tetano
Editor, Senior Moderator
Sci Rep
. 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[SUP] 1 [/SUP], Konstantina Kontogianni[SUP] 2 [/SUP], Thomas Edwards[SUP] 2 [/SUP], Dominic Wooding[SUP] 2 [/SUP], Kate Buist[SUP] 2 [/SUP], Caitlin R Thompson[SUP] 2 [/SUP], Christopher T Williams[SUP] 2 [/SUP], Edward I Patterson[SUP] 3 4 [/SUP], Grant L Hughes[SUP] 3 [/SUP], Lisa Baldwin[SUP] 2 [/SUP], Camille Escadafal[SUP] 5 [/SUP], Jilian A Sacks[SUP] 5 [/SUP], Emily R Adams[SUP] 2 [/SUP]
Affiliations
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 × 10[SUP]2[/SUP] pfu/ml (1.0 × 10[SUP]6[/SUP] 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.
. 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[SUP] 1 [/SUP], Konstantina Kontogianni[SUP] 2 [/SUP], Thomas Edwards[SUP] 2 [/SUP], Dominic Wooding[SUP] 2 [/SUP], Kate Buist[SUP] 2 [/SUP], Caitlin R Thompson[SUP] 2 [/SUP], Christopher T Williams[SUP] 2 [/SUP], Edward I Patterson[SUP] 3 4 [/SUP], Grant L Hughes[SUP] 3 [/SUP], Lisa Baldwin[SUP] 2 [/SUP], Camille Escadafal[SUP] 5 [/SUP], Jilian A Sacks[SUP] 5 [/SUP], Emily R Adams[SUP] 2 [/SUP]
Affiliations
- PMID: 34526517
- PMCID: PMC8443584
- DOI: 10.1038/s41598-021-97489-9
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 × 10[SUP]2[/SUP] pfu/ml (1.0 × 10[SUP]6[/SUP] 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.