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 the coronavirus disease 2019 (COVID-19) pandemic there has been an increase of the use of antigen-detection rapid diagnostic tests (Ag-RDT). The performance of Ag-RDT vary greatly between manufacturers and evaluating their analytical limit of detection (LOD) has become high priority. Here we describe a manufacturer-independent evaluation of the LOD of 19 marketed Ag-RDT using live SARS-CoV-2 spiked in different matrices: direct culture supernatant, a dry swab, and a swab in Amies. Additionally, the LOD using dry swab was investigated after 7 days' storage at - 80 °C of the SARS-CoV-2 serial dilutions. An LOD of ≈ 5.0 × 10² pfu/ml (1.0 × 10⁶ genome copies/ml) in culture media is defined as acceptable by the World Health Organization. Fourteen of 19 Ag

SUBMITTER: Cubas-Atienzar AI 

PROVIDER: S-EPMC8443584 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature