Progress in laboratory detection of acute human immunodeficiency virus infection_West China Medical Journal

Authors：

YANG Wenjuan ^1,2 , WEI Yinhao ¹ , WEI Bin ¹ ,  TAO Chuanmin ¹

1. Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;
2. Department of Laboratory Medicine, Panzhihua Central Hospital, Panzhihua, Sichuan 617067, P. R. China;

Corresponding author：

TAO Chuanmin, Email: taocm@scu.edu.cn

Keywords：

Acute human immunodeficiency virus infection; human immunodeficiency virus antibody; human immunodeficiency virus-1 nucleic acid detection

DOI：

10.7507/1002-0179.202104267

Video：

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Patients with acute human immunodeficiency virus (HIV) infection are the critical source of infection due to high viral load and strong transmission ability. The vast majority of patients in the acute infection stage have no or only mild clinical symptoms, and their screening and diagnosis often rely on laboratory tests. However, there are still some difficulties in early screening and detection for HIV infection due to the detection window period. In recent years, laboratory testing for acute HIV infection has made great progress. This article reviews the progress in laboratory testing of acute HIV infection, in order to provide a reference for follow-up related research.

Citation： YANG Wenjuan, WEI Yinhao, WEI Bin, TAO Chuanmin. Progress in laboratory detection of acute human immunodeficiency virus infection. West China Medical Journal, 2022, 37(1): 135-139. doi: 10.7507/1002-0179.202104267 Copy

