Department of Laboratory Medicine, Peking University Shenzhen Hospital, Shenzhen, Guangdong, China.
Department of Laboratory Medicine, Weifang People's Hospital, Weifang, Shandong, China.
Am J Clin Pathol. 2022 Jun 7;157(6):852-857. doi: 10.1093/ajcp/aqab196.
We aimed to evaluate the effects of hemoglobin (Hb) variants prevalent in China on HbA1c measurements and to identify them during HbA1c measurements.
We evaluated a cation-exchange high-performance liquid chromatography (HPLC) method (Bio-Rad D-100), a capillary electrophoresis (CE) method (Capillarys 3 TERA), an immunoassay (Cobas c501), and a boronate affinity method (Premier Hb9210, as a comparative method) for HbA1c measurements in the presence of Hb variants prevalent in China.
The Bio-Rad D-100 and Capillarys 3 TERA gave specific retention times and numeric migration positions for each Hb variant, respectively, showing excellent interindividual reproducibility. All methods showed statistically significant differences (P < .01) for several variants. Clinically significant effects were observed for the Bio-Rad D-100 (Hb New York and Hb J-Bangkok), Capillarys 3 TERA (Hb New York and Hb J-Bangkok), and Cobas c501 (Hb New York). Among 297 samples with Hb variants, there were 75 (25.3%) unacceptable results for Bio-Rad D-100, 28 (9.4%) for Capillarys 3 TERA, and 19 (6.4%) for Cobas c501 compared with the results from Premier Hb9210.
Some Hb variants prevalent in China affect HbA1c measurements. The HPLC retention time and CE migration position can aid in the presumptive identification of Hb variants.
评估在中国流行的血红蛋白(Hb)变体对 HbA1c 测量的影响,并在 HbA1c 测量过程中识别这些变体。
我们评估了阳离子交换高效液相色谱(HPLC)方法(Bio-Rad D-100)、毛细管电泳(CE)方法(Capillarys 3 TERA)、免疫测定法(Cobas c501)和硼酸亲和法(Premier Hb9210,作为比较方法)在存在中国流行的 Hb 变体时对 HbA1c 的测量。
Bio-Rad D-100 和 Capillarys 3 TERA 分别为每种 Hb 变体提供了特定的保留时间和数字迁移位置,显示出出色的个体间重现性。所有方法对几种变体均显示出统计学上的显著差异(P <.01)。Bio-Rad D-100(Hb New York 和 Hb J-Bangkok)、Capillarys 3 TERA(Hb New York 和 Hb J-Bangkok)和 Cobas c501(Hb New York)方法均观察到临床显著影响。在 297 个存在 Hb 变体的样本中,与 Premier Hb9210 的结果相比,Bio-Rad D-100 的不可接受结果为 75 个(25.3%),Capillarys 3 TERA 的为 28 个(9.4%),Cobas c501 的为 19 个(6.4%)。
在中国流行的一些 Hb 变体影响 HbA1c 的测量。HPLC 保留时间和 CE 迁移位置可辅助推定 Hb 变体的识别。