Abstract
PURPOSE: Real time reverse transcriptase polymerase chain reaction (RT-qPCR) is still considered a gold standard for the diagnosis of COVID-19. However, due to several limitations, use of RT-qPCR is limited in a resource poor setting like North East India. Rapid antigen detection testing kit has revolutionized the diagnosis and management of COVID-19 in India. However, conflicting reports exist regarding the efficacy of the kits for diagnosis of COVID-19. This study aims to highlight the performance of Standard Q COVID-19® Antigen detection kit (SD Biosensor) compared with RT-qPCR in the setup of North East India. METHODS: Nasopharyngeal and oropharyngeal swab samples were collected from consenting patients attending the flu clinic in the period from 1st July to December 31, 2020. Samples were transferred to Viral Research and Diagnostic Laboratory (VRDL) for RT-qPCR test. Antigen detection from the patient samples were undertaken using Standard Q ® COVID-19 antigen detection kit (SD Biosensor, Republic of Korea). Data were then analyzed for comparison between RT-qPCR and antigen kit results. RESULTS: During the study period, 189 samples were collected, out of which 119 were positive by RT-qPCR. Out of 119 positive samples, calculated sensitivity and specificity of the rapid antigen kit was 63% and 100% respectively. Sensitivity and diagnostic accuracy increases in symptomatic patients as compared to asymptomatic patients. Cohen's Kappa coefficient showed a moderate association (0.6) between the kit and RT-qPCR test. The kit performed optimally at a CT value of ≤32.5 for N gene with a predicted sensitivity of 77.3% and specificity of 93.3%. CONCLUSION: The study shows an overall acceptable sensitivity and specificity of the testing kit, with a better performance in symptomatic patients. The association of the kit result is moderate with the results obtained in RT-qPCR. In this study, the rapid antigen test kit performed optimally at N gene qRT PCR cut off value of ≤32.5.