CC BY-NC-ND 4.0 · J Lab Physicians 2022; 14(04): 398-402
DOI: 10.1055/s-0042-1744241
Original Article

Clinical Validation of Standard Q COVID-19 Antigen and IgM/IgG Combo Kit Assay at a Tertiary Care Center in Northern India

Parul Singh
1   Department of Microbiology, Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi, India
,
Vandana V. Kiro
1   Department of Microbiology, Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi, India
,
Sharad Srivastav
1   Department of Microbiology, Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi, India
,
Rajesh Malhotra
2   Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi, India
,
Purva Mathur
1   Department of Microbiology, Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi, India
› Institutsangaben

Abstract

Background Expansion of the testing capacities for severe acute respiratory syndrome-coronavirus-2 is an important issue in the face of ever-increasing case load. So, there is need of point-of-care diagnostic tests in the existing laboratory capacities for early treatment, isolation, and clinical decision making, especially in resource limited settings.

Materials and Methods This prospective cohort study was conducted at Jai Prakash Narayan Apex Trauma Center, All India Institute of Medical Sciences, New Delhi. Nasopharyngeal samples and blood samples were collected for antigen and antibody testing. Rapid antigen test was performed as per the kit's instructions. The performance of the kit was compared with the gold standard reverse transcription polymerase chain reaction (RT-PCR) testing.

Results Eighty-eight out of 110 patients tested positive by RT-PCR for coronavirus disease 2019 in last 48 to 72 hours were included in the study. Overall, the sensitivity of combined antibody test was 52%, antigen test 26%, and combined sensitivity of both antigen and antibody was 72.7%, respectively.

Conclusion The combo kit needs to be used with caution in low prevalence settings, where cases may be missed.



Publikationsverlauf

Artikel online veröffentlicht:
19. 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/)

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  • References

  • 1 WHO Coronavirus Disease (COVID-19) Dashboard [Internet]. [cited 16 june2021]. Accessed February17, 2022 from: https://covid19.who.int
  • 2 Sethuraman N, Jeremiah SS, Ryo A. Interpreting diagnostic tests for SARS-CoV-2. JAMA 2020; 323 (22) 2249-2251 [CrossRef] [PubMed]
  • 3 Yamayoshi S, Sakai-Tagawa Y, Koga M, Akasaka O, Nakachi I, Koh H. et al. Comparison of rapid antigen tests for COVID-19. Viruses 2020; 12: 1420 DOI: 10.3390/v12121420.
  • 4 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 2020; ••• : Epub ahead of print DOI: 10.4103/ijmr.IJMR_3305_20.
  • 5 Japanese Ministry of Health, Labour and Welfare, 2020, Approval of in vitro diagnostics for the novel coronavirus infection. Japanese Ministry of Health, Labour and Welfare, Tokyo, Japan. https://www.mhlw.go.jp/content/11124500/000632304.pdf . Accessed February 17, 2022
  • 6 Oh JM, Venters CC, Di C. et al. U1 snRNP regulates cancer cell migration and invasion in vitro. Nat Commun 2020; 11 (01) 1-5
  • 7 Bastos ML, Tavaziva G, Abidi SK. et al. Diagnostic accuracy of serological tests for COVID-19: systematic review and meta-analysis. BMJ 2020; x: 370
  • 8 Lin D, Liu L, Zhang M. et al. Evaluations of the serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak. Eur J Clin Microbiol Infect Dis 2020; 39 (12) 2271-2277
  • 9 Nagura-Ikeda M, Imai K, Tabata S. et al. Clinical evaluation of self-collected saliva by RT-qPCR, direct RT-qPCR, RT-LAMP, and a rapid antigen test to diagnose COVID-19. J Clin Microbiol 2020
  • 10 Imai K, Tabata S, Ikeda M. et al. Clinical evaluation of an immunochromatographic IgM/IgG antibody assay and chest computed tomography for the diagnosis of COVID-19. J Clin Virol 2020; 128: 104393 DOI: 10.1016/j.jcv.2020.104393.
  • 11 Indian Council of Medical Research. Advisory on Use of Rapid Antigen Detection Test for COVID-19. Accessed February 17, 2022 from: https://www.icmr.gov.in/pdf/covid/strategy/Advisory_for_rapid_antigen_test14062020.pdf
  • 12 Kubina R, Dziedzic A. Molecular and serological tests for COVID-19 a comparative review of SARS-CoV-2 coronavirus laboratory and point-of-care diagnostics. Diagnostics (Basel) 2020; 10 (06) 434
  • 13 Singh S. Rapid antibody-based tests for the diagnosis of COVID-19: a bigger epidemic of unscientific practices. J Lab Physicians 2020; 12 (01) 1-2