Introduction:A novel recombinant antigen-based capture enzyme immunoassay(RAg-CEIA)was optimized and used to determine technical parameters for estimating human immunodeficiency virus type 1(HIV-1)incidence in China.M...Introduction:A novel recombinant antigen-based capture enzyme immunoassay(RAg-CEIA)was optimized and used to determine technical parameters for estimating human immunodeficiency virus type 1(HIV-1)incidence in China.Methods:We employed orthogonal experimental design to optimize RAg-CEIA by adjusting raw material dilution ratios.The assay was used to measure normalized optical density(ODn)values in 171 longitudinal plasma specimens from 51 HIV-1 seroconverting individuals,plotted against estimated days post-seroconversion.We determined the optimal ODn threshold value for differentiating recent from long-term infections and calculated the mean duration of recent infection(MDRI)for incidence estimation.The false recent rate(FRR)was determined using 481 HIV-1 antibody-positive specimens with infection durations exceeding twice the MDRI.Results:Optimal RAg-CEIA parameters were established with a raw material dilution ratio of 1/12 for calibrator preparation and an enzyme conjugate titer of 1:1200.ODn values demonstrated consistent temporal increases across HIV-1 seroconverting individuals,though with notable kinetic heterogeneity in individual responses.The optimal ODn threshold value of 0.8 for distinguishing recent from long-term infections corresponded to an MDRI of 205 days and an FRR of 4.78%.Conclusions:The optimized RAg-CEIA effectively differentiates recent from long-term HIV-1 infections at the population level,enabling reliable HIV-1 incidence estimation in China.展开更多
基金Supported by the National Science and Technology Major Project of the 13th Five-year Plan(grants 2017ZX10201101-002-003 and 2018ZX10721102-003-002)。
文摘Introduction:A novel recombinant antigen-based capture enzyme immunoassay(RAg-CEIA)was optimized and used to determine technical parameters for estimating human immunodeficiency virus type 1(HIV-1)incidence in China.Methods:We employed orthogonal experimental design to optimize RAg-CEIA by adjusting raw material dilution ratios.The assay was used to measure normalized optical density(ODn)values in 171 longitudinal plasma specimens from 51 HIV-1 seroconverting individuals,plotted against estimated days post-seroconversion.We determined the optimal ODn threshold value for differentiating recent from long-term infections and calculated the mean duration of recent infection(MDRI)for incidence estimation.The false recent rate(FRR)was determined using 481 HIV-1 antibody-positive specimens with infection durations exceeding twice the MDRI.Results:Optimal RAg-CEIA parameters were established with a raw material dilution ratio of 1/12 for calibrator preparation and an enzyme conjugate titer of 1:1200.ODn values demonstrated consistent temporal increases across HIV-1 seroconverting individuals,though with notable kinetic heterogeneity in individual responses.The optimal ODn threshold value of 0.8 for distinguishing recent from long-term infections corresponded to an MDRI of 205 days and an FRR of 4.78%.Conclusions:The optimized RAg-CEIA effectively differentiates recent from long-term HIV-1 infections at the population level,enabling reliable HIV-1 incidence estimation in China.
