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Background <p>Early diagnosis is critical for the prompt initiation of antiretroviral therapy (ART) and the prevention of secondary HIV transmission. China’s diagnostic guidelines recently lowered the viral load (VL) threshold from 5,000 to 1,000 copies/mL. However, under the current Western blot (WB)-based confirmation system, the diagnostic significance of VL &lt; 1,000 copies/mL during acute HIV infection (AHI) remains unclear. This study aimed to assess the impact of low VL on AHI diagnosis.</p> Methods <p>This study utilized data from the Beijing PRIMO prospective cohort conducted between 2006 and 2013, enrolling 347 individuals at high risk for HIV infection. HIV RNA levels were tested every two months to screen for acute HIV-1 infection. By analyzing the association between VL and confirmatory WB antibody results among the 347 participants in the PRIMO cohort, we aimed to assess the diagnostic utility of low VL levels in identifying AHI. In addition, the characteristics of the CD4/CD8 T-cell ratio were evaluated.</p> Results <p> <?tk 2?>Among the 347 participants in the Beijing PRIMO cohort, 4 cases (1.15%) had VL &lt; 1,000 copies/mL prior to obtaining a confirmed positive antibody result, with 3 of these cases showing a transition from indeterminate to positive WB results. The longest interval observed between a VL &lt; 1,000 copies/mL and a subsequent positive WB result was 42 days. Additionally, 12 participants had at least one VL measurement between 1,000 and 5,000 copies/mL before confirmation of WB positivity. Among 112 participants with available CD4/CD8 T-cell ratio data from the time of, or prior to, confirmed WB positivity, 109 (97.3%) exhibited a CD4/CD8 T-cell ratio of &lt; 1.0.</p> Conclusion <p>Lowering the VL threshold to 1,000 copies/mL can reduce missed diagnoses; however, VL &lt; 1,000 copies/mL during AHI may still delay diagnosis under the WB-based system. Nucleic acid testing (NAT) should be prioritized for individuals with high-risk profiles and negative or indeterminate antibodies to shorten the diagnostic window and enable earlier ART initiation. These findings provide real-world evidence supporting recent guideline changes and underscore the diagnostic challenges posed by low VL. The study also supports broader NAT adoption to enhance early detection and reduce AHI underdiagnosis.</p>

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The performance of low HIV viral load values for the diagnosis of acute HIV infection in the Beijing PRIMO cohort

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月10日

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  • Fei Zhao,
  • Li Li,
  • Defu Yuan,
  • Xizhao An,
  • Xiaoxue Tian,
  • Bei Wang,
  • Hao Wu,
  • Tong Zhang,
  • Lifeng Liu,
  • Bin Su

摘要

Background

Early diagnosis is critical for the prompt initiation of antiretroviral therapy (ART) and the prevention of secondary HIV transmission. China’s diagnostic guidelines recently lowered the viral load (VL) threshold from 5,000 to 1,000 copies/mL. However, under the current Western blot (WB)-based confirmation system, the diagnostic significance of VL < 1,000 copies/mL during acute HIV infection (AHI) remains unclear. This study aimed to assess the impact of low VL on AHI diagnosis.

Methods

This study utilized data from the Beijing PRIMO prospective cohort conducted between 2006 and 2013, enrolling 347 individuals at high risk for HIV infection. HIV RNA levels were tested every two months to screen for acute HIV-1 infection. By analyzing the association between VL and confirmatory WB antibody results among the 347 participants in the PRIMO cohort, we aimed to assess the diagnostic utility of low VL levels in identifying AHI. In addition, the characteristics of the CD4/CD8 T-cell ratio were evaluated.

Results

Among the 347 participants in the Beijing PRIMO cohort, 4 cases (1.15%) had VL < 1,000 copies/mL prior to obtaining a confirmed positive antibody result, with 3 of these cases showing a transition from indeterminate to positive WB results. The longest interval observed between a VL < 1,000 copies/mL and a subsequent positive WB result was 42 days. Additionally, 12 participants had at least one VL measurement between 1,000 and 5,000 copies/mL before confirmation of WB positivity. Among 112 participants with available CD4/CD8 T-cell ratio data from the time of, or prior to, confirmed WB positivity, 109 (97.3%) exhibited a CD4/CD8 T-cell ratio of < 1.0.

Conclusion

Lowering the VL threshold to 1,000 copies/mL can reduce missed diagnoses; however, VL < 1,000 copies/mL during AHI may still delay diagnosis under the WB-based system. Nucleic acid testing (NAT) should be prioritized for individuals with high-risk profiles and negative or indeterminate antibodies to shorten the diagnostic window and enable earlier ART initiation. These findings provide real-world evidence supporting recent guideline changes and underscore the diagnostic challenges posed by low VL. The study also supports broader NAT adoption to enhance early detection and reduce AHI underdiagnosis.