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

CubasAtienzar, Ana, Kontogianni, Konstantina, Edwards, Thomas, Wooding, Dominic, Buist, Kate, Thompson, Caitlin, Williams, Chris, Patterson, Ian ORCID:, Hughes, Grant ORCID:, Baldwin, Lisa, Escadafal, Camille, Sacks, Jilian and Adams, Emily ORCID: (2021) 'Limit of detection in different matrices of 19 commercially available rapid antigen tests for the detection of SARS-CoV-2'. Scientific Reports, Vol 11, Issue 1, p. 18313.

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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.

Item Type: Article
Subjects: QW Microbiology and Immunology > Antigens and Antibodies. Toxins and Antitoxins > QW 573 Antigens
WA Public Health > Preventive Medicine > WA 110 Prevention and control of communicable diseases. Transmission of infectious diseases
WA Public Health > WA 20.5 Research (General)
WC Communicable Diseases > Virus Diseases > Viral Respiratory Tract Infections. Respirovirus Infections > WC 505 Viral respiratory tract infections
Faculty: Department: Biological Sciences > Department of Tropical Disease Biology
Biological Sciences > Vector Biology Department
Digital Object Identifer (DOI):
Depositing User: Stacy Murtagh
Date Deposited: 20 Sep 2021 15:21
Last Modified: 20 Sep 2021 15:21


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