ABSTRACT
Objective@#To evaluate the clinical application of a novel HIV-1 DNA reagent.@*Methods@#HIV-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.@*Results@#A 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 .@*Conclusions@#The 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.