Keywords
sorodiagnóstico da Aids
anticorpos anti-HIV
imunoensaio
soroconversão
How to Cite
Abstract
The enzyme immunoassay ELISA was marketed in Brazil shortly after being announced in the US and Europe and immediately used in several public and private laboratories. Newer technologies in HIV testing, such as fourth-generation tests that detect both anti-HIV antibodies and HIV p24 antigen, and the nucleic acid-based testing have markedly reduced the interval between exposure and infection detection. This brief review proposes to show the different HIV testing algorithms used in Brazil, from assays based only on the detection of anti-HIV antibodies to the new flowcharts in which molecular tests were included. In Brazil, until 1998, national authorities had not yet recommended a testing algorithm for diagnosis of HIV infection. After that, different testing algorithms have been recommended by the Brazilian Ministry of Health Ordinances for the diagnosis of HIV infection and followed by public and private laboratories. Considering the different scenarios in which the diagnosis of HIV has been performed, there is a need for frequent evaluation of the assays, because the quality of the results can be influenced by different biological factors of the host and the agent.
References
Brito AM, de Castilho E A, Szwarcwald CL. AIDS e infecção pelo HIV no Brasil: uma epidemia multifacetada. Rev Soc Bras Med Trop. 2001;34:207-17. https://doi.org/10.1590/S0037-86822001000200010
Programa Conjunto das Nações Unidas sobre HIV/Aids. Estatísticas globais sobre HIV 2021. UNAIDS Brasil. Disponível em: https://unaids.org.br/estatisticas/ [Acessado em: 10 Fev 2022].
Brasil. Ministério da Saúde. Secretaria de Vigilância em Saúde. Boletim Epidemiológico HIV/Aids 2021. Brasília 2021. Disponível em: http://www.aids.gov.br/pt-br/pub/2021/boletim-epidemiologico-hivaids-2021 [Acessado em: 10 Fev 2022].
Redoschi BRL, Zucchi ME, Barros CRS, Paiva VS. Uso rotineiro do teste anti-HIV entre homens que fazem sexo com homens: do risco à prevenção. Cad Saúde Pública. 2017;33(4):e00014716. https://doi.org/10.1590/0102-311X00014716
Baggaley RF, Irvine MA, Leber W, Cambiano V, Figueroa J, McMullen H, et al. Cost-effectiveness of screening for HIV in primary care: a health economics modelling analysis. Lancet HIV. 2017;4(10):e465-e474. https://doi.org/10.1016/S2352-3018(17)30123-6
Vermund SH. Control of HIV epidemic: improve access to testing and ART. Lancet HIV. 2017;4(12):e529-e576. https://doi.org/10.1016/S2352-3018(17)30166-2
Castejon MJ, Yamashiro R, Oliveira CAF, Brígido LFM, Generoso IP, Veras MASM, et al. Performance of rapid tests compared to conventional tests used for HIV diagnosis. J Bras Patol Med Lab. 2018;54(6):364-71.https://doi.org/10.5935/1676-2444.20180058
National Museum of American History. Abbott HTLV III EIA (Enzyme Immunoassay for the Detection of Antibody to Human T- Lymphotropic Virus Type III in Human Serum or Plasma). Disponível em: https://americanhistory.si.edu/collections/search/object/nmah_1322289 [Acessado em: 14 jun 2022)
Branson BM. State of the art for diagnosis of HIV infection. Clin Infect Dis. 2007;45 (4):221-25. https://doi.org/10.1086/522541
Gallo RC, Montagnier L. The discovery of HIV as the cause of AIDS. N Engl J Med. 2003;349(24):2283-85. https://doi.org/10.1056/NEJMp038194
Buttò S, Suligoi B, Fanales-Belasio E, Raimondo M. Laboratory diagnostics for HIV infection. Ann Ist Super Sanità. 2010;46(1):24-33. https://doi.org/10.4415/Ann_10_01_04
Ferreira Junior OC. da Motta LR. Três décadas de diagnóstico de HIV: a experiência brasileira. In: Brasil. Ministério da Saúde. Histórias de luta contra a Aids. Brasília: Ministério da Saúde. 2015:258-75. Disponível em: https://www.ucs.br/ips2/wp-content/uploads/2020/09/Tres-Decadas-de-Diagnostico-de-HIV-A-Experiencia-Brasileira.pdf [Acessado em: 5 mar 2022]
Fanales-Belasio E, Raimondo M, Suligoi B, Buttò S. HIV virology and pathogenetic mechanisms of infection: a brief overview. Ann Ist Super Sanità. 2010;46(1):5-14. https://doi.org/10.4415/ANN_10_01_02
Centers for Disease Control (CDC). Current trends update: Serologic testing for antibody to human immunodeficiency virus. MMWR. 1988;36(52):833-45.