1.	揣征然, 张云辉, 赵雅琳, 等. 全球及中国AIDS最新疫情概况. 传染病信息, 2020, 33(6): 501-503.
2.	Bao Y, Larney S, Peacock A, et al. Prevalence of HIV, HCV and HBV infection and sociodemographic characteristics of people who inject drugs in China: a systematic review and meta-analysis. Int J Drug Policy, 2019, 70: 87-93.
3.	Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med, 2011, 365(6): 493-505.
4.	Robb ML, Eller LA, Kibuuka H, et al. Prospective study of acute HIV-1 infection in adults in East Africa and Thailand. N Engl J Med, 2016, 374(22): 2120-2130.
5.	Yerly S, Hirschel B. Diagnosing acute HIV infection. Expert Rev Anti Infect Ther, 2012, 10(1): 31-41.
6.	中华医学会感染病学分会艾滋病丙型肝炎学组, 中国疾病预防控制中心. 中国艾滋病诊疗指南(2018年版). 中华内科杂志, 2018, 57(12): 867-884.
7.	European AIDS Clinical Society. EACS Guidelines 2021. (2021-10-26) [2022-01-01]. https://eacs.sanfordguide.com/.
8.	U. S. Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents Panel Members and Consultants. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. (2021-08-16) [2022-01-01]. https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines.
9.	Fiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS, 2003, 17(13): 1871-1879.
10.	Ananworanich J, Fletcher JL, Pinyakorn S, et al. A novel acute HIV infection staging system based on 4th generation immunoassay. Retrovirology, 2013, 10: 56.
11.	Pilcher CD, Joaki G, Hoffman IF, et al. Amplified transmission of HIV-1: comparison of HIV-1 concentrations in semen and blood during acute and chronic infection. AIDS, 2007, 21(13): 1723-1730.
12.	Morrison CS, Demers K, Kwok C, et al. Plasma and cervical viral loads among Ugandan and Zimbabwean women during acute and early HIV-1 infection. AIDS, 2010, 24(4): 573-582.
13.	Quinn TC, Wawer MJ, Sewankambo N, et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med, 2000, 342(13): 921-929.
14.	Miller WC, Rosenberg NE, Rutstein SE, et al. Role of acute and early HIV infection in the sexual transmission of HIV. Curr Opin HIV AIDS, 2010, 5(4): 277-282.
15.	Powers KA, Ghani AC, Miller WC, et al. The role of acute and early HIV infection in the spread of HIV and implications for transmission prevention strategies in Lilongwe, Malawi: a modelling study. Lancet, 2011, 378(9787): 256-268.
16.	Bellan SE, Dushoff J, Galvani AP, et al. Reassessment of HIV-1 acute phase infectivity: accounting for heterogeneity and study design with simulated cohorts. PLoS Med, 2015, 12(3): e1001801.
17.	中华人民共和国国家卫生健康委员会. 艾滋病和艾滋病病毒感染诊断. (2019-01-02)[2022-01-01]. http://www.nhc.gov.cn/wjw/s9491/201905/6430aa653728439c901a7340796e4723.shtml.
18.	Taylor D, Durigon M, Davis H, et al. Probability of a false-negative HIV antibody test result during the window period: a tool for pre- and post-test counselling. Int J STD AIDS, 2015, 26(4): 215-224.
19.	吴焱, 徐克沂, 王玉光, 等. 急性期/早期HIV-1感染的临床研究进展. 中国艾滋病性病, 2011, 17(3): 372-375.
20.	中国疾病预防控制中心. 全国艾滋病检测技术规范(2020修订版). (2020-05-18)[2022-01-01]. http://ncaids.chinacdc.cn/zxzx/zxdteff/202005/t20200518_216798.htm.
21.	周全华, 王越, 刘华, 等. 某国产人类免疫缺陷病毒1型核酸定量检测试剂的临床试验研究. 检验医学与临床, 2021, 18(5): 585-588.
22.	杨勇, 蒲伟, 罗小虎. 国产全自动HIV-1核酸定量检测试剂盒的性能评价. 检验医学, 2020, 35(2): 153-155.
23.	World Health Organization. WHO list of prequalified in vitro diagnostic products. (2020-10-13)[2022-01-01]. https://www.who.int/diagnostics_laboratory/evaluations/201013_prequalified_product_list.pdf.
24.	Gray ER, Bain R, Varsaneux O, et al. P24 revisited: a landscape review of antigen detection for early HIV diagnosis. AIDS, 2018, 32(15): 2089-2102.
25.	Fatin MF, Ruslinda AR, Md Arshad MK, et al. HIV-1 tat biosensor: current development and trends for early detection strategies. Biosens Bioelectron, 2016, 78: 358-366.
