Beijing Key Laboratory for HIV/AIDS Research, Sino-French Joint Laboratory for HIV/AIDS Research, Clinical and Research Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing, 100069, China.
Department of Clinical Laboratory, Beijing Youan Hospital, Capital Medical University, Beijing, 100069, China.
BMC Infect Dis. 2024 Jun 15;24(1):587. doi: 10.1186/s12879-024-09486-8.
Early diagnosis of HIV infection decreases the time from HIV diagnosis to viral suppression and reduces further HIV transmission. The Chinese Guidelines for the Diagnosis and Treatment of HIV/AIDS (2021 edition) state that an HIV RNA level > 5,000 copies/mL is the threshold for diagnosing HIV infection. The impact of low viral load values on HIV diagnosis needs to be investigated.
There were 3455 human immunodeficiency virus (HIV1 + 2) antibody results (immunoblotting method) and 65,129 HIV viral load values at Beijing Youan Hospital from 2019 to 2022. A total of 2434 patients had both antibody confirmatory results and viral load results. The confirmatory antibody results and HIV viral load results of 2434 patients were analyzed to investigate the impact of low viral load values on HIV diagnosis.
Of the 2434 patients who had both confirmatory antibody results and viral load results, the viral load values of 140 patients (5.8%) had viral loads ranging from 40 copies/mL to 5,000 copies/mL before positive confirmatory antibody result, and of these 140 patients, the sample receipt time for the viral load tests of 96 (66.7%) individuals was 1 to 6 days earlier than the corresponding sample receipt time for the confirmatory antibody test. In addition, 34 patients (1.4%) had low viral loads ranging from 40 copies/mL to 1,000 copies/mL before positive confirmatory antibody result.
This study revealed that there is a risk of missed diagnosis if a threshold of 5000 copies/mL is used for the diagnosis of HIV infection. These data provide valuable information for the early diagnosis of HIV infection, and our findings have potential benefits for decreasing HIV transmission.
早期诊断 HIV 感染可减少从 HIV 诊断到病毒抑制的时间，并减少进一步的 HIV 传播。《中国艾滋病诊疗指南（2021 年版）》规定 HIV RNA 水平>5000 拷贝/mL 是诊断 HIV 感染的阈值。需要研究低病毒载量值对 HIV 诊断的影响。
2019 年至 2022 年，北京佑安医院共检测到 3455 例人类免疫缺陷病毒（HIV1+2）抗体结果（免疫印迹法）和 65129 例 HIV 病毒载量值。共有 2434 例患者同时具有抗体确证结果和病毒载量结果。分析 2434 例患者的确证抗体结果和 HIV 病毒载量结果，探讨低病毒载量值对 HIV 诊断的影响。
在 2434 例同时具有确证抗体结果和病毒载量结果的患者中，140 例（5.8%）患者的病毒载量在阳性确证抗体结果之前处于 40 拷贝/mL 至 5000 拷贝/mL 之间，其中 140 例患者的病毒载量检测样本接收时间比对应的抗体确证检测样本接收时间早 1 至 6 天。此外，34 例（1.4%）患者在阳性确证抗体结果之前有低病毒载量（40 拷贝/mL 至 1000 拷贝/mL）。
本研究表明，如果使用 5000 拷贝/mL 的阈值诊断 HIV 感染，存在漏诊的风险。这些数据为 HIV 感染的早期诊断提供了有价值的信息，我们的发现可能有助于减少 HIV 的传播。
