Meta-analysis Regarding the Validity of the Immunodiagnosis of Human T-cell Lymphotropic Virus I/II in Blood Banks, 2000-2018
DOI:
https://doi.org/10.17533/udea.rfnsp.e343861Keywords:
blood bank, meta-analysis, prevention and control, immunological tests, human T-cell lymphotropic virus type I and type II (HTLV I/II)Abstract
Objective: To evaluate the validity of the immunodiagnosis of HTLV I/II in blood banks, based on studies published in the scientific literature. Methodology: A meta-analysis of diagnostic tests was carried out following the PRISMA guidelines and Cochrane recommendations. The methodological quality was evaluated with QUADAS, and reproducibility and completeness were guaranteed. A random effects analysis was also performed with respect to sensitivity, specificity, likelihood ratios, diagnostic odds ratio, and receiver operating characteristic curve (ROC) with their 95 % confidence intervals (CI). Results: 4,604 studies were screened, of which only three complied with the protocol. 548 subjects infected with HTLV I/II and 6,643 healthy subjects were evaluated. The immunodiagnosis of HTLV I/II had a sensitivity of 99 % (95 % CI = 98.0-99.0), a specificity of 100 % (95 % CI = 99.9-100), a positive likelihood ratio of 315.8 (95 % CI = 128.2-778.5) and a negative likelihood ratio of 0.02 (95 % CI = 0.01-0.04), a diagnostic odds ratio of 24,373 (95 % CI = 6,864-86,545), and an area under the ROC curve of 99.9 %. Conclusion: Few studies are available in the field of HTLV I/II immunodiagnosis. The high number of subjects analyzed showed high validity of the immunodiagnosis, which is decisive to guarantee the safety of the blood units, the detection of asymptomatic carriers, the decrease in transmission, and the start of treatment.
Downloads
References
(1). Segurado AA, Biasutti C, Zeigler R, et al. Identification of human T-lymphotropic virus type i (htlv-i) subtypes using restricted fragment length polymorphism in a cohort of asymptomatic carriers and patients with htlv-i-associated myelopathy/tropical spastic paraparesis from São Paulo, Brazil. Mem. Inst. Oswaldo Cruz. 2002;97(3):329-33. DOI: https://doi.org/10.1590/S0074-02762002000300009
(2). Berini CA, Susana Pascuccio M, Bautista CT, et al. Comparison of four commercial screening assays for the diagnosis of human T-cell lymphotropic virus types 1 and 2. J Virol Methods. 2008;147(2):322-7. DOI: https://doi.org/10.1016/j.jviromet.2007.09.012
(3). Kapprell H-P, Stieler M, Oer M, et al. Evaluation of a new third-generation architect rhtlv-i/ii assay for blood screening and diagnosis. Diagn Microbiol Infect Dis. 2010;67(1):61-69. DOI: https://doi.org/10.1016/j.diagmicrobio.2009.12.021
(4). Rivera C, López D, Zamora T, et al. Infección por el virus linfotrópico humano de células T tipo 1 (htlv-1) y paraparesia espástica. Avances y diagnóstico 35 años después de su descubrimiento. iatreia. 2017;30(2):146-59. DOI: https://doi.org/10.17533/udea.iatreia.v30n2a04
(5). Yun S, Kim S, et al. Evaluation of Elecsys htlv‐i/ii assay in comparison with architect rhtlv‐i/ii assay with Korean samples. J Clin Lab Anal. 2019; 33(6):e22909. DOI: https://doi.org/10.1002/jcla.22909
(6). Bermúdez-Forero MI, Berrío-Pérez M, Herrera-Hernández AM, et al. Prevalencia de la infección con el virus linfotrópico de células T humanas de tipo 1 y 2 en donantes de sangre en Colombia, 2001-2014: implicaciones sobre la seguridad de la transfusión. Biomédica. 2016;36(Supl. 2):194-200. DOI: https://doi.org/10.7705/biomedica.v36i0.2943
(7). Laperche S, Sauleda S, Piron M, et al. Evaluation of sensitivity and specificity performance of Elecsys htlv-i/ii assay in a multicenter study in Europe and Japan. J Clin Microbiol. 2017;55(7):2180-7. DOI: https://doi.org/10.1128/JCM.00169-17