26.	Caglayan MO, Üstündağ Z. Spectrophotometric ellipsometry based Tat-protein RNA-aptasensor for HIV-1 diagnosis. Spectrochim Acta A Mol Biomol Spectrosc, 2020, 227: 117748.
27.	Li HY, Jia WN, Li XY, et al. Advances in detection of infectious agents by aptamer-based technologies. Emerg Microbes Infect, 2020, 9(1): 1671-1681.
28.	詹少兵, 张晓光, 李红霞, 等. 筛选HIV-1 P24蛋白适配子的一种简便的SELEX方法. 中华实验和临床病毒学杂志, 2013, 27(3): 218-220.
29.	Yamamoto R, Katahira M, Nishikawa S, et al. A novel RNA motif that binds efficiently and specifically to the Ttat protein of HIV and inhibits the trans-activation by tat of transcription in vitro and in vivo. Genes Cells, 2000, 5(5): 371-388.
30.	Liu D, Zhang Y, Zhu M, et al. Microfluidic-integrated multicolor immunosensor for visual detection of HIV-1 p24 antigen with the naked eye. Anal Chem, 2020, 92(17): 11826-11833.
31.	Zhan L, Granade T, Liu Y, et al. Development and optimization of thermal contrast amplification lateral flow immunoassays for ultrasensitive HIV p24 protein detection. Microsyst Nanoeng, 2020, 6: 54.
32.	Delaney KP, Hanson DL, Masciotra S, et al. Time until emergence of HIV test reactivity following infection with HIV-1: implications for interpreting test results and retesting after exposure. Clin Infect Dis, 2017, 64(1): 53-59.
33.	Centers for Disease Control and Prevention and Association of Public Health Laboratories. Laboratory testing for the diagnosis of HIV infection: updated recommendations. (2014-06-27)[2022-01-01]. http://dx. doi.org/10.15620/cdc.23447.
34.	Sickinger E, Jonas G, Yem AW, et al. Performance evaluation of the new fully automated human immunodeficiency virus antigen-antibody combination assay designed for blood screening. Transfusion, 2008, 48(4): 584-593.
35.	Zhang K, Wei B, Tang Z, et al. Acute HIV infection in a large teaching hospital in western China: clinical, virological, and molecular epidemiological characteristics. J Med Virol, 2020, 92(12): 3288-3294.
36.	李秀华, 许四宏, 宋爱京, 等. 4种国产和3种进口第4代HIV抗原抗体检测试剂的质量评价. 中华微生物学和免疫学杂志, 2011, 31(9): 847-850.
37.	Bourlet T, Pretis C, Pillet S, et al. Comparative evaluation of the vidas HIV Duo ultra assay for combined detection of HIV-1 antigen and antibodies to HIV. J Virol Methods, 2005, 127(2): 165-167.
38.	Mühlbacher A, Sauleda S, Piron M, et al. A multicentre evaluation of the Elecsys^® HIV Duo assay. J Clin Virol, 2019, 112: 45-50.
39.	Ghisetti V, Coignard C, Allice T, et al. Evaluation of the performance of a new automated HIV combination assay. J Clin Virol, 2017, 96: 80-83.
40.	Eshleman SH, Piwowar-Manning E, Sivay MV, et al. Performance of the BioPlex 2200 HIV Ag-Ab assay for identifying acute HIV infection. J Clin Virol, 2018(99/100): 67-70.
41.	宋淑静, 马小亮, 杨晓玲, 等. HIV抗原抗体光激化学发光法联合检测试剂的评价. 标记免疫分析与临床, 2019, 26(10): 1758-1761.
42.	宋炜路, 于茂河, 李志军, 等. 男男性行为者HIV感染急性期筛查诊断和治疗工作模式探索. 中国艾滋病性病, 2017, 23(12): 1124-1127.
43.	庞贤武, 何芹, 唐凯玲, 等. 高危人群HIV急性期/早期感染检测策略应用研究. 现代预防医学, 2020, 47(3): 518-521.
44.	Elliott T, Sanders EJ, Doherty M, et al. Challenges of HIV diagnosis and management in the context of pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), test and start and acute HIV infection: a scoping review. J Int AIDS Soc, 2019, 22(12): e25419.
45.	Fogel JM, Piwowar-Manning E, Debevec B, et al. Brief report: impact of early antiretroviral therapy on the performance of HIV rapid tests and HIV incidence assays. J Acquir Immune Defic Syndr, 2017, 75(4): 426-430.
46.	Hare CB, Pappalardo BL, Busch MP, et al. Seroreversion in subjects receiving antiretroviral therapy during acute/early HIV infection. Clin Infect Dis, 2006, 42(5): 700-708.

