Diagnostic utility and performance of rapid antigen test in SARS CoV- 2 in symptomatic and asymptomatic patients during the second pandemic wave in Kashmir, North India

PURPOSE: Real time reverse transcriptase PCR (rRT PCR) although gold standard test for the diagnosis of SARS CoV-2, carries disadvantages of a sophisticated set up, long time to results and centralized services. The rapid antigen tests (RAT) can be used as a primary screening tool with the advantages of rapid turnaround time and ease of use. The study was conducted to determine the performance of rapid antigen test (standard Q COVID 19 Ag) in comparison to rRT PCR in symptomatic patients and asymptomatic contacts and asymptomatic patients with no apparent contact history. METHODS: Nasopharyngeal swabs taken in duplicate from 1034 patients were collected over a 5 months period. These included 248 (23.98%) symptomatic, 386 (37.34%) asymptomatic contacts and 400 (38.68%) asymptomatic subjects who were routinely screened in pre-operative period, as a prerequisite for travel, or pregnant females. Both rRT PCR and RAT were performed as per manufacturers’ instructions. Performance of test in different subgroups of patients was evaluated. Performance of RAT test on basis of duration of illness and Ct values was also analyzed. RESULTS: In this study, 445 (43.04%) were rRT PCR positive, out of which 374 samples were RAT positive as well. 31 samples were RAT positive but PCR negative. The sensitivity, specificity, PPV and NPV of the rapid antigen test was 84.04%, 94.74%, 92.35% and 88.71% respectively. The negative predictive value of the test in asymptomatic patients without any significant contact history was 97.07%. CONCLUSIONS: This study recommends the use of the antigen test as a method of diagnosis for SARS CoV-2. However a negative result with RAT in suspected patients and their contacts should be viewed with caution. This study also finds the utility of using RAT test in the community settings as a screening test in schools, colleges and mass gatherings.