微生物改良法与电化学发光法检测血清叶酸的方法比较  

Comparative study of serum folate detection using improved microbial assay and electrochemiluminescence method

作　　者：孟莹 宋沁峰 张明轩 余洪钊 李宏田[1] 刘建蒙[1] 周玉博[1] Meng Ying;Song Qinfeng;Zhang Mingxuan;Yu Hongzhao;Li Hongtian;Liu Jianmeng;Zhou Yubo(Institute of Reproductive and Child Health/National Health Commission Key Laboratory of Reproductive Health/Department of Epidemiology and Biostatistics,School of Public Health,Peking University,Beijing100191,China)

机构地区：[1]北京大学生育健康研究所/国家卫生健康委员会生育健康重点实验室,北京大学公共卫生学院流行病与卫生统计学系,北京100191

出　　处：《中华检验医学杂志》2024年第11期1321-1325,共5页Chinese Journal of Laboratory Medicine

摘　　要：目的比较微生物改良法(IMA)和电化学发光法(ECL)检测血清叶酸的结果,探究两种方法检测结果的线性或非线性关系。方法本方法比较研究于2020年10月至2021年2月在国家卫生健康委生育健康重点实验室开展,应用IMA和ECL分别检测251份人血清样本叶酸浓度。根据叶酸浓度,叶酸营养状态分为充足(叶酸浓度≥13.5 nmol/L)、边缘性缺乏(6.8≤叶酸浓度<13.5 nmol/L)和缺乏(叶酸浓度<6.8 nmol/L)。采用Pearson相关和多元分式多项式模型评价两种方法检测结果的关系,以IMA为金标准计算ECL判定叶酸营养状态的敏感度。结果ECL和IMA法测得叶酸平均浓度分别为(19.8±8.2)nmol/L和(23.0±9.7)nmol/L,差异有统计学意义(t=11.593,P<0.001)。两种方法检测结果的Pearson相关系数r=0.894(P<0.001),但多元分式多项式模型提示二者存在非线性关联。当IMA测得叶酸≤9.1 nmol/L,r=0.070(P>0.05);当IMA测得叶酸>9.1 nmol/L,r=0.867(P<0.001);对于非溶血血清样本(n=221),r=0.902(P<0.001)。此外,ECL检出叶酸缺乏的敏感度仅为27.78%,检出叶酸不充足(缺乏和边缘性缺乏)的敏感度为93.33%。结论当叶酸水平>9.1 nmol/L时,ECL与IMA法的检测结果相关性强;但当叶酸水平偏低时,两者相关性较弱,提示ECL不适用于叶酸营养状况不良的人群。Objective To compare improved microbial assay(IMA)and electrochemiluminescence(ECL)for measuring serum folate,and to investigate the linear or non-linear correlation between the results of the two methods.Methods This comparative study was conducted in National Health Commission Key Laboratory of Reproductive Health from October 2020 to February 2021,in which the folate concentration of 251 serum samples were measured by IMA and ECL.According to the serum folate concentration,the folate status was divided into sufficient(≥13.5 nmol/L),marginal deficiency(6.8≤serum folate<13.5 nmol/L),and deficiency(<6.8 nmol/L).Pearson correlation analysis and multivariate fractional polynomial(MFP)model were used to evaluate the correlation between the results measured by the two methods.The sensitivity of ECL for detecting folate status were calculated based on the IMA results as the golden standard.Results The average folate concentrations in serum samples measured by ECL and IMA were(19.8±8.2)nmol/L and(23.0±9.7)nmol/L,respectively(P<0.001).The Pearson correlation coefficient(r)of the two methods was 0.894(P<0.001),yet the MFP model demonstrated non-linear correlation between the two methods.When the IMA results were≤9.1 nmol/L,the r was 0.070(P>0.05);when the IMA results were>9.1 nmol/L,the r was 0.867(P<0.001);for non-hemolytic serum samples(n=221),the r was 0.902(P<0.001).Additionally,the sensitivity of ECL detecting folate deficiency was 27.78%,and the sensitivity of ECL detecting folate insufficiency(deficiency and marginal deficiency)was 93.33%.Conclusion When folate concentrations was>9.1 nmol/L),the results of ECL and IMA were highly correlated;yet the correlation between the two methods was weak at lower folate concentrations,indicating that ECL was not applicable for serum folate measurement among folate insufficiency population.

关 键 词：叶酸 血清 微生物改良法 电化学发光法 方法比较 

分 类 号：R446.1[医药卫生—诊断学]