TY - JOUR
T1 - Evaluation of COVID-19 antigen fluorescence immunoassay test for rapid detection of SARS-CoV-2
AU - Kiro, Vandana
AU - Gupta, Ankesh
AU - Singh, Parul
AU - Sharad, Neha
AU - Khurana, Surbhi
AU - Prakash, S.
AU - Dar, Lalit
AU - Malhotra, Rajesh
AU - Wig, Naveet
AU - Kumar, Arvind
AU - Trikha, Anjan
AU - Mathur, Purva
N1 - Publisher Copyright:
© 2021 Wolters Kluwer Medknow Publications. All rights reserved.
PY - 2021/4/1
Y1 - 2021/4/1
N2 - 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.
AB - 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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U2 - 10.4103/jgid.jgid_316_20
DO - 10.4103/jgid.jgid_316_20
M3 - Article
AN - SCOPUS:85122669741
SN - 0974-777X
VL - 13
SP - 91
EP - 93
JO - Journal of Global Infectious Diseases
JF - Journal of Global Infectious Diseases
IS - 2
ER -
