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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Detalles Bibliográficos
Autores principales: Kiro, Vandana Vijayeta, Gupta, Ankesh, Singh, Parul, Sharad, Neha, Khurana, Surbhi, Prakash, S, Dar, Lalit, Malhotra, Rajesh, Wig, Naveet, Kumar, Arvind, Trikha, Anjan, Mathur, Purva
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2021
Materias:
Microbiology Report
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8213088/
https://www.ncbi.nlm.nih.gov/pubmed/34194176
http://dx.doi.org/10.4103/jgid.jgid_316_20
Descripción
Sumario: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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