It has been nearly three years since the first COVID-19 case was found in Wuhan, China in December 2019 [1,2].The coronavirus disease 2019(COVID-19), also known as Severe Acute Respiratory Syndrome Coronavirus-2(SARS-COV-2), has become a global pandemic disease.It has a profound impact on the health systems around the world, and requires national governments to take appropriate prevention and control measures against COVID-19. Rapid and accurate detection of COVID-19 cases is a prerequisite to prevent the further spread of COVID-19 and timely treatment of infected persons.Initially, the World Health Organization (WHO) recommended the gold standard for viral RNA detection of SARS-COV-2,probe-based Reverse Transcriptasequantitative polymerase chain reaction (RT-qPCR) [3], [4], [5].However, RT-qPCR requires specialized space, professional equipment, trained sample collection personnel and operators, and longer detection cycles [6].

The Antigen-detection rapid diagnostic tests(Ag-RDTs) take much less time than RT-qPCR, and they do not need to be performed in a special laboratory, making them very convenient to use [7,8].The World Health Organization recommends that Ag-RDTs with at least 80 % sensitivity and 97 % specificity can be used for diagnosis [8].In response to the growing number of patients, countries have developed Ag-RDTs.In May 2020, SARS-CoV-2 Ag-RDTs were approved by the U. S. Food and Drug Administration (FDA) to improve quarantine strategies worldwide [9].A number of Ag-RDTs have been marketed in Bangladesh, Malaysia, Ethiopia for clinical evaluation, and have shown good specificity and sensitivity [6,9,10].

With the spread of SARS-COV-2,we have faced several variants of concern(VOCs), such as Alpha, Beta, Gamma, Delta, and now Omicron [11,12].The national epidemic prevention policy has also changed with the change of the COVID-19 variant, and the clinical demand for rapid antigen detection kits with certain sensitivity and specificity alone has increased.People also need to test for COVID-19 in the community to reduce the risk of cross-infection. In this study, a new antigen detection kit developed by us was clinically evaluated to address the need of a large number of people for easier and faster COVID-19 testing.