Abstract
The Ministry of Health of Brazil recommends for HTLV-1/2 diagnosis the use of one enzyme immunoassay (EIA) which contains selected antigens for HTLV-1 and HTLV- 2 in sera screening, and in reactive sera, re-testing in duplicate on the same EIA. This study had the objective to present the algorithm of screening tests used by Instituto Adolfo Lutz of São Paulo (IAL), that differs from the algorithm recommended by the Ministry of Health. Serum samples sent to IAL from Public Health clinics, and AIDS Reference Centers during December 1998 to March 2006 were analyzed for the presence of anti-HTLV-1/2 antibodies using two EIAs of different formats and composition. The results obtained are presented as st nd rd values of sensitivity, specificity and efficiency of EIA kits of 1 , 2 , and 3 generations in st nd rd relation to the confirmatory Western Blotting assay. Neither 1 and 2 , nor 3 generations EIA kits were able to detect all truly HTLV-1/2 positive sera. In spite of the best performance of nd 2 generation EIA kits, the results obtained emphasizes the need of using two EIAs as screening.The results obtained confirm and advise the use of two HTLV-1/2 EIAs as screening in Public Health Laboratories from Brazil, differently of the recommended by the Ministry of Health.
References
Proietti AB de FC. HTLV Cadernos Hemominas. Belo Horizonte: Fundação Centro de Hematologia e Hemoterapia de Minas Gerais; 2006.
Posada-Vergara MP, Montanheiro P, Fukumori LMI, Bonasser F, Duarte AJS, Penalva De Oliveira AC et al. Clinical and epidemiological aspects of HTLV-II infection in São Paulo, Brazil: presence of tropical spastic paraparesis/HTLVassociated myelopathy (TSP/HAM) simile diagnosis in HIV-1-coinfected subjects. Rev Inst Med Trop S Paulo. 2006;48:207-10.
Brites C, Alencar R, Gusmão R, Pedroso C, Pedral-Sampaio D, Badaró R et al. Coinfection with HTLV-1 is associated with a shorter survival time for HIV-1-infected patients in Bahia, Brazil. AIDS. 2001;15:2053- 55.
Turci M, Pilotti E, Ronzi P, Magnani G, Boschini A, Parisi SG, et al. Coinfection with HIV-1 and human T-cell lymphotropic virus type II in intravenous drug users is associated with delayed progression to AIDS. J Acquir Immune Defic Syndr. 2006;41:100-6.
Roucoux DF & Murphy EL. The epidemiology and disease outcomes of human Tlymphotropic virus type II. AIDS Rev. 2004;6:144-54.
Ministério da Saúde. Portaria 1.376, de nov. 1993. Diário Oficial da União, Brasília, 2 de dez. 1993. [Aprova alterações na Portaria n. 721/GM, de 9 de ago. 1989, que aprova normas técnicas para coleta, processamento e transfusão de sangue, componentes e derivados, e da outras providências].
Ministério da Saúde. HTLV-I/II – Triagem e diagnóstico sorológico em unidades hemoterápicas e laboratórios de saúde pública. Brasília: Ministério da Saúde, Coordenação Nacional de Doenças Sexualmente Transmissíveis e Aids. 1998. II (Série TELELAB); 54p.
Centers for Disease Control and Prevention. Current trends licensure of screening tests for antibody to human T-limphotropic virus type I. Morb Mortal Wkly Rep. 1988 [acessado em 11 set. 2001];37(48):736-40. Disponível em: http://www.cdc.gov/mmwr/preview/mmwrhtm l/00001311.htm
Manns A, Blattner WA. The epidemiology of the human T-cell lymphotropic virus type I and II: etiologic role in human disease. Transfusion. 1991;31:67-75.
Franchini G. Molecular mechanisms of human T-cell leukemia/lymphotropic virus type I infection. Blood. 1995; 86:3619-39.
Wiktor SZ, Pate EJ, Weiss SH, Gohd RS, Correa P, Fontham ET, et al. Sensitivity of HTLV-I antibody assays for HTLV-II. Lancet. 1991;338:512-13.
