同型半胱氨酸室内质控物互换性研究  

The Evaluation of the Commutability of Quality Control Materials of the Homocysteine

作　　者：王尉 李虎金 卢楠 孙继云[2] 王雅杰 凌云 WANG Wei;LI Hujin;LU Nan;SUN Jiyun;WANG Yajie;LING Yun(Department of Blood Transfusion,Beijing Ditan Hospital,Capital Medical University,Beijing 100015,China;Department of Clinical Laboratory,Beijing Ditan Hospital,Capital Medical University,Beijing 100015,China)

机构地区：[1]首都医科大学附属北京地坛医院输血科,北京100015 [2]首都医科大学附属北京地坛医院检验科,北京100015

出　　处：《标记免疫分析与临床》2020年第11期1986-1989,共4页Labeled Immunoassays and Clinical Medicine

基　　金：首都医科大学附属北京地坛医院科研基金“启航计划”(编号:DTQH201807)。

摘　　要：目的评价自制人血清基质同型半胱氨酸(Hcy)室内质控物在四个检测系统上使用的互换性。方法依据美国临床实验室标准化协会(CLSI)EP14-A2评价方案,采用实验室常规方法的四种测定系统测定20个新鲜血清和自制人血清基质Hcy室内质控物,评价质控物的互换性。结果3个水平人血清基质Hcy室内质控物均落在4种临床常规使用检测系统分别构建的线性回归方程的95%预测区间内,均呈现良好的互换性。结论本实验室自制人血清基质Hcy质控物互换性良好,相对于目前商用质控品,具有广泛的应用前景和临床实用价值。Objective To evaluate the commutability of homocysteine(Hcy)internal quality control among four systems.Methods According to the Clinical and Laboratory Standardization Institute(CLSI)EP14-A2,20 fresh serum and self-made human serum matrix Hcy internal quality controls were determined by four determination systems of laboratory routine methods,and the commutability of quality control substances was evaluated.Results The three human serum matrix Hcy internal quality controls were all within the 95%prediction range of the linear regression equations constructed by the three clinical routine detection systems,suggesting a good commutability.Conclusion The quality control of human serum matrix Hcy made in this laboratory can be used as an indoor quality control or supplement in the laboratory,which can be used to effectively control the routine detection methods in clinical laboratory and improve the quality of laboratory Hcy test results.

关 键 词：室内质控物 互换性 同型半胱氨酸 

分 类 号：R-331[医药卫生]