【摘要】 目的 明确上海市HIV抗体确证不确定或阴性病例中可通过HIV-1核酸检测进行诊断的感染者规模，探讨常规化开展核酸检测对增加感染者发现的价值。方法 对上海市三家艾滋病检测确证实验室在HIV抗体确证检测中发现的136例不确定和210例阴性病例的检测余样(多来源分析)进行HIV-1核酸定量检测，结合样本来源进行分析；根据初步结果在某自愿咨询及检测点(VCT试点)开展HIV-1核酸检测工作试点，对抗体确证不确定和阴性样本进行HIV-1核酸定量检测、HIV-1 DNA定性检测，对可根据HIV-1病毒载量诊断的病例进行CD4~+T淋巴细胞检测。结果 2021年2月—2022年2月多来源样本的HIV-1核酸定量检测结果显示：136例确证不确定样本中，24例(17.7%)超过5 000 CPs/ml、2例(1.5%)检出但低于5 000 CPs/ml; 210例确证阴性样本中，4例(1.9%)超过5 000 CPs/ml。VCT来源的抗体不确定病例病毒载量高于检测限的比例(85.7%)高于此外来源。根据上述结果，在2022年1—9月某VCT开展试点：84例HIV抗体筛查有反应的样本中，70例确证阳性；14例确证不确定或阴性者中8例(57.1%)可由核酸检测诊断，占同期病例报告数的10.3%。结论 目前以HIV抗体确证为主要补充试验方法的框架下，有必要对确证不确定者进行HIV-1核酸检测。HIV-1核酸检测对VCT来源的HIV感染者发现有重要贡献，且包含核酸检测的工作流程在基层艾滋病确证实验室具有较强的可操作性。更多还原

【Abstract】 Objective To clarify the scale of people living with HIV who can be diagnosed by HIV-1 nucleic acid test among indeterminate or negative cases detected by antibody confirmatory test in Shanghai Municipality, and to explore the value of performing routine nucleic acid test in increasing the detection of infected individuals. Methods Quantitative HIV-1 nucleic acid tests were performed on remaining samples(multi-source analysis) of 136 indeterminate and 210 negative cases detected in three laboratories for HIV antibody confirmatory test in Shanghai Municipality, and analyses on the results and the sample sources were conducted. According to the preliminary results, a pilot study on HIV-1 nucleic acid test was performed at a HIV voluntary counseling and testing site(VCT site). Quantitative detection of HIV-1 nucleic acid and qualitative detection of HIV-1 DNA were carried out on samples with antibody confirmatory indeterminate and negative results, and CD4~+T lymphocytes of cases that could be diagnosed based on HIV-1 viral load were tested. Results From February 2021 to February 2022, HIV-1 nucleic acid quantitative tests were performed on samples from multi-sources. Of the HIV-1 viral loads of 136 confirmatory indeterminate samples, 24(17.7%) samples exceeded 5,000 CPs/ml and 2(1.5%) were detected but less than 5,000 CPs/ml. Of the HIV-1viral loads of 210 confirmatory negative samples, 4(1.9%) exceeded 5,000 CPs/ml. The proportion of antibody-indeterminate samples from VCT with detectable HIV-1 nucleic acid results(85.7%) was higher than that from other sources. According to the above-mentioned results, a VCT pilot study was carried out from January to September in 2022. Of the 84 HIV antibody screening reactive samples, 70 were confirmed positive. Eight(57.1%) of the 14 cases with indeterminate or negative results of antibody confirmatory test could be diagnosed through nucleic acid test, accounting for 10.3% of the cases reported in the same period． Conclusion Under the current framework that HIV antibody confirmatory test works as the dominant supplementary test method,it is necessary to perform HIV-1 nucleic acid test on those with indeterminate results in HIV antibody confirmatory test. HIV-1nucleic acid test makes an important contribution to the detection of HIV infected individuals at VCT sites, and the workflow that includes nucleic acid detection has a strong operability in grass-roots laboratories for HIV confirmatory test.更多还原