Evaluation of rapid antigen detection kit from the WHO Emergency Use List for detecting SARS-CoV-2

Mak, Gannon C.K.; Lau, Stephen S.Y.; Wong, Kitty K.Y.; Chow, Nancy L.S.; Lau, C.S.; Lam, Edman T.K.; Chan, Rickjason C.W.; Tsang, Dominic N.C.

BACKGROUND: Currently, there are two rapid antigen detection (RAD) kits from the WHO Emergency Use List for detecting SARS-CoV-2. OBJECTIVE: The Panbio COVID-19 Ag Rapid Test Device was selected to evaluate the performance for detecting SARS-CoV-2. STUDY DESIGN: Analytical sensitivity for the detection of SARS-CoV-2 virus was determined by limit of detection (LOD) using PCR as a reference method. Clinical sensitivity was evaluated by using respiratory samples collected from confirmed COVID-19 patients. RESULTS: The LOD results showed that the RAD kit was 100 fold less sensitive than RTPCR. Clinical sensitivity of the RAD kit was 68.6% for detecting samples from COVID-19 patients. CONCLUSIONS: The RAD kit evaluated in the present study shared similar performance with another kit from the WHO Emergency Use List, the Standard Q COVID-19 Ag. Understanding the clinical characteristics of RAD kits can guide us to decide different testing strategies in different settings.