False-positive HIV-1 nucleic acid testing results in patients with severe thalassemia after receiving cell and gene therapy
10.3760/cma.j.cn114452-20231228-00380
- VernacularTitle:重度地中海贫血患者接受基因治疗后出现HIV-1核酸检测结果假阳性1例
- Author:
Yifan ZHONG
1
;
Jifei NIU
;
Yue LI
;
Jing LIU
;
Xiaohui WANG
;
Hao LI
;
Yongxia GAN
;
Guilian LI
;
Chenli ZHENG
;
Chenglong LI
;
Yifan CAI
;
Zijie YANG
;
Wei TAN
;
Xiaozhen CHEN
;
Tiejian FENG
;
Cong JIN
;
Jin ZHAO
Author Information
1. 深圳市疾病预防控制中心，深圳 518055
- Keywords:
HIV-1;
Lentiviral vector;
Gene therapy;
Nucleic acid testing
- From:
Chinese Journal of Laboratory Medicine
2024;47(4):451-454
- CountryChina
- Language:Chinese
-
Abstract:
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>5 000 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.
