Performance of the SARS-CoV-2 antigen detection test in in nasopharyngeal swabs
Abstract
This work aims to verify the analytical performance of a SARS-CoV-2 virus antigen detection test, under laboratory conditions and compare the result with the RT-PCR performed at the National Institute of Hygiene “Rafael Rangel”-Venezuela, 2020 -2021. 80 nasopharyngeal swab samples from symptomatic patients with suspected COVID-19 with five or fewer days of evolution were included. Of the 80 samples, 14 were positive for SARS-CoV-2 with the rapid test and 66 were classified as negative; These samples were sent to be evaluated with RT-PCR and 56 were positive and 24 were negative. The sensitivity of the rapid antigenic test for SARS-CoV-2 was 19.6%, while the specificity was high at 87.5%. The positive predictive values were adequate, the negative ones very low. The likelihood ratio values were considered not very useful. Despite the low diagnostic power of the test, it can be useful as a test for detecting epidemiological outbreaks, due to its low cost and speed in obtaining a diagnosis; Since it allows us to discard the truly negative ones, it does not have the potential to identify the truly positive ones
References
World Health Organization. Novel Coronavirus (2019-nCoV)-Situation reports. 2020. Disponible en: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports
Rodríguez-Morales AJ, Sánchez-Duque JA, Hernández Botero S, Pérez-Díaz CE, Villamil-Gómez WE, Méndez CA, et al. Preparación y control de la enfermedad por coronavirus 2019 (COVID-19) en América Latina. Acta Medica Peru [Internet]. 2020;37(1):3-7. Disponible en: http://www.scielo.org.pe/pdf/amp/v37n1/1728-5917-amp-37-01-3.pdf DOI: 10.35663/amp.2020.371.909
OPS. Actualización sobre la variante de interés EG.5 y la variante bajo vigilancia BA.2.86. Disponible en: https://www.paho.org/es/noticias/23-8-2023-actualizacion-sobre-variante-interes-eg5-variante-bajo-vigilancia-ba286
Lippi G, Plebani M, Graber ML. Building a bridge to safe diagnosis in health care. The role of the clinical laboratory. Clin Chem Lab Med [Internet]. 2016;54(1):1-3. Disponible en: https://www.degruyterbrill.com/document/doi/10.1515/cclm-2015-1135/html DOI: 10.1515/cclm-2015-1135 PMID 26630697
Shen Z, Xiao Y, Kang L, Ma W, Shi L, Zhang L, et al. Genomic Diversity of Severe Acute Respiratory Syndrome-Coronavirus 2 in Patients With Coronavirus Disease 2019. Clin Infect Dis [Internet]. 2020;71(15):713-20. Disponible en: https://academic.oup.com/cid/article/71/15/713/5780800 DOI: 10.1093/cid/ciaa203 PMID 32129843 PMCID PMC7108196
Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, et al. Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology [Internet]. 2020;296(2):E32-40. Disponible en: https://pubs.rsna.org/doi/10.1148/radiol.2020200642?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed DOI: 10.1148/radiol.2020200642 PMID 32101510 PMCID PMC7233399
Chun L, Linzhu R. Recent progress on the diagnosis of 2019 Novel Coronavirus. Transbound Emerg Dis [Internet]. 2020;67(4):1485-91. Disponible en: https://onlinelibrary.wiley.com/doi/10.1111/tbed.13620 DOI 10.1111/tbed.13620 PMID 32395897 PMCID PMC7272792
da Silva SJR, Silva CTA da, Guarines KM, Mendes RPG, Pardee K, Kohl A, et al. Clinical and Laboratory Diagnosis of SARS-CoV-2, the Virus Causing COVID-19. ACS Infect Dis [Internet]. 2020;6(9):2319-36. Disponible en: https://pubs.acs.org/doi/10.1021/acsinfecdis.0c00274 DOI: 10.1021/acsinfecdis.0c00274 PMID 32786280
Interim Guidance for Rapid Antigen Testing for SARS-CoV-2. Centers for Disease Control and Prevention. 2020. Disponible en: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html
Larremore DB, Wilder B, Lester E, Shehata S, Burke JM, Hay JA, et al. Test sensitivity is secondary to frequency and turnaround time for COVID-19 screening. Sci Adv [Internet]. 2021;7(1). Disponible en: https://www.science.org/doi/10.1126/sciadv.abd5393?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed DOI 10.1126/sciadv.abd5393 PMID 33219112 PMCID PMC7775777
Bravo-Grau S, Cruz Q. JP. Estudios de exactitud diagnóstica: Herramientas para su Interpretación. Rev Chil Radiol [Internet]. 2015;21(4):158-64. Disponible en: https://www.elsevier.es/es-revista-revista-chilena-radiologia-222-articulo-estudios-exactitud-diagnostica-herramientas-su-X0717201X15493805 DOI 10.4067/S0717-93082015000400007
González-Fiallo S, Mena-Rodríguez I, Doeste-Hernández V, Castro-Batista P, Espinosa-Reyes S. Validación de pruebas rápidas de COVID-19. Isla de la juventud, Cuba. Vaccimonitor [Internet]. 2021;30(3):105-14. Disponible en: https://www.redalyc.org/journal/2034/203468846002/203468846002.pdf
