Evaluation of a novel SARS-CoV-2 rapid antigenic test diagnostic value in respiratory samples; is the reported test accuracy similar to values in the real-world? A cross-sectional study

Abstract

Background and Aims: Although reverse transcription-polymerase chain reaction (RT-PCR) assay was introduced as the gold standard to detect SARS-CoV-2, the method was known to be time-consuming besides the requirement for an equipped laboratory. This survey aims to investigate a novel SARS-CoV-2 antigen test as a diagnostic tool in COVID-19 patients to overcome these limitations in addition to evaluating COVID-19 population characteristics. Methods: A retrospective cross-sectional study was carried out during the first semester of 2021, and about 1070 nasopharyngeal samples were collected to compare the E-Health Barakat Company SARS-CoV-2 antigen rapid test results with RT-PCR reports as the reference method. Results: Totally 537 participants were included in this study for employing RT-PCR and the antigen test sequentially. The novel antigen rapid test sensitivity is considered 21.09% in the real world, though 81% in the manufacturer's instruction has been mentioned. Moreover, the most revealed manifestations were found respiratory symptoms and fatigue sensations. Conclusion: This study is the first one on evaluating the SARS-CoV-2 antigen test in our country. Although the novel antigen assay was found quick and easy to perform, the test performance was very disappointing. The extensive false-negative results made it an inappropriate candidate for mass screening.