Evaluation of the COVID-19 diagnostic performance of Rapiim SARS-CoV-2-H, the highly sensitive SARS-CoV-2 antigen qualitative test kit

Abstract

We evaluated the diagnostic performance of Rapiim SARS-CoV-2-H (Rapiim-H)—a point-of-care qualitative antigen test—using nasopharyngeal swabs (NPS) and saliva samples and compared its results with those from antigen quantification and nucleic acid amplification tests. NPS and saliva were collected from patients with confirmed and suspected coronavirus disease (COVID-19). In total, 142 NPS and saliva samples were collected. In symptomatic cases, in which the first NPS sample was collected within 10 days of disease onset, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for COVID-19 diagnosis were 91.7%, 88.6%, 93.2%, and 86.1%, respectively. A similar analysis was performed on saliva samples, and the sensitivity, specificity, PPV, and NPV were 50.8%, 91.4%, 91.2%, and 51.6%, respectively. The Rapiim-H test using NPS demonstrated approximately 90% sensitivity and specificity, particularly within the first 10 days after disease onset.