Cortés Rubio JA, Costa Zamora MP, Canals Aracil M, Pulgar Feio M, Mata Martínez A, Carrasco Munera A. Evaluación de la prueba diagnóstica de detección rápida de antígeno de COVID-19 (Panbio Covid rapid test) en atención primaria. Semergen [Internet]. 2021;47(8):508-14. Disponible en: https://www.sciencedirect.com/science/article/pii/S1138359321001751?via%3Dihub DOI 10.1016/j.semerg.2021.06.001 PMID 34531125 PMCID PMC8220939
Dinnes J, Sharma P, Berhane S, van Wyk SS, Nyaaba N, Domen J, et al. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection. Cochrane database Syst Rev [Internet]. 2022;7(7):CD013705. Disponible en: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013705.pub3/full DOI 10.1002/14651858.CD013705.pub3 PMID 35866452 PMCID PMC9305720
European Centre for Disease Prevention and Control. Options for the use of rapid antigen tests for COVID-19 in the EU/EEA and the UK. [Internet]. 2020. Disponible en: https://www.ecdc.europa.eu/sites/default/files/documents/Options-use-of-rapid-antigen-tests-for-COVID-19.pdf
Albert E, Torres I, Bueno F, Huntley D, Molla E, Fernández-Fuentes MÁ, et al. Field evaluation of a rapid antigen test (PanbioTM COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres. Clin Microbiol Infect [Internet]. 2021;27(3):472.e7-472.e10. Disponible en: https://www.clinicalmicrobiologyandinfection.org/article/S1198-743X(20)30697-2/fulltext DOI 10.1016/j.cmi.2020.11.004 PMID 33189872 PMCID PMC7662075
Linares M, Pérez-Tanoira R, Carrero A, Romanyk J, Pérez-García F, Gómez-Herruz P, et al. Panbio antigen rapid test is reliable to diagnose SARS-CoV-2 infection in the first 7 days after the onset of symptoms. J Clin Virol [Internet]. 2020;133:104659. Disponible en: https://www.sciencedirect.com/science/article/pii/S1386653220304017?via%3Dihub DOI: 10.1016/j.jcv.2020.104659 PMID 33160179 PMCID PMC7561603
Fenollar F, Bouam A, Ballouche M, Fuster L, Prudent E, Colson P, et al. Evaluation of the Panbio COVID-19 Rapid Antigen Detection Test Device for the Screening of Patients with COVID-19. J Clin Microbiol [Internet]. 2021;59(2):e02589-20. Disponible en: https://journals.asm.org/doi/10.1128/jcm.02589-20?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed DOI 10.1128/JCM.02589-20 PMID 33139420 PMCID PMC8111145
Gremmels H, Winkel BMF, Schuurman R, Rosingh A, Rigter NAM, Rodriguez O, et al. Real-life validation of the PanbioTM COVID-19 antigen rapid test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection. EClinicalMedicine [Internet]. 2021;31:100677. Disponible en: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(20)30421-1/fulltext DOI 10.1016/j.eclinm.2020.100677 PMID 33521610 PMCID PMC7832943
Centre for Disease Prevention and Control (CDC). Interim Guidance for Antigen Testing for SARS-CoV-2 [Internet]. 2020. Disponible en: https://stacks.cdc.gov/view/cdc/113645
Porte L, Legarraga P, Vollrath V, Aguilera X, Munita JM, Araos R, et al. Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples. Int J Infect Dis [Internet]. 2020;99:328-33. Disponible en: https://www.ijidonline.com/article/S1201-9712(20)30405-7/fulltext DOI 10.1016/j.ijid.2020.05.098 PMID 32497809 PMCID PMC7263236
Copyright (c) 2025 María Claret Robertis Colmenares, Amelia Patricia Panunzio Rodríguez, Jennifer Lucila Gotera Zambrano
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Kasmera journal is registered under a Creative Commons an Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0), available at: https://creativecommons.org/licenses/by-nc-sa/4.0/deed.en; which guarantees the freedom to share-copy and redistribute the material in any medium or format and adapt-remix, transform and build from the material, provided that the name of the authors, the Department of Infectious and Tropical Diseases, Zulia´s University and Kasmera Journal, you must also provide a link to the original document and indicate if changes have been made.
The Department of Infectious and Tropical Diseases, University of Zulia and Kasmera Journal do not retain the rights to published manuscript and the contents are the sole responsibility of the authors, who retain their moral, intellectual, privacy and publicity rights. The guarantee on the intervention of the manuscript (revision, correction of style, translation, layout) and its subsequent dissemination is granted through a license of use and not through a transfer of rights, which represents the Kasmera Journal and Department Infectious Diseases, University of Zulia are exempt from any liability that may arise from ethical misconduct by the authors.
Kasmera is considered a green SHERPA/RoMEO journal, that is, it allows self-archiving of both the pre-print (draft of a manuscript) and the post-print (the corrected and peer-reviewed version) and even the final version (layout as it will be published in the journal) both in personal repositories and in institutional and databases.
_pequeño1.png)
_pequeña.png)
_pequeña.png)
_pequeña.jpg)
