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

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 RT-PCR as a reference method. Clinical sensitivity was evaluated by using respiratory specimens collected from confirmed COVID-19 patients. Results: The LOD results showed that the RAD kit was 100 fold less sensitive than RT-PCR. Clinical sensitivity of the RAD kit was 68.6 % for detecting specimens 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.

Automated summary

The Panbio COVID-19 Ag Rapid Test Device showed lower sensitivity compared to RT-PCR, with a clinical sensitivity of 68.6% for detecting specimens from COVID-19 patients. It shared similar performance with another kit from the WHO Emergency Use List, the Standard Q COVID-19 Ag, indicating the importance of understanding the clinical characteristics of RAD kits for guiding testing strategies in different settings.