medigraphic.com
ISSN 1527-3172 (Electronic)

2022, Number 2

<< Back Next >>

MEDICC Review 2022; 24 (2)

Evaluation of SARS-CoV-2 Rapid Antigen Tests in Use on the Isle of Youth, Cuba

González-Fiallo S, Mena-Rodríguez I, Castro-Batista P, Doeste-Hernández VM, Louit-Laborit V

Language: English
References: 31
Page: 15-19
PDF size: 158.71 Kb.


ABSTRACT

INTRODUCTION The use of various diagnostic techniques is increasingly common in pandemic scenarios. It is important to update evaluations of their metric properties in different times and settings.
OBJECTIVE Evaluate metric properties of a SARS-CoV-2 rapid antigen test relative to a reference standard.
METHODS We carried out a prospective evaluation study of the SARS-CoV-2 rapid antigen test as compared to the RT-PCR test, which is considered the reference standard. Our sample was comprised of 778 individuals, and we calculated sensitivity, specificity, predictive values, prevalence and validity indices.
RESULTS Of the total 778 samples, 70 were true positives, 658 were true negatives, and 27 were false negatives when compared to RT-PCR test results. We obtained a sensitivity of 75.3% (95% CI = 65.96–84.50); a specificity of 96.1% (95% CI = 94.53–97.59); 72.2% for positive predictive value, and 96.6% for negative predictive value. The estimated prevalence was 11.9% and the validity index was 93.6%.
CONCLUSIONS The index values validate use of the SARS- CoV-2 rapid antigen test until prevalence falls below 2.5%, since as SARS-CoV-2 infection prevalence decreases, so does the predictive value of the PCR result.
The use of the SARS-CoV-2 rapid antigen test on the Isle of Youth, Cuba, was decisive in the pandemic’s clinical– epidemiological management.


REFERENCES

  1. Cañete Villafranca R, Noda Albelo AL, FerreiraMoreno V, Brito Pérez K, García Herrera AL.SARS-Cov-2, el virus emergente que causala pandemia de COVID-19. Rev Med ElectrónMatanzas [Internet]. 2020 May–Jun [cited 2021May 17];42(3):1862–81. Available at: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1684-18242020000301862&lng=es. Spanish.

  2. Folgueira López ME. Utilización del test de detecciónde antígeno de SARS-CoV-2 en exudadonasofaríngeo para el control de la infecció+n porCOVID-19. Rev Esp Quimioter [Internet]. 2020Dec [cited 2021 Apr 25];33(6):390–1. Availableat: https://seq.es/abstract/rev-esp-quimioter-2020-november-24. https://doi.org/10.37201/req/127.2020. Spanish.

  3. Bachelet VC. ¿Conocemos las propiedades diagnósticasde las pruebas usadas en COV- ID-19?Una revisión rápida de la literatura reci- entementepublicada. Medwave. 2020 Apr 28;20(3):e7890.https://doi.org/10.5867/medwave.2020.03.7891.Spanish, English.

  4. Mojica Crespo R, Morales Crespo MM. PandemiaCOVID-19, la nueva emergencia sanitariade preocupación internacional: una revisión.Semergen. 2020 Aug;46 Suppl 1:65–77. Availableat: https://www.sciencedirect.com/science/article/pii/S1138359320301714. https://doi.org/10.1016/j.semerg.2020.05.010. Spanish.

  5. Sheridan C. Fast, portable tests comeonline to curb coronavirus pandemic. Nat Biotechnol.2020 May;38(5):515–8. https://doi.org/10.1038/d41587-020-00010-2.

  6. Aleaga Santiesteban Y, Sanabria Negrín JG.Evaluación de los test rápidos en el HospitalGeneral de Bata, Guinea Ecuatorial. Rev CienciasMédicas [Internet]. 2015 Nov–Dec [cited2021 Apr 25];19(6):1201–9. Available at: https://www.researchgate.net/publication/317514943_Evaluacion_de_los_test_rapidos_en_el_Hos pital_General_de_Bata_Guinea_Ecuatorial. Spanish.

  7. Bravo Grau S, Cruz JP. Estudios de exactituddiagnóstica: herramientas para su interpretación.Rev Chil Radiol [Internet]. 2015 [cited 2021 Apr20];21(4):158–64. Available at: https://scielo.conicyt.cl/pdf/rchradiol/v21n4/art07.pdf. Spanish.

  8. Redacción Médica [Internet]. Madrid: RedacciónMédica; c2004-2022. SANIDAD HOY. Coronavirus:OMS apela al “test, test, test” para evitarmuertes en niños; 2020 Mar 16 [cited 2021Jan 15]; [about 2 p.]. Available at: https://www.redaccionmedica.com/secciones/sanidad-hoy/coronavirus-oms-apela-al-test-test-test-para-evitar-muertes-en-ninos-5431. Spanish.

