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Evaluation of COVID-19 antigen fluorescence immunoassay test for rapid detection of SARS-CoV-2
Vandana Vijayeta Kiro1, Ankesh Gupta2, Parul Singh1, Neha Sharad1, Surbhi Khurana3, Prakash S4, Lalit Dar5, Rajesh Malhotra6, Naveet Wig7, Arvind Kumar7, Anjan Trikha8, Purva Mathur9
1 Department of Microbiology (Laboratory Medicine), AIIMS, New Delhi, India
2 Department of Infectious Diseases, AIIMS, New Delhi, India
3 Department of Laboratory Medicine, AIIMS, New Delhi, India
4 Department of Hospital Administration, AIIMS, New Delhi, India
5 Department of Microbiology, AIIMS, New Delhi, India
6 Department of Orthopedics, AIIMS, New Delhi, India
7 Department of Medicine, AIIMS, New Delhi, India
8 Department of Anaesthesia and Critical Care, AIIMS, New Delhi, India
9 Department of Laboratory Medicine (Microbiology Division), JPNATC, AIIMS, New Delhi, India
Correspondence Address:
Dr. Purva Mathur
Department of Laboratory Medicine, Division of Clinical Microbiology, JPNATC, AIIMS, New Delhi - 110 029,
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/jgid.jgid_316_20
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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.
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