Meta-analysis of the diagnostic validity of human immunodeficiency virus screening tests in blood banks, 2000-2020
DOI:
https://doi.org/10.17533/udea.rfnsp.e347170Keywords:
blood bank, enzyme-linked immunosorbent assay (ELISA), meta-analysis, diagnostic validity, human immunodeficiency virus (HIV)Abstract
Objective: To evaluate the diagnostic validity of the enzyme-linked immunosorbent assay (ELISA) for human immunodeficiency virus (HIV) in blood banks, based on studies published between 2000 and 2020.
Methodology: We performed a systematic review and meta-analysis of diagnostic tests, using a random-effects model for the sensitivity, specificity, positive and negative likelihood ratio, diagnostic odds ratio (DOR), and ROC curve, with 95% confidence intervals. Heterogeneity was assessed with the DerSimonian-Laird Q(χ2) statistic and the I2 inconsistency statistic. Uncertainty was assessed using percentage study weights.
Results: 15 studies were included. The third-generation ELISA (antibody detection) was applied for 2,992 infected and 4,076 healthy individuals, and the fourth-generation ELISA (simultaneous antigen-antibody detection) was used for 967 infected and 154,264 healthy individuals. Both showed close to 100% sensitivity, but there was an improved specificity in the fourth-generation assays (98% vs. 100%). Both technologies’ likelihood ratios, DOR, and ROC curve aptly distinguished between healthy and infected individuals.
Conclusion: The third and fourth-generation ELISA were confirmed to have excellent validity and diagnostic utility in blood donors, which is important for HIV control and blood safety policies.
Downloads
References
Tobón J, Toro A. Estudio del paciente con infección por vih. Medicina & Laboratorio [internet]. 2008 [citado 2021, ene. 29]; 14(1-2):11-42 Disponible en: https://www.medigraphic.com/pdfs/medlab/myl-2008/myl081-2b.pdf
Organización Mundial de la Salud (oms). vih/sida [internet]. 2021 [citado 2021, ene. 29]. Disponible en: https://www.who.int/es/news-room/fact-sheets/detail/hiv-aids
Alcamí J, Coiras M. Inmunopatogenia de la infección por el virus de la inmunodeficiencia humana. Enferm Infecc Microbiol Clin. 2011;29(4):297-307. doi: https://doi.org/10.1016/j.eimc.2011.01.006
Organización Mundial de la Salud (oms). Universal access to safe blood transfusion. Global Strategic Plan, 2008-2015 [internet]. 2007 [citado 2020, ene. 29]. Disponible en: http://www.who.int/bloodsafety/StrategicPlan2008-2015AccessSafeBloodTransfusion.pdf
Ghaleb Y, Al-Somainy A, Alamad M, et al. Evaluation of blood transfusion services in public and private blood bank centers, Sana’a capital, Yemen. Inq J Health Care Organ Provis Financ. 2019;56:1-8. doi: https://doi.org/10.1177/0046958019870943
Andrade K, Marinho F, Santos Junior M, et al. Seroprevalence of transfusion-transmissible infectious diseases at a hemotherapy service located in southwest Bahia, Brazil. Hematol Transfus Cell Ther. 2019;41(4):324-28. doi: https://doi.org/10.1016/j.htct.2019.03.007
Aboud S, Urassa W, Lyamuya E, et al. Evaluation of hiv antibody and antigen/antibody combination elisas for use in an alternative confirmatory hiv testing strategy in Dar es Salaam, Tanzania. J Virol Methods. 2006;135(2):192-6. doi: https://doi.org/10.1016/j.jviromet.2006.03.005
Urio L, Mohamed M, Mghamba J, et al. Evaluation of hiv antigen /antibody combination elisas for diagnosis of hiv infection in Dar Es Salaam, Tanzania. Pan Afr Med J. 2015;20:196-202. doi: https://doi.org/10.11604/pamj.2015.20.196.4934
Saville R, Constantine N, Cleghorn F, et al. Fourth-generation enzyme-linked immunosorbent assay for the simultaneous detection of human immunodeficiency virus antigen and antibody. J Clin Microbiol. 2001; 39(7):2518-24. doi: https://doi.org/10.1128/JCM.39.7.2518-2524.2001
