Liang Wenli, Wang Jibao, Yan Hongxia, Zhang Xinhui, Li Dongmin, Duan Xing, Wu Hao, Wang Yinyin, Bai Li, Sun Jian, Han Mengjie, Wang Yikui, Su Bin, Wang Min, Xing Wenge, Zhang Cui, Qiao Ruijuan, Qiu Maofeng
National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
Department of AIDS/STD Control and Prevention, Dehong Center for Disease Control and Prevention, Mangshi County, Dehong Dai and Jingpo Autonomous Prefecture, Yunnan Province, China.
China CDC Wkly. 2024 Nov 29;6(48):1278-1282. doi: 10.46234/ccdcw2024.255.
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.
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.
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%.
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.
一种新型的基于重组抗原的捕获酶免疫测定法（RAg-CEIA）得到优化，并用于确定估计中国1型人类免疫缺陷病毒（HIV-1）发病率的技术参数。
我们采用正交实验设计，通过调整原材料稀释比例来优化RAg-CEIA。该测定法用于测量51名HIV-1血清转化个体的171份纵向血浆标本中的标准化光密度（ODn）值，并将其与估计的血清转化后天数作图。我们确定了区分近期感染和长期感染的最佳ODn阈值，并计算了近期感染的平均持续时间（MDRI）以进行发病率估计。使用481份感染持续时间超过MDRI两倍的HIV-1抗体阳性标本确定假近期感染率（FRR）。
确定了最佳的RAg-CEIA参数，校准品制备的原材料稀释比例为1/12，酶结合物效价为1:1200。ODn值在HIV-1血清转化个体中呈现出一致的时间性增加，尽管个体反应存在明显的动力学异质性。区分近期感染和长期感染的最佳ODn阈值为0.8，对应的MDRI为205天，FRR为4.78%。
优化后的RAg-CEIA在人群水平上能有效区分近期和长期的HIV-1感染，从而在中国实现可靠的HIV-1发病率估计。