Centers for Disease Control and Prevention. Current trends human T lymphotropic virus type I screening in volunteer blood donors – United States, 1989. Morb Mortal Wkly Rep. 1990 [acessado em 15 jul. 2001]; 39(50): 915, 921-24. Di sponí vel em:ht tp: / /www. cdc .gov / mmwr/preview/mmwrhtml/00001864.htm.
Andersson S, Thorstensson R, Ramirez KG, Krook A, Von Sydow M, Dias F et al. Comparative evaluation of 14 immunoassay for the detection of antibodies to the human Tlymphotropic virus types I and II using painels of sera Sweden and West Africa. Transfusion. 1999;39:845-51.
Vrielink H, Reesing HW, Habibuw M, Schuller M, Van Der Meer C. Comparision of four HTLV-I and HTLV-I + II ELISAs. Vox Sang. 1999;76:187-91.
Thorstensson R, Albert J, Andersson S. Strategies for diagnosis of HTLV-I and II. Transfusion. 2002;42:780-91.
Santos TJT. Biomolecular study of seroindeterminate individuals for the retrovirus HTLVI/ II. Arq Neuropsiquiatr. 2001;60:174-75.
Jacob F, Santos-Fortuna E, Azevedo RS, Caterino-De-Araujo A. Performances of HTLV serological tests in diagnosing HTLV infection in high-risk population of São Paulo, Brazil. Rev Inst Med Trop S Paulo. 2007a; 49(6): 361-364.
Morimoto HK, Morimoto AA, Reiche EMV, Ueda LT, Matsuo T, Reiche FV et al. Difficulties in the diagnosis of HTLV-2 infection in HIV/AIDS patients from Brazil. Comparative performances of serologic and molecular assays, and detection of HTLV-2b subtype. Rev Inst Med Trop S Paulo. 2007; 49(4): 225-230.
Jacob F, Santos-Fortuna E, Azevedo RS, Caterino-De-Araujo A. Serological patterns for HTLV-I/II and its temporal trend in highrisk populations attended at Public Health Units of São Paulo, Brazil. J Clin Virol (em revisão, 2007b).
Catalan-Soares B, Carneiro-Proietti AB, Proietti FA, Interdisciplinary HTLV Research Group – Heterogeneous geographic distribution of human T-cell lymphotropic viruses I and II (HTLV-I/II): serological screening prevalence rates in blood donors from large urban areas in Brazil. Cadern Saúde Publ. 2005;21:926-31.
De-Araujo AC, Casseb JSR, Neitzert E, Xavier De Souza ML, Mammano F, Del Mistro A, et al. HTLV-I and HTLV-II infections among HIV-1 seropositive patients in São Paulo, Brazil. Eur J Epidem. 1994;10:165-71.
Gallo D, Diggs JL, Hanson CV. Evaluation of two commercial human T-cell lymphotropic virus Western blot (immunoblot) kits with problems specimens. J Clin Microbiol. 1994; 32: 2046-49.
Casseb J, Souza T, Pierre-Lima MT, Yeh E, Hendry MR, Gallo D. Testing problems in diagnosing HTLV infection among intravenous drug users with AIDS in São Paulo city, Brazil. AIDS Res hum Retrovir. 1997;13:1639-41.
Caterino-De-Araujo A, Santos-Fortuna E, Meleiro MCZ, Suleiman J, Calabro ML, Favero A, et al - Sensitivity of two ELISA tests in relation to Western blot in detecting HTLV-I and HTLV-II infection among HIV-1-infected patients from São Paulo, Brazil. Diagn Microbiol infect Dis. 1998;30:173-82.
Zehender G, De Maddalena C, Gianotto M, Cavalli B, Santambrogio S, Orso M, et al. High prevalence of false-negative anti- HTLV type I/II enzyme-linked immunosorbent assay results in HIV type 1-positive patients. AIDS Res Hum Retrovir. 1997;13:1141-46.
Bassani S, Toro C, Jiménez V, Rodés B, Soriano V. Can the level of immunosuppression in human immunodeficiency virus-infected patients affect the reliability of human T-cell lymphotropic virus type 2 serological diagnosis? Clin Vacc Immunol. 2006;13:160-61.
This work is licensed under a Creative Commons Attribution 4.0 International License.
Copyright (c) 2008 Fabrício Jacob, Elizabeth de los Santos-Fortuna, Adele Caterino-de-Araujo