Yeom J, Jun G, Chang Y, et al. Evaluation of a new fourth generation enzyme-linked immunosorbent assay, the lg hiv Ag–Ab plus, with a combined hiv p24 antigen and anti-hiv-1/2/O screening test. J Virol Methods. 2006;137(2): 292-7. doi: https://doi.org/10.1016/j.jviromet.2006.07.002
Wesolowski L, Delaney K, Hart C, et al. Performance of an alternative laboratory-based algorithm for diagnosis of hiv infection utilizing a third generation immunoassay, a rapid hiv-1/hiv-2 differentiation test and a dna or rna-based nucleic acid amplification test in persons with established hiv-1 infection and blood donors. J Clin Virol. 2011;52:S45-S49. doi: https://doi.org/10.1016/j.jcv.2011.09.026
Tagny CT, Mbanya D, Leballais L, et al. Reduction of the risk of transfusion-transmitted human immunodeficiency virus (hiv) infection by using an hiv antigen/antibody combination assay in blood donation screening in Cameroon. Transfusion. 2011;51(1):184-90. doi: https://doi.org/10.1111/j.1537-2995.2010.02782.x
Sommerfelt M, Ohlsson I, Flolid I, et al. A simple semi-rapid hiv-1&2 confirmatory immunoassay using magnetic particles. J Virol Methods. 2004;115(2):191-8. doi: https://doi.org/10.1016/j.jviromet.2003.09.031
Higgins J, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. The Cochrane Collaboration; 2011.
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. Bogotá: Ediciones Universidad Cooperativa de Colombia [internet]; 2016. pp. 25-40. 2016 [citado 2021, ene. 29]. Disponible en: http://ediciones.ucc.edu.co/index.php/ucc/catalog/download/24/38/193-1
Moher D, Liberati A, et al. Preferred reporting items for systematic reviews and meta‐analyses: The prisma Statement. Ann Intern Med. 2009;151(4):264-9. doi: https://doi.org/10.7326/0003-4819-151-4-200908180-00135
Whiting P, Rutjes A, Westwood M, et al. quadas-2: A revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med. 2011;155(8):529-36. doi: https://doi.org/10.7326/0003-4819-155-8-201110180-00009
García F, Álvarez M, Bernal C, et al. Diagnóstico de laboratorio de la infección por el vih, del tropismo viral y de las resistencias a los antirretrovirales. Enferm Infecc Microbiol Clin. 2011;29(4):297-307. doi: https://doi.org/10.1016/j.eimc.2010.12.006
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 [internet]. 2011 [citado 2021, ene. 29]. Disponible en: https://www.ins.gov.co/Direcciones/RedesSaludPublica/DonacionSangre/NormatividadRelNalBancosSangro/Anexo%204%20Circular%20082%20de%202011.pdf
Dogbe EE, Arthur F. Diagnostic accuracy of blood centers in the screening of blood donors for viral markers. Pan Afr Med J. 2015; 20:119. doi: https://doi.org/10.11604/pamj.2015.20.119.5263
Ha J, Park Y, Kim H-S. Evaluation of clinical sensitivity and specificity of hepatitis B virus (hbv), hepatitis C virus, and human immunodeficiency Virus-1 by cobas mpx: Detection of occult hbv infection in an hbv-endemic area. J Clin Virol. 2017;96:60-63. doi: https://doi.org/10.1016/j.jcv.2017.09.010
Eller L, Eller M, Ouma B, et al. Large-Scale human immunodeficiency virus rapid test evaluation in a low-prevalence Ugandan blood bank population. J Clin Microbiol. 2007;45(10):3281-5. doi: https://doi.org/10.1128/JCM.00894-07
Lyamuya E, Aboud S, Urassa W, et al. Evaluation of simple rapid hiv assays and development of national rapid hiv test algorithms in Dar es Salaam, Tanzania. bmc Infect Dis. 2009;9(1):19-25. doi: https://doi.org/10.1186/1471-2334-9-19
Tinguely C, Schild-Spycher T, Bahador Z, et al. Comparison of a conventional hiv 1/2 line immunoassay with a rapid confirmatory hiv 1/2 assay. J Virol Methods. 2014; 206:1-4. doi: https://doi.org/10.1016/j.jviromet.2014.05.010