Hehlmann R. Human Retroviruses. In: Manning S & Thorp D, eds. Mosby Year Book. Human Virology, 2nd ed., Belshe RB, St. Louis, 1990. cap. 9. p. 274-306.
Constantine NT, Callahan JD, Watts DM. HIV testing and quality control: A guide for laboratory personnel. Durham, North Carolina, USA: Family Health International. 1991. 170 pp.
World Health Organization. HIV testing methods. Technical update. UNAIDS, 1997. Disponível em: https://www.unaids.org/sites/default/files/media_asset/testmtu_en_0.pdf [Acessado em: 5 mar 2022]
World Health Organization. Guidelines for using HIV testing technologies in surveillance. UNAIDS 01.22E, 2001. Disponível em: https://apps.who.int/iris/handle/10665/42688?locale-attribute=zh&mode=full [Acessado em: 5 Mar 2022]
Constantine NT, Zink H. HIV testing technologies after two decades of evolution. Indian J Med Res. 2005;121:519-38.
Yılmaz G. Diagnosis of HIV infection and laboratory monitoring of its therapy. J Clin Virol. 2001;21:187-96. https://doi.org/10.1016/s1386-6532(01)00165-2
Smith JA, Daniel R. Following the path of the virus: the exploitation of host DNA repair mechanisms by retroviruses. Acs Chem Biol. 2006;1(4):217-26. https://doi.org/10.1021/cb600131q
Levy JA. Human immunodeficiency viruses and the pathogenesis of AIDS. JAMA. 1989; 261(20):2997-3006. https://doi.org/ 10.1001/jama.1989.03420200087044
Klimas N, Koneru AO, Fletcher MA. Overview of HIV. Psychosom Med. 2008;70(5): 523-30. https://doi.org/10.1097/PSY.0b013e31817ae69f
Fuentes GM, Fay PJ, Bambara RA. Relationship between plus strand DNA synthesis removal of downstream segments of RNA by human immunodeficiency virus, murine leukemia virus and avian myeloblastoma virus reverse transcriptases. Nucleic Acids Res. 1996;24(9):1719-26. https://doi.org/10.1093/nar/24.9.1719
Craigie R. HIV integrase, a brief overview from chemistry to therapeutics. J. Biol. Chem. 2001;276(26):23213-16. https://doi.org/10.1074/jbc.R100027200
Bentsen C, McLaughlin L, Mitchell E, Ferrera C, Liska S, Myers R, et al. Performance evaluation of the Bio-Rad Laboratories GS HIV Combo Ag/Ab EIA, a 4th generation HIV assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma. J Clin Virol. 2011;52S:S57- S61. https://doi.org/10.1016/j.jcv.2011.09.023
Simon D, Béria JU, Tietzmann DC, de Carli R, Stein AT, Lunge VR. Prevalência de subtipos do HIV-1 em amostra de pacientes de um centro urbano no sul do Brasil. Rev Saúde Pública. 2010;44(6). https://doi.org/10.1590/S0034-89102010005000039
Brasil. Ministério da Saúde. Portaria SVS/MS nº 29, de 17 de dezembro de 2013. Aprova o manual técnico para o diagnóstico da infecção pelo HIV em adultos e crianças e dá outras providências. Disponível em: http://www.aids.gov.br/pt-br/node/56078 [Acessado em: 23 fev 2022].
