ion-exchange high-performance liquid chromatography (HPLC; HPLC-HbA1c) in a hospital. A total of 96 individuals (53 males and 43 females; age, 68.9 ± 8.4 years old; 70 diabetic and 26 non-diabetic individuals) whose HbA1c levels were measured by both the methods listed above were included in the study. Since no HPLC-HbA1c levels were measured on the day of the health checkup, HPLC-HbA1c levels were estimated using HPLC-HbA1c levels measured before and after the health checkup. A significant correlation of HbA1c levels was observed between the two groups (R = 0.973; p < 0.001). However, EA-HbA1c levels measured off-site during health checkups are lower than estimated HPLC-HbA1c levels measured on-site (6.37 ± 0.75% vs. 6.69 ± 0.75%; p < 0.001). Since lower EA-HbA1c levels measured during health checkups, which diverged from on-site measurements, may lead to underestimating diabetes mellitus, accurate measurement of HbA1c is required irrespective of the measuring method. Further investigation of the cause of falsely low EA-HbA1c levels and the strategy for reconciling HbA1c to reflect plasma glucose accurately are warranted.
Tài liệu tham khảo
American Diabetes Association. Glycemic targets: standards of medical care in diabetes—2019. Diabetes Care. 2019;42(Suppl 1):S61–70.
Yonehara S, Inamura N, Fukuda M, Sugiyama K. Use of fructosyl peptide oxidase for HbA1c assay. J Diabetes Sci Technol. 2015;9:200–5.
NGSP. Harmonizing hemoglobin A1c testing. http://www.ngsp.org/.
Japan Medical Association. External quality control program. https://www.jmaqc.jp/.
Otabe S, Nakayama H, Ohki T, Soejima E, Tajiri Y, Yamada K. Haemoglobin variants may cause significant differences in haemoglobin A1c as measured by high-performance liquid chromatography and enzymatic methods in diabetic patients: a cross-sectional study. Ann Clin Biochem. 2017;54:432–7.
Kondou M. Introduction of enzymatic HbA1c assay reagent Metabo Lead® HbA1c for automated biochemistry analyzer. J Anal Bio-Sci. 2015;38:287–93.
Fujimoto K, Nakamura M, Tanide M, Hirai K, Inoue K. Performance evaluation of measuring HbA1c kit ‘Metabo Lead’ measured by enzymatic assay. J Clin Lab Inst Reag. 2013;36:525–32.
Miyashital T, Yamadate S, Nakayama T. Influence of the hemolysis in the HbAlc measurement which used the centrifugated erythrocyte layer for the sample. JJCLA. 2014;39:328–34.
Nakashima K, Nishizaki O, Andoh Y, Takei H, Itai A, Yoshida Y. Glycated hemoglobin in fractionated erythrocytes. Clin Chem. 1989;35:958–62.
Oikawa J, Nakamura K, Ukawa S, Kishi T, Nakamura A, Tamakoshi A. Influence of different methods for measuring HbA1c on health checkups in a rural town in Hokkaido, Japan. Diabetol Int. 2006;7:391–7.
Shimizu I, Kohzuma T, Koga M. A proposed glycemic control marker for the future: glycated albumin. J Lab Precis Med. 2019;4:23.
Cohen RM, Holmes YR, Chenier TC, et al. Discordance between A1C and fructosamine: evidence for a glycosylation gap and its relation to diabetic nephropathy. Diabetes Care. 2003;26:163–7.
Mukai N, Yasuda M, Ninomiya T, et al. Thresholds of various glycemic measures for diagnosing diabetes based on prevalence of retinopathy in community-dwelling Japanese subjects: the Hisayama Study. Cardiovasc Diabetol. 2014;13:45.
Mukai N, Ninomiya T, Hata J, et al. Hemoglobin A1c and glycated albumin are strongly associated with carotid atherosclerosis in community-dwelling Japanese subjects: the Hisayama Study. Cardiovasc Diabetol. 2015;14:84.