The Indian Journal of Chest Diseases and Allied Sciences

Register      Login

VOLUME 64 , ISSUE 3 ( July-September, 2022 ) > List of Articles

Original Article

Viral Load-based Evaluation of the Sensitivity of Antigen-based Rapid Detection Assay for SARS-CoV-2

Madhu Khanna, Mandira Varma Basil, Nilanshu Manocha, Nishtha Agarwal, Varsha Chauhan, Rohan Arora, Anmol Guleria, Chanchal Kumar, Jyoti Choudhary, Anupriya Singh, Kamal Shrivastava, Harish Kumar, Nitin Goel, Sonam Spalgais, Parul Mrigpuri, Raj Kumar

Keywords : Assay sensitivity, COVID-19 pandemic, Rapid antigen test, SARS-CoV-2, Viral load, Viral surveillance

Citation Information : Khanna M, Basil MV, Manocha N, Agarwal N, Chauhan V, Arora R, Guleria A, Kumar C, Choudhary J, Singh A, Shrivastava K, Kumar H, Goel N, Spalgais S, Mrigpuri P, Kumar R. Viral Load-based Evaluation of the Sensitivity of Antigen-based Rapid Detection Assay for SARS-CoV-2. Indian J Chest Dis Allied Sci 2022; 64 (3):196-198.

DOI: 10.5005/jp-journals-11007-0042

License: CC BY-NC 4.0

Published Online: 08-12-2022

Copyright Statement:  Copyright © 2022; The Author(s).


Abstract

Background: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has become a global public health problem. The real-time reverse transcription-polymerase chain reaction (RT-PCR) is the gold standard test for the detection of SARS-CoV-2. However, the assay requires hours to get the final results. Therefore, antigen-based rapid assays are being used extensively to reduce the time. We have evaluated the performance of the antigen-based rapid test for the detection of SARS-CoV-2 virus in comparison with RT-PCR. Materials and methods: Nasopharyngeal and throat swabs were collected from 366 suspected patients of COVID-19 visiting our institute and subjected to qualitative RT-PCR and antigen-based rapid assays to detect the presence of SARS-CoV-2 virus. The sensitivity and specificity of the antigen-based assay were calculated in comparison with RT-PCR. Results: Compared with RT-PCR, sensitivity and specificity of the antigen-based rapid assay were observed to be 70.5% and 98.6%, respectively, in comparison with RT-PCR. However, the sensitivity of antigen-based rapid assay varied significantly with decreasing viral load. The sensitivity of the rapid antigen assay was equivalent to RT-PCR (23/23, 100%) at a higher viral load (Ct value 15–20). In contrast, the antigen assay could only detect 3/21 (14.28%) samples with Ct value >30. Conclusion: The antigen-based assay could assist in the rapid screening of a large population. However, the rapid antigen assay might not detect early stages of infection represented by low viral load. Therefore, the antigen-based assay could not replace RT-PCR testing. The study reiterates that all antigen-based negative tests should be confirmed by RT-PCR.


HTML PDF Share
  1. Zhu H, Wei L, Niu P. The novel coronavirus outbreak in Wuhan, China. Glob Health Res Policy 2020;5:6. DOI: 10.1186/s41256-020-00135-6.
  2. WHO Coronavirus Disease (COVID-19) Dashboard. Available from: https://covid19.who.int.
  3. Lokhandwala S, Gautam P. Indirect impact of COVID-19 on environment: A brief study in Indian context. Environ Res 2020;188: 109807. PMCID: PMC7299871.
  4. Tahamtan A, Ardebili A. Real-time RT-PCR in COVID-19 detection: Issues affecting the results. Expert Rev Mol Diagn 2020;20(5):453–454. DOI: 10.1080/14737159.2020.1757437.
  5. Corman VM, Landt O, Kaiser M, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill 2020; 25(3):2000045. DOI: 10.2807/1560-7917.ES.2020.25.3.2000045.
  6. Jayamohan H, Lambert CJ, Sant HJ, et al. SARS-CoV-2 pandemic: A review of molecular diagnostic tools including sample collection and commercial response with associated advantages and limitations. Anal Bioanal Chem 2021;413(1):49–71. DOI: 10.1007/s00216-020-02958-1.
  7. Chaimayo C, Kaewnaphan B, Tanlieng N, et al. Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand. Virol J 2020;17(1):177. DOI: 10.1186/s12985-020-01452-5.
  8. Nalumansi
  9. To KK-W, Tsang OT-Y, Leung W-S, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: An observational cohort study. Lancet Infect Dis 2020;20(5):565–574. DOI: 10.1016/S1473-3099(20)30196-1.
  10. Liu Y, Yan L-M, Wan L, et al. Viral dynamics in mild and severe cases of COVID-19. Lancet Infect Dis 2020;20(6):656–657. DOI: 10.1016/S1473-3099(20)30232-2.
PDF Share
PDF Share

© Jaypee Brothers Medical Publishers (P) LTD.