Kassutto S, Johnston MN, Rosenberg ES. Incomplete HIV type 1 antibody evolution and seroreversion in acutely infected individuals treated with early antiretroviral therapy. Clin Infect Dis. 2005;40(6):868-73. https://doi.org/10.1086/428127
Hare CB, Pappalardo BL, Busch MP, Karlsson AC, Phelps BH, Alexander SS, et al. Seroreversion in subjects receiving antiretroviral therapy during acute/early HIV infection. Clin Infect Dis. 2006;1;42(5):700-8. https://doi.org/10.1086/500215
Spivak AM, Sydnor ERM, Blankson JN, Gallant JE. Seronegative HIV-1 infection: a review of the literature. AIDS. 2010;24:1407-14. https://doi.org/10.1097/QAD.0b013e32833ac65c
Brasil. Ministério da Saúde. Secretaria de Políticas de Saúde. Coordenação Nacional de DST e Aids. Desafios para a equidade e o acesso. Série Estudos pesquisa e avaliação n. 11. Brasília (DF); 2008. Disponível em: https://bvsms.saude.gov.br/bvs/publicacoes/centros_testagem_aconselhamento_brasil.pdf [Acessado em: 10 Fev 2022
Rezende ELLF, Vasconcelos AMN, Pereira MG. Causes of death among people living with HIV/AIDS in Brazil. Braz J Infect Dis. 2010;14(6):558-63. https://doi.org/10.1590/S1413-86702010000600003
Centers for Disease Control and Prevention. Notice to readers: Protocols for confirmation of reactive rapid HIV tests. MMWR Weekly. 2004;53(10):221-22. Disponível em: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5310a7.htm [Acessado em: 23 Fev 2022].
Centers for Disease Control and Prevention. Technical update on HIV-1/2 differentiation assays. 2016. Disponível em: https://stacks.cdc.gov/view/cdc/40790. [Acessado em: 23 Fev 2022].
Manak MM, Jagodzinski LL, Shutt A, Malia JA, Leos M, Ouellette J, et al. Decreased seroreactivity in individuals initiating antiretroviral therapy during acute HIV infection. J Clin Microbiol. 2019;57(10):e00757-19. https://doi.org/10.1128/JCM.00757-19
Castejon MJ, Dordetto Priscila R. Yamashiro R, Brígido LFM, Alves A A, Oliveira CAF. Antiretroviral therapy in patient living with HIV leads negative HIV serological results. J Bras Patol Med Lab. 2021;57:1-6. https://doi.org/10.5935/1676-2444.20210057
Centers for Disease Control and Prevention. Interpretation and use of the Western blot assay for serodiagnosis of human immunodeficiency virus type 1 infections. MMWR Suppl. 1989;38(7):1-7. Disponível em: https://www.cdc.gov/mmwr/preview/mmwrhtml/00001431.htm [Acessado em: 23 fev 2022].
O'Brien TR, George JR, Epstein JS, Holmberg SD, Schochetman G. Testing for antibodies to human immunodeficiency virus type 2 in the United States. MMWR. Recomm Rep. 1992; 41(RR-12):1-9. https://www.cdc.gov/mmwr/preview/mmwrhtml/00038078.htm
Branson BM, Owen SM, Wesolowski LG, Bennett B, Werner BG, Wroblewski KE, et al. Laboratory testing for the diagnosis of HIV infection: updated recommendations. 2014. Disponível em: http://dx.doi.org/10.15620/cdc.23447 [Acessado em 10 Fev 2022]
Guarner J. Human immunodeficiency virus: Diagnostic approach. Semin Diagn Pathol. 2017; 34(4):318-24. https://doi.org/10.1053/j.semdp.2017.04.008.
Owen SM. Testing for acute HIV infection: implications for treatment as prevention. Curr Opin HIV AIDS. 2012;7(2):125-30. https://doi.org/10.1097/COH.0b013e3283506613
Alexander TS. Human immunodeficiency virus diagnostic testing: 30 years of evolution. Clin Vaccine Immunol. 2016;23(4):249-53. https://doi.org/10.1128/CVI.00053-16
Nkengasong J , van Kerckhoven I, Carpels G, Vercauteren G, Piot P, van der Groen G. HIV screening and confirmation: a simplified and less expensive testing algorithm. Ann Soc Belg Med Trop. 1992;72(2):129-39.
