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Comparative Study
. 2021 Sep 15;11(1):18313.
doi: 10.1038/s41598-021-97489-9.

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

Ana I Cubas-Atienzar  1 , Konstantina Kontogianni  2 , Thomas Edwards  2 , Dominic Wooding  2 , Kate Buist  2 , Caitlin R Thompson  2 , Christopher T Williams  2 , Edward I Patterson  3   4 , Grant L Hughes  3 , Lisa Baldwin  2 , Camille Escadafal  5 , Jilian A Sacks  5 , Emily R Adams  2
Affiliations
Comparative Study

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

Ana I Cubas-Atienzar et al. Sci Rep. .

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-RDTs (ActiveXpress, Espline, Excalibur, Innova, Joysbio, Mologic, NowCheck, Orient, PanBio, RespiStrip, Roche, Standard-F, Standard-Q and Sure-Status) exceeded this performance criteria using direct culture supernatant applied to the Ag-RDT. Six Ag-RDT were not compatible with Amies media and a decreased sensitivity of 2 to 20-fold was observed for eleven tests on the stored dilutions at - 80 °C for 7 days. Here, we provide analytical sensitivity data to guide appropriate test and sample type selection for use and for future Ag-RDT evaluations.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Heatmap of the LODs on all matrices. Ag-RDTs in direct culture matrix colored blue fulfilled WHO criteria. Note: no colored cells for direct culture indicates no Ag-RDT was tested with that matrix, no colored cells in swab in Amies swab means interference with that matrix, hence LOD is not available.
See this image and copyright information in PMC

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