Diagnostic Accuracy of Rapid Antigen Tests for SARS-CoV-2 Approved for Use in China

Abstract

Rapid antigen tests (RATs), a simple, inexpensive test that can be performed at home by residents, have been widely used in COVID-19 diagnosis around the world. Until 29th April 2022, the Chinese National Medical Products Administration (CNMPA) has approved a total of 31 items of RAT products. Review the existing research evaluating the diagnostic accuracy of CNMPA-approved RATs, then collect the raw data of included texts, calculate the sensitivity and specificity in each study, and compare them with these two aspects to provide optimal choice for RAT used in real-life practice. Using the Cochrane and WHO COVID-19 databases, studies with full texts published between 2020-2022 were included if they aimed detection for SARS-CoV-2 infection, had CNMPA-approved RAT for index testing and compared with RT-PCR results. Studies were excluded if they failed to provide primary data for accuracy testing or the data provided did not allow the calculation of sensitivity or specificity. No language restrictions were applied in this review, and all study designs that provided diagnostic accuracy data were accepted. Results: 22 studies were included in this review. All CNMPA-approved RATs included in the review performed well in diagnostic specificity except for four individual studies. However, the sensitivity of CNMPA-approved RATs varied widely among different RATs and different studies. The two worst sensitivity-performing RATs were Savant and LEPU, while the best was Wondfo.