摘要
患者女,11岁,因患重度β型地中海贫血于2022年7月27日在深圳市儿童医院接受细胞与基因治疗(CGT)。出院后2次随访检测均发现患者的HIV-1病毒抗原及抗体筛查实验(化学发光法)结果呈阳性,2次HIV-1核酸定量试验病毒载量结果均>5000拷贝/ml,按照《全国艾滋病检测技术规范(2020年修订版)》可判定为HIV/AIDS感染。但经深入调查与比对实验发现:该患者HIV-1核酸检测结果异常,系其CGT治疗过程中自体造血干祖细胞基因组整合的慢病毒载体片段与现用HIV-1核酸检测试剂盒检测靶位点存在交叉反应所致,提示在对接受过CGT的人群进行HIV-1核酸检测时,需根据其所用基因工程载体选择合适的、不会引起交叉反应的检测平台。同时建议设计开发专门用于HIV核酸补充试验的采用多靶点不同荧光标记的检测平台,以降低艾滋病病毒感染的假阳性诊断风险。
A 11-year old female patient with severe thalassemia,receipt a lentivirus-based cell and gene therapy(CGT)therapy in Shenzhen Children′s Hosptial on July 27th,2021.At the two follow-up visits after discharge,patient were continuously tested positive for HIV screening through HIV Ag/Ab Combo assay(chemiluminescence Immunoassay),and the viral load results of HIV-1 nucleic acid testing(NAT)were both>5000 copies/ml.The patient can be diagnosed with HIV infection according to the National Guideline for Detection of HIV/AIDS(2020 Revised Edition).The thorough investigation findings and supplementary experiment results indicated that the false-positive HIV-1 NAT results was caused by cross-reactivity between the target sites detected by conventional HIV-1 NAT reagents and the lentiviral vectors fragments integrated into the genome of patient′s hematopoietic stem/progenitor cells.In conclusion,it is important for laboratories to select appropriate HIV-1 NAT testing platforms which won′t cause cross-reactivity for the testing of samples from patients who have been treated with HIV-derived vectors.It is also recommended to design and develop NAT testing platforms with multiple target regions labeled by different fluorescents for HIV NAT supplementation experiment to reduce the risk of false-positive diagnoses of HIV infection.
作者
钟一帆
牛姬飞
李越
刘静
王晓辉
李浩
甘永霞
黎桂连
郑陈丽
李诚龙
蔡一凡
杨梓杰
谭唯
陈小珍
冯铁建
金聪
赵锦
Zhong Yifan;Niu Jifei;Li Yue;Liu Jing;Wang Xiaohui;Li Hao;Gan Yongxia;Li Guilian;Zheng Chenli;Li Chenglong;Cai Yifan;Yang Zijie;Tan Wei;Chen Xiaozhen;Feng Tiejian;Jin Cong;Zhao Jin(Shenzhen Center for Disease Control and Prevention,Shenzhen 518055,China;Futian District Center for Disease Control and Prevention,Shenzhen 518040,China;Hematological Oncology Department,Shenzhen Children′s Hosptial,Shenzhen 518034,China;National Center for AIDS/STD Control and Prevention,Beijing 102211,China;Preventive Care Department,Shenzhen Children′s Hosptial,Shenzhen 518034,China)
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2024年第4期451-454,共4页
Chinese Journal of Laboratory Medicine
基金
国家自然科学基金(82373651)
深圳市医疗卫生三名工程(SZSM202311015)
深圳市医学重点学科建设经费(SZXK064)。
