| 唐夕佳,段蕾静,梁雯丽,程思,董婷丽,解祯,刘康迈,于飞,陈子煌,米国栋,梁良,闫红静,陈琳,林丽,康殿民,付笑冰,邱茂锋,江震,徐杰,吴尊友.采用限制性抗原亲和力酶联免疫法估算男男性行为人群HIV-1新发感染率的研究[J].中华流行病学杂志,2022,43(1):72-77 |
| 采用限制性抗原亲和力酶联免疫法估算男男性行为人群HIV-1新发感染率的研究 |
| Application of limiting antigen avidity enzyme immunoassay for estimating HIV-1 incidence in men who have sex with men |
| 收稿日期:2021-06-09 出版日期:2022-01-26 |
| DOI：10.3760/cma.j.cn112338-20210609-00463 |
| 中文关键词: 限制性抗原亲和力酶联免疫法 HIV-1新发感染率 男男性行为人群 |
| 英文关键词: LAg-Avidity EIA Incidence HIV-1 infection Men who have sex with men |
| 基金项目:国家科技重大专项（2018ZX10721102-003） |
| 作者 | 单位 | E-mail | | 唐夕佳 | 中国疾病预防控制中心性病艾滋病预防控制中心宣传教育干预室, 北京 102206 | | | 段蕾静 | 中国疾病预防控制中心性病艾滋病预防控制中心参比实验室, 北京 102206 | | | 梁雯丽 | 中国疾病预防控制中心性病艾滋病预防控制中心参比实验室, 北京 102206 | | | 程思 | 中国疾病预防控制中心性病艾滋病预防控制中心宣传教育干预室, 北京 102206 | | | 董婷丽 | 中国疾病预防控制中心性病艾滋病预防控制中心宣传教育干预室, 北京 102206 | | | 解祯 | 中国疾病预防控制中心性病艾滋病预防控制中心宣传教育干预室, 北京 102206 | | | 刘康迈 | 中国疾病预防控制中心性病艾滋病预防控制中心宣传教育干预室, 北京 102206 | | | 于飞 | 淡蓝(北京)传媒有限公司, 北京 100020 | | | 陈子煌 | 淡蓝(北京)传媒有限公司, 北京 100020 | | | 米国栋 | 淡蓝(北京)传媒有限公司, 北京 100020 | | | 梁良 | 河北省疾病预防控制中心, 石家庄 050021 | | | 闫红静 | 江苏省疾病预防控制中心, 南京 210009 | | | 陈琳 | 浙江省疾病预防控制中心, 杭州 310051 | | | 林丽 | 福建省疾病预防控制中心, 福州 350001 | | | 康殿民 | 山东省疾病预防控制中心, 济南 250014 | | | 付笑冰 | 广东省疾病预防控制中心, 广州 511430 | | | 邱茂锋 | 中国疾病预防控制中心性病艾滋病预防控制中心参比实验室, 北京 102206 | | | 江震 | 中国疾病预防控制中心性病艾滋病预防控制中心宣传教育干预室, 北京 102206 | jiangzhen@chinaaids.cn | | 徐杰 | 中国疾病预防控制中心性病艾滋病预防控制中心宣传教育干预室, 北京 102206 | | | 吴尊友 | 中国疾病预防控制中心性病艾滋病预防控制中心宣传教育干预室, 北京 102206 | |
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| 中文摘要: |
| 目的 采用限制性抗原亲和力酶联免疫法（LAg-Avidity EIA）估算我国重点地区男男性行为人群（MSM）的HIV-1新发感染率，分析估算结果的偏差及影响因素，为提高估算结果准确性提供参考依据。方法 采用群组随机化社区干预对照研究设计，根据人口规模及MSM中HIV感染者数选择20个城市作为研究现场；基于MSM中HIV-1感染率（7%），估算样本量共700例（各城市HIV-1新发感染者35人）。通过MSM手机社交软件，建立检测预约和问卷填写系统，于2019年4-11月开展基线横断面调查并对符合新发感染检测条件的样本进行LAg-Avidity EIA检测；将试验所得参数代入WHO指南中估算公式，得到MSM的HIV-1新发感染率，根据实际情况对结果进行校正。同时梳理样本收集及检测流程，分析影响新发感染率的因素。结果 研究对象完成HIV-1初筛10 650例中，阳性反应799例，样本缺失198例。实际送检621例，排除误报样本后，完成LAg-Avidity EIA检测520例，其中判定为HIV-1新发感染155例。20个城市MSM的HIV-1新发感染率为4.06%（95%CI：3.27%~4.85%）；校正样本缺失后，HIV-1新发感染率为5.53%（95%CI：4.45%~6.60%）；同时校正缺失及误报情况后，HIV-1新发感染率为5.66%（95%CI：4.67%~6.65%）。20个城市MSM的HIV-1新发感染率实际值为4.06%~5.66%。结论 样本缺失及误报可能导致HIV-1新发感染率的估算偏差。确保样本均来源于调查人群并对样本收集及检测各环节进行严格质控，可减小HIV-1新发感染率的估算偏差。 |
| 英文摘要: |
| Objective To estimate the incidence of HIV-1 infection in men who have sex with men (MSM) in key areas of China through HIV-1 limiting antigen avidity enzyme immunoassay (LAg-Avidity EIA), analyze the deviation from the actual results and identify influencing factors, and provided reference for improving the accuracy of estimation results.Methods Based on the principle of the cohort randomized study design, 20 cities were selected in China based on population size and the number of HIV-positive MSM. The sample size was estimated to be 700 according to the HIV-1 infection rate in MSM. MSM mobile phone app. was used to establish a detection appointment and questionnaire system, and the baseline cross-sectional survey was conducted from April to November 2019. LAg-Avidity EIA was used to identify the recent infected samples. The incidence of HIV-1 infection was calculated and then adjusted based on the estimation formula designed by WHO. The influencing factors were identified by analyzing the sample collection and detection processes.Results Among the 10 650 blood samples from the participants, 799 were HIV-positive in initial screening, in which 198 samples (24.78%) missed during confirmation test. Only 621 samples were received by the laboratory. After excluding misreported samples, 520 samples were qualified for testing. A total of 155 samples were eventually determined as recent infection through LAg-Avidity EIA; Based on the estimation formula, the incidence of HIV-1 infection in MSM in 20 cities was 4.06% (95%CI: 3.27%-4.85%), it increased to 5.53% (95%CI: 4.45%-6.60%)after the adjusting for sample missing rate. When the sample missing rate and misreporting rate were both adjusted, the incidence of HIV-1 infection in the MSM increased to 5.66% (95%CI: 4.67%-6.65%). The actual incidence of HIV-1 infection in MSM in the 20 cities might be between 4.06% and 5.66%.Conclusions Sample missing and misreporting might cause the deviation of the estimation of HIV-1 infection incidence. It is important to ensure the sample source and the quality of sample collection and detection to reduce the deviation in the estimation of HIV-1 infection incidence. |
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