A. Shlykova, D. Kireev, I. Lapovok, D. Saleeva, A. Pokrovskaya, A. Shemshura, P. V. Lebedev, L. V. Khoteleva, E. Strebkova, D.G. Khurtin, A. Spirin, O. Agafonova, A. Kirichenko, A. Lopatukhin, V. Pokrovskiy
{"title":"Effectiveness of the algorithm for detecting cases of recent HIV-1 infection in the Russian Federation","authors":"A. Shlykova, D. Kireev, I. Lapovok, D. Saleeva, A. Pokrovskaya, A. Shemshura, P. V. Lebedev, L. V. Khoteleva, E. Strebkova, D.G. Khurtin, A. Spirin, O. Agafonova, A. Kirichenko, A. Lopatukhin, V. Pokrovskiy","doi":"10.20953/1729-9225-2021-2-37-50","DOIUrl":null,"url":null,"abstract":"Objective. Accurate identification of recent HIV-1 infection cases will ensure a more effective and precise assessment of the dynamics of virus transmission, the time between infection and diagnosis, and the quality of screening and prevention programs. This study was undertaken to adjust the recent HIV-1 infection testing algorithm using a cohort of patients, in whom the time since infection was known. Materials and methods. We used blood plasma samples obtained from 264 HIV-infected patients with a known date of infection. All samples were analyzed using two serological assays aimed to differentiate between cases of recent and established HIV infection. Using the results of sequencing of the pol region, we calculated the proportion of variable positions in order to determine the duration of infection. To identify the cases of recent HIV infection, we evaluated different variants of a diagnostic algorithm that included a combination of serological tests, molecular genetic analysis of the viral genome, and other clinical and laboratory parameters. Results. The effectiveness of the DS-ELISA-HIV-AB-TERM (DS) assay for the detection of recent infection was higher than that of the Architect HIV Ag/Ab Combo assay (Abbott). The sensitivity and specificity of the DS assay were 94.4% and 96.7%, respectively. The sensitivity and specificity of the Abbott assay were 86.4% and 77,4%, respectively. The HIV-1 genome variability threshold of 0.33% allowed the differentiation between samples depending on the time since infection with a cut-off of 12 months: 82.1% of recent samples and 62.7% of established samples were correctly identified using this method. We analyzed the effectiveness of schemes of the algorithm for the detection of recent infection lasting no longer than 9 months. Conclusion. Our findings allow us to recommend the algorithm based on the Russian DS assay for the detection of recent HIV-1 cases in routine clinical practice. This algorithm will enable the detection of new HIV cases, thereby improving the disease control. Key words: HIV-1, HIV infection, genetic variability, time since infection, duration of infection, recent infection, early infection, seroconversion","PeriodicalId":37794,"journal":{"name":"Infektsionnye Bolezni","volume":"53 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Infektsionnye Bolezni","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.20953/1729-9225-2021-2-37-50","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
Abstract
Objective. Accurate identification of recent HIV-1 infection cases will ensure a more effective and precise assessment of the dynamics of virus transmission, the time between infection and diagnosis, and the quality of screening and prevention programs. This study was undertaken to adjust the recent HIV-1 infection testing algorithm using a cohort of patients, in whom the time since infection was known. Materials and methods. We used blood plasma samples obtained from 264 HIV-infected patients with a known date of infection. All samples were analyzed using two serological assays aimed to differentiate between cases of recent and established HIV infection. Using the results of sequencing of the pol region, we calculated the proportion of variable positions in order to determine the duration of infection. To identify the cases of recent HIV infection, we evaluated different variants of a diagnostic algorithm that included a combination of serological tests, molecular genetic analysis of the viral genome, and other clinical and laboratory parameters. Results. The effectiveness of the DS-ELISA-HIV-AB-TERM (DS) assay for the detection of recent infection was higher than that of the Architect HIV Ag/Ab Combo assay (Abbott). The sensitivity and specificity of the DS assay were 94.4% and 96.7%, respectively. The sensitivity and specificity of the Abbott assay were 86.4% and 77,4%, respectively. The HIV-1 genome variability threshold of 0.33% allowed the differentiation between samples depending on the time since infection with a cut-off of 12 months: 82.1% of recent samples and 62.7% of established samples were correctly identified using this method. We analyzed the effectiveness of schemes of the algorithm for the detection of recent infection lasting no longer than 9 months. Conclusion. Our findings allow us to recommend the algorithm based on the Russian DS assay for the detection of recent HIV-1 cases in routine clinical practice. This algorithm will enable the detection of new HIV cases, thereby improving the disease control. Key words: HIV-1, HIV infection, genetic variability, time since infection, duration of infection, recent infection, early infection, seroconversion
目标。准确识别最近的HIV-1感染病例将确保更有效和准确地评估病毒传播的动态、感染和诊断之间的时间以及筛查和预防方案的质量。本研究采用一组已知感染时间的患者,对最近的HIV-1感染检测算法进行了调整。材料和方法。我们使用了264名已知感染日期的hiv感染患者的血浆样本。所有样本均采用两种血清学分析方法进行分析,目的是区分新近和已确诊的HIV感染病例。利用pol区的测序结果,我们计算了可变位置的比例,以确定感染的持续时间。为了确定最近的HIV感染病例,我们评估了一种诊断算法的不同变体,该算法包括血清学测试、病毒基因组的分子遗传分析以及其他临床和实验室参数的组合。结果。DS- elisa -HIV- Ab - term (DS)检测近期感染的有效性高于Architect HIV Ag/Ab组合检测(Abbott)。DS检测的灵敏度和特异性分别为94.4%和96.7%。雅培法的敏感性为86.4%,特异性为77.4%。HIV-1基因组变异阈值为0.33%,允许根据感染后的时间区分样本,截止时间为12个月:使用这种方法正确识别了82.1%的新样本和62.7%的已建立样本。我们分析了该算法在检测最近感染持续时间不超过9个月的方案中的有效性。结论。我们的研究结果使我们能够推荐基于俄罗斯DS检测的算法用于常规临床实践中检测最近的HIV-1病例。该算法将能够发现新的HIV病例,从而改善疾病控制。关键词:HIV-1, HIV感染,遗传变异,感染时间,感染持续时间,近期感染,早期感染,血清转化
期刊介绍:
The journal publishes original research works, reviews of literature, lectures, methodological recommendations, clinical observations. Main topics: problems of etiology, pathogenesis, clinical manifestations of infectious diseases, new techniques and methods of their diagnosis, prevention and treatment; special attention is paid to the problems of antibacterial and antiviral therapy, the use of immunoglobulins and interferons, and also to intensive therapy of critical states. The journal is in the List of leading scientific journals and periodicals of the Supreme Attestation Committee, where the principal results of doctoral dissertations should be published.