Seyoum E, Wolday D, Mekonen T, et al. Alternative Approach to Blood Screening Using the exavir Reverse Transcriptase Activity Assay. Curr hiv Res. 2005;3(4):371-6. doi: https://doi.org/10.2174/157016205774370438
Malm K, Von-Sydow M, Andersson S. Performance of three automated fourth-generation combined hiv antigen/antibody assays in large-scale screening of blood donors and clinical samples. Transfus Med. 2009;19(2):78-88. doi: https://doi.org/10.1111/j.1365-3148.2009.00907.x
Maity S, Nandi S, Biswas S, et al. Performance and diagnostic usefulness of commercially available enzyme linked immunosorbent assay and rapid kits for detection of hiv, hbv and hcv in India. Virol J. 2012; 9(1): 290-9. doi: https://doi.org/10.1186/1743-422X-9-290
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(1):31-43. doi: https://doi.org/10.1186/1471-2288-6-31
Torres D, Sierra F, Beltrán OA. Cuando la evidencia evalúa pruebas diagnósticas... ¿Qué debemos saber, qué debemos hacer?. Rev Colomb Gastroenterol [internet]. 2004 [citado 2021, ene. 29]; 19(4):281-5. Disponible en: http://www.scielo.org.co/scielo.php?script=sci_arttext&pid=S0120-99572004000400010
Campo L, Gutiérrez L, Cardona J. Infección por Strongyloides stercoralis: metanálisis sobre evaluación de métodos diagnósticos convencionales (1980-2013). Rev Esp Salud Pública. 2014;88(5):581-600. doi: https://doi.org/10.4321/s1135-57272014000500004
Molina M, Ochoa C. Evaluación de la validez de las pruebas diagnósticas (III). Cocientes de probabilidades. Evid Pediatr [internet]. 2016 [citado 2021, ene. 29]; 12:69-71. Disponible en: https://evidenciasenpediatria.es/articulo/7014/evaluacion-de-la-validez-de-las-pruebas-diagnosticas-iii-cocientes-de-probabilidades
Bravo S, Cruz J. Estudios de exactitud diagnóstica: herramientas para su interpretación. Rev Chil Radiol. 2015;21(4):158-64. doi: https://doi.org/10.4067/S0717-93082015000400007
Cerda J, Cifuentes L. Uso de curvas roc en investigación clínica. Aspectos teórico-prácticos. Rev Chil Infect. 2012;29 (2):138-41. doi: https://doi.org/10.4067/S0716-10182012000200003
Sudha T, Teja V, Gopal M, et al. Comparative evaluation of tri-dot Rapid hiv test with fourth-generation elisa for the detection of human immunodeficiency virus. Clin Microbiol Infect. 2005;11(10):850-2. doi: https://doi.org/10.1111/j.1469-0691.2005.01231.x
Programa Conjunto de las Naciones Unidas sobre el vih/sida (ONUsida). 90-90-90 Un ambicioso objetivo de tratamiento para contribuir al fin de la epidemia de sida [internet]. 2015 [citado 2020, feb. 3]. Disponible en: https://www.unaids.org/sites/default/files/media_asset/90_90_90_es.pdf
Organización Mundial de la Salud (oms). La oms publica nuevas directrices sobre el autoanálisis del vih con motivo del Día Mundial del Sida [internet]. 2016 [citado 2020, feb. 3]. Disponible en: https://www.who.int/es/news-room/detail/29-11-2016-who-issues-new-guidance-on-hiv-self-testing-ahead-of-world-aids-day
Organización Mundial de la Salud (oms). Estrategia mundial del sector de la salud contra el vih 2016-2021 Hacia el fin del sida [internet]. 2016 [citado 2020, feb. 3]. Disponible en: https://apps.who.int/iris/bitstream/handle/10665/250574/WHO-hiv-2016.05-spa.pdf;jsessionid=FA62BCA5D63DF9158BE8135556FBC52F?sequence=1
Organización Panamericana de Salud (ops). Servicios de detección del vih [internet]. 2015 [citado 2020, feb. 3]. Disponible en: https://www.paho.org/es/temas/servicios-deteccion-vih
Published
How to Cite
Issue
Section
Categories
License
Copyright (c) 2022 Universidad de 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. "
-- 
--
