Evaluation of rapid antigen test for detection of SARS-COV2 Virus in comparison with real-time reverse transcription-polymerase chain reaction assay

Abstract

Introduction: The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread worldwide. Antigen point-of-care tests are needed to help speed up the testing of SARS-CoV-2. In this study, we evaluated the performance of a rapid SARS-CoV-2 antigen detection assay to the SARS-CoV-2 real-time reverse transcription-polymerase chain reaction (RT-PCR) test. Materials and Methods: COVID-19 infection suspected patients and contact individuals provided 185 respiratory samples (mostly nasopharyngeal and throat swabs) during the study from April to June 2021. The rapid SARS-CoV-2 antigen detection test was compared to the real-time RT-PCR test for SARS-CoV-2 detection in respiratory specimens. Results: By real-time RT-PCR testing, 80 (43.2%) of 185 respiratory samples were positive for SARS-CoV-2 RNA, while 105 (56.8%) were negative. The sensitivity and specificity of the fast SARS-CoV-2 antigen detection test were 63.1% and 90.1%, respectively. Conclusion: The sensitivity and specificity of the fast assay for SARS-CoV-2 antigen detection were comparable to those of the real-time RT-PCR assay. As a result, the rapid and easy SARS-CoV-2 antigen detection test could be used as a screening assay.