(8). Da Silva B, Santos F, Gonçalves N, et al. Performance of commercially available serological screening tests for human T-cell lymphotropic virus infection in Brazil. J Clin Microbiol. 2018;56(12):e00961-18. DOI: https://doi.org/10.1128/JCM.00961-18
(9). Proietti F, Carneiro A, et al. Global epidemiology of htlv-i infection and associated diseases. Oncogene. 2005;24(39):6058-68. DOI: https://doi.org/10.1038/sj.onc.1208968
(10). Carneiro A, Catalan B, Castro C, et al. htlv in the Americas: Challenges and perspectives. Rev Panam Salud Pública. 2006;19(1):44-53. DOI: https://doi.org/10.1590/s1020-49892006000100007
(11). Moreno C, Balangero M, Barbás M, et al. Diagnóstico serológico de htlv-1/2: combinación de técnicas de tamizaje para definir el estatus serológico en donantes de sangre. Rev Argent Microbiol. 2013;45(3):165-8. DOI: https://doi.org/10.1016/S0325-7541(13)70019-1
(12). Morimoto H, Morimoto A, Reiche E, 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 São Paulo. 2007;49(4):225-30. DOI: https://doi.org/10.1590/s0036-46652007000400006
(13). Cardona J, Higuita L, Ríos Osorio L. Ejecución de revisiones sistemáticas y metaanálisis. En Revisiones sistemáticas de la literatura científica: la investigación teórica como principio para el desarrollo de la ciencia básica y aplicada (pp. 27-40). Bogotá: Ediciones Universidad Cooperativa de Colombia; 2016. DOI: http://dx.doi.org/10.16925/9789587600377
(14). Moher D, Liberati A, et al. Preferred reporting items for systematic reviews and meta‐analyses: The prisma Statement. PLos Med. 2009;6(7):e1000097. DOI: https://doi.org/10.1371/journal.pmed.1000097
(15). Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. London: The Cochrane Collaboration; 2011.
(16). Whiting PF, Rutjes AWS, Westwood ME, et al. quadas-2: A revised tool for the Quality Assessment of Diagnostic Accuracy Studies. Ann Intern Med. 2011;155(8):529-36. DOI: http://dx.doi.org/10.7326/0003-4819-155-8-201110180-00009
(17). Zamora J, Abraira V, Muriel A, et al. Meta-DiSc: A software for meta-analysis of test accuracy data. bmc Med Res Methodol. 2006;6:31 DOI: https://doi.org/10.1186/1471-2288-6-31
(18). Biglione M, Berini C. Aportes y consideraciones sobre la infección por los virus linfotrópicos-T humanos tipo 1 y 2 en Argentina. asei [internet]. 2013 [citado 2020 jul. 19]; 21(81):84-94. Disponible en: https://www.huesped.org.ar/wp-content/uploads/2014/11/ASEI-81-84-94.pdf
(19). Gessain A, Cassar O. Epidemiological aspects and world distribution of htlv-1 infection. Front Microbiol. 2012;3:388. DOI: https://doi.org/10.3389/fmicb.2012.00388
(20). Eusebio-Ponce E, Anguita E, et al. htlv-1 infection: An emerging risk. Pathogenesis, epidemiology, diagnosis and associated diseases. Rev Esp Quimioter. 2019;32(6):485-96. Epub 2019 Oct 25. pmid: 31648512; pmcid: PMC6913074.
(21). Torres D, Sierra F, Beltrán OA. Cuando la evidencia evalúa pruebas diagnósticas... ¿Qué debemos saber, qué debemos hacer? Rev Colomb Gastroenterol [internet]. 2004 [citado 2020 jul. 15]; 19(4);281-5. http://www.scielo.org.co/pdf/rcg/v19n4/v19n4a10.pdf
(22). Pasamontes J, Cabrera M, Delgado R, et al. Revisión sistemática y metaanálisis de la eficacia diagnóstica de la pet 18F-fdg en recurrencia tumoral de cánceres de cabeza y cuello. Acta Otorrinolaringol Esp. 2008;59(4):190-7. DOI: https://doi.org/10.1016/S0001-6519(08)73292-8
(23). Colombia, Ministerio de Salud y Protección Social. Resolución 437, por la cual se establece la práctica obligatoria de pruebas de anticuerpos contra el virus linfotrópico de células T humanas i/ii (htlv i/ii) y la detección de anticuerpos contra el antígeno core del virus de la hepatitis B (Anti HBc) (2014 feb. 14).
