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. 2022 Nov 23;14(12):2609.
doi: 10.3390/v14122609.

Comparison of a Prototype SARS-CoV-2 Lateral Flow IMMUNOASSAY with the BinaxNOWTM COVID-19 Antigen CARD

Haydon J Hill  1 , Timsy Uppal  1 , Derrick Hau  1 , Sujata G Pandit  1 , Jose Arias-Umana  1 , Abigail J Foster  1 , Andrew Gorzalski  2 , Kathryn J Pflughoeft  3 , Amanda R Burnham-Marusich  3 , Dana E Reed  1 , Marcellene A Gates-Hollingsworth  1 , Lynette Gumbleton  2 , Subhash C Verma  1 , David P AuCoin  1   3
Affiliations

Comparison of a Prototype SARS-CoV-2 Lateral Flow IMMUNOASSAY with the BinaxNOWTM COVID-19 Antigen CARD

Haydon J Hill et al. Viruses. .

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus responsible for the COVID-19 pandemic. From the onset of the pandemic, rapid antigen tests have quickly proved themselves to be an accurate and accessible diagnostic platform. The initial (and still most commonly used antigen tests) for COVID-19 diagnosis were constructed using monoclonal antibodies (mAbs) specific to severe acute respiratory syndrome coronavirus (SARS-CoV) nucleocapsid protein (NP). These mAbs are able to bind SARS-CoV-2 NP due to high homology between the two viruses. However, since first being identified in 2019, SARS-CoV-2 has continuously mutated, and a multitude of variants have appeared. These mutations have an elevated risk of leading to possible diagnostic escape when using tests produced with SARS-CoV-derived mAbs. Here, we established a library of 18 mAbs specific to SARS-CoV-2 NP and used two of these mAbs (1CV7 and 1CV14) to generate a prototype antigen-detection lateral flow immunoassay (LFI). A side-by-side analysis of the 1CV7/1CV14 LFI and the commercially available BinaxNOWTM COVID-19 Antigen CARD was performed. Results indicated the 1CV7/1CV14 LFI outperformed the BinaxNOWTM test in the detection of BA.2, BA.2.12.1, and BA.5 Omicron sub-variants when testing remnant RT-PCR positive patient nasopharyngeal swabs diluted in viral transport media.

Keywords: COVID-19; SARS-CoV-2; antigen assays; lateral flow immunoassay (LFI); monoclonal antibodies (mAb).

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Conflict of interest statement

Amanda R. Burnham-Marusich and David P. AuCoin are shareholders of DxDiscovery, Inc. The remaining authors have no conflict of interest to declare.

Figures

Figure 1
Figure 1
Schematic illustrating positive and negative LFI readings. Additionally, the performance of 1CV7/1CV14 LFI in comparison with BinaxNOWTM for the detection of SARS-CoV-2 variants at 500 TCID50/test. A control matrix with known amounts of live SARS-CoV-2 virus was loaded onto the 1CV7/1CV14 LFI as well as the BinaxNOWTM test in triplicates. Signals were recorded through visual inspection of the test lines.
Figure 2
Figure 2
Analytical sensitivities of 1CV7/1CV14 LFI in comparison with BinaxNOWTM for the detection of both Delta (A) and Omicron BA.1 (B) variants. A control matrix with known amounts of live SARS-CoV-2 virus of the respective variant was loaded onto the 1CV7/1CV14 LFI as well as the BinaxNOWTM test in triplicate. Signals were recorded through visual inspection of the test lines.
Figure 3
Figure 3
Sensitivities of the 1CV7/1CV14 LFI and BinaxNOWTM in detecting Omicron (BA.1) variant in clinical samples.
Figure 4
Figure 4
Sensitivities of 1CV7/1CV14 LFIs in comparison with BinaxNOWTM for the detection of Omicron BA.2 (A) and BA.2.12.1 (B).
Figure 5
Figure 5
Sensitivities of 1CV7/1CV14 LFIs in comparison with BinaxNOWTM for the detection of Omicron BA.4 (A) and BA.5 (B).
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