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

JOURNAL TITLE: The Indian Journal of Chest Diseases and Allied Sciences

Author
1. Jyoti Choudhary
2. Kamal Shrivastava
3. Chanchal Kumar
4. Madhu Khanna
5. Anupriya Singh
6. Raj Kumar
7. Harish Kumar
8. Parul Mrigpuri
9. Nitin Goel
10. Sonam Spalgais
11. Mandira Varma Basil
12. Varsha Chauhan
13. Rohan Arora
14. Anmol Guleria
15. Nilanshu Manocha
16. Nishtha Agarwal
ISSN
0377-9343
DOI
10.5005/jp-journals-11007-0042
Volume
64
Issue
3
Publishing Year
2022
Pages
3
Author Affiliations
    1. Department of Respiratory Virology, Vallabhbhai Patel Chest Institute, University of Delhi, Delhi, India
    1. Department of Microbiology, VP Chest Institute, University of Delhi, New Delhi, India
    1. Department of Virology Unit, VP Chest Institute, University of Delhi, New Delhi, India
    1. Department of Virology Unit, VP Chest Institute, University of Delhi, New Delhi, India
    1. NOVA IVI Fertility, Ahmedabad, Gujarat, India
    1. Department of Microbiology, VP Chest Institute, University of Delhi, New Delhi, India
    1. Department of Microbiology, VP Chest Institute, University of Delhi, New Delhi, India
    1. Ankura Hospital for Women and Children, Hyderabad, Telangana, India
    1. Department of Microbiology, VP Chest Institute, University of Delhi, New Delhi, India
    1. Department of Prosthodontics, Rishiraj College of Dental Sciences and Research Centre, Bhopal, Madhya Pradesh, India
    1. Department of Microbiology, VP Chest Institute, University of Delhi, New Delhi, India
    1. VP Chest Institute, New Delhi, India
    1. Department of pulmonary Medicine ESI-PGIMSR Basaidarapur New Delhi 110015
    1. Department of Pulmonary Medicine, Vallabhbhai Patel Chest Institute, University of Delhi, Delhi, India
    1. Vallabhbhai Patel Chest Institute, University of Delhi, New Delhi, India
    2. Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raibarielly, Lucknow, Uttar Pradesh, India
    3. Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
    4. Vallabhbhai Patel Chest Institute, University of Delhi, Delhi
    5. Trauma Center, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
    6. National Center of Respiratory Allergy, Asthma, and Immunology, Vallabhbhai Patel Chest Institute, University of Delhi, New Delhi, India
    7. All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India
    8. Kanchi Kamakoti CHILDS Trust Hospital and CHILDS Trust Medical Research Foundation, Chennai, Tamil Nadu, India
    9. Max Superspecialty Hospital, Saket, New Delhi, India
    10. Asthma and Immunology (NCRAAI); Vallabhbhai Patel Chest Institute, University of Delhi, New Delhi, India
    11. Max Super Specialty Hospital, New Delhi, India
    12. Vallabhbhai Patel Chest Institute, University of Delhi, Delhi, India
  • Article keywords
    Assay sensitivity, COVID-19 pandemic, Rapid antigen test, SARS-CoV-2, Viral load, Viral surveillance

    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.

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