Stone M, Bainbridge J, Sanchez AM, Keatinga SM, Pappasc A, Rountree W, et al. Comparison of detection limits of fourth- and fifth-generation combination HIV antigen-antibody, p24 antigen, and viral load assays on diverse HIV isolates. J Clin Microbiol. 2018;56(8):e02045-17. https://doi.org/10.1128/JCM.02045-17
Brasil. Ministério da Saúde. Secretaria de Políticas de Saúde. Coordenação Nacional de DST e Aids. Diretrizes dos Centros de Testagem e Aconselhamento (CTA): Manual. Brasília (DF); 1999. Disponível em: https://bvsms.saude.gov.br/bvs/publicacoes/diretrizes_cta.pdf [Acessado em 24 Fev 2022]
Comparini RA, da Silva ET, Pereira DCR. Estratégias de ampliação do diagnóstico da infecção pelo Vírus da Imunodeficiência Humana no Brasil, 2015. Com. Ciências Saúde. 2017;28(2):158-67. https://doi.org/10.51723/ccs.v28i02.210
Brasil. Ministério da Saúde. Secretaria de Vigilância em Saúde. Programa Nacional de DST e Aids. Manual de adesão ao tratamento para pessoas vivendo com HIV e aids. Série A. Normas e nanuais técnicos. 2008; n.84. 130p. Disponível em: https://bvsms.saude.gov.br/bvs/publicacoes/manual_adesao_tratamento_hiv.pdf [Acessado em: 24 Fev 2022].
Brasil. Ministério da Saúde. Portaria SVS/MS nº 488, de 17 de junho de 1998. Brasília: Diário Oficial [da República Federativa do Brasil] nº 114 de 18 de junho.
Okay TS, Granato CFH. O diagnóstico molecular da infecção pelo vírus da imunodeficiência humana (HIV-1) em crianças entre dois e 24 meses. Rev Ass Med Brasil. 2000;46(4):298-99.
Brasil. Ministério da Saúde. Portaria GM/MS nº 59, de 28 de janeiro de 2003. Brasília: Diário Oficial [da República Federativa do Brasil] nº 22 de 30 de janeiro.
Brasil. Ministério da Saúde. Portaria SVS/MS nº 34, de 28 de julho de 2005. Brasília: Diário Oficial [da República Federativa do Brasil] nº 145 de 29 de julho.
Brasil. Ministério da Saúde. Portaria SVS/MS nº 151, de 14 de outubro de 2009. Brasília: Diário Oficial [da República Federativa do Brasil] nº 198 de 16 de outubro.
Elliott T, Sanders EJ, Doherty M, Ndung’u T, Cohen M, Patel P, 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:e25419. https://doi.org/10.1002/jia2.25419.
Deeks SG, Overbaugh J, Phillips A, Buchbinder S. HIV infection. Nat Rev Dis Primers. 2015;1:15035. https://doi.org/10.1038/nrdp.2015.35
Deeks SG, Lewin SR, Ross AL, Ananworanich J, Benkirane M, Cannon P, et al. International AIDS Society global scientific strategy: towards an HIV cure 2016. Nat. Med. 2016;22(8):839-50. https://doi.org/10.1038/nm.4108
Bongertz V, Ouverney EP, Fernandez SC, Grinsztejn B, Veloso V, Couto-Fernandez JC, et al. Anti-human immunodeficiency virus type 1 humoral immune response and highly active antiretroviral treatment. Mem Inst Oswaldo Cruz. 2007;102(7):817-25. https://doi.org/10.1590/S0074-02762007005000119
Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, et al. Antiretroviral therapy for the prevention of HIV-1 transmission. N Engl J Med. 2016;375(9):830-39. https://doi.org/10.1056/NEJMoa1600693
Stefic K, Novelli S, Mahjoub N, Seng R, Molina J-M, Cheneau C, et al. Nonreactive human immunodeficiency virus type 1 rapid tests after sustained viral suppression following antiretroviral therapy initiation during primary infection. J Infect Dis. 2018;217(11):1793-97. https://doi.org/10.1093/infdis/jiy120
Stoffels K, Vanroye F, Mortier V, Debaisieux L, Delforge M-L, Depypere M, et al. Chronic and early antiretroviral therapy impact human immunodeficiency virus (HIV) serological assay sensitivity, leading to more false-negative test results in HIV diagnosis. J Infect Dis. 2020;222(10):1660-69. https://doi.org/10.1093/infdis/jiaa271
This work is licensed under a Creative Commons Attribution 4.0 International License.
Copyright (c) 2022 Márcia Jorge Castejon, Celso Francisco Hernandes Granato , Carmem Aparecida de Freitas Oliveira