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.
ABSTRACT
Objective To compare the effects of TRIzol and magnetic beadsmethods on quantitative detection of hepatitis C virus (HCV) RNA. Methods Serum samples and genotype information of 117 patients with positive HCV infection were collected. HCV RNA was extracted from serum samples by TRIzol method and magnetic bead method, respectively. And then the viral load of HCV RNA was detected by quantitative PCR to compare the difference between the two methods. Results qPCRresults showed that a good linear correlation existed between TRIzol and magnetic beads methods: y=0. 978x+0. 063 (R2=0. 973). Bland-Altman statistical analysis showed that the average logarithmic value of viral load ofHCV RNA extracted by TRIzol method was slightly lower than that of magnetic beads method, without significant difference (P>0. 05). There were no significant difference among the genotypes 1a, 1b, 2a, 3a or 6a between the two methods (P>0. 05). Conclusion TRIzol method is comparable to magnetic beads method in HCV RNA quantitative detection, with less samplevolume and lower cost, indicating that t might be widely used for developing ktt and HCV RNA clinical detection in China.