1. 揣征然, 张云辉, 赵雅琳, 等. 全球及中国AIDS最新疫情概况. 传染病信息, 2020, 33(6): 501-503.
2. Bao Y, Larney S, Peacock A, et al. Prevalence of HIV, HCV and HBV infection and sociodemographic characteristics of people who inject drugs in China: a systematic review and meta-analysis. Int J Drug Policy, 2019, 70: 87-93.
3. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med, 2011, 365(6): 493-505.
4. Robb ML, Eller LA, Kibuuka H, et al. Prospective study of acute HIV-1 infection in adults in East Africa and Thailand. N Engl J Med, 2016, 374(22): 2120-2130.
5. Yerly S, Hirschel B. Diagnosing acute HIV infection. Expert Rev Anti Infect Ther, 2012, 10(1): 31-41.
6. 中华医学会感染病学分会艾滋病丙型肝炎学组, 中国疾病预防控制中心. 中国艾滋病诊疗指南(2018年版). 中华内科杂志, 2018, 57(12): 867-884.
7. European AIDS Clinical Society. EACS Guidelines 2021. (2021-10-26) [2022-01-01]. https://eacs.sanfordguide.com/.
8. U. S. Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents Panel Members and Consultants. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. (2021-08-16) [2022-01-01]. https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines.
9. Fiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS, 2003, 17(13): 1871-1879.
10. Ananworanich J, Fletcher JL, Pinyakorn S, et al. A novel acute HIV infection staging system based on 4th generation immunoassay. Retrovirology, 2013, 10: 56.
11. Pilcher CD, Joaki G, Hoffman IF, et al. Amplified transmission of HIV-1: comparison of HIV-1 concentrations in semen and blood during acute and chronic infection. AIDS, 2007, 21(13): 1723-1730.
12. Morrison CS, Demers K, Kwok C, et al. Plasma and cervical viral loads among Ugandan and Zimbabwean women during acute and early HIV-1 infection. AIDS, 2010, 24(4): 573-582.
13. Quinn TC, Wawer MJ, Sewankambo N, et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med, 2000, 342(13): 921-929.
14. Miller WC, Rosenberg NE, Rutstein SE, et al. Role of acute and early HIV infection in the sexual transmission of HIV. Curr Opin HIV AIDS, 2010, 5(4): 277-282.
15. Powers KA, Ghani AC, Miller WC, et al. The role of acute and early HIV infection in the spread of HIV and implications for transmission prevention strategies in Lilongwe, Malawi: a modelling study. Lancet, 2011, 378(9787): 256-268.
16. Bellan SE, Dushoff J, Galvani AP, et al. Reassessment of HIV-1 acute phase infectivity: accounting for heterogeneity and study design with simulated cohorts. PLoS Med, 2015, 12(3): e1001801.
17. 中华人民共和国国家卫生健康委员会. 艾滋病和艾滋病病毒感染诊断. (2019-01-02)[2022-01-01]. http://www.nhc.gov.cn/wjw/s9491/201905/6430aa653728439c901a7340796e4723.shtml.
18. Taylor D, Durigon M, Davis H, et al. Probability of a false-negative HIV antibody test result during the window period: a tool for pre- and post-test counselling. Int J STD AIDS, 2015, 26(4): 215-224.
19. 吴焱, 徐克沂, 王玉光, 等. 急性期/早期HIV-1感染的临床研究进展. 中国艾滋病性病, 2011, 17(3): 372-375.
20. 中国疾病预防控制中心. 全国艾滋病检测技术规范(2020修订版). (2020-05-18)[2022-01-01]. http://ncaids.chinacdc.cn/zxzx/zxdteff/202005/t20200518_216798.htm.
21. 周全华, 王越, 刘华, 等. 某国产人类免疫缺陷病毒1型核酸定量检测试剂的临床试验研究. 检验医学与临床, 2021, 18(5): 585-588.
22. 杨勇, 蒲伟, 罗小虎. 国产全自动HIV-1核酸定量检测试剂盒的性能评价. 检验医学, 2020, 35(2): 153-155.
23. World Health Organization. WHO list of prequalified in vitro diagnostic products. (2020-10-13)[2022-01-01]. https://www.who.int/diagnostics_laboratory/evaluations/201013_prequalified_product_list.pdf.
24. Gray ER, Bain R, Varsaneux O, et al. P24 revisited: a landscape review of antigen detection for early HIV diagnosis. AIDS, 2018, 32(15): 2089-2102.
25. Fatin MF, Ruslinda AR, Md Arshad MK, et al. HIV-1 tat biosensor: current development and trends for early detection strategies. Biosens Bioelectron, 2016, 78: 358-366.
