Evaluation of Rapid Antigen Test Results and Real-time Reverse Transcription Polymerase Chain Reaction for the Laboratory Diagnosis of SARS-CoV-2

Introduction: Real-time reverse transcription-polymerase chain reaction (RT-PCR) is the gold standard method for the diagnosis of Severe acute respiratory syndrome-Coronavirus-2 (SARS-CoV-2) infection. However, real-time RT-PCR is time-consuming, expensive, and requires special laboratory conditions and experienced personnel. Thus, the diagnostic importance of faster and easier-to-perform antigen-detecting rapid diagnostic tests (Ag-RDTs) has increased. With on-site application and fast turnaround time, Ag-RDTs provide quick isolation, minimizing the risk of transmission. We aimed to compare the results of the Mö-Screen Corona Antigen Test (MöLab, Langenfeld, Germany) and real-time RT-PCR. Materials and Methods: Nasopharyngeal swabs from 863 patients from January 2022 to March 2022 were included in the study. The SARS-CoV-2 antigen was assessed for using the Mö-Screen Corona Antigen Test. The SARS-CoV-2 real-time RT-PCR results were obtained within two days in 417 patients. Results: The agreeability of the real-time RT-PCR and Ag-RDT results was 96.2%. The sensitivity and specificity of Ag-RDT were 84.8% and 100%, respectively. The test sensitivity increased to 92% in specimens with Ct value <25. Conclusion: The Mö-Screen Corona Antigen Test (MöLab, Langenfeld, Germany), an Ag-RDT test with a high specificity and sensitivity, may be an alternative to real-time RT-PCR for the diagnosis of SARS-CoV-2