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. 2021 May 31;13(2):91-93.
doi: 10.4103/jgid.jgid_316_20. eCollection 2021 Apr-Jun.

Evaluation of COVID-19 Antigen Fluorescence Immunoassay Test for Rapid Detection of SARS-CoV-2

Vandana Vijayeta Kiro  1 , Ankesh Gupta  2 , Parul Singh  1 , Neha Sharad  1 , Surbhi Khurana  3 , S Prakash  4 , Lalit Dar  5 , Rajesh Malhotra  6 , Naveet Wig  7 , Arvind Kumar  7 , Anjan Trikha  8 , Purva Mathur  9
Affiliations

Evaluation of COVID-19 Antigen Fluorescence Immunoassay Test for Rapid Detection of SARS-CoV-2

Vandana Vijayeta Kiro et al. J Glob Infect Dis. .

Abstract

Introduction: Tests detecting SARS-CoV-2-specific antigen have recently been developed, and many of them are now commercially available. However, the real-world performance of these assays is uncertain; therefore, their validation is important. In this study, we have evaluated the performance of STANDARD F COVID-19 antigen fluorescence immunoassay (FIA) kit.

Methods: Nasopharyngeal samples collected from patients were subjected to the test as per manufacturer's instructions. The performance of the kit was compared with the gold standard real-time polymerase chain reaction.

Results: A total of 354 patients were tested with STANDARD F COVID-19 antigen FIA test kit. The overall sensitivity, specificity, positive predictive value, and negative predictive value of this test were found to be 38%, 99%, 96.2%, and 72%, respectively, with a diagnostic accuracy of 75.7%.

Conclusion: STANDARD F COVID-19 antigen FIA showed high specificity and positive predictive value but low sensitivity and negative predictive value.

Keywords: Analyzer; COVID-19; SARS-CoV-2; fluorescence immunoassay; rapid antigen test.

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Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Receiver operator curve: Performance of antigen fluorescence immunoassay test
See this image and copyright information in PMC

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