Background: COVID-19 rapid antigen test plays a crucial role in managing the COVID-19 pandemic by diagnosing COVID-19 infection. However, the sensitivity and specificity of rapid antigen tests are not known because there are no adequate studies to substantiate. While PCR-tests are considered as the gold standard assay to confirm infection with the SARS-CoV-2 infection because of their sensitivity as well as specificity, antigen tests offer more advantages in terms of low cost, time, space constraints and personnel involved and are implemented in testing strategies around the world and antigen testing can be deployed for testing many individuals, considering their advantages cited above. Objectives: The aim of this study was to assess the diagnostic accuracy (sensitivity, specificity, positive predictive value and negative predictive value) of STANDARD Q rapid antigen test kit in diagnosing SARS-CoV-2 infection in a tertiary care testing facility and compare it with the standard RT- PCR test. Methods: The patients reporting to COVID-19 sample collection center of the tertiary care testing facility were included in the study after getting proper consent. A total of 400 patients were involved in the study. Nasopharyngeal swabs were obtained from the study participants and the STANDARD Q rapid antigen test was run in parallel with real-time PCR tests and both the results were documented. Results: Among the 400 patients who were included in the study, RT-PCR was positive in 95 individuals, with a prevalence of 23.75% and negative in 305 patients (76.25%). The sensitivity of the rapid antigen test was 88.4% and the specificity was 100 %. The positive and negative predictive values were 100% and 96.52% respectively. Conclusion: The accuracy of the SARS-CoV-2 STANDARD Q rapid antigen test in diagnosing SARS-CoV-2 infections in a tertiary care testing facility was almost equal when compared with the manufacturer’s data. However they can be used for mass screening purposes considering their ease of use, portability and convenience. The Area under the Curve (AUC) is 0.942 which signifies that the kit can distinguish well between the true positive and true negative.

Background: COVID-19 rapid antigen test plays a crucial role in managing the COVID-19 pandemic by diagnosing COVID-19 infection. However, the sensitivity and specificity of rapid antigen tests are not known because there are no adequate studies to substantiate. While PCR-tests are considered as the gold standard assay to confirm infection with the SARS-CoV-2 infection because of their sensitivity as well as specificity, antigen tests offer more advantages in terms of low cost, time, space constraints and personnel involved and are implemented in testing strategies around the world and antigen testing can be deployed for testing many individuals, considering their advantages cited above. Objectives: The aim of this study was to assess the diagnostic accuracy (sensitivity, specificity, positive predictive value and negative predictive value) of STANDARD Q rapid antigen test kit in diagnosing SARS-CoV-2 infection in a tertiary care testing facility and compare it with the standard RT- PCR test. Methods: The patients reporting to COVID-19 sample collection center of the tertiary care testing facility were included in the study after getting proper consent. A total of 400 patients were involved in the study. Nasopharyngeal swabs were obtained from the study participants and the STANDARD Q rapid antigen test was run in parallel with real-time PCR tests and both the results were documented. Results: Among the 400 patients who were included in the study, RT-PCR was positive in 95 individuals, with a prevalence of 23.75% and negative in 305 patients (76.25%). The sensitivity of the rapid antigen test was 88.4% and the specificity was 100 %. The positive and negative predictive values were 100% and 96.52% respectively. Conclusion: The accuracy of the SARS-CoV-2 STANDARD Q rapid antigen test in diagnosing SARS-CoV-2 infections in a tertiary care testing facility was almost equal when compared with the manufacturer’s data. However they can be used for mass screening purposes considering their ease of use, portability and convenience. The Area under the Curve (AUC) is 0.942 which signifies that the kit can distinguish well between the true positive and true negative.