Performance evaluation of sd biosensor- standard q covid-19 ag test in comparison with rt- pcr assay from a testing site in India

Background: The current gold standard for the detection of SARS-CoV-2 is the RT-PCR test. The RT-PCR tests are not rapid (it typically takes 3–4 h for results), and it requires specialized laboratory equipment and skilled technicians. Timely and accurate COVID-19 testing is an essential part for surveillance. The aim of the study is to assess diagnostic accuracy of CE-approved POCT, the STANDARD Q COVID19 Ag for the detection of SARS CoV-2 nucleoprotein in NP swabs in comparison with the gold standard RT-PCR. Methods: RT-PCR (EURO Real Time SARS-CoV-2 RT PCR test) and Rapid Antigen testing (STANDARD Q COVID-19 Ag test) was performed following manufactures instructions. Results: The STANDARD Q COVID-19 Ag Test showed a sensitivity of 97.11% and a specificity of 100%. There were no Invalid Test results while using Standard Q Covid-19 AgTest. Conclusion: The rapid test provided comparable results with RT- PCR in terms of sensitivity, specificity, accuracy, negative and positive predictive values