Diagnostic Efficacy of COVID-19 Rapid Antigen Detection Card in Diagnosis of SARS-CoV-2

Abstract

Introduction The rapid surge of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) cases globally makes it essential for rapid diagnosis of coronavirus disease 2019 (COVID-19). Real-time reverse-transcription polymerase chain reaction (rtRT-PCR) remains as the gold standard to detect COVID-19 cases because of its greater sensitivity and specificity. However, because of its prolonged turnaround time and technical expertise, recommendations have been made to employ the use of rapid diagnostic test for rapid diagnosis and to curb the spread of the disease. Methods This prospective study was performed in a tertiary COVID-19 care hospital located amidst the semi-urban settings. Both nasopharyngeal and throat swabs collected from the COVID 19 suspected study participants were subjected to both COVID 19 rtRT-PCR and rapid antigen testing. Results Of the total 599 samples tested by rtRT-PCR, 310 (52%) were positive and 289 (48%) tested negative for SARS-CoV-2. Of the 599 samples tested by rapid antigen test (RAT), 230 (38%) were positive and 369 (62%) were negative. The overall sensitivity and specificity of our study kit was found to be 74.19 and 100%, respectively. The sensitivity of the RAT greatly overlaps with the viral load which is determined by the cycle threshold (CT) values of SARS-CoV-2, E gene, and RdRp gene. Conclusion RAT yields rapid results within a short-turnaround time and found to be cost effective. Therefore, this test can be adopted in areas with rapid surge in SARS-CoV-2 cases which can help to rapidly identify the positive cases and to implement isolation and infection control measures.

Keywords: SARS-CoV-2; novel corona virus; point of care test; rapid diagnostic test; real-time RT-PCR; sensitivity; specificity.