应用间接法建立北京地区健康成人HPLC法测定血清维生素B1与B2水平的参考区间

Reference Interval of the Determination of Serum Vitamin B1 and B2 Levels Established by An Indirect Method of HPLC in Healthy Adults in Beijing

目的建立北京地区健康人群采用高效液相色谱法(high performance liquid chromatography,HPLC)检测血清中维生素B1与B2的参考值范围,为临床诊断提供参考依据。方法采用回顾性研究,收集2019年1月~2021年12月北京和合医学检验所5563例维生素B1与5476例维生素B2常规体检结果,受试者按性别、年龄分组,妊娠期女性分开统计,使用Z检验来确定各组数据有无显著差异,后根据改进的霍夫曼方法估算血清中维生素B1与B2的参考区间,并选取2022年1~3月北京和合医学检验所18~60周岁体检人群作为验证人群,将检测值与建立的参考区间进行比较,对其适用性进行验证。结果不同年龄、性别成年人血清中维生素B1与B2水平没有显著差异[Z<Z^(*)并且s_(2)/(s_(2)-s_(1))>3],妊娠期也没有明显变化,可以合并建立参考区间。血清中维生素B1的参考区间为5~23 nmol/L,维生素B2的参考区间为3.0~24.0 ng/ml。参考区间验证符合率≥91.2%,适用性良好。结论建立了北京地区健康成人血清中维生素B1与B2的参考区间,可以为临床测定维生素B1与B2的含量提供参考。

Objective Establishing of the reference value range for the high performance liquid chromatography(HPLC)method determination of serum vitamin B1 and vitamin B2 detection in healthy people in Beijing area,and provide reference for clinical diagnosis.Methods From January 2019 and December 2021,5563 vitamin B1 and 5476 vitamin B2 routine results from existing laboratory data were collected.Subjects were sub-grouped according to sex and age,pregnant women were counted separately among women.The Z test was used to determine whether the data between groups were significantly different.The reference intervals of vitamin B1 and vitamin B2 were established according to the improved Hoffmann method.Selected 18~60 years old physical examination population of Beijing Harmony Health Medical Laboratory from January to March 2022 as the verification population,compared the detection value with the reference interval of this study to verify its applicability.Results There were no significant differences in serum vitamin B1 and vitamin B2 levels among adults of different ages and genders[Z<Z^(*) with s_(2)/(s_(2)-s_(1))>3]and no significant change during pregnancy.The reference interval for vitamin B1 in serum was 5~23 nmol/L,and the reference interval for vitamin B2 was 3.0~24.0 ng/ml.The verification compliance rate of the reference interval was up to 91.2%,and the applicability was good.Conclusion The reference intervals of vitamin B1 and vitamin B2 in serum of healthy adults in Beijing area were established.It can provide reference for the clinical determination of vitamin B1 and vitamin B2 content.