应用国际间能力验证实验结果设立HLA抗体判定界限值及临床应用  

Using experimental results of international proficiency testing for establishing the decision limit value of mean fluorescent intensity of anti-human leukocyte antigen antibody and its clinical application

作　　者：陈璐瑶[1] 袁晓妮[1] 鲍晓晶[1] 李杨[1] 张腾腾[1] 杨天杰[1] 姜雪 何军[1] Chen Luyao;Yuan Xiaoni;Bao Xiaojing;Li Yang;Zhang Tengteng;Yang Tianjie;Jiang Xue;He Jun(HLA Laboratory of Jiangsu Institute of Hematology,First Affiliated Hospital of Soochow University,Suzhou 215031,China)

机构地区：[1]苏州大学附属第一医院江苏省血液研究所HLA配型实验室,苏州215031

出　　处：《中华器官移植杂志》2021年第8期468-474,共7页Chinese Journal of Organ Transplantation

基　　金：国家自然科学基金(82070180);江苏省医学创新团队与领军人才项目(CXTDB2017009);江苏省社会发展重点项目临床前沿技术(BE2019656)。

摘　　要：目的通过美国组织相容性和免疫遗传学委员会(ASHI)组织的国际间能力验证(PT)结果,设立抗人类白细胞抗原(HLA)抗体的判定界限值。方法在液相芯片(Luminex)技术平台采用Single Antigen试剂检测HLA抗体,回顾分析2012年至2019年间江苏省血液研究所HLA配型实验室参加ASHI组织的11次共55个质控样本的HLA抗体PT结果。结果在79种HLA-Ⅰ类抗体中检测到HLA-A、B、Cw抗体21、43、15种类型;44种HLA-Ⅱ类抗体中检测到HLA-DRB1、DQB1、DPB1抗体18、7、19种类型。分析每个质控样本中本实验室上报的所有HLA抗体的中位荧光强度(MFI)值,以及ASHI汇总的同期多中心对该特异性抗体判断其阴/阳性结果的符合率,并以95%、90%、80%、79%~50%、<50%的符合率范围,将MFI值由高到低排列成HLA抗体可能饱和度值、阳性决定值、阳性判定界限值、可疑阳性参考值及可疑阴性参考值的区间,建立了本实验室HLA抗体的判定界限值表,其中42种HLA-Ⅰ类、Ⅱ类特异性抗体类型数据完整。当实验室检测HLA-Ⅰ类、Ⅱ类抗体的MFI值处于判定界限值表中80%及以上符合率时,可用于判断检测到HLA抗体。当HLA抗体的MFI值达到阳性决定值时可能对临床诊断及治疗有一定的指导意义。当抗体达到饱和值、处于可疑阳性或可疑阴性参考判定界限值时,可提示临床需要进行HLA抗体检测的动态随访。结论通过国际间PT的实验结果制定实验室HLA抗体的判定界限值,并对实验结果的判读及临床诊断和治疗均有参考价值,故移植中心应重视HLA抗体检测的室间比对质量控制工作。Objective Establish the decision threshold value of mean fluorescence intensity of anti-human leukocyte antigen(HLA)antibody through statistical analyzing the results of international proficiency testing(PT)organized by American Society for Histocompatibility and Immunogenetics(ASHI).Methods Single antigen reagent and liquid chip(Luminex)technique were used to detect anti-HLA antibody.A retrospective analysis of the HLA antibody PT results of 55 quality control samples from 11 times organized by ASHI from 2012 to 2019 was reviewed.Results Among 79 kinds of HLA-I antibodies,21,43 and 15 types of HLA-A,B and Cw antibodies were detected respectively,while among 44 kinds of HLA-Ⅱantibodies,18,7 and 19 types of HLA-DRB1,DQB1 and DPB1 antibodies were detected respectively.After analyzing the MFI detection value of different specific antibodies in each PT samples at our laboratory and the coincidence rate of the negative/positive results judged by ASHI through summarizing the results of multicenter participating in the same period,MFI values of HLA antibody were arranged from high to low into the intervals of possible saturation value,positive decision value,positive judgment threshold value,suspicious positive reference value and suspicious negative reference value,according to the coincidence rate of 95%,90%,80%,79%~50%and<50%.Thus,the decision limit value table of HLA specific antibody at our laboratory was established.And 42 kinds of HLA antibody types were detected with complete data.When the MFI values of various HLA-I or HLA-Ⅱantibodies are found to be 80%or more in the table,it can be used to judge the detection of HLA antibodies.When HLA antibody MFI value reaches the positive decision value,it may have a certain guiding significance for clinical diagnosis and treatment.And when antibody MFI value reaches the saturation value and lies in the suspicious positive or suspicious negative reference threshold,it just suggests that the clinical need for dynamic follow-up of anti-HLA antibody detection.Conclusions

关 键 词：人类白细胞抗原 抗体 阈值 

分 类 号：R446.6[医药卫生—诊断学]