COVID‑19 Antigen Fluorescence Immunoassay, 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
Read more