Limit of detection in different matrices of 19 commercially available rapid antigen tests for the detection of SARS-CoV-2

Abstract In the context of coronavirus disease 2019 (COVID-19) pandemic there has been an increase use antigen-detection rapid diagnostic tests (Ag-RDT). The performance Ag-RDT vary greatly between manufacturers and evaluating their analytical limit detection (LOD) become high priority. Here we describe a manufacturer-independent evaluation LOD 19 marketed using live SARS-CoV-2 spiked in different matrices: direct culture supernatant, dry swab, swab Amies. Additionally, was investigated after 7 days’ storage at ? 80 °C serial dilutions. An ? 5.0 × 10 2 pfu/ml (1.0 6 genome copies/ml) media is defined as acceptable by World Health Organization. Fourteen Ag-RDTs (ActiveXpress, Espline, Excalibur, Innova, Joysbio, Mologic, NowCheck, Orient, PanBio, RespiStrip, Roche, Standard-F, Standard-Q Sure-Status) exceeded this criteria supernatant applied to Ag-RDT. Six were not compatible with Amies decreased sensitivity 20-fold observed for eleven on stored dilutions days. Here, provide data guide appropriate test sample type selection future evaluations.