评价糖化血红蛋白即时检验法和高效液相色谱法的一致性

Evaluation on consistency between glycosylated hemoglobin instant assay and high performance liquid chromatography

目的:评价糖化血红蛋白(HbAlc)即时检验法(POCT)与高效液相色谱法(HPLC)的一致性,探讨即时检验方法的可行性。方法:选取2015年6月-2017年3月我院内分泌科收治的300例糖尿病患者血液标本为研究对象,对其HbAlc水平同时进行POCT与HPLC两种方法测定,评价两种测定方法的一致性。结果:以HPLC法测定的HbAlc结果为依据进行分组:a组:HbAlc小于等于6.0%;b组:HbAlc6.0%-8.0%,c组:HbAlc8.0%-10.0%,d组:HbAlc大于10.0%,四组各自比较POCT与HPLC两种检测方法所得的HbAlc数值,差异均无统计学意义(P>0.05);两种测定方法之间存在良好相关性(P<0.05);Bland-Altman法对两种测定方法一致性进行分析,认为两种方法具有良好一致性。结论:POCT与HPLC两种检测方法法具有较好一致性,能满足临床需求。POCT法更为简洁方便可作为临床检测糖化血红蛋白的优先选择方法。

Objective： To evaluate the consistency of glycated hemoglobin（HbAlc） instant test（POCT） and high performance liquid chromatography（HPLC）, and to explore the feasibility of the immediate test method. Methods： The blood samples of 300 patients with diabetes mellitus admitted to our department of endocrine department from June 2015 to March 2017 were selected as the research subjects. The HbAlc levels were measured by POCT and HPLC simultaneously, and the consistency of the two methods was evaluated. Results： Grouping on the basis of HbAlc results measured by HPLC method： Group A： HbAlc ≤ 6.0%; Group B： HbAlc 6.0%-8.0%; Group C： HbAlc 8.0%-10.0%; Group D： HbAlc ≥ 10%. The HbAlc values obtained by POCT and HPLC were compared among the four groups, and there was no significant difference among the four groups（P〉0.05）. There was a good correlation between the two methods（P〈0.05）; The Bland-Altman method was used to analyze the consistency of the two methods, and it was concluded that the two methods had good consistency. Conclusion： The two detection methods of POCT and HPLC had good consistency and could meet the clinical needs. POCT was more simple and convenient and could be used as the preferred method for clinical detection of glycosylated hemoglobin（Hb A1 c）.