Technical Method
Evaluation of a novel HIV-1 DNA reagent in clinical application
Long Li, Cong Du, Fangning Zhao, Bin Xu, Minna Zheng, Zongna Li, Ning Zhou, Hui Gong, Yan Guo, Shaohui Cheng, Maohe Yu
Published 2018-12-30
Cite as Chinese J Exp Clin Virol, 2018, 32(6): 646-649. DOI: 10.3760/cma.j.issn.1003-9279.2018.06.019
Abstract
ObjectiveTo evaluate the clinical application of a novel HIV-1 DNA reagent.
MethodsHIV-1-infected and non-infected human blood samples were selected, as well as weakly positive samples, indeterminate samples, specific samples. Compared the result of HIV-1 DNA reagent with HIV-1 infection status (refer to the National Guideline for Detection of HIV/AIDS (2015)), the accuracy of the HIV-1 DNA reagent was evaluated in clinical application; Meanwhile, the commercially available RNA quantification kit was selected as reference reagent for parallel detection, and then the consistency and differences were evaluated between HIV-1 DNA reagent and RNA quantification reagent.
ResultsA total of 95 whole blood samples were tested by the HIV-1 DNA reagent. Taking the HIV-1 infection status as the reference standard, the result showed that the positive agreement rate was 100% (95%CI: 93.94%-100%), the negative agreement rate was 100% (95%CI: 90.26%-100%), and the overall agreement rate was 100% (95%CI: 96.19%-100%). The Kappa value was 1 (95%CI: 1.00-1.00). The HIV-1 DNA reagent could detect weakly positive samples and indeterminate samples of early infection, and could effectively distinguish false-positive samples tested by the Ag-Ab reagent. The specific samples had no false-positive result .
ConclusionsThe result of HIV-1 DNA reagent were consistent with the HIV-1 infection status. It can be considered as equivalent to the HIV-1 detection reagent commercially available in our country. It can effectively identify the indeterminate samples in the early infection. Compared with the RNA quantification reagent, it can effectively detect HIV-1 DNA of virus reservoirs.
Key words:
HIV-1 DNA; Indeterminate; Virus reservoirs; RNA quantification
Contributor Information
Long Li
Department for AIDS/STD Control and Prevention, Tianjin Centers for Disease Control and Prevention, Tianjin 300011, China
Cong Du
Genetic Biotech Company, Tianjin 300400, China
Fangning Zhao
Department for AIDS/STD Control and Prevention, Tianjin Centers for Disease Control and Prevention, Tianjin 300011, China
Bin Xu
Genetic Biotech Company, Tianjin 300400, China
Minna Zheng
Department for AIDS/STD Control and Prevention, Tianjin Centers for Disease Control and Prevention, Tianjin 300011, China
Zongna Li
Genetic Biotech Company, Tianjin 300400, China
Ning Zhou
Department for AIDS/STD Control and Prevention, Tianjin Centers for Disease Control and Prevention, Tianjin 300011, China
Hui Gong
Department for AIDS/STD Control and Prevention, Tianjin Centers for Disease Control and Prevention, Tianjin 300011, China
Yan Guo
Department for AIDS/STD Control and Prevention, Tianjin Centers for Disease Control and Prevention, Tianjin 300011, China
Shaohui Cheng
Department for AIDS/STD Control and Prevention, Tianjin Centers for Disease Control and Prevention, Tianjin 300011, China
Maohe Yu
Department for AIDS/STD Control and Prevention, Tianjin Centers for Disease Control and Prevention, Tianjin 300011, China
