Evaluation of COVID‑19 Antigen Fluorescence Immunoassay

Vandana Vijayeta Kiro, Ankesh Gupta1, Parul Singh, Neha Sharad, Surbhi Khurana2,, Prakash S3
, Lalit Dar4, Rajesh Malhotra5, Naveet Wig6, Arvind Kumar6,Anjan Trikha7, Purva Mathur

COVID‑19 Antigen Fluorescence Immunoassay

Evaluation of COVID‑19 Antigen Fluorescence Immunoassay: Tests detecting SARS‑CoV‑2‑specific antigens 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 the STANDARD F COVID‑19 antigen fluorescence immunoassay (FIA) kit. Methods: Nasopharyngeal samples collected from patients were subjected to the test as per the 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 the 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.

Introduction

The coronavirus pandemic has infected more than 13.8 million people and killed more than 590,000 worldwide since late January 2020, when this disease was first reported. The enormous gap between a large number of patients or contacts and the laboratory capacities to perform real‑time polymerase chain reaction (RT‑PCR) in a timely manner is a major challenge to the current public health containment
strategies. Antibody tests in the market that could potentially indicate a person’s immunity have been unreliable so far. Therefore, there is a need for alternative assays such as antigen detection tests, which, in contrast to antibody tests, can detect the presence of the virus.

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