26. Caglayan MO, Üstündağ Z. Spectrophotometric ellipsometry based Tat-protein RNA-aptasensor for HIV-1 diagnosis. Spectrochim Acta A Mol Biomol Spectrosc, 2020, 227: 117748.
27. Li HY, Jia WN, Li XY, et al. Advances in detection of infectious agents by aptamer-based technologies. Emerg Microbes Infect, 2020, 9(1): 1671-1681.
28. 詹少兵, 张晓光, 李红霞, 等. 筛选HIV-1 P24蛋白适配子的一种简便的SELEX方法. 中华实验和临床病毒学杂志, 2013, 27(3): 218-220.
29. Yamamoto R, Katahira M, Nishikawa S, et al. A novel RNA motif that binds efficiently and specifically to the Ttat protein of HIV and inhibits the trans-activation by tat of transcription in vitro and in vivo. Genes Cells, 2000, 5(5): 371-388.
30. Liu D, Zhang Y, Zhu M, et al. Microfluidic-integrated multicolor immunosensor for visual detection of HIV-1 p24 antigen with the naked eye. Anal Chem, 2020, 92(17): 11826-11833.
31. Zhan L, Granade T, Liu Y, et al. Development and optimization of thermal contrast amplification lateral flow immunoassays for ultrasensitive HIV p24 protein detection. Microsyst Nanoeng, 2020, 6: 54.
32. Delaney KP, Hanson DL, Masciotra S, et al. Time until emergence of HIV test reactivity following infection with HIV-1: implications for interpreting test results and retesting after exposure. Clin Infect Dis, 2017, 64(1): 53-59.
33. Centers for Disease Control and Prevention and Association of Public Health Laboratories. Laboratory testing for the diagnosis of HIV infection: updated recommendations. (2014-06-27)[2022-01-01]. http://dx. doi.org/10.15620/cdc.23447.
34. Sickinger E, Jonas G, Yem AW, et al. Performance evaluation of the new fully automated human immunodeficiency virus antigen-antibody combination assay designed for blood screening. Transfusion, 2008, 48(4): 584-593.
35. Zhang K, Wei B, Tang Z, et al. Acute HIV infection in a large teaching hospital in western China: clinical, virological, and molecular epidemiological characteristics. J Med Virol, 2020, 92(12): 3288-3294.
36. 李秀华, 许四宏, 宋爱京, 等. 4种国产和3种进口第4代HIV抗原抗体检测试剂的质量评价. 中华微生物学和免疫学杂志, 2011, 31(9): 847-850.
37. Bourlet T, Pretis C, Pillet S, et al. Comparative evaluation of the vidas HIV Duo ultra assay for combined detection of HIV-1 antigen and antibodies to HIV. J Virol Methods, 2005, 127(2): 165-167.
38. Mühlbacher A, Sauleda S, Piron M, et al. A multicentre evaluation of the Elecsys^® HIV Duo assay. J Clin Virol, 2019, 112: 45-50.
39. Ghisetti V, Coignard C, Allice T, et al. Evaluation of the performance of a new automated HIV combination assay. J Clin Virol, 2017, 96: 80-83.
40. Eshleman SH, Piwowar-Manning E, Sivay MV, et al. Performance of the BioPlex 2200 HIV Ag-Ab assay for identifying acute HIV infection. J Clin Virol, 2018(99/100): 67-70.
41. 宋淑静, 马小亮, 杨晓玲, 等. HIV抗原抗体光激化学发光法联合检测试剂的评价. 标记免疫分析与临床, 2019, 26(10): 1758-1761.
42. 宋炜路, 于茂河, 李志军, 等. 男男性行为者HIV感染急性期筛查诊断和治疗工作模式探索. 中国艾滋病性病, 2017, 23(12): 1124-1127.
43. 庞贤武, 何芹, 唐凯玲, 等. 高危人群HIV急性期/早期感染检测策略应用研究. 现代预防医学, 2020, 47(3): 518-521.
44. Elliott T, Sanders EJ, Doherty M, et al. Challenges of HIV diagnosis and management in the context of pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), test and start and acute HIV infection: a scoping review. J Int AIDS Soc, 2019, 22(12): e25419.
45. Fogel JM, Piwowar-Manning E, Debevec B, et al. Brief report: impact of early antiretroviral therapy on the performance of HIV rapid tests and HIV incidence assays. J Acquir Immune Defic Syndr, 2017, 75(4): 426-430.
46. Hare CB, Pappalardo BL, Busch MP, et al. Seroreversion in subjects receiving antiretroviral therapy during acute/early HIV infection. Clin Infect Dis, 2006, 42(5): 700-708.

West China Medical Journal

Progress in laboratory detection of acute human immunodeficiency virus infection

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