(24). Herrera A, García M, Bermúdez M. Anexo técnico 4. Circular 082 de 2011. Actualización de algoritmos para pruebas confirmatorias y complementarias (2019-06-14). Instituto Nacional de Salud de Colombia [internet]; 2011 [citado 2020 jun. 25]. Disponible en: https://www.ins.gov.co/Direcciones/RedesSaludPublica/DonacionSangre/NormatividadRelNalBancosSangro/Anexo%204%20Circular%20082%20de%202011.pdf
(25). Andrade R, Ribeiro M, Namen M, et al. Evaluation of the use of real-time pcr for human T cell lymphotropic virus 1 and 2 as a confirmatory test in screening for blood donors. Rev Soc Bras Med Trop. 2010;43(2):111-5. DOI: https://doi.org/10.1590/s0037-86822010000200001
(26). Iwanaga M. Epidemiology of htlv-1 Infection and atl in Japan: An update. Front Microbiol. 2020;29;11:1124. DOI: https://doi.org/10.3389/fmicb.2020.01124
(27). Cardona-Arias JA, Vélez-Quintero C, Calle-González OV, et al. Seroprevalence of human T-lymphotropic virus htlv and its associated factors in donors of a blood bank of Medellín-Colombia, 2014-2018. PLoS One. 2019;14(8):e0221060. DOI: https://doi.org/10.1371/journal.pone.0221060
(28). Yousefi M, Sharifzadeh GR, Ebrahimzadeh A, et al. Prevalence and associated risk factors of htlv-1 and co-infections of blood-borne viruses in Birjand, Iran’s eastern border. Arch Iran Med. 2020;23(10):672-7. DOI: https://doi.org/10.34172/aim.2020.85
(29). Zhao J, Zhao F, Han W, et al. htlv screening of blood donors using chemiluminescence immunoassay in three major provincial blood centers of China. bmc Infect Dis. 2020;20(1):581. DOI: https://doi.org/10.1186/s12879-020-05282-2
(30). Oliveros H. La heterogeneidad en los metaanálisis, ¿es nuestra mejor aliada? Rev Colomb Anestesiol. 2015;43(3):176-8. DOI: https://doi.org/10.1016/j.rca.2015.05.002
Published
How to Cite
Issue
Section
Categories
License
Copyright (c) 2021 University of Antioquia
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
The contents of the articles are the responsibility of the authors
The editorial committee has editorial independence from the National School of Public Health "Héctor Abad Gómez" of the University of Antioquia.
The editorial committee is not responsible for aspects related to copying, plagiarism or fraud that may appear in the articles published in it.
When you are going to reproduce and disclose photographs or personal data in printed or digital format, informed consent is required. Therefore, this requirement is required of the author at the time of receipt of the manuscript.
Authors are responsible for obtaining the necessary permissions to reproduce any material protected by reproduction rights.
The authors preserve the moral rights and assign the economic rights that will correspond to the University of Antioquia, to publish it, distribute electronic copies, include them in indexing services, directories or national and international databases in Open Access, under the Creative Commons Attribution license -Not Commercial-Share Equal 4.0 International Commercial (CC BY-NC-SA) which allows others to distribute, remix, retouch, and create from the work in a non-commercial way, as long as the respective credit and license are granted. new creations under the same conditions.
The authors will sign the declaration of transfer of economic rights to the University of Antioquia, after the acceptance of the manuscript.
The editorial committee reserves the right to reject the articles whose authors do not offer satisfactory explanations about the contribution of each author, to meet the criteria of authorship in the submission letter. All authors must meet the four criteria of authorship according to ICMJE: "a) .- That there is a substantial contribution to the conception or design of the article or to the acquisition, analysis or interpretation of the data. b) That they have participated in the design of the research work or in the critical review of its intellectual content. c) .- That has been intervened in the approval of the final version that will be published.d). That they have the capacity to respond to all aspects of the article in order to ensure that issues related to the accuracy or integrity of any part of the work are adequately investigated and resolved. "
-- 
--
