Evaluation of COVID-19 antigen fluorescence immunoassay test for rapid detection of SARS-CoV-2

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 STA...

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Bibliographic Details
Published in:Journal of global infectious diseases 2021-04, Vol.13 (2), p.91-93
Main Authors: Kiro, Vandana, Gupta, Ankesh, Singh, Parul, Sharad, Neha, Khurana, Surbhi, S, Prakash, Dar, Lalit, Malhotra, Rajesh, Wig, Naveet, Kumar, Arvind, Trikha, Anjan, Mathur, Purva
Format: Article
Language:English
Subjects:
analyzer
Antigens
Coronaviruses
COVID-19
Evaluation
Fluorescence
fluorescence immunoassay
Immune system
Immunoassay
Medical testing products
Microbiology Report
rapid antigen test
sars-cov-2
Severe acute respiratory syndrome coronavirus 2
Testing
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Summary: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.
ISSN:0974-777X
0974-8245
DOI:10.4103/jgid.jgid_316_20