  9. World Health Organization. Implementaciónde la prueba rápida de detección deantíge- nos para COVID-19 – Estudio piloto.Geneva: World Health Organization; 2020 Oct27 [cited 2021 April 25]. 4 p. Available at: https://docs.bvsalud.org/biblioref/2020/10/1127580/ops-implementacion-prd-ag.pdf. Spanish.

  10. Bulilete O, Lorente P, Leiva A, Carandell E,Oli- ver A, Rojo E, et al. Evaluation of the Panbio™ rapid antigen test for SARS-CoV-2 inprimary health care centers and test sites.medRx- iv [Preprint]. 2020 Nov 16. https://doi.org/10.1101/2020.11.13.20231316

  11. Iglὁi Z, Velzing J, van Beek J, van de Vijver D,Aron G, Ensing R, et al. Clinical evaluation ofthe Roche/SD Biosensor rapid antigen testwith symptomatic, nonhospitalized patients ina municipal health service drive-through testingsite. medRxiv [Preprint]. 2020 Nov 20. https://doi.10.3201/eid2705.204688

  12. Pollock NR, Jacobs JR, Tran K, CranstonAE, Smith S, O’Kane CY, et al. Performanceand implementation evaluation of the AbbottBinaxNOW rapid antigen test in a high-throughputdrive-through community testing site in Massachusetts.J Clin Microbiol. 2021 Apr 20. https://doi.org/10.1128/jcm.00083-21

  13. Pilarowski G, Márquez C, Rubio L, Peng J, MartínezJ, Black D, et al. Field performance andpublic health response using the BinaxNOWTM rapid Severe Acute Respiratory SyndromeCoronavirus 2 (SARSCoV-2) antigen detectionassay during community-based testing. ClinInfect Dis [Internet]. 2021 Nov 1 [cited 2021 Nov29];73(9):e3098–101. Available at: https://academic.oup.com/cid/article/73/9/e3098/6052342

  14. Shah M, Salvatore PP, Ford L, Kamitani E,Whal- ey MJ, Mitchell K, et al. Performanceof repeat BinaxNOW Severe Acute RespiratorySyndrome Coronavirus 2 antigen testing ina community setting, Wisconsin, November2020–Decem- ber 2020. Clin Infect Dis. 2021 Jul

  15. 15;73(Suppl1):S54–7. https://doi.org/10.1093/cid/ciab30915. Mboma O, Rieke E, Ahmad-Nejad P, Wirth S,Aydin M. Diagnostic performance of SARS-CoV-2rapid antigen test in a large, German cohort. Children[Internet]. 2021 [cited 2021 Nov 29];8:682.https://doi.org/10.3390/children8080682

  16. World Health Organization. Geneva: WorldHealth Organization; c2022. Publications. Overview.Antigen-detection in the diagnosis of SARSCoV-2 infection: Interim guidance; 2021 Oct 6. 20p. Available at: https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays

  17. Pelegrino Martínez de la Cotera JL, RodríguezLay L, Guzmán Tirado MG. Evaluación de laprueba inmunocromatográfica Sars-Cov-2 Rapidantigen test para detectar antígenos de Sars-Cov-2. Rev Cubana Med Trop [Internet]. 2021Aug 1 [cited 2021 Nov 29];73(2):e682. Availableat: http://www.revmedtropical.sld.cu/index.php/medtropical/article/view/682/523. Spanish.

  18. Thell R, Kallab V, Weinhappel W, Mueckstein W,Heschl L, Heschl M, et al. Evaluation of anovel, rapid antigen detection test for the diagnosisof SARS-CoV-2. PLoS One. 2021 Nov29;16(11):e0259527. https://doi.org/10.1371/journal.pone.0259527

  19. Mboumba Bouassa RS, Veyer D, Péré H, BélecL. Analytical performances of the point-of-careSIENNA™COVID-19 antigen rapid test for thedetection of SARS-CoV-2 nucleocapsid proteinin nasopharyngeal swabs: a prospectiveevaluation during the COVID-19 second wave inFrance. Int J Infect Dis. 2021 May 1;106:8–12.https://doi.org/10.1016/j.ijid.2021.03.051 PMID:33746093.

