人类白细胞抗原组织配型基因分型国家参考品的协作标定  

Collaborative calibration of national reference for human leukocyte antigen tissue match typing

作　　者：胡泽斌[1] 孙彬裕[1] 刘湘 兰更欣 孙晶 于婷[1] 黄杰[1] HU Ze-bin;SUN Bin-yu;LIU Xiang;LAN Geng-xin;SUN Jing;YU Ting;HUANG Jie(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院体外诊断试剂检定所,北京100050 [2]北京博奥晶典生物技术有限公司,北京101111

出　　处：《中国生物制品学杂志》2021年第11期1330-1333,共4页Chinese Journal of Biologicals

基　　金：国家科技重大专项(2018ZX10732-401-003-009)。

摘　　要：目的对人类白细胞抗原(human leukocyte antigen,HLA)组织配型基因分型国家参考品进行协作标定。方法选择具有良好资质的4家实验室按统一的协作标定方案进行实验。采用PCR-SSO法、PCR-SBT测序法、NGS测序法对38支HLA组织配型基因分型国家参考品样本进行协作标定,NGS测序法及PCR-SBT测序法每个样本测定1次,PCR-SSO法每个样本测定3次。同时采用PCR-SBT测序法检测国际HLA质控盘(51份样本),进行实验的质量控制。结果4家协作单位对38支HLA组织配型基因分型国家参考品样本的HLA-A、B、C、DRB1、DQB1位点均能全部检出,5个位点的2或4位分辨率的分型结果均一致,最终选用4位高分辨率的分型结果作为国家参考品定值。51份国际HLA质控盘样本全部检出,且其HLA-A、B、C、DRB1、DQB1分型结果与IHWG公布结果一致。结论HLA组织配型基因分型国家参考品定值准确,可用于HLA-A、B、C、DRB1、DQB1分型检测试剂准确性的评价。Objective To collaboratively calibrate the national reference for human leukocyte antigen(HLA)tissue match typing.Methods Four laboratories with good qualification were selected to carry out the experiment according to the unified collaborative calibration scheme.PCR-SSO,PCR-SBT and NGS sequencing were used to calibrate 38 samples of the national reference.Each sample was determined by PCR-SBT sequencing and NGS sequencing for one time each,Meanwhile,the international HLA typing control panel(51 samples)was determined by PCR-SBT sequencing to control the quality of the experiment.Results All the HLA-A,B,C,DRB1 and DQB1 sites of 38 samples of the national reference were detected by four laboratories,and the typing results of the five sites at 2-bit and 4-bit resolutions were in agreement.Finally,4-bit high-resolution typing results were selected for the value of the national reference.All the typing results of HLA-A,B,C,DRB1 and DQB1 sites of 51 samples of international HLA typing control panel were consistent with those reported in IHWG.Conclusion The value of national reference for HLA tissue match typing is accurate,which may be used for the accuracy evaluation of HLA-A,HLA-B,HLA-C,HLA-DRB1,HLA-DQB1 gene typing detection reagents.

关 键 词：人类白细胞抗原 国家参考品 基因分型 协作标定 

分 类 号：R44[医药卫生—诊断学]