Evaluation of three rapid lateral flow antigen detection tests for the diagnosis of SARS-CoV-2 infection

Jääskeläinen, AE; Ahava, MJ; Jokela, P; Szirovicza, L; Pohjala, S; Vapalahti, O; Lappalainen, M; Hepojoki, J; Kurkela, S

INTRODUCTION: The COVID-19 pandemic has led to high demand of diagnostic tools. Rapid antigen detection tests have been developed and many have received regulatory acceptance such as CE IVD or FDA markings. Their performance needs to be carefully assessed. MATERIALS AND METHODS: 158 positive and 40 negative retrospective samples collected in saline and analyzed by a laboratory-developed RT-PCR test were used to evaluate Sofia (Quidel), Standard Q (SD Biosensor), and Panbioâ„¢ (Abbott) rapid antigen detection tests (RADTs). A subset of the specimens was subjected to virus culture. RESULTS: The specificity of all RADTs was 100% and the sensitivity and percent agreement was 80% and 85% for Sofia, 81% and 85% for Standard Q, and 83% and 86% for Panbioâ„¢, respectively. All three RADTs evaluated in this study reached a more than 90% sensitivity for samples with a high viral load as estimated from the low Ct (Cycle threshold) values in the reference RT-PCR. Virus culture was successful in 80% of specimens with a Ct value <25. CONCLUSIONS: As expected, the RADTs were less sensitive than RT-PCR. However, they benefit from the speed and ease of testing, and lower price as compared to RT-PCR. Repeated testing in appropriate settings may improve the overall performance.