  20. Foundation for Innovative New Diagnostics. FINDevaluation of SD Biosensor, Inc. STANDARD™FCOVID-19 Ag FIA. External Report Version 2.1,10 December 2020 [Internet]. Geneva: Foundationfor Innovative New Diagnostics; 2020 Dec[cited 2021 Dec 6]. 5 p. Available at: https://www.finddx.org/wp-content/uploads/2020/12/STANDARD_F_Ag-Public-Report_20201210-v2-1.pdf

  21. Liotti FM, Menchinelli G, Lalle E, Palucci I, MarchettiS, Colavita F, et al. Performance of a noveldiagnostic assay for rapid SARS-CoV-2 antigendetection in nasopharynx samples. Clin MicrobiolInfect. 2020 Mar 1;27:487–8. https://doi.org/10.1016/j.cmi.2020.09.030 PMID: 32979567.

  22. Weitzel T, Legarraga P, Iruretagoyena M, PizarroG, Vollrath V, Araos R, et al. Comparative evaluationof four rapid SARS-CoV-2 antigen detectiontests using universal transport medium.Travel Med Infect Dis. 2020;39:101942. https://doi.org/10.1016/j.tmaid.2020.101942 PMID: 33278609.

  23. Gupta A, Khurana S, Das R, Srigyan D, SinghA, Mittal A, et al. Rapid chromatographic immunoassaybasedevaluation of COVID-19: a crosssectional,diagnostic test accuracy study & itsimplications for COVID-19 management in India.Indian J Med Res. 2020;153(1):126. https://doi.org/10.4103/ijmr.IJMR_3305_20.

  24. Ministry of Health (AR). Consenso sobre el usode pruebas diagnósticas para SARS-CoV-2[Internet]. Caba (AR): Sociedad Argentina deMedicina; 2021 May [cited 2021 Dec 2]. 42 p.Available at: https://www.samsociedad.com.ar/noticia/consenso-sobre-el-uso-de-pruebas-diagn-sticas-para-sars-cov-2-/1124. Spanish.

  25. World Health Organization [Internet]. Geneva:World Health Organization; c2022. Todo IRIS.Esta Colección. Realización de pruebas dediagnóstico de la COVID-19 en el contexto delos viajes internacionales. Nota científica, 16 dediciembre 2020; 2020 Dec 16 [cited 2021 Dec2]. 5 p. Available at: https://apps.who.int/iris/handle/10665/339883. Spanish.

  26. Acta Sanitaria [Internet]. Madrid: Acta Sanitaria;c2022. Tecnología e Investigación. La OMSadvierte de la disminución del valor predictivopositivo de las PCR para Covid-19; 2021 Jan22 [cited 2021 Jun 4]; [about 2 p.]. Available at:https://www.actasanitaria.com/oms-predictivo-pcr/. Spanish.

  27. European Centre for Disease Prevention andControl. Technical Report. Options for the use ofrapid antigen tests for COVID-19 in the EU/EEAand the UK [Internet]. Stockholm County (SE):European Centre for Disease Prevention andControl; 2020 Nov 19 [cited 2021 Nov 29]. 22 p.Available at: https://www.ecdc.europa.eu/sites/default/files/documents/Options-use-of-rapid-antigen-tests-for-COVID19-19-11-2020.pdf

  28. Berger A, Ngo Nsoga MT, Pérez Rodríguez FJ,Diagnostic accuracy of two commercial SARSCoV-2 Antigen-detecting rapid tests at the pointof care in community-based testing centers.PloS One. 2021 Mar 31;16(3):e0248921. https://doi.org/10.1371/journal.pone.0248921. PMID:33788882; PMCID: PMC8011749.

  29. Takeuchi Y, Akashi Y, Kato D, Kuwahara M, MuramatsuS, Ueda A, et al. The evaluation of a newlydeveloped antigen test (QuickNaviTM-COVID19Ag) for SARS-CoV-2: a prospective observationalstudy in Japan. J Infect Chemother. 2021Jun 1; 27(6):890–4. https://doi.org/10.1016/j.jiac.2021.02.029

  30. Gili A, Paggi R, Russo C, Cenci E, Pietrella D,Graziani D, et al. Evaluation of Lumipulse GSARS-CoV-2 antigen assay automated test fordetecting SARS-CoV-2 nucleocapsid protein(NP) innasopharyngeal swabs for community andpopulation screening. 2021. Int J Infect Dis. 2021Apr 1;105:391–6. https://doi.org/10.1016/j.ijid.2021.02.098

  31. Thirion-Romero I, Guerrero-Zúñiga S, Arias-Mendoza A, Cornejo Juárez DP, Meza-MenesesP, Torres-Erazo DS, et al. Evaluation of Panbiorapid antigen test for SARS-CoV-2 in symptomaticpatients and their contacts: a multicenter study.Int J Infect Dis. 2021 Dec 1;113:218–24. https://doi.org/10.1016/j.ijid.2021.10.027




2020     |     www.medigraphic.com