CC BY-NC-ND 4.0 · J Lab Physicians 2022; 14(03): 324-328
DOI: 10.1055/s-0042-1744237
Original Article

Diagnostic Efficacy of COVID-19 Rapid Antigen Detection Card in Diagnosis of SARS-CoV-2

1   Department of Microbiology, Chettinad Hospital and Research Institute, Kelambakkam, Tamil Nadu, India
,
Lino V. Koshy
1   Department of Microbiology, Chettinad Hospital and Research Institute, Kelambakkam, Tamil Nadu, India
,
Priyadarshini Shanmugam
1   Department of Microbiology, Chettinad Hospital and Research Institute, Kelambakkam, Tamil Nadu, India
› Author Affiliations

Abstract

Introduction The rapid surge of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) cases globally makes it essential for rapid diagnosis of coronavirus disease 2019 (COVID-19). Real-time reverse-transcription polymerase chain reaction (rtRT-PCR) remains as the gold standard to detect COVID-19 cases because of its greater sensitivity and specificity. However, because of its prolonged turnaround time and technical expertise, recommendations have been made to employ the use of rapid diagnostic test for rapid diagnosis and to curb the spread of the disease.

Methods This prospective study was performed in a tertiary COVID-19 care hospital located amidst the semi-urban settings. Both nasopharyngeal and throat swabs collected from the COVID 19 suspected study participants were subjected to both COVID 19 rtRT-PCR and rapid antigen testing.

Results Of the total 599 samples tested by rtRT-PCR, 310 (52%) were positive and 289 (48%) tested negative for SARS-CoV-2. Of the 599 samples tested by rapid antigen test (RAT), 230 (38%) were positive and 369 (62%) were negative. The overall sensitivity and specificity of our study kit was found to be 74.19 and 100%, respectively. The sensitivity of the RAT greatly overlaps with the viral load which is determined by the cycle threshold (CT) values of SARS-CoV-2, E gene, and RdRp gene.

Conclusion RAT yields rapid results within a short-turnaround time and found to be cost effective. Therefore, this test can be adopted in areas with rapid surge in SARS-CoV-2 cases which can help to rapidly identify the positive cases and to implement isolation and infection control measures.

Ethical Approval

This study was approved by the Ethical Committee with proposal no.: 187/IHEC/November2020.


Authors' Contribution

P.S. and A.P.S.R. designed the study. A.P.S.R. and P.S. collected and analyzed the data. L.K., P.S., and A.P.S.R. participated in the manuscript revision. All authors approved the final draft of the manuscript.




Publication History

Article published online:
25 April 2022

© 2022. The Indian Association of Laboratory Physicians. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

Thieme Medical and Scientific Publishers Pvt. Ltd.
A-12, 2nd Floor, Sector 2, Noida-201301 UP, India

 
  • References

  • 1 Mohan A, Tiwari P, Bhatnagar S. et al. Clinico-demographic profile & hospital outcomes of COVID-19 patients admitted at a tertiary care centre in north India. Indian J Med Res 2020; 152 (1, 2): 61-69
  • 2 Banerjee J, Reddy SG, Darapuneni RC, Bilolikar AK. A comparative study: Results of rapid antigen detection assay and real time RT-PCR for diagnosis of COVID-19 in a tertiary care hospital. J Med Sci Res. 2020; 8 (S1): 33-40
  • 3 WHO coronavirus (COVID-19) dashboard. Accessed February 14, 2022 at: https://covid19.who.int/
  • 4 Albert E, Torres I, Bueno F. et al. Field evaluation of a rapid antigen test (Panbio COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres. Clin Microbiol Infect 2021; 27 (03) 472.e7-472.e10
  • 5 Tahamtan A, Ardebili A. Real-time RT-PCR in COVID-19 detection: issues affecting the results. Expert Rev Mol Diagn 2020; 20 (05) 453-454
  • 6 Gupta A, Khurana S, Das R. et al. Rapid chromatographic immunoassay-based evaluation of COVID-19: a cross-sectional, diagnostic test accuracy study & its implications for COVID-19 management in India. Indian J Med Res 2021; 153 (1, 2): 126-131
  • 7 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 (05) 2988-2991
  • 8 Krüttgen A, Cornelissen 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. J Virol Methods 2021; 288: 114024
  • 9 Pérez-García F, Romanyk J, Moya Gutiérrez H. et al. Comparative evaluation of Panbio and SD Biosensor antigen rapid diagnostic tests for COVID-19 diagnosis. J Med Virol 2021; 93 (09) 5650-5654
  • 10 Corman VM, Haage VC, Bleicker T. et al. Comparison of seven commercial SARS-CoV-2 rapid point-of-care antigen tests: a single-centre laboratory evaluation study. Lancet Microbe 2021; 2 (07) e311-e319
  • 11 Yamayoshi S, Sakai-Tagawa Y, Koga M. et al. Comparison of rapid antigen tests for COVID-19. Viruses 2020; 12 (12) 1420
  • 12 Peña M, Ampuero M, Garcés C. et al. Performance of SARS-CoV-2 rapid antigen test compared with real-time RT-PCR in asymptomatic individuals. Int J Infect Dis 2021; 107: 201-204