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Published on: April 6, 2021
Evaluation of COVID-19 Antigen Fluorescence Immunoassay Test for Rapid Detection of SARS-CoV-2
Vandana Vijayeta Kiro1, Ankesh Gupta2, Parul Singh1
1Department of Microbiology (Laboratory Medicine), AIIMS, New Delhi, India.
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.
