Comparison of the Rapid Antigen Test to RT-qPCR in Diagnosis of SARS-CoV-2: A University Experience in Northern Cyprus

Year 2023, , 525 - 529, 11.09.2023

Emrah Güler , Ferdiye Taner , Erdal Şanlıdağ , Pinar Tulay , Mahmut Cerkez Ergoren , Buket Baddal , Cenk Serhan Özverel , Gülten Tuncel , Kaya Süer , Tamer Şanlıdağ

https://doi.org/10.33808/clinexphealthsci.1082079

Abstract

Objective: As an alternative to RT-qPCR assays used in the diagnosis SARS-CoV-2, antigen-detecting rapid diagnostic tests (Ag-RDTs) are available for the qualitative detection of SARS-CoV-2 in nasopharyngeal swab samples. The aim of this study was to assess the accuracy and reliability of Ag-RDTs as a diagnostic method of detecting SARS-CoV-2 positive cases within a given population.
Methods: In first phase of this investigation, 357 nasopharyngeal swab samples were screened for SARS-CoV-2 using Ag-RDTs. For the purposes of this study RT-qPCR was then applied to the same 357 nasopharyngeal swab samples in order to compare the reliability of the two detection methods. In the second phase of this investigation, Ag-RDTs were applied to an additional 75 nasopharyngeal swab samples that were already known to be RT-qPCR positive.
Results: In the first phase of this investigation, of the 357 samples screened using Ag-RDTs 14 samples were positive for SARS-CoV-2, in contrast, when RT-qPCR analysis was applied to the same 357 samples no SARS-CoV-2 samples were detected. Therefore, the false antigen positivity was determined to be at 3.9%. In the second phase of this investigation 75 RT-qPCR positive samples were re-evaluated with a rapid antigen test. Twenty-four of the 75 RT-qPCR positive sample were undetected.
Conclusion: Solely relying on rapid antigen tests to detect SARS-CoV-2 infections in the community could consequently result in infectious individuals remaining in the population. The impact of false negative rapid test results can be reduced by implementing confirmatory RT-qPCR analysis particularly in symptomatic patients.

Keywords

SARS-CoV-2, RT-qPCR, Antigen, Test, Northern Cyprus

References

• Berger A, Ngo Nsoga MT, Perez-Rodriguez FJ, Abi Aad Y, Sattonnet-Roche P, Gayet-Ageron A, Jaksic C, Torriani G, Boehm E, Kronig I, Sacks JA, de Vos M, Bausch FJ, Chappuis F, Renzoni A, Kaiser L, Schibler M, Eckerle I. Diagnostic accuracy of two commercial SARS-CoV-2 antigen-detecting rapid tests at the point of care in community-based testing centers. PLoS ONE 2021;16(3):e0248921.
• Jakobsen KK, Jensen JS, Todsen T, Lippert F, Jean-Marie Martel C, Klokker M, von Buchwald C. Detection of SARS-CoV-2 infection by rapid antigen test in comparison with RT-PCR in a public setting. January 25, 2021. DOI:10.1101/2021.01.22.21250042
• Krüttgen A, Gornelissen CG, Dreher M, Hornef MW, Imöhl M, Kleines M. Comparison of the SARS-CoV-2 Rapid antigen test to the real star SARS-CoV-2 RT PCR kit. Journal of Virological Methods 2021;288:114024.
• World Health Organization (WHO). Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays: Interim guidance. 06 October 2021, COVID-19: Laboratory and diagnosis. Access date: 30 December 2022. Available from: https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays
• Mak GCK, Cheng PKC, Lau SSY, Wong KKY, Lau GS, Lam ETK, Chan RCW, Tsang DNC. Evaluation of rapid antigen test for detection of SARS-CoV-2 virus. Journal of Clinical Virology 2020;129:104500.
• Pay IW, Ford L, Cole D, Lee C, Bigouette JP, Abedi GR et al. Performance of an Antigen-Based Test for Asymptomatic and Symptomatic SARS-CoV-2 Testing at Two University Campuses-Wisconsin, September-October 2020. Morbidity and Mortality Report 2021;69:51-52.
• Altındiş M, Toptan H. SARS CoV 2 Laboratory Diagnosis. J Biotechnol and Strategic Health Res 2020;1(Special issue):76-84.
• World Health Organization (WHO). SARS-CoV-2 antigen-detecting rapid diagnostic tests: An implementation guide. 21 December 2020, COVID-19: Laboratory and diagnosis. Access date: 30 December 2022. Available from: https://www.who.int/publications/i/item/9789240017740
• CovidNow SARS-CoV-2 Assay. Instructions for Use-For Emergency Use Authorization (EUA) Only For In-Vitro Diagnostic Use Rx only. 14 October 202. Access date: 30 December 2022. Available from: https://www.fda.gov/media/153175/download
• Abusrewil Z, Alhudiri IM, Kaal HH, El Meshri SE, Ebrahim FO, Dalyoum T, Efrefer AA, Ibrahim K, Elfghi MB, Abusrewil S, Elzagheid A. Time scale performance of rapid antigen testing for SARS-CoV-2: Evaluation of 10 rapid antigen assays. J Med Virol 2021;93(12):6512-6518.
• Ciotti M, Maurici M, Pieri M, Andreoni M, Bernardini S. Performance of a rapid antigen test in the diagnosis of SARS-CoV-2 infection. J Med Virol 2021;93;2988-2991.
• Peña M, Ampuerob M, Garcés C, Gaggero A, García P, Velasquez MS, Luza R, Alvarez P, Paredes F, Acevedo J, Farfan MJ, Solari S, Soto-Rifo R, Valiente-Echeverria F. Performance of SARS-CoV-2 rapid antigen test compared with real-time RT-PCR in asymptomatic individuals. Internatoinal Journal of Infectious Diseases 2021;107:201-204.
• Landaas ET, Storm ML, Tollånes MC, Barlinn R, Kran AMB, Bragstad K, Christensen A, Andreassen T. Diagnostic performance of a SARS-CoV-2 rapid antigen test in a large, Norwegian cohort. Journal of Clinical Virology 2021;137:104789.
• Barrera-Avalos C, Luraschi R, Vallejos-Vidal E, Mella-Torres A, Hernández F, Figueroa M, Rioseco C, Valdés D, Imarai M, Acuña-Castillo C, Reyes-López FE, Sandino AM. The Rapid Antigen Detection Test for SARS-CoV-2 Underestimates the Identification of COVID-19 Positive Cases and Compromises the Diagnosis of the SARS-CoV-2 (K417N/T, E484K, and N501Y) Variants. Front. Public Health 9:780801.
• Centers for Disease Control and Prevention (CDC). COVID-19. Guidance for Antigen Testing for SARS-CoV-2 for Healthcare Providers Testing Individuals in the Community, 04 April 2022. Access date: 30 December 2022. Available from: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html